Market Research for the Pharmaceutical Benefits Schedule ...File/market-research-report-09-2016.pdf · Market Research for the Pharmaceutical Benefits Schedule (PBS) and Biosimilar

Market Research for the Pharmaceutical Benefits Schedule (PBS) and Biosimilar Medicines Quantitative – Report

Market Research for the PBS and Biosimilar Medicines: December 2016

Copyright

© 2016 Commonwealth of Australia as represented by the Department of Health

This work is copyright. You may copy, print, download, display and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation:

do not use the copy or reproduction for any commercial purpose; and

retain this copyright notice and all disclaimer notices as part of that copy or reproduction.

Apart from rights as permitted by the Copyright Act 1968 (Cth) or allowed by this copyright notice, all other rights are reserved, including (but not limited to) all commercial rights.

Requests and inquiries concerning reproduction and other rights to use are to be sent to the Communication Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected].

mailto:[email protected]

2016 ORC International PBS and biosimilar medicines:

Page 3 of 137

Sponsor: National Medicines Policy Section Department of Health Australian Government

Authors: Shannon Coughlin

ORC International Ref: 3000290 Report Level 8, 171 La Trobe Street Melbourne Vic 3000 Australia www.ORCInternational.com

Version: 1.0

Release Date: December 2016

http://www.orcinternational.com/


Page 4 of 137

Contents

Contents 4

1 Executive Summary 10

1.1 Professional stakeholders 10

1.2 Consumers 12

1.3 Conclusions and recommendations 13

2 Introduction 18

3 Objectives 19

4 Methodology 20

4.1 Quantitative benchmark research 20

4.2 Profile of target audiences 22

4.3 Reporting conventions 27

5 Key Findings: Professional Stakeholders 29

5.1 About this chapter 29

5.2 Familiarity with biologic and biosimilar medicines 29

5.3 Prevalence of prescribing/dispensing biologic and biosimilar medicines 33

5.4 Sources of awareness: biologic and biosimilar medicines 34

5.5 Advantages and disadvantages of biosimilars 43

5.6 Confidence in prescribing/dispensing biosimilar medicines 51

5.7 Intention to switch/use/accept biosimilar medicines 73

5.8 Understanding of the PBS 80

6 Key Findings Consumers 84

6.1 About this chapter 84

6.2 Familiarity with biologic and biosimilar medicines 85

6.3 Prevalence of use of biologic and biosimilar medicines 88

6.4 Sources of awareness: biologic and biosimilar medicines 89

6.5 Advantages and disadvantages of biosimilar medicines 96

6.6 Confidence in taking biosimilar medicines 100

6.7 Intention to switch/use/accept biosimilar medicines 118


Page 5 of 137

6.8 Understanding of the PBS 122

7 Conclusions & Recommendations 126

7.1 Professional stakeholders 127

7.2 Consumers 130

Appendix A: Specialist questionnaire 131

Appendix B: GP questionnaire 146

Appendix C: Pharmacist questionnaire 160

Appendix D: Consumer questionnaire 175


Page 6 of 137

Table of Figures

Figure 1: Specialist overview diagram .................................................................................................. 14

Figure 2: GP overview diagram ............................................................................................................ 15

Figure 3: Pharmacist overview diagram ................................................................................................ 16

Figure 4: Consumer overview diagram ................................................................................................. 17

Figure 5: Years of experience ............................................................................................................... 22

Figure 6: Location ................................................................................................................................. 23

Figure 7: Capital city or regional location .............................................................................................. 23

Figure 8: Area of specialisation ............................................................................................................. 24

Figure 9: Length of time since diagnosis .............................................................................................. 24

Figure 10: Location ............................................................................................................................... 25

Figure 11: Capital city or regional location ............................................................................................ 25

Figure 12: Associated conditions - patients .......................................................................................... 26

Figure 13: Associated conditions - carers ............................................................................................. 26

Figure 14: Type of person cared for - carers ........................................................................................ 27

Figure 15: Familiarity with biologic medicines....................................................................................... 30

Figure 16: Familiarity with biologic medicines – sub group differences ................................................ 30

Figure 17: Familiarity with biosimilar medicines.................................................................................... 31

Figure 18: Familiarity with biosimilar medicines – sub group differences ............................................. 31

Figure 19: Familiarity with biologic and biosimilar medicines - comparison ......................................... 32

Figure 20: Prescribed/dispensed biologic or biosimilar medicines ....................................................... 33

Figure 21: Prescribed/dispensed biologic or biosimilar medicines – sub group differences ................ 33

Figure 22: All sources of awareness biologic medicines – sub group differences ............................... 36

Figure 23: All sources of awareness biosimilar medicines – sub group differences ............................ 39

Figure 24: Barriers and benefits of biosimilar medicines ...................................................................... 43

Figure 25: Barriers and benefits of biosimilar medicines – sub group differences ............................... 44

Figure 26: Barriers to prescribing/dispensing biosimilar medicines – sub group differences ............... 46

Figure 27: Benefits to prescribing/dispensing biosimilar medicines – sub group differences .............. 49

Figure 28: Unprompted confidence prescribing/dispensing biosimilar medicines ................................ 51

Figure 29: Unprompted confidence prescribing/dispensing biosimilar medicines – sub group differences ............................................................................................................................................. 51

Figure 30: Prompted confidence prescribing/dispensing biosimilar medicines .................................... 53

Figure 31: Prompted confidence prescribing/dispensing biosimilar medicines – sub group differences .............................................................................................................................................................. 53


Page 7 of 137

Figure 32: Unprompted and prompted confidence prescribing/dispensing biosimilar medicines - comparison ............................................................................................................................................ 54

Figure 33: Confidence in efficacy of biosimilar medicines .................................................................... 55

Figure 34: Confidence in efficacy of biosimilar medicines – sub group differences ............................. 55

Figure 35: Confidence in comparability of biosimilar medicines ........................................................... 56

Figure 36: Confidence in comparability of biosimilar medicines – sub group differences .................... 56

Figure 37: Confidence in the efficacy and comparability of biosimilar medicines - comparison ........... 58

Figure 38: Comfort prescribing/dispensing biologic medicines ............................................................. 59

Figure 39: Colleague recommendation ................................................................................................. 60

Figure 40: Biosimilars and confidence in Australia’s regulatory processes .......................................... 61

Figure 41: Biosimilars and medication access programs ..................................................................... 62

Figure 42: Biosimilars are essentially the same as generic medicines ................................................ 63

Figure 43: Awareness of PBACs decision making processes .............................................................. 64

Figure 44: Impact of biosimilars ............................................................................................................ 65

Figure 45: Biosimilars and biologic-naive patients ................................................................................ 66

Figure 46: Biosimilars and biologic-stable patients ............................................................................... 67

Figure 47: Biosimilars and cost-effectiveness....................................................................................... 68

Figure 48: Biosimilars and sustainability of the PBS ............................................................................ 69

Figure 49: Attitudes to biosimilar medicines – specialist sub group differences ................................... 69

Figure 50: Attitudes to biosimilar medicines – GPs sub group differences .......................................... 71

Figure 51: Attitudes to biosimilar medicines – Pharmacists sub group differences.............................. 72

Figure 52: Confidence switching a patient ............................................................................................ 73

Figure 53: Confidence switching a patient – sub group differences ..................................................... 73

Figure 54: Confidence counselling a patient ......................................................................................... 74

Figure 55: Confidence counselling a patient – sub group differences .................................................. 75

Figure 56: Feelings about substitution - detail ...................................................................................... 76

Figure 57: Feelings about substitution - summary ................................................................................ 77

Figure 58: Feelings about substitution – sub group differences ........................................................... 77

Figure 59: Confidence in medicine regulation....................................................................................... 80

Figure 60: Confidence in medicine regulation – sub group differences ................................................ 80

Figure 61: Need to increase understanding of the PBS ....................................................................... 81

Figure 62: Need to increase understanding of the PBS – sub group differences ................................. 81

Figure 63: Familiarity with biologic medicines....................................................................................... 85

Figure 64: Familiarity with biologic medicines – sub group differences ................................................ 85


Page 8 of 137

Figure 65: Familiarity with biosimilar medicines.................................................................................... 86

Figure 66: Familiarity with biosimilar medicines – sub group differences ............................................. 86

Figure 67: Familiarity with biologic and biosimilar medicines - comparison ......................................... 87

Figure 68: Used biologic or biosimilar medicines.................................................................................. 88

Figure 69: Used biologic or biosimilar medicines – sub group differences ........................................... 88

Figure 70: All sources of awareness of biologic medicines – sub group differences ........................... 90

Figure 71: All sources of awareness of biosimilar medicines – sub group differences ........................ 93

Figure 72: Barriers and benefits of biosimilar medicines ...................................................................... 96

Figure 73: Barriers and benefits to taking biosimilar medicines – sub group differences .................... 96

Figure 74: Potential benefits to taking biosimilar medicines – sub group differences .......................... 99

Figure 75: Unprompted confidence taking biosimilar medicines ........................................................ 100

Figure 76: Unprompted confidence taking biosimilar medicines – sub group differences ................. 100

Figure 77: Unprompted and prompted confidence taking biosimilar medicines - comparison ........... 101

Figure 78: Prompted confidence taking biosimilar medicines – sub group differences ...................... 101

Figure 79: Confidence in effectiveness of biosimilar medicines ......................................................... 102

Figure 80: Confidence in effectiveness of biosimilar medicines – sub group differences .................. 102

Figure 81: Confidence in comparability of biosimilar medicines ......................................................... 103

Figure 82: Confidence in comparability of biosimilar medicines – sub group differences .................. 103

Figure 83: Confidence in the effectiveness and comparability of biosimilar medicines - comparison 104

Figure 84: Comfort with biologic medicines ........................................................................................ 105

Figure 85: Other people’s recommendation ........................................................................................ 106

Figure 86: Biosimilars and confidence in Australia’s regulatory processes ........................................ 107

Figure 87: Biosimilars and medication access programs ................................................................... 108

Figure 88: Biosimilars are essentially the same as generic medicines .............................................. 109

Figure 89: Awareness of PBACs decision making processes ............................................................ 110

Figure 90: Impact of biosimilars .......................................................................................................... 111

Figure 91: Biosimilar medicine consideration ..................................................................................... 112

Figure 92: Biosimilars and biologic-treatment stable .......................................................................... 113

Figure 93: Biosimilars and cost-effectiveness..................................................................................... 114

Figure 94: Biosimilars and sustainability of the PBS .......................................................................... 115

Figure 95: Biosimilar medicine recommended by doctor .................................................................... 116

Figure 96: Attitudes to biosimilar medicines – sub group differences ................................................ 116

Figure 97: Confidence switching ......................................................................................................... 118

Figure 86: Confidence switching – sub group differences .................................................................. 118


Page 9 of 137

Figure 99: Feelings about substitution - detail .................................................................................... 119

Figure 100: Feelings about substitution - summary ............................................................................ 120

Figure 101: Feelings about substitution – sub group differences ....................................................... 120

Figure 102: Confidence in medicine regulation .................................................................................. 122

Figure 103: Confidence in medicine regulation – sub group differences ............................................ 122

Figure 104: Need to increase understanding of the PBS ................................................................... 123

Figure 105: Specialist overview diagram ............................................................................................ 127

Figure 106: GP overview diagram ...................................................................................................... 128

Figure 107: Pharmacist overview diagram .......................................................................................... 129

Figure 108: Consumer overview diagram ........................................................................................... 130

List of Tables

Table 1: Fieldwork dates ....................................................................................................................... 21

Table 2: Response rates ....................................................................................................................... 21

Table 3: Sources of awareness of biologic medicines .......................................................................... 35

Table 4: Sources of awareness of biosimilar medicines ....................................................................... 37

Table 5: Sources of awareness of biologic and biosimilar medicines - comparison ............................. 41

Table 6: Potential barriers to prescribing/dispensing biosimilar medicines .......................................... 45

Table 7: Potential benefits to prescribing/dispensing biosimilar medicines .......................................... 48

Table 8: Additional comments about biosimilar medicines ................................................................... 78

Table 9: Information the Australian Government Department of Health should communicate to increase understanding of the PBS ...................................................................................................... 82

Table 10: Sources of awareness of biologic medicines ........................................................................ 89

Table 11: Sources of awareness of biosimilar medicines ..................................................................... 91

Table 12: Sources of awareness of biologic and biosimilar medicines – comparison .......................... 94

Table 13: Potential barriers to taking biosimilar medicines ................................................................... 97

Table 14: Potential benefits to taking biosimilar medicines .................................................................. 98

Table 15: Additional comments about biosimilar medicines ............................................................... 121

Table 16: Information the Australian Government Department of Health should communicate to increase understanding of the PBS .................................................................................................... 124


Page 10 of 137

1 Executive Summary 1.1 Professional stakeholders Professionals had much higher levels of knowledge of biologic medicines than biosimilar medicines (no doubt due to the relatively recent introduction of the latter into the market). Levels of knowledge of both types of medicine were considerably lower among GPs compared with specialists and pharmacists.

Knowledge of the two types of medicine are highly correlated (in all three professions). Knowledge is also a key driver in confidence in prescribing/dispensing both; and in switching patients from a reference biologic to the biosimilar medicine.

Specialists and pharmacists were significantly more likely to have prescribed/dispensed biologic medicines than biosimilar medicines. However, GPs were equally likely to prescribe both biologic and biosimilar medicines.

Comparison of the results across the two types of medicine, and between the different professions, highlights the fact that levels of prescribing biosimilars among specialists are relatively low (in light of their very high use of biologics). This is likely to be a function of specialists’ concerns about comparability, their reluctance to switch a patient who is stable on a biologic (as described later), and the limited number of biosimilar medicines listed on the PBS.

Sources of biosimilar medicine knowledge varied between groups. Specialists tended to have been informed by academic channels and word of mouth; pharmacists relied more on Continuing Professional Development (CPD) and the National Prescribing Service (NPS); whereas GPs were more likely to have found out about biosimilars online and through media (including social media).

All professional stakeholders were more likely to see potential benefits to prescribing biosimilar medicines than potential barriers. Notably, even stakeholders who saw barriers to prescribing/dispensing biosimilar medicines were nevertheless likely to also see benefits to doing so. Notwithstanding, a considerable proportion of the sample perceived potential barriers.

The relative importance of perceived barriers varied between professions. Specialists and GPs were more likely than pharmacists to raise concerns over patient outcomes. Pharmacists, on the other hand, were twice as likely as the other groups to mention cost-related barriers; particularly the lack of patient incentives. GPs saw the largest barrier as being lack of information, and specifically insufficient information on biosimilar medicines for prescribers.

The most commonly reported perceived benefit was a financial one; with GPs being somewhat less likely to report this than the other two professions. GPs were, on the other hand, more likely to see patient outcomes as an important advantage of biosimilars (notably a relatively small number of specialists mentioned patient outcome benefits).

As well as prioritising the benefits of cost savings, pharmacists were (relative to the other two audiences) comparatively more likely to mention the fact that biosimilars mitigate against medicine shortages.

Pharmacists and specialists tended to be confident in dispensing/prescribing biosimilars; while GPs had the lowest confidence levels.

Importantly, even a minimal amount of information on biosimilar medicine (in the form of a definition presented part-way through the online survey) had an impact on reported confidence levels;


Page 11 of 137

particularly among GPs. This suggests that a targeted and informative communication initiative is likely to have significant impact on confidence levels among the research audiences.

Levels of confidence in the comparability between biosimilar medicine and the reference medicine varied. Pharmacists were the most confident in comparability and GPs the least. Familiarity with biosimilar medicine was positively associated with confidence – the more knowledge about biosimilar medicine, the greater the confidence in comparability with the reference medicine.

Despite high levels of confidence and knowledge around biosimilar medicine, specialists (particularly rheumatologists) expressed concerns about substitution, and were reluctant to switch a biologic treatment-stable patient to the biosimilar medicine; this suggests a degree of intractability which is likely to be impervious to a communications initiative. GPs were also reluctant to switch patients who were doing well on biologics; but this tended to be associated with a lack of sufficient knowledge. Pharmacists were much more open to the idea of substitution.

The majority of pharmacists and specialists were confident in counselling a patient about biosimilar medicines. However, only around a half of GPs felt sufficiently confident to do so. This is an important finding, given that GPs were highlighted by consumers as their most important source of information about biosimilar medicine (as described below).

All professional stakeholder audiences raised the need for more information, education and marketing about biosimilar medicines. This highlights the fact that the Department’s forthcoming communication initiative will fill an important and identified information gap, and should, therefore, be well received by stakeholders

In developing its communications initiative, the Department should be mindful of the most common barriers to prescribing/dispensing biosimilars, as well as promoting the benefits that are in the mindset of prescribers/dispensers who are more confident about biosimilar medicines. For stakeholder communications, the specific issues that could be addressed include;

• Evidence to support indication extrapolation

• Immunogenicity concerns

• Strength of pharmacovigilance activities

• If possible, reducing concerns about the delay of biosimilar medicines due to legal/ international patent issues

• The reasons why it is important to change what is prescribed/dispensed – to temper the expectation that biosimilar medicines will offer reduced price (or some other incentive) for patients.

Further, the Department may consider highlighting benefits such as...

• Saving the taxpayer money

• Enables more medicines to be listed on the PBS

• Improved affordability for hospitals

• Mitigates against medicine shortages.

Also important in developing the initiative is being mindful of the common attitudes held by professionals who felt confident prescribing/dispensing biosimilar medicines:

• They were generally comfortable prescribing biologic medicines to their patients


Page 12 of 137

• They would prescribe a biosimilar medicine to their patients because they are confident in Australia’s regulatory processes

• They believed that biosimilar medicines are essentially the same as generic medicines

• They were aware of the PBAC’s decision making processes for the subsidy of medicines

• They believed that biosimilar medicines will lead to a reduction in costs and therefore increase the sustainability of the PBS.

The Department should consider promotion of these messages within the initiative.

1.2 Consumers Familiarity among consumers was lower for biosimilar medicine than biologic medicine; and, as with professionals, awareness of the two types of medicine was correlated.

Consumers with conditions other than diabetes or arthritis, were most likely to be aware of biosimilar medicine; as were those from capital cities.

Use of biosimilar medicine and biologic medicine was at similar levels - around a third of consumers (16% previously and 16% currently). Over a quarter of consumers, however, did not know what type of drugs they used/had used. Biosimilar medicines were more likely to be taken by consumers with ‘other conditions’ and by those who had previously been on a biologic medicine.

Provider channels were the most common source of information for consumers. GPs were a particularly important source of information; revealing a notable disparity in that GPs were the profession who felt least confident in counselling patients (as described above). This also suggests that communication targeted at providers – particularly GPs – will have the associated impact of informing and communicating with consumers. Information found online was also a frequently mentioned source for consumers.

Consumers were more likely to see potential benefits to taking biosimilar medicines than potential barriers. However more than half did not know if there were barriers or benefits.

Consumers had greatest concern around patient outcomes overall, and considered the largest barrier to be ‘concern about personal adverse outcomes’; followed by ‘concern about having a fail and this counting against me in terms of PBS subsidised access to biologic medicines in the future’. Two in five consumers raised information-related concerns.

In terms of benefits, consumers were most likely to mention price-related advantages, particularly that biosimilar medicines would be ‘more affordable for patients’, ‘lower prices through competition’, and ‘enables more medicines to be listed on the PBS’. Consumers also highlighted patient outcomes benefits, particularly around treatment choice.

Three in five consumers were confident in taking biosimilar medicines. Conversely, nearly two fifths reported that they were not confident. Notably, familiarity with biosimilar medicine was positively associated with confidence; once more highlighting the importance of knowledge.

Importantly, even a minimal amount of information on biosimilar medicine (in the form of a definition presented part-way through the online survey) had an impact on reported confidence levels. As with professionals, this points to a significant impact resulting from a communication initiative (even if it is indirect impact; through communications with providers).

Levels of confidence in the comparability of biosimilar medicine and the reference brand were relatively high among consumers (almost seven in ten).


Page 13 of 137

The results highlight the importance of GPs and specialists in the process of education and reassurance of consumers. Seven in ten consumers said that they would accept a biosimilar if recommended by their doctor.

There is a significant opportunity for the Department to build consumer awareness of biologic and biosimilar medicines via its proposed communications initiative. In developing the initiative, the Department should be mindful of the most common barriers to prescribing/dispensing biosimilars, as well as promoting the benefits that are in the mindset of prescribers/dispensers who are more confident about biosimilar medicines.

For consumer communications, the issues that could be addressed include...

• The process that biosimilar medicines need to go through to receive PBS approval

• How a fail will be treated if a biologic-stable patient switches to a biosimilar and has a fail in terms of PBS subsidised access to biologic medicines in the future

• Immunogenicity concerns

• Strength of pharmacovigilance activities

• The reasons why it is important to change what is taken – to temper the expectation that biosimilar medicines will offer reduced prices (or some other incentive) for patients.

Further, the Department may consider highlighting benefits such as...

• Treatment choice

• Advances in medicine technology

• Enables more medicines to be listed on the PBS

• Saving the taxpayer money, and increasing the sustainability of the PBS

• Improved affordability for hospitals

• Mitigates against medicine shortages.

Also important in developing the initiative is being mindful of the common attitudes held by consumers who were confident taking biosimilar medicines and were confident switching to a biosimilar medicine:

• They would accept a biosimilar medicine if recommended by their doctor

• They would accept a biosimilar medicine to their patients because they are confident in Australia’s regulatory processes.

The Department should consider promotion of the thoroughness of Australia’s regulatory processes within the initiative.

1.3 Conclusions and recommendations The diagrams below illustrate the salient issues around biosimilar medicine for professional stakeholders, and how these issues interact with each other (based on the survey results). The diagram also highlights the factors that are most important to highlight in a communication initiative; as well as the recommended channels of dissemination. Given the variation between stakeholders, a separate diagram is presented for each profession. The survey results strongly suggest that GPs are the priority target audience for a communications initiative.


Page 14 of 137

Figure 1: Specialist overview diagram


Page 15 of 137

Figure 2: GP overview diagram


Page 16 of 137

Figure 3: Pharmacist overview diagram


Page 17 of 137

Figure 4: Consumer overview diagram


Page 18 of 137

2 Introduction The Australian Government has committed $20 million over three years (2015-2018) to undertake information and education activities to improve the public understanding of biosimilar medicine. Otherwise known as a biopharmaceutical, a biosimilar is a drug derived or extracted from biological, rather than chemical, sources. A biosimilar medicine is a version of an already registered biological medicine (the reference medicine) that has demonstrable similarity in physiochemical, biological and immunological characteristics, efficacy and safety. The active substances of biological medicines are larger and more complex than those of non-biological medicines. Their complexity, as well as the way they are produced, may result in a degree of variability, particularly between batches of the medicine.

The availability of biosimilar medicines in Australia encourages competition, which could, in turn, lower the price that the government pays for biologic medicine and biosimilar medicine. Lower prices will contribute to the financial sustainability of the Pharmaceutical Benefits Scheme (PBS), provide economic benefits to the wider Australian health care system, and save taxpayers money.


Page 19 of 137

3 Objectives The Department of Health and Ageing (the Department) commissioned ORC International to conduct market research with the following overall objectives:

• To assess attitudes, knowledge and intentions regarding biosimilar medicines, particularly those on the PBS;

• To inform the development of future communication strategies and materials;

• To assess associated understanding and information requirements around the Pharmaceutical Benefits Scheme (PBS).

The aim of the research was to obtain a quantitative baseline measure of awareness, knowledge and intentions around biosimilar medicines.

The Department’s objectives for the quantitative research included obtaining baseline measures for:

• Awareness of biologic and biosimilar medicines and sources of awareness

• Knowledge of biologic and biosimilar medicines

• Attitudes towards biologic and biosimilar medicines, including confidence in their efficacy

• Intention to switch/use/accept biosimilar medicines

• Awareness/knowledge of the PBS.

The findings of research are the subject of this report.


Page 20 of 137

4 Methodology

4.1 Quantitative benchmark research The aim of the quantitative research was to provide a benchmark of current understanding of, attitudes, beliefs, intentions and behaviour towards biosimilar medicines, among the target audiences.

The outcomes of this research will inform the development of future communications strategies and educational materials. The key target audiences for this research are:

• Specialists who are potential prescribers of biologic and biosimilar medicines;

• General practitioners who are potential prescribers of biologic and biosimilar medicines;

• Community pharmacists who are potential dispensers of biologic and biosimilar medicines and advisors to patients; and

• Patients with associated conditions and their carers.

The questionnaires were drafted by ORC International in collaboration with the Department. The final questionnaires were approved by the Department.

The final questionnaires are appended to this report (Appendix A to Appendix D).

A series of screening questions have been included at the start of each survey, to confirm that those invited to participate actually qualify. The relevant screening criteria are:

• Specialists

o Area of specialisation (S1 in the questionnaire)

o Have at least heard of biologic medicines (Q1) and/or biosimilar medicines (Q2). If the respondent had ‘never heard of’ both biologic medicines and biosimilar medicines, they were terminated as they do not qualify to participate (on the basis that they have no understanding of the subject matter). One specialist was terminated.

• General practitioners

o Currently work as a general practitioner (S1)

o Have at least heard of biologic medicines (Q1) and/or biosimilar medicines (Q2). If the respondent had ‘never heard of’ both biologic medicines and biosimilar medicines, they were terminated as they do not qualify to participate (on the basis that they have no understanding of the subject matter). One GP was terminated.

• Community pharmacists

o Have worked in a community pharmacy in the past 12 months (S1)

o Have at least heard of biologic medicines (Q1) and/or biosimilar medicines (Q2). If the respondent had ‘never heard of’ both biologic medicines and biosimilar medicines, they were terminated as they do not qualify to participate (on the basis that they have no understanding of the subject matter). No pharmacists were terminated.

• Patients with associated conditions or their carers

o Patients need to have one of the associated conditions (S1)


Page 21 of 137

o Carers are those who do not have an associated condition personally (S1), but are responsible for the care of a child under 18 with one of the associated conditions, or the care of a close relative with one of these associated conditions who is unable to manage their own healthcare (and therefore the carer attends all medical appointments and are fully informed about medical care) (S2).

o In the case of both patients and carers the respondent needed to have at least heard of biologic medicines (Q1) and/or biosimilar medicines (Q2). If the respondent had ‘never heard of’ both biologic medicines and biosimilar medicines, they were terminated as they do not qualify to participate (on the basis that they have no understanding of the subject matter). Sixty five (65) consumers were terminated.

Fieldwork was conducted from July 25 to August 19, 2016. The table below provides details by target audience.

Table 1: Fieldwork dates

Online survey soft launch date

Online survey full launch date

Online survey close date

Final sample size

Specialists July 25 July 26 August 17 N=200

General practitioners August 2 August 3 August 11 N=100

Community pharmacists

August 2 August 3 August 5 N=100

Patients with associated conditions and their carers

August 16 August 17 August 19 N=200 N=165 patients N=35 carers

An online survey approach was used for each of the four target audiences. The professional audiences were sourced from the Ekas medical professional panel, while those with associated conditions and their carers were sourced from the SSI panel.

Respondents for this survey were selected from among those who have registered to participate in EKAS/SSI online surveys. The data has not been weighted to reflect the demographic composition of target population. Because the sample is based on those who initially self-selected for participation [in the panel] rather than a probability sample, we do not recommend the findings be projected to the entire population.

As is common practice for online survey research using a panel, an incentive was offered to participants to compensate for their time, this was $130 for specialists, $50 for GPs and $50 for Pharmacists. Consumers were compensated by SSI in line with their panel membership arrangements.

The response rate and average survey length for each target audience is shown in the table below.

Table 2: Response rates

Target audience

People invited Reminders Final response

rate Average survey length

Specialists 1,5878 2 reminders were sent on 29/07/16 and 1/08/16 to

13% 9.04 minutes


Page 22 of 137

Target audience

People invited Reminders Final response

rate Average survey length

group A 2 reminders were sent on 2/08/16 and 16/08/16 to group B

General practitioners

657 No reminders required 14% 9.79 minutes

Community pharmacists

320 No reminders required 39% 11.53 minutes

Patients with associated conditions and/or their carers

2,050 No reminders required 10% 8.00 minutes

4.2 Profile of target audiences 4.2.1 Professional stakeholders The figures below provide details of the demographic profile of professional stakeholders.

Figure 5: Years of experience

D1. How long have you personally been working as a [specialist in this area/General Practitioner/pharmacist]?


Page 23 of 137

Figure 6: Location

D2. In what state do you work?

Figure 7: Capital city or regional location

D3. Do you mainly work in a...?


Page 24 of 137

Figure 8: Area of specialisation

S1. First of all we need to know your area of specialisation...?

4.2.2 Consumers The figures below provide details of the demographic profile of consumers.

Figure 9: Length of time since diagnosis

D1. How long ago were you/the person you care for] diagnosed with the condition/s?


Page 25 of 137

Figure 10: Location

D2. In what state do you live?

Figure 11: Capital city or regional location

D3. Do you live in a...?


Page 26 of 137

Figure 12: Associated conditions - patients

S1. Do you have any of the following conditions...? MULTIPLE RESPONSE ALLOWED (so may total to more than 100%)

Figure 13: Associated conditions - carers

S2. If you are responsible for the care of a child aged under 18 with one of these conditions (and therefore you attend all medical appointments and are fully informed about their medical care); OR care of a close relative with one of these conditions who is incapable of managing their own healthcare (and therefore you attend all medical appointments and are fully informed about their medical care) please select the condition(s) below...? MULTIPLE RESPONSE ALLOWED (so may total to more than 100%)


Page 27 of 137

Figure 14: Type of person cared for - carers

S3. Is the person (or people) that you care for with [INSERT CONDITIONS FROM S2] a...? MULTIPLE RESPONSE

4.3 Reporting conventions Statistical tests have been carried out (t tests, using the 95% confidence interval) to highlight significant differences between the following key analysis variables amongst respondents.

• Area of specialisation (for specialists, with sample size being large enough for examination of differences for Rheumatologists, Oncologists, Dermatologists, Endocrinologists, Nephrologists, Haematologists and ‘others’ which include immunologist, paediatric rheumatologists, gastroenterologists and consultant physicians)

• Associated condition for consumers (with sample size being large enough for examination of differences for patients with diabetes; arthritis (including juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis); and all ‘other conditions’ combined (ankylosing spondylitis, Crohn’s disease, treatment of anaemia in renal disease, chronic lymphocytic leukaemia, active polyangitis, chronic plaque psoriasis, malignant melanoma and metastatic colorectal cancer), as the sample sizes were too small to examine differences individually.

• Years of experience (in role/with condition)

• State of residence (with NSW/ACT combined, QLD/SA/WA combined and VIC/TAS combined)

• Capital or other location

• Familiarity with biologic medicines

• Familiarity with biosimilar medicines

• Experience prescribing/dispensing/taking biologic medicines

• Experience prescribing/dispensing/taking biosimilar medicines

• Confidence prescribing/dispensing/taking biosimilar medicines (prompted)

• Confidence in switching to biosimilar medicines.


Page 28 of 137

Significant differences for these analysis variables are reported in the text; where no differences are found this is not mentioned. Within the body of the report, where the results are significantly higher than other sub-groups (for example specialists versus others), this is denoted with a green font in the tables and a green triangle in the charts. Where results are significantly lower than other sub-groups this is denoted with a red font in the tables and a red triangle in the charts.

Percentages have been rounded up to whole integers. Single-response items may not add to 100% due to rounding. Multiple-response items may add to more than 100% due to respondents selecting multiple response codes.

Some sections reported have a small sample size – these findings should be treated with caution.

The project was carried out in compliance with ISO 20252 and membership requirements for AMSRO and AMSRS.


Page 29 of 137

5 Key Findings: Professional Stakeholders 5.1 About this chapter This chapter details the results for the professional stakeholders included in the quantitative market research, namely:

• Specialists

• General practitioners (GPs)

• Community pharmacists (pharmacists).

The profile of each professional group is detailed at Section 4.2. Where there are common questions across the three target audiences, the commentary will compare and contrast the findings for each audience.

The vast majority of professional stakeholders had heard of biosimilar medicines. Just n=2 GPs had ‘never heard of biosimilars before’.

In order to explore in detail different facets and nuances of understanding, attitudes and use of biologic and biosimilar medicines, the questionnaire covered the following, related, areas:

• Familiarity with biologic and biosimilars medicines;

• Prevalence of prescribing/dispensing biologic and biosimilar medicines;

• Sources of information about biosimilar medicines;

• Perceived benefits and barriers of biosimilar medicines;

• Perceived efficacy, comparability, intention to switch and associated confidence; and

• Understanding of the PBS.

5.2 Familiarity with biologic and biosimilar medicines 5.3.1 Familiarity with biologic medicines Professional stakeholders were asked how familiar they were with biologic medicines. Levels of familiarity were highest among specialists, followed by pharmacists and then GPs. Almost nine in ten specialists (89%) were familiar with biologic medicines (either ‘very familiar’ or ‘familiar’), compared with about half (53%) of pharmacists and just under a third (31%) of GPs.


Page 30 of 137

Figure 15: Familiarity with biologic medicines

Q1. How familiar are you with biologic medicines?

The figure below provides details of statistically significant sub-group differences.

Figure 16: Familiarity with biologic medicines – sub group differences

Specialists General Practitioners Community pharmacists

• Specialists 'very familiar' with biologic medicines (54%) were more likely to be: – Rheumatologists (81%) – From VIC/TAS (65%) – Also familiar with

biosimilar medicines (62%).

• GP's more likely to be 'very familiar' or 'familiar' with biologic medicines (31%) were more likely to: – Have prescribed biologic

medicines (47%) – Have confidence

prescribing biosimilar medicines (49%).

• Pharmacists 'very familiar' with biologic medicines (22%) were more likely to: – Have dispensed biologic

medicines (29%) – Be familiar with


5.3.2 Familiarity with biosimilar medicines As with biologics, familiarity with biosimilars was highest among specialists and lowest among GPs. Two in three specialists (66%) were familiar with biosimilar medicines (either ‘very familiar’ or ‘familiar’), compared with 57% of pharmacists and 25% of GPs. Familiarity with biosimilar medicines was lower than for biologic medicines for specialists and GPs, but the reverse was true for pharmacists (however this difference was not statistically significant).


Page 31 of 137

Figure 17: Familiarity with biosimilar medicines

Q2. How familiar are you with biosimilar medicines?


Figure 18: Familiarity with biosimilar medicines – sub group differences


• Specialists 'very familiar' or 'familiar' with biosimilar medicines (66%) were more likely to : – Have prescribed

biosimilar medicines (81%)

– Were confident prescribing biosimilar medicines (79%)

– Were confident switching a patient from a reference biologic to a biosimilar medicine (74%).

• GP's more likely to be 'very familiar' or 'familiar' with biosimilar medicines (25%) were more likely to: – Also be familiar with

biologic medicines (61%)

– Have prescribed biologic medicines (41%)

– Have confidence prescribing biosimilar medicines (41%)

– Were confident switching (36%).

• Pharmacists 'very familiar' or 'familiar' with biosimilar medicines (57%) were more likely to: – Also be familiar with

biologic medicines (92%)

– Have dispensed biosimilar medicines (85%).


Page 32 of 137

Figure 19: Familiarity with biologic and biosimilar medicines - comparison

Q1. How familiar are you with biologic medicines? Q2. How familiar are you with biosimilar medicines?


Page 33 of 137

5.3 Prevalence of prescribing/dispensing biologic and biosimilar medicines

Professional stakeholders were asked if they had ever prescribed (or in the case of pharmacists, dispensed) a biologic or biosimilar medicine to a patient.

Specialists were significantly more likely to have prescribed biologic medicines than biosimilars (93% and 39% respectively). The same was true (in dispensing terms) for pharmacists (67% compared with 33%). However, GPs were equally likely to dispense biologics (34%) and biosimilars (33%).

Comparison of the results across the two types of medicine, and between the different professions, highlights the fact that levels of prescribing biosimilars among specialists are relatively low (in light of their very high use of biologics). This could, of course, be a simple function of the fact that biosimilars are new to the market; or it could indicate a level of resistance on their part. The subsequent sections of this chapter shed further light on this finding.

Figure 20: Prescribed/dispensed biologic or biosimilar medicines

Q4. Have you ever prescribed/dispensed a biologic medicine to a patient? Q6. Have you ever prescribed/dispensed a biosimilar medicine to a patient?


Figure 21: Prescribed/dispensed biologic or biosimilar medicines – sub group differences


• Specialists who had prescribed a biologic medicine to a patient (93%, n=185) were more likely to: – Be familiar with

• GPs who had prescribed a biologic medicine to a patient (34%, n=34) were more likely to: – Be from VIC/TAS (52%)

• Pharmacists who had dispensed a biologic medicine to a patient (66%, n=66) were more likely to: – Have dispensed


Page 34 of 137



– Have prescribed biosimilar medicines (99%)

– Be confident prescribing biosimilar medicines (96%).

• Specialists who had prescribed a biosimilar medicine to a patient (39%, n=78) were more likely to: – Be Oncologists (59%) – Be confident prescribing


– Be confident switching a patient to a biosimilar (58%).

– Have prescribed biosimilar medicines (69%)

– Be confident prescribing biosimilar medicines (51%)


• GPs who had prescribed a biosimilar medicine to a patient (32%, n=33) were more likely to: – Have prescribed biologic

medicines (65%) – Be confident prescribing




Pharmacists who had dispensed a biosimilar medicine to a patient (39%, n=39) were more likely to: – Be familiar with biologic

medicines (55%) – Have dispensed biologic

medicines (48%) – Be familiar with biosimilar

medicines (58%).

5.4 Sources of awareness: biologic and biosimilar medicines 5.4.1 Sources of awareness: biologic medicines Professional stakeholders were asked how they had found out about biologic medicines. Where respondents mentioned more than one source of information, the most recent source of awareness was explored further.

As shown in the table below, academic channels were the most common source, particularly for specialists overall (96%) and as the most recent source (66%). Medical journals/academic papers (88% overall and 27% most recent source) and conferences (80% overall and 34% most recent source) also played an important role for specialists.

Pharmacists’ continuing professional development activities featured highly (61% overall and 20% most recent), as did medical journals/academic papers (49% overall). Pharmacists were more likely to mention the National Prescribing Service/NPS Radar email alerts than other professional stakeholders: 44% overall compared with about a quarter of the other two groups; and 14% as the most recent source, compared with 2% of specialist and 6% of GPs.

Word of mouth was also an important channel, particularly for specialists (89%), with 76% mentioning pharmaceutical reps; 22% as the most recent source. Word of mouth was also mentioned by 75% of GPs, with 41% saying it was their most recent source.

Almost half of GPs (45%) had found information online but were unable to recall specifically where. GPs were the most likely group to mention the media (including social media) - 30% of GPs compared with 15% of pharmacists and 14% of specialists.

The Department was attributed as being a source of awareness by 29% of GPs, 21% of pharmacists and 20% of specialists.


Page 35 of 137

Table 3: Sources of awareness of biologic medicines

All sources of awareness mentioned

Most recent source of awareness

Specialists (n=200) %

GPs (n=100) %

Pharma-cists (n=99) %


GPs (n=100) %


Academic channels - total 96 71 91 66 28 62

Medical journals / academic papers

88 54 49 27 17 14

Conferences related to your area of specialisation (Conferences/symposiums)

80 19 18 34 5 7

National Prescribing Service (NPS) / NPS Radar email alerts

23 27 44 2 6 14

Communications from specialty associations (i.e. Australian College of...)

41 17 15 3 - 4

University studies 21 5 25 - - 2

Continuing professional development (CPD) activities

- - 61 - - 20

From hospital Drug and Therapeutics Committee (DTC)

19 - 2 - -

Personal involvement - trials/research/etc.

4 - - - - -

Word of mouth - total 89 75 63 30 41 30

Pharmaceutical company representatives

76 40 46 22 10 18

Word of mouth via colleagues 55 40 29 4 14 4

General information online, but can’t recall specifically where

17 45 21 4 17 8

Department channels - total 20 29 21 1 5 2

Online information from the Australian Government Department of Health

14 14 10 1 4 1

Brochures or pamphlets from the Australian Government Department of Health

8 20 6 - - -

State / Territory based government Department of Health

8 9 7 1 1 1


Page 36 of 137




GPs (n=100) %



GPs (n=100) %


Media - total 14 30 15 1 6 -

Media (including social media) 14 30 15 1 6 -

Other (please specify) 1 1 1 0 1 0

Don't know/Can't Say 2 6 2 3 19 6

Average number of mentions 4.66 3.32 3.5 Q3a. How did you find out about biologic medicines? MULTIPLE RESPONSE Q3b. And which was your most recent source of information about biologic medicines? SINGLE RESPONSE


Figure 22: All sources of awareness biologic medicines – sub group differences


• Compared with other specialties, rheumatologists were more likely mention: – Medical

journals/academic papers (98%), conferences (93%), communications from specialty associations (64%), Department channels overall (38%) and specifically online information from the Australian Government Department of Health (26%).

• Oncologists were more likely than others to mention conferences (94%).

• Respondents from NSW/ACT were more likely to mention: – Department channels

overall (29%), specifically online information (20%) and State based information (17%). They were also more likely to mention

• GPs who had prescribed biologic medicines were more likely than non-prescribers to mention: – Communications from

specialty associations (29% c.f. 11%) and visits from pharmaceutical reps (56% c.f. 32%).

• Pharmacists who had dispensed biologic medicines were more likely than non-dispensers to mention: – University studies (32%

c.f. 12%).


Page 37 of 137


general information online (25%).

5.4.2 Sources of awareness: biosimilar medicines Professional stakeholders were then asked how they found out about biosimilar medicines. As with biologics, where respondents mentioned more than one source of information, the most recent source of awareness was explored.

The patterns mirrored those for biologic medicines. As shown in the table below, academic channels were the most common general source of information, particularly for specialists (93% as an overall source, and 57% as the most recent). Conferences (71% overall and 29% most recent source) and medical journals/academic papers (71% overall and 20% most recent source) also featured highly for specialists.

As with biologics, pharmacists’ continuing professional development activities featured highly (56% overall and 21% most recent), as did medical journals/academic papers (47% overall). Again, pharmacists were more likely to mention the National Prescribing Service/NPS Radar email alerts than other professional stakeholders (40% overall and 9% most recent source; compared with 17% and 2% respectively for specialists, and 28% and 7% for GPs).

Word of mouth was also an important general source, particularly for specialists (85%), with 66% overall mentioning pharmaceutical reps and 20% saying this was the most recent source of information. Word of mouth was mentioned by 66% of pharmacists and 65% of GPs.

More than two in five GPs overall (42%) found information online but were unable to recall specifically where, and for 16% of GPs this was their most recent source. Of note 15% of GPs were unable to nominate what their overall source of awareness was, and 22% of GPs could not nominate their most recent source.

The Department was attributed as being a source of awareness by 26% of GPs, 22% of pharmacists and 14% of specialists.

Table 4: Sources of awareness of biosimilar medicines




GPs (n=98) %



GPs (n=98) %



Conferences related to your area of specialisation/symposiums

71 12 15 29 3 7


71 45 47 20 15 11


39 15 20 4 2 5


Page 38 of 137




GPs (n=98) %



GPs (n=98) %



17 28 40 2 7 9


- - 56 - - 21

University studies 10 - 18 - - 2


18 - - 2 - -


2 - - - - -



66 28 43 20 11 15



23 42 24 7 16 7



6 16 17 1 4 4


8 13 6 - 2 2


6 7 2 - 1 -

Media - total 14 20 15 1 5 3

Media (including social media) 14 20 15 1 5 3

Other (please specify) 1 - - 2 - -


Average number of mentions 3.96 2.61 3.30 Q5a. How did you find out about biosimilar medicines? MULTIPLE RESPONSE Q5b. And which was your most recent source of information about biosimilar medicines? SINGLE RESPONSE


Page 39 of 137


Figure 23: All sources of awareness biosimilar medicines – sub group differences


• Compared with other specialties, rheumatologists were more likely to mention: – Conferences (93%),

communications from specialty associations (60%), Department channels overall (24%).

• Respondents with 20 or more years’ experience were more likely than others with less experience to mention: – Medical journals/

academic papers (80%) and general information online (32%).

• Respondents from QLD/SA/WA were more likely to mention communications from specialty associations (49%).

• Those familiar with biosimilar medicines (‘very familiar’ and ‘familiar’ combined) were more likely to mention: – Academic channels

generally (97%) and specifically medical journals/ academic papers (77%), conferences (80%), communications from specialty associations (45%), Drug and Therapeutics Committee (24%) and university studies (13%).

– Word of mouth generally (92%) and specifically pharmaceutical company reps (74%).

• GPs who had prescribed biosimilar medicines were more likely than non-prescribers to mention: – Communications from

specialty associations (28%) and pharmaceutical company reps (50%).

• GPs who were confident prescribing biosimilars were more likely to mention: – Academic channels

generally (76%) and specifically medical journals/academic papers (61%), Department channels generally (35%) and specifically online information from the Department (24%), and pharmaceutical reps (41%).

• GPs who were confident switching a patient to a biosimilar were more likely to mention: – Medical journals /

academic papers (56%).

• Pharmacists familiar with biosimilar medicines (‘very familiar’ and ‘familiar’ combined) were more likely to mention: – Academic channels

generally (98%) and specifically continuing professional development activities (65%), medical journals/academic papers (56%) and university studies (28%).

• Pharmacists who had dispensed biosimilar medicines were more likely than non-dispensers to mention: – University studies (33%),

Department channels generally (33%) and specifically online information from the Department (28%).


Page 40 of 137


• Those who had prescribed biosimilar medicines were more likely than non-prescribers to mention: – Drug and

Therapeutics committee (26%), university studies (15%). While the sample is very small, all three respondents who mentioned being personally in trials had prescribed biosimilars.

• Specialists who were confident prescribing biosimilars were more likely: – Conferences (75%)

word of mouth generally (89%) and specifically pharmaceutical reps (71%).

5.4.3 Sources of awareness: biologic and biosimilar medicines - comparison

The sources of awareness of biologic and biosimilar medicines were similar for each professional stakeholder audience.

• For specialists the ‘top three’ sources of awareness for both biologic and biosimilar medicines were medical journals/academic papers (more so for biologic medicines than biosimilars 88% c.f. 71%), conferences (80% c.f. 71%), and pharmaceutical reps (76% c.f. 66%).

• For GPs the ‘top three’ sources of awareness for both biologic and biosimilar medicines were medical journals/academic papers (more so for biologic medicines than biosimilars 54% c.f. 45%), general information online (45% c.f. 42%), and word of mouth via colleagues (40% c.f. 34%) with pharmaceutical reps also being important (40% c.f. 28%).

• For pharmacists the ‘top three’ sources of awareness for both biologic and biosimilar medicines were continuing professional development (CPD) activities (more so for biologic medicines than biosimilars 61% c.f. 56%), medical journals/academic papers (49% c.f. 47%), and from pharmaceutical reps (46% c.f. 43%).


Page 41 of 137

Table 5: Sources of awareness of biologic and biosimilar medicines - comparison

All sources of awareness mentioned about biologic medicines

All sources of awareness mentioned about biosimilar medicines


GPs (n=100) %



GPs (n=98) %




88 54 49 71 45 47

Conferences related to your area of specialisation (Conferences/symposiums)

80 19 18 71 12 15


23 27 44 17 28 40


41 17 15 39 15 20

University studies 21 5 25 10 - 18


- - 61 - - 56


19 - 18 - -


4 - - 2 - -



76 40 46 66 28 43



17 45 21 23 42 24



14 14 10 6 16 17


8 20 6 8 13 6


8 9 7 6 7 2

Media - total 14 30 15 14 20 15



Page 42 of 137

All sources of awareness mentioned about biologic medicines

All sources of awareness mentioned about biosimilar medicines


GPs (n=100) %



GPs (n=98) %


Other (please specify) 1 1 1 1 - -


Average number of mentions 4.66 3.32 3.5 3.96 2.61 3.30 Q3a. How did you find out about biologic medicines? MULTIPLE RESPONSE Q5a. How did you find out about biosimilar medicines? MULTIPLE RESPONSE


Page 43 of 137

5.5 Advantages and disadvantages of biosimilars 5.5.1 Barriers and benefits to prescribing/dispensing biosimilar medicines All professional stakeholders were asked if they could see any potential barriers to prescribing/dispensing biosimilar medicines, as well as potential benefits of doing so.

All professional stakeholders were more likely to see potential benefits to prescribing biosimilar medicines than potential barriers.

Pharmacists (87%), specialists (85%) and GPs (71%) were all more likely to see benefits than barriers (64%, 64% and 56% respectively).

GPs were the least likely group to see benefits to prescribing biosimilars, suggesting an important opportunity for further education among this prescriber audience. However, they were also the group least likely to see barriers, suggesting a degree of neutrality around the issue on the part of GPs.

Notably, even stakeholders who saw barriers to prescribing/dispensing biosimilar medicines were nevertheless likely to see benefits to doing so (73% of GPs, 84% of specialists and 86% of pharmacists with barriers also saw benefits).

Figure 24: Barriers and benefits of biosimilar medicines

Q7. Do you think there are any potential barriers to you prescribing/dispensing biosimilar medicines? Q9. Do you think there are any potential benefits to you prescribing/dispensing biosimilar medicines?



Page 44 of 137

Figure 25: Barriers and benefits of biosimilar medicines – sub group differences


In terms of barriers... • Rheumatologists were

more likely than other specialists to think there were barriers to prescribing biosimilar medicines (79%).

• Specialists who were not confident prescribing biosimilars were more likely to see barriers (83%).

• Specialists who were not confident switching patients to a biosimilar medicine were more likely to see barriers (80%).

In terms of benefits... • Specialists who were

confident prescribing biosimilars were more likely to see benefits (90%).

• Respondents from QLD/SA/WA were less likely to see benefits (76%).

In terms of barriers... • GPs who were not

confident switching patients to a biosimilar medicine were more likely to see barriers (66%).

In terms of benefits... • GPs who had prescribed

biosimilars were more likely to see benefits (88%).

• GPs who were confident prescribing biosimilars were more likely to see benefits (82%).

In terms of barriers... • Pharmacists who had

dispensed biologic medicines were more likely to see barriers (73%).

In terms of benefits... • Pharmacists who were

familiar with biosimilar medicines were more likely to see benefits (95%).

• Those who had dispensed biosimilars were more likely to see benefits (97%).

Of those specialists who thought that there were barriers to prescribing biosimilar medicines (n=128), 84% felt there were also benefits to doing so, while 16% did not.

Of those GPs who thought that there were barriers to prescribing biosimilar medicines (n=56), 73% felt there were also benefits to doing so, while 27% did not.

Of those pharmacists who thought that there were barriers to dispensing biosimilar medicines (n=64), 86% felt there were also benefits to doing so, while 14% did not.

5.5.2 Perceived barriers to prescribing/dispensing biosimilar medicines Those professional stakeholders who could see potential barriers to prescribing/dispensing biosimilar medicines (n=128 specialists, 56 GPs and n=64 pharmacists) were prompted as to what those potential barriers might be.

In summary, specialists (94%) and GPs (89%) were more likely than pharmacists to raise concerns over patient outcomes (69%). Pharmacists, on the other hand, were twice as likely as the other groups to mention cost-related barriers (69% compared with a third of the other two professions.)

As shown in the following table:

• Specialists had greatest concern for patient outcomes overall (94%), and particularly considered the largest barrier to be ‘concern with the availability/transparency of the evidence used to support indication extrapolation’ (71%). Other patient related outcomes where


Page 45 of 137

specialists were more likely to have concerns compared to other stakeholders were ‘immunogenicity concerns’ (57%) and ‘concern over the strength of pharmacovigilance activities’ (53%). Of note, one in three specialists said ‘I don’t see the need to change what I prescribe’ (33%).

• GPs saw the largest barrier as being information related overall (93%), and specifically ‘insufficient information on biosimilar medicines for prescribers’ (89%). GPs were the group most likely to mention ‘concern over the delay of biosimilar medicines due to legal/international patent issues’ (38%, compared to 25% of specialists and 17% of pharmacists).

• Pharmacists felt the biggest barriers were price related overall (69%), and specifically the ‘absence of incentives for patients to use biosimilar medicines’ (61%), as well as patient outcomes overall (although pharmacists were less likely to mention this than other stakeholders), with half mentioning ‘concern about adverse outcomes for my patients’ (50% compared with 61% of specialists and 64% of GPs).

Table 6: Potential barriers to prescribing/dispensing biosimilar medicines


General practitioners (n=56) %

Community pharmacists (n=64) %

Patient outcomes – total 94 89 69

Concern with the availability / transparency of the evidence used to support indication extrapolation

71 63 31

Concern about adverse outcomes for my patients

61 64 50

Immunogenicity concerns 57 34 22

Concern over the strength of pharmacovigilance activities

53 45 28

Information related - total 72 93 70

Insufficient information on biosimilar medicines for prescribers

59 89 50

Insufficient information on biosimilar medicines for patients (and for specialist survey - and stakeholders)

54 59 58

Price related - total 34 32 69

Absence of incentives for patients to use biosimilar medicines

25 16 61

Absence of incentives for physicians to prescribe biosimilar medicines

23 27 17

Absence of incentives for pharmacists to dispense biosimilar medicines

- - 33


Page 46 of 137




Other - total 44 43 38

I don’t see the need to change what I prescribe/dispense

33 18 13

Concern over the delay of biosimilar medicines due to legal / international patent issues

17 38 25

Other (please specify) 1 2 2

Average number of mentions

4.53 4.54 3.89

Q7. Do you think there are any potential barriers to you prescribing/dispensing biosimilar medicines? MULTIPLE RESPONSE


Figure 26: Barriers to prescribing/dispensing biosimilar medicines – sub group differences


• Rheumatologists were more likely than other specialists to mention ‘immunogenicity concerns’ (79%) as well as ‘I don’t see the need to change what I prescribe’ (52%)

• Specialists who were unfamiliar with biosimilar medicines were more likely to mention information related issues overall (83%). They were also more likely to mention ‘concern with the availability / transparency of the evidence used to support indication extrapolation’ (83%).

• Specialists with 10 years or less experience were more likely to mention information related issues overall (87%)

• Specialists with 20 years+ experience were more likely to mention the ‘absence of incentives for patients to use biosimilar medicines’ (38%)

• Respondents from

• There were no statistically significant sub group differences.

• Pharmacists with 10 years or less experience were more likely to mention ‘concern over the delay of biosimilar medicines due to legal/ international patent issues’ (39%).


Page 47 of 137


QLD/SA/WA were more likely to raise ‘I don’t see the need to change what I prescribe’ as a barrier (47%)

• Specialists who were not confident prescribing biosimilar medicines were more likely to mention: – Information related

overall (87%), including ‘insufficient information on biosimilar medicines for prescribers’ (70%) and ‘insufficient information on biosimilar medicines for patients and stakeholders’ (72%)

– Patient outcome concerns overall (100%), specifically ‘concern about adverse outcomes for my patients’ (77%) ‘immunogenicity concerns’ (68%), and ‘concern over the strength of pharmacovigilance activities’ (66%).

– They were also more likely to ‘not see the need to change’ (45%).

• Specialists who were not confident switching a patient to biosimilar medicines were more likely to mention ‘I don’t see the need to change what I prescribe’ (42%).

5.5.3 Perceived benefits to prescribing/dispensing biosimilar medicines Those professional stakeholders who could see potential benefits to prescribing/dispensing biosimilar medicines (n=170 specialists, n=71 GPs and n=87 pharmacists) were prompted as to what those potential benefits might be.

The most commonly reported benefit was financial, with GPs being somewhat less likely to report this (86%) than the other two groups (98-99%).

GPs were, on the other hand, more likely to see patient outcomes as an important advantage of biosimilars (82% compared with 75% of pharmacists and only 59% of specialists).


Page 48 of 137

As well as prioritising the benefits of cost savings, pharmacists were (relative to the other two audiences) comparatively more likely to mention the fact that they mitigate against medicine shortages (52%, compared with around a quarter of the other two segments).

• Specialists were most likely to mention price related benefits overall (99%), particularly that biosimilar medicines would ‘lower prices through competition’ (88%), would be ‘more affordable for the PBS’ (84%), would ‘save taxpayers money’ (84%) and would be ‘more affordable for hospitals’ (74%). Specialists were less likely than other stakeholders to mention patient outcomes (59%) or industry outcomes (20%).

• GPs were most likely to mention price related benefits (86%), but – as previously stated – they were the group least likely to mention this. GPs were the stakeholder group most likely to expect benefits in terms of patient outcomes (82%), and particularly ‘treatment choice’ (52%, compared with a quarter of the other two professions). One in three GPs (and a similar proportion of pharmacists) expected benefits regarding industry outcomes; compared with only 20% of specialists.

• Almost all pharmacists mentioned price related benefits overall (98%), with greatest focus on ‘more affordable for the PBS’ (80%). Seven in ten pharmacists also expected benefits in terms of pharmacy business (71%), in terms of ‘larger profit margins’ (62%) and ‘lower stock holding costs’ (52%).

Table 7: Potential benefits to prescribing/dispensing biosimilar medicines





Lower prices through competition

88 66 47

More affordable for the PBS

84 61 80

Save taxpayers money 84 55 59

More affordable for hospitals

74 51 43

More affordable for patients

58 59 61

Enables more medicines to be listed on the PBS

58 51 66

Patient outcomes - total

59 82 75

Broadens access for patients at an earlier stage of disease

39 45 39

Treatment choice 28 52 26

Mitigate against medicine shortages

26 28 52

Positive impact on 14 44 30


Page 49 of 137




patient outcome

Industry outcomes - total

20 37 34

Advances in medicine technology

16 31 32

Improved manufacturing processes

8 18 11

Pharmacy business outcomes - total

- - 71

Larger profit margin for pharmacies

- - 62

Lower stock holding costs for pharmacies

- - 52

Other (please specify) - 1 -

Average number of mentions

5.76 5.62 6.60

Q9. Do you think there are any potential benefits to you prescribing/dispensing biosimilar medicines? MULTIPLE RESPONSE


Figure 27: Benefits to prescribing/dispensing biosimilar medicines – sub group differences


• Rheumatologists were less likely than other specialists to mention potential benefits such as ‘more affordable for hospitals’ (58%), ‘more affordable for patients’ (31%), ‘enables more medicines to be listed on the PBS’ (42%) ‘mitigates against medicine shortages’ (11%).

• Specialists who were confident switching a patient to biosimilar medicines were more likely to mention: – ‘More affordable for

hospitals’ (81%) – ‘More affordable for

patients’ (68%) – Benefits to patient

outcomes overall (68%),

• GPs confident switching a patient to biosimilar medicines were more likely to mention ‘save taxpayers money’ (68%).

• Pharmacists who had dispensed biosimilar medicines were more likely to mention ‘more affordable for patients’ (74%).

• Pharmacists who were familiar with biosimilar medicines were more likely to mention patient outcomes overall (83%), particularly ‘mitigate against medicine shortages’ (61%). They were also more likely to mention ‘larger profit margin for pharmacies’ (70%).


Page 50 of 137


particularly ‘mitigate against medicine shortages’ (37%), and ‘positive impact on patient outcomes’ (23%).

– Benefits related to industry outcomes overall (28%), specifically ‘improved manufacturing processes’ (13%).


Page 51 of 137

5.6 Confidence in prescribing/dispensing biosimilar medicines 5.6.1 Unprompted confidence prescribing/dispensing biosimilar

medicines

Professional stakeholders were asked how confident they were, personally, in prescribing/ dispensing biosimilar medicines.

Four in five pharmacists (80%) were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) dispensing biosimilar medicines, 68% of specialists were confident prescribing biosimilar medicines; while GPs had the lowest confidence levels (51%).

Figure 28: Unprompted confidence prescribing/dispensing biosimilar medicines

Q11. Which of the following best describes how confident you are personally in prescribing/dispensing biosimilar medicines?


Figure 29: Unprompted confidence prescribing/dispensing biosimilar medicines – sub group differences


• Specialists familiar with biosimilar medicines had higher confidence prescribing them (82%).

• Specialists who had prescribed biosimilar medicines had higher confidence prescribing them (86%).

• GPs familiar with biologic medicines had higher confidence prescribing biosimilar medicines (81%).

• GPs who had prescribed biologic medicines had higher confidence prescribing biosimilar

• Pharmacists familiar with biologic medicines had higher confidence dispensing biosimilar medicines (91%).

• Pharmacists familiar with biosimilar medicines had higher confidence dispensing them (96%).


Page 52 of 137


• Specialists who had confidence switching patients to biosimilar medicines had higher confidence prescribing them (94%).

medicines (76%). • GPs who had prescribed

biosimilar medicines had higher confidence prescribing them (91%).

• GPs who had confidence switching patients to biosimilar medicines had higher confidence prescribing them (80%).

• Pharmacists who had dispensed biosimilar medicines had higher confidence dispensing them (95%).

5.6.2 Prompted confidence prescribing/dispensing biosimilar medicines In order to establish whether clarity around the concept of biosimilars would have any impact on reported confidence levels, a definition of biosimilars was provided (part-way through the online survey). Notably, even after such minimal intervention/education, confidence levels increased slightly. This suggests that a targeted and informative communication initiative is likely to have significant impact on confidence levels among the research audiences.

After prompting, more than four in five pharmacists were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) dispensing biosimilar medicines (84% - up slightly from the unprompted result of 80%), while 76% of specialists (up 8 percentage points from 68% unprompted) were confident prescribing biosimilar medicines. GPs had the lowest confidence (67%) but showed the largest improvement (from 51% unprompted at baseline). This marked impact is perhaps not surprising, since GPs were most likely to cite that insufficient information was a barrier to prescribing biosimilar medicines.


Page 53 of 137

Figure 30: Prompted confidence prescribing/dispensing biosimilar medicines

Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that has demonstrable similarity in physiochemical, biological and immunological characteristics, efficacy and safety. The active substances of biologic medicines and their complexity as well as the way they are produced may result in a degree of variability, between brands as well as between batches within a brand of the medicine. Considering this, how confident do you feel about prescribing/dispensing biosimilar medicines?


Figure 31: Prompted confidence prescribing/dispensing biosimilar medicines – sub group differences


• Specialists familiar with biosimilar medicines had higher confidence prescribing them (82%).

• Specialists who had prescribed biosimilar medicines had higher confidence prescribing them (88%).

• Specialists who had confidence switching patients to biosimilar medicines had higher confidence prescribing them (98%).

• GPs who had prescribed biologic medicines had higher confidence prescribing biosimilar medicines after prompting (82%).

• GPs who had prescribed biosimilar medicines had higher confidence prescribing them (91%).

• GPs who had confidence switching patients to biosimilar medicines had higher confidence prescribing them after prompting (94%).

• Pharmacists familiar with biologic medicines had higher confidence dispensing biosimilar medicines after prompting (94%).

• Pharmacists familiar with biosimilar medicines had higher confidence dispensing them after prompting (95%).

• All pharmacists from regional areas were confident dispensing biosimilar medicines after prompting (100%).


Page 54 of 137

Figure 32: Unprompted and prompted confidence prescribing/dispensing biosimilar medicines - comparison

Q11. Which of the following best describes how confident you are personally in prescribing/dispensing biosimilar medicines? Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that has demonstrable similarity in physiochemical, biological and immunological characteristics, efficacy and safety. The active substances of biologic medicines and their complexity as well as the way they are produced may result in a degree of variability, between brands as well as between batches within a brand of the medicine. Considering this, how confident do you feel about prescribing/dispensing biosimilar medicines?

5.6.3 Confidence in efficacy of biosimilar medicines Professional stakeholders were asked how confident they were in the efficacy of biosimilar medicines.

Pharmacists were the most confident profession, followed by specialists and GPs. Almost nine in ten (89%) pharmacists were confident with the efficacy overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined), compared with 74% of specialists and 58% of GPs.

There was a positive association between familiarity with, confidence in, and prescription/dispensing of biosimilar medicines; further supporting the potential impact of a comprehensive communications initiative to increase familiarity and knowledge.


Page 55 of 137

Figure 33: Confidence in efficacy of biosimilar medicines

Q12. Which of the following best describes how confident you are in the efficacy of biosimilar medicines?


Figure 34: Confidence in efficacy of biosimilar medicines – sub group differences


• Specialists familiar with biosimilar medicines had higher confidence in their efficacy (85%).

• Specialists who had prescribed biosimilar medicines had higher confidence in their efficacy (87%).

• Specialists who had confidence prescribing biosimilar medicines had higher confidence in their efficacy (96%).

• Specialists who had confidence switching patients to biosimilar medicines had higher confidence in their efficacy (93%).

• GPs familiar with biologic medicines had higher confidence in the efficacy of biosimilars (74%).

• GPs who had prescribed biologic medicines had higher confidence in the efficacy of biosimilar medicines (79%).

• GPs who had prescribed biosimilar medicines had higher confidence in their efficacy (88%).

• GPs who had confidence prescribing biosimilar medicines had higher confidence in their efficacy (92%).

• GPs who had confidence switching patients to biosimilar medicines had higher confidence in their

• Pharmacists familiar with biologic medicines had higher confidence in the efficacy of biosimilars (96%).

• Pharmacists familiar with biosimilar medicines had higher confidence in their efficacy (98%).


Page 56 of 137


efficacy (88%).

5.6.4 Confidence in comparability to the reference biologic medicine All professional stakeholders were asked how confident they were that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market).

Again, pharmacists were the most confident, and GPs the least. Almost nine in ten pharmacists were confident with the comparability overall (‘totally confident’, ‘very confident’ and ‘confident enough to prescribe/dispense’ combined) dispensing biosimilar medicines (89%), while 73% of specialists were confident in the comparability of biosimilar medicines. GPs had the lowest confidence (60%). Again, familiarity was positively associated with confidence – the more awareness the more likely to believe in the comparability with the reference medicine.

Figure 35: Confidence in comparability of biosimilar medicines

Q13. Which of the following best describes how confident you are that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market)?


Figure 36: Confidence in comparability of biosimilar medicines – sub group differences


• Specialists familiar with biosimilar medicines had higher confidence in their comparability (83%).

• GPs who had prescribed biosimilar medicines had higher confidence in their comparability (84%).

• Pharmacists familiar with biologic medicines had higher confidence in the comparability of biosimilars


Page 57 of 137


• Specialists who had prescribed biosimilar medicines had higher confidence in their comparability (86%).

• Specialists who had confidence prescribing biosimilar medicines had higher confidence in their comparability (94%).

• Specialists who had confidence switching patients to biosimilar medicines had higher confidence in their comparability (94%).

• GPs who had confidence prescribing biosimilar medicines had higher confidence in their comparability (92%).

• GPs who had confidence switching patients to biosimilar medicines had higher confidence in their comparability (88%).

(98%). • Pharmacists familiar with

biosimilar medicines had higher confidence in their comparability (98%).


Page 58 of 137

5.6.5 Confidence in the efficacy and comparability of biosimilar medicines - comparison

There was a strong alignment in attitudes towards the efficacy of biosimilars and levels of confidence that they are comparable to the reference medicine. Pharmacists were the most positive (89% for both the efficacy and comparability of biosimilar medicines) followed by specialists (75% and 73% respectively), with GPs having the lowest confidence (58% and 60% respectively). This suggests that a (perhaps the) key driving factor in confidence levels around biosimilars is the degree of belief that they are comparable with the reference drug. In which case, an effective communication initiative would need to provide reassurance and information about this issue.

Figure 37: Confidence in the efficacy and comparability of biosimilar medicines - comparison

Q12. Which of the following best describes how confident you are in the efficacy of biosimilar medicines? Q13. Which of the following best describes how confident you are that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market)?


Page 59 of 137

5.6.6 Attitudes towards biosimilar medicines Professional stakeholders were asked how strongly they agreed or disagreed with a number of statements about biologic and biosimilar medicines using the scale ‘strongly agree’, ‘agree’, ‘neutral’, ‘disagree’, ‘strongly disagree’ and ‘unsure/not relevant’.

Four in five pharmacists agreed overall (either ‘strongly agreed’ or ‘agreed’) that they were generally comfortable dispensing biologic medicines to their patients, while 77% of specialists agreed and significantly fewer GPs agreed (39%). Also notable was that of the 8 respondents who said ‘unsure/don’t know’, 7 were GPs.

Figure 38: Comfort prescribing/dispensing biologic medicines

Q14a. How strongly do you agree or disagree with the statement ‘I am generally comfortable prescribing/dispensing biologic medicines to my patients’?


Page 60 of 137

The smallest proportion of professional stakeholders agreed overall (either ‘strongly agreed or ‘agreed’) that they were disinclined to offer a new medicine to their patients until their colleagues recommend it. Just over one in ten pharmacists overall agreed (13%, which was significantly lower than other stakeholder groups), while 25% of specialists and significantly more GPs (35%) were likely to agree.

Figure 39: Colleague recommendation

Q14b. How strongly do you agree or disagree with the statement ‘I am disinclined to offer a new medicine to my patients until my colleagues recommend it’?


Page 61 of 137

More than four in five pharmacists agreed that they would dispense a biosimilar medicine to patients because they were confident in Australia’s regulatory processes (84%), while significantly fewer specialists (53%) or GPs (51%) agreed. Also notable was that of the 9 respondents who said ‘unsure/don’t know’, 5 were GPs.

Figure 40: Biosimilars and confidence in Australia’s regulatory processes

Q14c. How strongly do you agree or disagree with the statement ‘I would prescribe a biosimilar medicine to my patients because I am confident in Australia’s regulatory processes’?


Page 62 of 137

Three in five specialists agreed that medication access programs offered by pharmaceutical companies have an impact on which treatments are offered to patients (61%), while 55% of GPs said that this was the case. This question was not asked of pharmacists. Also notable was that of the 9 respondents who said ‘unsure/don’t know’, 7 were GPs.

Figure 41: Biosimilars and medication access programs

Q14d. How strongly do you agree or disagree with the statement ‘medication access programs offered by pharmaceutical companies have an impact on which treatments I offer to my patients’?


Page 63 of 137

Around two fifths of pharmacists agreed that biosimilar medicines are ‘essentially the same as generic medicines’ (42%); compared to 29% of GPs and 28% of specialists. Also notable was that of the 16 respondents who said ‘unsure/don’t know’, 10 were GPs.

Figure 42: Biosimilars are essentially the same as generic medicines

Q14e. How strongly do you agree or disagree with the statement ‘biosimilar medicines are essentially the same as generic medicines’?


Page 64 of 137

Specialists were significantly more likely to agree that they were aware of the PBAC’s decision making processes for the subsidy of medicines (63%, compared to 49% of pharmacists and 40% of GPs). Also notable was that 20 respondents said ‘unsure/don’t know’ (11 were GPs, 7 pharmacists and 2 specialists).

Figure 43: Awareness of PBACs decision making processes

Q14f. How strongly do you agree or disagree with the statement ‘I am aware of the PBAC’s decision making processes for the subsidy of medicines’?


Page 65 of 137

Seven in ten specialists (70%) agreed that biosimilar medicines will have a significant impact on their area of specialisation and how patients are treated; which was significantly higher than GPs (42%), and pharmacists (38%). Also notable was that of the 16 respondents who said ‘unsure/don’t know’, 9 were GPs.

Figure 44: Impact of biosimilars

Q14g. How strongly do you agree or disagree with the statement ‘biosimilar medicines will have a significant impact on my area of specialisation and how patients are treated’?


Page 66 of 137

Two in three pharmacists (66%) and 59% of specialists agreed that it is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the brand name (66%). GPs were markedly less open to this idea (35%). Also notable was that of the 12 respondents who said ‘unsure/don’t know’, 8 were GPs.

Figure 45: Biosimilars and biologic-naive patients

Q14h. How strongly do you agree or disagree with the statement ‘it is appropriate to offer a biosimilar medicine to a biologic-naive patient’?


Page 67 of 137

Similarly, pharmacists were much more likely to agree that it is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (if a-flagged on the PBS) - (72%), compared with 31% of GPs and only 24% of specialists. Also notable was that of the 13 respondents who said ‘unsure/don’t know’, 10 were GPs.

Figure 46: Biosimilars and biologic-stable patients

Q14i. How strongly do you agree or disagree with the statement ‘it is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine [if a-flagged on the PBS]’?


Page 68 of 137

Four in five specialists and pharmacists agreed that biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for other patient groups, who could then access PBS subsidy for the medicine (80%). This was significantly higher than the result for GPs (60%). Also notable was that of the 11 respondents who said ‘unsure/don’t know’, 7 were GPs.

Figure 47: Biosimilars and cost-effectiveness

Q14j. How strongly do you agree or disagree with the statement ‘biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for other patient groups, who could then access PBS subsidy for the medicine’?


Page 69 of 137

More than four in five specialists (85%) and 80% of pharmacists agreed that biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of the PBS. Again, this figure was significantly lower among GPs (62%). Also notable was that of the 13 respondents who said ‘unsure/don’t know’, 9 were GPs.

Figure 48: Biosimilars and sustainability of the PBS

Q14k. How strongly do you agree or disagree with the statement ‘biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of the PBS’?

The figures below detail sub-group differences by professional stakeholder audience

Figure 49: Attitudes to biosimilar medicines – specialist sub group differences

More likely to agree

Specialists who were unfamiliar with biosimilar medicines were more likely to agree that...

• They were disinclined to offer a new medicine to patients until their colleagues recommend it (34%).

Specialists who were familiar with biosimilar medicines were more likely to agree that...

• They would prescribe a biosimilar medicine to patients because they were confident in Australia’s regulatory processes (61%).

• Biosimilar medicines would have a significant impact on their area of specialisation and how patients are treated (77%).

Specialists who had prescribed biosimilar medicines were more likely to agree that...

• They would prescribe a biosimilar medicine to patients because they were confident in Australia’s regulatory processes (68%).

• Biosimilar medicines are essentially the same as generic medicines (40%).


Page 70 of 137

More likely to agree • It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (40%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (91%).

Specialists who were confident prescribing biosimilar medicines were more likely to agree that...

• They were generally comfortable prescribing biologic medicines to their patients (85%). • They would prescribe a biosimilar medicine to patients because they were confident in Australia’s

regulatory processes (68%). • Biosimilar medicines are essentially the same as generic medicines (35%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (68%). • Biosimilar medicines would have a significant impact on their area of specialisation and how

patients are treated (78%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the brand name

(71%). • It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (33%). • Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for

other patient groups, who could then access PBS subsidy for the medicine (88%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (93%).

Specialists who were not confident prescribing biosimilar medicines were more likely to agree that...


Specialists who were confident switching a patient to biosimilar medicines were more likely to agree that...

• They were generally comfortable prescribing biologic medicines to their patients (88%). • They would prescribe a biosimilar medicine to patients because they were confident in Australia’s

regulatory processes (83%). • Medication access programs offered by pharmaceutical companies have an impact on which

treatments they offer to patients (70%). • Biosimilar medicines are essentially the same as generic medicines (42%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (73%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the brand name

(77%). • It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (49%). • Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for

other patient groups, who could then access PBS subsidy for the medicine (91%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (93%).

Differences by experience – more likely to agree

• Specialists with 10 years or less experience were more likely to agree with the statement ‘medication access programs offered by pharmaceutical companies have an impact on which treatments I offer to my patients‘ (75%) compared to those with 20 years or more experience (48%).

Differences by location – more likely to agree

• Specialists working outside of the capital cities were more likely to agree with the statement ‘I am aware of the PBAC’s decision making processes for the subsidy of medicines’ (81%) compared with those in the capital cities (60%).

Differences by specialist type – more likely to agree

• Oncologists were more likely to agree with the statement ‘medication access programs offered by


Page 71 of 137

More likely to agree pharmaceutical companies have an impact on which treatments I offer to my patients‘ (88%).

• Oncologists were more likely to agree with the statement ‘it is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine’ (44%).

Figure 50: Attitudes to biosimilar medicines – GPs sub group differences


GPs who were familiar with biologic medicines were more likely to agree that...

• They were generally comfortable prescribing biologic medicines to their patients (55%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (61%). • Biosimilar medicines will have a significant impact on how patients are treated (58%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

biologic medicine (52%).

GPs who were unfamiliar with biologic medicines were more likely to agree that...


GPs who had prescribed biologic medicines were more likely to agree that...

• They were generally comfortable prescribing biologic medicines to their patients (59%). • They would prescribe a biosimilar medicine to their patients because they are confident in

Australia’s regulatory processes (74%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (59%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

biologic medicine (56%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (76%).

GPs who had prescribed biosimilar medicines were more likely to agree that...


Australia’s regulatory processes (69%). • Biosimilar medicines are essentially the same as generic medicines (50%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (56%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

biologic medicine (56%). • Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for

other patient groups who could then access PBS subsidy for the medicine (84%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (88%).

GPs who had not prescribed biosimilar medicines were more likely to agree that...


GPs who were confident prescribing biosimilar medicines were more likely to agree that...


Australia’s regulatory processes (67%). • Biosimilar medicines are essentially the same as generic medicines (43%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (57%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

biologic medicine (55%).


Page 72 of 137

More likely to agree • It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (45%). • Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for


the PBS (80%).

GPs who were not confident prescribing biosimilar medicines were more likely to agree that...

• They were disinclined to offer a new medicine to patients until their colleagues recommend it (51%). GPs who were confident switching a patient to biosimilar medicines were more likely to agree that...


Australia’s regulatory processes (72%). • Medication access programs offered by pharmaceutical companies have an impact on which

treatments they offer patients (70%). • Biosimilar medicines are essentially the same as generic medicines (40%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (62%). • It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

biologic medicine (46%). • It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine (48%). • Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for


the PBS (82%).

Figure 51: Attitudes to biosimilar medicines – Pharmacists sub group differences


Pharmacists who were familiar with biologic medicines were more likely to agree that...

• They were generally comfortable dispensing biologic medicines to their patients (91%). • They would dispense a biosimilar medicine to their patients because they are confident in

Australia’s regulatory processes (92%).

Pharmacists who were familiar with biosimilar medicines were more likely to agree that...


Australia’s regulatory processes (93%). • Biosimilar medicines are essentially the same as generic medicines (53%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (58%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of

the PBS (88%).

Pharmacists who had dispensed biosimilar medicines were more likely to agree that....


Australia’s regulatory processes (97%). • They were aware of the PBAC’s decision making processes for the subsidy of medicines (62%).


Page 73 of 137

5.7 Intention to switch/use/accept biosimilar medicines 5.7.1 Confidence switching a patient from a reference biologic medicine to

a biosimilar medicine Professional stakeholders were asked how confident they were in switching a patient from a reference biologic medicine to a biosimilar medicine.

Three in four pharmacists were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to switch a patient’ combined) to switch a patient (76%), and half of GPs were confident (50%). Notably, specialists had the lowest confidence levels (44%); despite their high levels of confidence and willingness to prescribe biosimilars (reported above). The issue here seems to be a reluctance to switch if they do not deem it necessary from a patient outcome point of view.

Figure 52: Confidence switching a patient

Q16. Which of the following best describes generally how confident you are in switching a patient from a reference biologic medicine to a biosimilar medicine?


Figure 53: Confidence switching a patient – sub group differences


• Rheumatologists were less likely to not be confident in switching a patient (14%).

• Specialists familiar with biosimilar medicines had higher confidence in

• GPs who had prescribed biologic medicines had higher confidence in switching (74%).

• GPs who had prescribed biosimilar medicines had higher confidence in

• Pharmacists familiar with biologic medicines had higher confidence in switching (94%).

• Pharmacists familiar with biosimilar medicines had higher confidence in


Page 74 of 137


switching (49%). • Specialists who had

prescribed biosimilar medicines had higher confidence in switching (65%).

• Specialists who had confidence prescribing biosimilar medicines had higher confidence in switching (61%).

switching (72%). • GPs who had

confidence prescribing biosimilar medicines had higher confidence in switching (78%).

switching (93%). • Pharmacists who had

dispensed biosimilar medicines had higher confidence in switching (87%).

5.7.2 Confidence counselling patients about biosimilar medicines Professional stakeholders were asked how confident they were in counselling patients about biosimilar medicines.

Around four in five pharmacists and specialists were confident (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) counselling a patient about biosimilar medicines (84% and 79% respectively); while significantly fewer GPs were confident to counsel a patient (55%).

Figure 54: Confidence counselling a patient

Q17. How confident are you in counselling patients about biosimilar medicines?


Page 75 of 137


Figure 55: Confidence counselling a patient – sub group differences


• Specialists familiar with biosimilar medicines had higher confidence in counselling (89%).

• Specialists who had prescribed biosimilar medicines had higher confidence in counselling (88%).

• Specialists who had confidence prescribing biosimilar medicines had higher confidence in counselling (93%).

• Specialists who had confidence switching a patient to biosimilar medicines had higher confidence in counselling (94%).

• GPs familiar with biologic medicines had higher confidence in counselling (71%).

• GPs who had prescribed biologic medicines had higher confidence in counselling (79%).

• GPs who had prescribed biosimilar medicines had higher confidence in counselling (78%).

• GPs who had confidence prescribing biosimilar medicines had higher confidence in counselling (78%).

• GPs who had confidence switching a patient to biosimilar medicines had higher confidence in counselling (84%).

• Pharmacists familiar with biologic medicines had higher confidence in counselling (94%).

• Pharmacists familiar with biosimilar medicines had higher confidence in counselling (93%).


Page 76 of 137

5.7.3 Feelings about substitution Professional stakeholders were advised that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future. In this context, respondents were asked how they felt about pharmacists offering substitution.

Again, a reluctance emerged from the perspective of specialists, with around four in five expressing concern (‘very concerned’, ‘concerned’ and ‘mildly concerned’ combined) about substitution (79%). Levels of concern were also high among GPs (69%) but were significantly lower among pharmacists (31%).

Figure 56: Feelings about substitution - detail

Q18. You may or may not be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future. Which of the following best describes how you feel about pharmacists offering substitution?


Page 77 of 137

Figure 57: Feelings about substitution - summary

Q18. You may or may not be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future. Which of the following best describes how you feel about pharmacists offering substitution?


Figure 58: Feelings about substitution – sub group differences


• Rheumatologists were more likely to have concerns about substitution (98%).

• Specialists with 10 years or less experience were more likely to not have concerns about substitution (29%).

• Specialists who had prescribed biosimilar medicines had less concerns about substitution (72%).

• Specialists who had

• GPs who had not prescribed biosimilar medicines had more concerns about substitution (76%).

• Pharmacists unfamiliar with biologic medicines had more concerns about substitution (43%).


Page 78 of 137


prescribed biosimilar medicines were more likely to not be concerned (28%).

• Specialists who did not have confidence prescribing biosimilar medicines had higher concerns about substitution (88%).

• Specialists who did not have confidence switching a patient to biosimilar medicines had more concerns about substitution (93%).

5.7.4 Additional comments about biosimilar medicines Professional stakeholders were asked if they had any specific additional comments that they wanted to make about biosimilar medicines. This was a fully open ended, free-text question.

Three in five specialists made comments (62%) with the most frequent being related to ‘more data/evidence/long-term monitoring needed’ (17%), ‘substitution by the pharmacist should not be allowed’ (14%) and ‘more information/education/marketing needed’ (8%).

Two in five GPs made comments (39%) with the most frequent being related to ‘more information/education/marketing needed’ (9%), ‘concerns about adverse health outcomes/variances in efficacy’ (7%) and ‘more data/evidence/long-term monitoring needed’ (6%).

One in four pharmacists made comments (27%) with the most frequent being related to the importance of ‘stabilised consistent therapies’ (5%), ‘general positive comments – good idea/see value/ etc.’ (5%), ‘concerns over practitioner resistance’ (4%) and ‘more information/education/ marketing needed’ (4%).

Table 8: Additional comments about biosimilar medicines




Additional comments made - total 62 39 27

More data/evidence/long-term monitoring needed

17 6 2

Substitution by the pharmacist should not be allowed

14 5 -


Page 79 of 137




More information/education/marketing needed

8 9 4

Immunogenicity concerns 7 - -

Concerns about adverse health outcomes/variances in efficacy

6 7 2

General positive comments - good idea/see value/etc.

6 4 5

Cost effective/will reduce costs 5 - -

Cost benefits must be matched by patient interests

4 3 2

Stabilised/consistent therapies important

2 1 5

Support as long as regulations/restrictions in place

2 3 1

Confusing for patients 1 3 -

Increase/ensure availability 1 - 1

Would consider for new patients only 1 - -

Concerns about practitioner resistance - - 4

Other 4 5 3

No comments 38 61 73

Q19. Do you have any specific additional comments that you would like to make about biosimilar medicines? OPEN ENDED


Page 80 of 137

5.8 Understanding of the PBS 5.8.1 Confidence in the way medicines regulated in Australia Professional stakeholders were asked how confident they were in the way that medicines are regulated in Australia.

More than nine in ten stakeholders were confident overall (‘totally confident’, ‘very confident’ and ‘confident’ combined), with almost all pharmacists being confident (99%) and 91% of specialists and GPs being confident.

Figure 59: Confidence in medicine regulation

Q20. Thinking about the PBS now, how confident are you in the way that medicines are regulated in Australia?


Figure 60: Confidence in medicine regulation – sub group differences


• Oncologists were more likely than other specialists to say ‘little confidence’ (19%).

• Specialists from QLD/SA/WA were more likely than other specialists to say ‘little confidence’ (15%).

• GPs located outside of capital cities were more likely to say ‘little confidence’ (18%).

• There were no sub-group differences of note.


Page 81 of 137

5.8.2 Need to increase the understanding of the PBS All professional stakeholders were asked how strongly they agreed or disagreed that there was a need to increase the understanding of the PBS amongst the general community.

More than four in five stakeholders agreed overall (‘strongly agreed’ and ‘agreed’ combined) that there was a need, with 93% of GPs agreeing, 92% of pharmacists, and slightly fewer specialists at 85% (specialists were more likely to be ‘neutral’ than to disagree).

Figure 61: Need to increase understanding of the PBS

Q21. How strongly do you agree or disagree that there is a need to increase the understanding of the PBS amongst the general community?


Figure 62: Need to increase understanding of the PBS – sub group differences


• Specialists located outside of the capital cities were more likely to agree (‘strongly agree’ or ‘agree’ combined) (97%).

• There were no sub-group differences of note for GPs.

• There were no sub-group differences of note for community pharmacists.


Page 82 of 137

The types of information professional stakeholders thought the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community were similar for each professional stakeholder audience. The most frequently mentioned issues to communicate were:

• The need to communicate ‘what co-payments are relative to the true costs of medicines’ (78% specialists, 81% GPs and 77% pharmacists).

• Specialists and GPs were most likely to mention the need to communicate ‘the importance of the PBS in the context of the overall health budget’ (83% specialists, 86% GPs).

• Specialists and pharmacists both frequently mentioned ‘the role of the PBS in terms of providing affordable access to important new medicines’ (84% and 78% respectively).

• GPs frequently mentioned ‘what the PBS is’ (76%). • Pharmacists frequently mentioned ‘the importance of sustainability in terms of wider access to

important and new medicines’ (72%).

As such, general education and messages around sustainability and accessibility all appear to be important.

Table 9: Information the Australian Government Department of Health should communicate to increase understanding of the PBS




General education - total 97 96 96

What co-payments are relative to the true costs of medicines

78 81 77

What the PBS is 63 76 67

How you know when you’ve received a medicine subsidised through the PBS

64 71 66

The role of the PBAC in recommending medicine be listed on the PBS

67 50 48

Sustainability - total 94 87 89

The role of the PBS in terms of providing affordable access to important and new medicines

84 75 78

The importance of sustainability in terms of wider access to important and new medicines

77 72 72

Accessibility - total 89 91 82


Page 83 of 137




The importance of the PBS in the context of the overall health budget

83 86 68

Responsibility to the taxpayer in light of the greying population and increased incidence of chronic disease

67 71 61

Other comments (out of scope) 2 3 1


No information needs to be communicated

1 1 -

Don't know 1 1 1

Q22.Which if any of the following do you think the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community? MULTIPLE RESPONSE


Page 84 of 137

6 Key Findings Consumers 6.1 About this chapter This chapter details the results for the consumers included in the research, namely:

• Patients

• Carers.

The profile of consumers is detailed at Section 4.2.

While the majority of those who completed the survey had heard of biosimilars, n=32 consumers had ‘never heard of biosimilars before’.

In order to explore in detail different facets and nuances of understanding, attitudes and use of biologic and biosimilar medicines, the questionnaire covered the following, related, areas:

• Familiarity with biologic and biosimilars medicines;

• Prevalence of prescribing/dispensing biologic and biosimilar medicines;

• Sources of information about biosimilar medicines;

• Perceived benefits and barriers of biosimilar medicines;

• Perceived efficacy, comparability, intention to switch and associated confidence; and

• Understanding of the PBS.


Page 85 of 137

6.2 Familiarity with biologic and biosimilar medicines 6.2.1 Familiarity with biologic medicines All consumers were asked how familiar they were with biologic medicines. Less than a quarter of consumers (23%) were familiar with biologic medicines (either ‘very familiar’ or ‘familiar’), while half were ‘somewhat familiar’ (51%). Only two consumers mentioned that they had ‘never heard of them before’.

Notably, carers reported higher levels of familiarity than patients (51% c.f. 33%).

Figure 63: Familiarity with biologic medicines

Q1. How familiar are you with biologic medicines?


Figure 64: Familiarity with biologic medicines – sub group differences

Consumers

More likely to be familiar (so ‘very familiar’ or ‘familiar’ combined) • Those from capital cities (28%) • Those who have been on biological (52%) or biosimilar medicines before (49%) • Consumers who were confident in taking biosimilar medicine (32%) or switching to a biosimilar

medicine (28%).


Page 86 of 137

6.2.2 Familiarity with biosimilar medicines All consumers were then asked how familiar they were with biosimilar medicines. Familiarity with biosimilar medicines was lower than for biologic medicines. Only 15% were familiar with biosimilar medicines (either ‘very familiar’ or ‘familiar’), while the largest proportion (45%) was ‘unfamiliar’ and a further 23% had ‘never heard of’ biosimilar medicines.

Figure 65: Familiarity with biosimilar medicines

Q2. How familiar are you with biosimilar medicines?


Figure 66: Familiarity with biosimilar medicines – sub group differences

Consumers

More likely to be familiar (so ‘very familiar’ or ‘familiar’ combined) • Consumers with ‘other conditions’ (24%) • Those from capital cities (20%) • Those familiar with biologic medicines (55%) • Those who have been on biological (41%) or biosimilar medicines before (43%) • Consumers confident in switching to a biosimilar medicine (19%).


Page 87 of 137

Patients tended to be more familiar with biologic medicine than their carers (24% c.f. 14%); whereas carers were somewhat more familiar with biosimilar medicines compared with patients (20% c.f. 14%); however these differences are not statistically significant.

Figure 67: Familiarity with biologic and biosimilar medicines - comparison

Q1. How familiar are you with biologic medicines? Q2. How familiar are you with biosimilar medicines?


Page 88 of 137

6.3 Prevalence of use of biologic and biosimilar medicines Consumers were asked if they (or the person they cared for) had used a biological or biosimilar medicine. Nearly one third of consumers said that they had used biologic medicines (32% - with 16% currently on one, and 16% saying they were previously on one). A similar proportion said that they have used biosimilar medicines (31% - with 13% currently on one and 18% previously on one).

Over one quarter of consumers did not know if they were on or previously on a biologic medicine (27%), or a biosimilar medicine (29%).

Figure 68: Used biologic or biosimilar medicines

Q4. [Are you/ Is a person you care for] currently on or have [you/they] previously been on a biologic medicine? Q6. [Are you/ Is a person you care for] currently on or have [you/they] previously been on a biosimilar medicine?


Figure 69: Used biologic or biosimilar medicines – sub group differences

Consumers

More likely to currently be on a biologic medicine • Consumers with ‘other conditions’ (29%) • Those from capital cities (20%) • Those who have previously been on biosimilar medicines (51%) • Consumers who were confident in taking a biosimilar medicine (23%) or switching to a biosimilar

medicine (22%) Consumers who were previously on a biologic medicine, but not currently, were more likely to be • Those with ‘other conditions’ (28%) • Those who have been on biosimilar medicines before (37%)


Page 89 of 137

Consumers

• Those who were confident in taking a biosimilar medicine (20%) More likely to currently be on a biosimilar medicine • Those who have been on a biologic medicine (33%) • Consumers who were confident in taking a biosimilar medicine (20%) or switching to a biosimilar

medicine (16%) Consumers who were previously on a biosimilar medicine, but not currently, were more likely to be • Those with ‘other conditions’ (31%)

6.4 Sources of awareness: biologic and biosimilar medicines 6.3.2 Sources of awareness: biologic medicines All consumers (with the exception of two) were aware of biologic medicines and were asked how they found out about biologic medicines. Where respondents mentioned more than one source of information, the most recent source of awareness was explored. As shown in the table below, provider channels were the most common (46%), and for three in ten they were also the most recent source (29%). Word of mouth was also important with 42% overall and 23% mentioning this as the most recent source. The Department was attributed as being a source of awareness by 24% of consumers overall, while peak bodies/support groups were mentioned by one in five consumers overall (20%). The media (11%) and academic channels (10%) were less common sources of awareness of biologic medicines.

Table 10: Sources of awareness of biologic medicines



Total consumer (n=198) %

Patients (n=163) %

Carers (n=35) %


Patients (n=163) %

Carers (n=35) %

Provider channels - total 46 48 40 29 30 26

General practitioner 28 28 29 13 13 11

Pharmacist 18 20 11 7 6 9

Specialist 17 18 11 8 8 6

Nurse 11 11 9 2 2 -


General information online, but can't recall specifically where

23 25 11 12 13 9

Word of mouth 18 17 20 8 8 9

Online forums that I participate in 8 8 9 3 2 6



Page 90 of 137




Patients (n=163) %

Carers (n=35) %


Patients (n=163) %

Carers (n=35) %


13 12 17 4 3 6


12 13 6 6 6 3

Information sources from State / Territory based Health Departments

9 10 3 1 1 -

Peak bodies/support groups - total

20 19 23 8 7 9

Communications (including pamphlets and brochures) from national patient peak bodies related to your condition or the person you care for or their state arms

17 17 20 7 6 9

Patient support groups that I attend 5 4 9 1 1 -

Media - total 11 12 9 4 4 3



University studies 6 5 11 3 2 6

Medical journals / academic papers 6 5 9 1 1 3

Other (please specify) 1 1 0 3 3 -


Average number of mentions 2.0 2.24 1.83 Q3a. How did you find out about biologic medicines? MULTIPLE RESPONSE Q3b. And which was your most recent source of information about biologic medicines? SINGLE RESPONSE


Figure 70: All sources of awareness of biologic medicines – sub group differences

Consumers

• Consumers who had been on a biologic medicine were more likely to mention:


Page 91 of 137

Consumers

– ‘Provider channels’ overall (77%), particularly ‘GPs’ (39%), ‘pharmacists’ (30%), ‘specialists’ (31%) and ‘nurses’ (22%)

– ‘Department channels’ overall (38%), particularly ‘brochures or pamphlets from the Australian Government Department of Health’ (20%) and ‘information sources from State/ Territory based Health Departments’ (16%)

– ‘Online forums that I participate in’ (17%) – ‘Academic channels’ overall (16%) and particularly ‘University studies’ (11%)

• Consumers who had been on biosimilar medicines were more likely to mention: – ‘Provider channels’ overall (75%), particularly ‘specialists’ (31%) and ‘nurses’ (20%) – ‘Brochures or pamphlets from the Australian Government Department of Health’ (22%) – ‘Academic channels’ overall (18%) and particularly ‘University studies’ (14%)

• Consumers with arthritis-related conditions were more likely to mention their ‘GP’ (35%) as a source of information

• Consumers with ‘other conditions’ were more likely to mention: – ‘Department channels’ overall (34%), and particularly ‘brochures or pamphlets from the

Australian Government Department of Health’ (26%) – ‘Nurses’ (19%)

• Consumers who were confident taking biosimilar medicines were more likely to mention: – ‘Provider channels’ overall (55%) – ‘Department channels’ overall (30%), particularly ‘brochures or pamphlets from the Australian

Government Department of Health’ (16%) – ‘Academic channels’ overall (14%) and particularly ‘University studies’ (9%) – ‘Online forums that I participate in’ (11%)

6.3.3 Sources of awareness: biosimilar medicines The 84% of consumers who were aware of biosimilar medicines were asked how they found out about them. Where respondents mentioned more than one source of information, the most recent source of awareness was explored. As shown in the table below (and similar to biologic medicines), overall provider channels were the most common (44%) and for three in ten they were also the most recent source (30%). Word of mouth was also important with 33% overall and 19% mentioning this as the most recent source. The Department was attributed as being a source of awareness by 25% of consumers overall, while peak bodies/support groups were mentioned by one in five consumers overall (18%). Academic channels (10%) and the media (8%) were less common sources of awareness for biosimilar medicines.

Table 11: Sources of awareness of biosimilar medicines

All sources of awareness

mentioned Most recent source of

awareness


Patients (n=141) %

Carers (n=27) %


Patients (n=141) %

Carers (n=27) %




Page 92 of 137



awareness


Patients (n=141) %

Carers (n=27) %


Patients (n=141) %

Carers (n=27) %

Pharmacist 17 16 19 8 6 15

Specialist 15 14 19 7 7 7

Nurse 7 7 7 2 3 -


Word of mouth 17 17 15 7 7 7


15 16 11 8 8 7

Online forums that I participate in 6 7 - 4 5 -



16 16 15 6 6 4


10 9 15 4 4 4


8 6 15 2 1 7


18 18 22 8 8 7


16 15 22 5 5 7

Patient support groups that I attend 4 4 4 2 3 -



Medical journals / academic papers 5 5 7 1 1 -

Medial - total 8 9 7 2 2 4



Page 93 of 137



awareness


Patients (n=141) %

Carers (n=27) %


Patients (n=141) %

Carers (n=27) %



Average number of mentions 1.73 1.72 1.89 Q5a. How did you find out about biosimilar medicines? MULTIPLE RESPONSE Q5b. And which was your most recent source of information about biosimilar medicines? SINGLE RESPONSE


Figure 71: All sources of awareness of biosimilar medicines – sub group differences

Consumers

• Consumers who had been on a biologic medicine were more likely to mention: – ‘Provider channels’ overall (59%), particularly ‘specialists’ (31%) – ‘Word of mouth’ (25%) – ‘Academic channels’ overall (16%)

• Consumers who had been on biosimilar medicines were more likely to mention: – ‘Provider channels’ overall (63%), particularly ‘specialists’ (31%) – ‘Department channels’ overall (39%), particularly ‘brochures or pamphlets from the Australian

Government Department of Health’ (27%) – ‘Peak bodies/support groups’ overall (27%) – ‘Media’ overall (16%) – ‘University studies’ (12%)

• Consumers with arthritis-related conditions were more likely to mention their ‘pharmacist’ (24%) as a source of information

• Consumers with ‘other conditions’ were more likely to mention: – ‘Peak bodies/support groups’ overall (29%) – ‘Nurses’ (19%) – ‘Brochures or pamphlets from the Australian Government Department of Health’ (17%) – ‘Online forums that I participate in’ (13%) – ‘University studies’ (12%)

• Consumers who were confident taking biosimilar medicines were more likely to mention: – ‘Provider channels’ overall (53%) – ‘Department channels’ overall (31%), particularly ‘brochures or pamphlets from the Australian

Government Department of Health’ (21%)

6.3.3 Sources of awareness: biologic and biosimilar medicines - comparison

The sources of awareness of both biologic and biosimilar medicines were similar for consumers.


Page 94 of 137

• For consumers the most common sources of awareness for both biologic and biosimilar medicines were GPs (with the same result for biologic and biosimilar medicines 24%), pharmacists (18% c.f. 17%), and word of mouth (18% c.f. 17%). General information found online was also a frequently mentioned source about biologic medicines (23%).

Table 12: Sources of awareness of biologic and biosimilar medicines – comparison

All sources of awareness mentioned about biologic

medicines

All sources of awareness mentioned about biosimilar

medicines


Patients (n=163) %

Carers (n=35) %


Patients (n=141) %

Carers (n=27) %



Pharmacist 18 20 11 17 16 19

Specialist 17 18 11 15 14 19

Nurse 11 11 9 7 7 7



23 25 11 15 16 11

Word of mouth 18 17 20 17 17 15

Online forums that I participate in 8 8 9 6 7 -



13 12 17 10 9 15


12 13 6 16 16 15


9 10 3 8 6 15


20 19 23 18 18 22


17 17 20 16 15 22

Patient support groups that I attend 5 4 9 4 4 4


Page 95 of 137

All sources of awareness mentioned about biologic

medicines

All sources of awareness mentioned about biosimilar

medicines


Patients (n=163) %

Carers (n=35) %


Patients (n=141) %

Carers (n=27) %

Media - total 11 12 9 8 9 7




Medical journals / academic papers 6 5 9 5 5 7



Average number of mentions 2.0 2.24 1.83 1.73 1.72 1.89 Q3a. How did you find out about biologic medicines? MULTIPLE RESPONSE Q5a. How did you find out about biosimilar medicines? MULTIPLE RESPONSE


Page 96 of 137

6.5 Advantages and disadvantages of biosimilar medicines 6.4.1 Barriers and benefits to taking biosimilar medicines Consumers were asked if they could see any potential barriers to taking biosimilar medicines, as well as potential benefits of doing so.

Consumers were more likely to see potential benefits to taking biosimilar medicines (39%) than potential barriers (18%). However more than half did not know if there were barriers (53%) or benefits (53%).

Figure 72: Barriers and benefits of biosimilar medicines

Q7. Do you think there are any potential barriers to [you/a person you care for] taking biosimilar medicines? Q9. Do you think there are any potential benefits to [you/a person you care for] taking biosimilar medicines?


Figure 73: Barriers and benefits to taking biosimilar medicines – sub group differences

Consumers

• Consumers who saw barriers were more likely to: – Have ‘other conditions’ (28%), familiar with biologic medicines (45%), have been on biologic

(42%) or biosimilar (49%) medicines, and confident taking biosimilar medicines (22%). • Consumers who saw benefits were more likely to be:

– Familiar with biologic medicines (75%), had been on biologic (63%) or biosimilar (73%) medicines, and were confident taking (54%) or switching to (49%) biosimilar medicines.


Page 97 of 137

6.4.2 Perceived barriers to taking biosimilar medicines Those consumers who could see potential barriers to taking biosimilar medicines (n=35) were prompted as to what those potential barriers might be. As shown in the following table:

• Consumers had greatest concern for patient outcomes overall (69%), and considered the largest barrier to be ‘concern about personal adverse outcomes’ (26%) followed by ‘concern about having a fail and this counting against me in terms of PBS subsidised access to biologic medicines in the future’ (23%).

• Two in five consumers raised information related concerns (40%). Of note, the largest proportion of consumers overall mentioned ‘insufficient information on biosimilar medicines for patients’ (29%) as being a barrier. A further 17% mentioned ‘insufficient information on biosimilar medicines for prescribers’.

Table 13: Potential barriers to taking biosimilar medicines


Patients (n=29) %

Carers (n=6)* %

Patient outcomes - total 69 69 67

Concern about adverse outcomes for [me/the person I care for]

26 28 17

Concern about having a fail and this counting against [me/the person I care for] in terms of PBS subsidised access to biologic medicines in the future

23 24 17

Immunogenicity concerns 20 24 -

Concern over the strength of pharmacovigilance activities

20 17 33

Information related - total 40 41 33

Insufficient information on biosimilar medicines for patients

29 28 33

Insufficient information on biosimilar medicines for prescribers

17 21 -


Absence of incentives for patients to use biosimilar medicines

9 7 17

Absence of incentives for physicians to prescribe biosimilar medicines

9 7 17

Other - total 17 17 17

Concern over the delay of biosimilar medicines due to legal / international

9 7 17


Page 98 of 137

patent issues

I don’t see the need to change what [I/the person I care for] take/s

9 10 -

Other (please specify) 11 7 -

Average number of mentions 1.74 1.79 1.5 Q8. Which of the following do you think are potential barriers to [you/a person you care for] taking biosimilar medicines? MULTIPLE RESPONSE

The sample size is too small to provide comment on statistically significant sub-group differences.

6.4.3 Perceived benefits to taking biosimilar medicines Those consumers who could see potential benefits to taking biosimilar medicines (n=77) were prompted as to what those potential benefits might be.

• Consumers were most likely to mention price related benefits overall (84%), particularly that biosimilar medicines would be ‘more affordable for patients’ (44%), ‘lower prices through competition’ (35%), and ‘enables more medicines to be listed on the PBS’ (31%).

• Seven in ten mentioned patient related outcomes (71%), particularly ‘treatment choice’ and generally ‘positive impact on patient outcomes’ (both 35%).

• In terms of perceived industry outcome benefits, three in ten thought that biosimilar medicines could lead to ‘advances in medicine technology’ (30%).

Table 14: Potential benefits to taking biosimilar medicines


Patients (n=63) %

Carers (n=14)* %


More affordable for patients 44 41 57

Lower prices through competition 35 37 29

Enables more medicines to be listed on the PBS

31 32 29

Save taxpayers money 29 32 14

More affordable for hospitals 27 29 21

More affordable for the PBS 22 21 29

Patient outcomes - total 71 71 71

Treatment choice 35 37 29

Positive impact on patient outcomes 35 35 36


Page 99 of 137

Broadens access for patients at an earlier stage of disease

26 29 14

Mitigate against medicine shortages 22 22 21

Industry outcomes - total 38 33 57

Advances in medicine technology 30 27 43

Improved manufacturing processes 16 14 21

Other (please specify) - - -

Average number of mentions 3.52 3.54 3.43 Q10. Which of the following do you think are potential benefits to [you/a person you care for] taking biosimilar medicines? MULTIPLE RESPONSE


Figure 74: Potential benefits to taking biosimilar medicines – sub group differences

Consumers

• Consumers unfamiliar with biologic medicines were more likely to mention ‘lower prices through competition’ (48%)

• Consumers with an arthritis associated condition were more likely to mention ‘save taxpayers money’ (43%)


Page 100 of 137

6.6 Confidence in taking biosimilar medicines 6.5.1 Unprompted confidence taking biosimilar medicines

Consumers were asked how confident they were personally in taking (or in the case of carers, the person they care for taking) biosimilar medicines.

Three in five consumers were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) taking biosimilar medicines (62%). Conversely, nearly two fifths (39%) reported that they were not confident (‘little confidence’ and ‘not confident at all’ combined). Notably, those who were familiar with biosimilar medicines were significantly more likely to report confidence in taking them (89%); once more highlighting the importance of knowledge.

Figure 75: Unprompted confidence taking biosimilar medicines

Q11. Which of the following best describes how confident you are personally [in taking/in a person you care for taking] biosimilar medicines?


Figure 76: Unprompted confidence taking biosimilar medicines – sub group differences

Consumers

The characteristics of consumers more likely to be confident taking biosimilar medicines (on an unprompted basis) were: • Consumers familiar with biologic medicines had higher confidence taking them (89%). • Those who had been on biologic (83%) or biosimilar (84%) medicines were more likely to be

confident. • Consumers who were confident switching to biosimilars were more likely to be confident taking

them (79%).


Page 101 of 137

6.5.2 Prompted confidence taking biosimilar medicines In order to explore the potential impact of information on confidence levels, all consumers were provided with a definition of biosimilar medicines, and then asked how confident they felt in taking biosimilar medicines in light of the information provided. Importantly, confidence levels were increased – even after receiving a small amount of information.

After prompting, more than seven in ten consumers were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) taking biosimilar medicines (72% ten percentage points from the unprompted result of 62%).

Figure 77: Unprompted and prompted confidence taking biosimilar medicines - comparison

Q11. Which of the following best describes how confident you are personally [in taking/in a person you care for taking] biosimilar medicines? Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that is demonstrably similarity in chemical and biological characteristics, effectiveness and safety. The active substances of biologic medicines and their complexity as well as the way they are produced may result in a degree of variability, between brands as well as between batches within a brand of the medicine. Considering this, how confident do you feel about taking biosimilar medicines?


Figure 78: Prompted confidence taking biosimilar medicines – sub group differences

Consumers

The characteristics of consumers more likely to be confident taking biosimilar medicines (after prompting) were: • Consumers from VIC/TAS (84%) • Consumers familiar with biologic medicines (93%) • Those who had been on biologic (91%) or biosimilar (92%) medicines.


Page 102 of 137

6.5.3 Confidence in effectiveness of biosimilar medicines Consumers were asked how confident they were in the effectiveness of biosimilar medicines.

Two in three consumers (65%) were confident with the effectiveness of biosimilar medicine overall (‘totally confident’, ‘very confident’ and ‘confident enough to take biosimilars’ combined). Conversely, over a third (35%) were not confident overall (‘little confidence’ and ‘not confident at all’ combined).

Figure 79: Confidence in effectiveness of biosimilar medicines

Q12. Which of the following best describes how confident you are in the effectiveness of biosimilar medicines?


Figure 80: Confidence in effectiveness of biosimilar medicines – sub group differences

Consumers

The characteristics of consumers more likely to be confident in the effectiveness of biosimilar medicines were: • Consumers familiar with biologic medicines (93%) • Those who had been on biologic (86%) or biosimilar (90%) medicines • Consumers who were confident taking biosimilars (94%) • Consumers who were confident switching to biosimilars (81%).


Page 103 of 137

6.5.4 Confidence in comparability to the reference biologic medicine All consumers were asked how confident they were that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market).

Almost seven in ten consumers were confident with the comparability overall (‘totally confident’, ‘very confident’ and ‘confident enough to take biosimilar medicines’ combined) - 68%, while 32% were not confident overall (‘little confidence’ and ‘not confident at all’ combined).

Figure 81: Confidence in comparability of biosimilar medicines

Q13. Which of the following best describes how confident you are that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market)?


Figure 82: Confidence in comparability of biosimilar medicines – sub group differences

Consumers

The characteristics of consumers more likely to be confident in the comparability of biosimilar medicines were: • Consumers familiar with biologic medicines (93%) • Those who had been on biologic (91%) or biosimilar (92%) medicines • Consumers who were confident taking biosimilars (95%) • Consumers who were confident switching to biosimilars (84%).


Page 104 of 137

6.5.5 Confidence in the effectiveness and comparability of biosimilar medicines - comparison

There was a high degree of alignment between the results of confidence in the effectiveness of biosimilars, and confidence that they are comparable to the reference medicine (66% and 69% respectively).

Figure 83: Confidence in the effectiveness and comparability of biosimilar medicines - comparison

Q12. Which of the following best describes how confident you are in the effectiveness of biosimilar medicines? Q13. Which of the following best describes how confident you are that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market)?

6.5.6 Attitudes towards biosimilar medicines Consumers were asked how strongly they agreed or disagreed with twelve statements about biologic and biosimilar medicines using the scale ‘strongly agree’, ‘agree’, ‘neutral’, ‘disagree’, ‘strongly disagree’ and ‘unsure/not relevant’.

The statements with the highest levels of agreement were:

• I would accept a biosimilar medicine if recommended by my doctor (71%)

• I would accept a biosimilar medicine because I am confident in Australia’s regulatory processes (61%)

• Biosimilar medicines will lead to a reduction in costs meaning the treatments is cost-effective for other patient groups, who could then access PBS subsidy for the medicine (55%)

The statements with the highest levels of disagreement were:


Page 105 of 137

• I am disinclined to accept a new medicine until other people I know with the same condition recommend it (22%)

• Biosimilars are essentially the same as generic medicines (19%)

• I am aware of the Pharmaceutical Benefits Advisory Committee’s (PBAC’s) decision making processes for the subsidy of medicines (19%).

The ‘unsure/not relevant’ response was higher than average for ‘it would be appropriate for me to consider a biosimilar medicine if I had never taken the reference biologic’ (17%).

The results for the consumer segments for each statement are detailed below.

Less than half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that they were generally comfortable with biologic medicines (45%), while 10% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (35%) and 11% said ‘unsure/not relevant’.

Figure 84: Comfort with biologic medicines

Q14a. How strongly do you agree or disagree with the statement ‘I am generally comfortable with biologic medicines’?


Page 106 of 137

One in three consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that they were disinclined to accept a new medicine until other people they know with the same condition recommend it (37%), while 22% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (34%) and 8% said ‘unsure/not relevant’.

Figure 85: Other people’s recommendation

Q14b. How strongly do you agree or disagree with the statement ‘I am disinclined to accept a new medicine until other people I know with the same condition recommend it’?


Page 107 of 137

Three in five consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that they would accept a biosimilar medicine because they were confident in Australia’s regulatory processes (61%), while 9% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in four were ‘neutral’ (23%) and 8% said ‘unsure/not relevant’.

Figure 86: Biosimilars and confidence in Australia’s regulatory processes

Q14c. How strongly do you agree or disagree with the statement ‘I would accept a biosimilar medicine because I am confident in Australia’s regulatory processes’?


Page 108 of 137

Less than half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that medication access programs offered by pharmaceutical companies have an impact on treatments available for their condition (45%), while 8% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (33%) and 15% said ‘unsure/not relevant’.

Figure 87: Biosimilars and medication access programs

Q14d. How strongly do you agree or disagree with the statement ‘medication access programs offered by pharmaceutical companies have an impact on treatments available for [my/this] condition’’?


Page 109 of 137

One in three consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that biosimilar medicines are essentially the same as generic medicines (37%), while 19% disagreed overall (either ‘strongly disagree’ or ‘disagree’). Three in ten were ‘neutral’ (30%) and 15% said ‘unsure/not relevant’.

Figure 88: Biosimilars are essentially the same as generic medicines

Q14e. How strongly do you agree or disagree with the statement ‘biosimilar medicines are essentially the same as generic medicines’?


Page 110 of 137

Less than half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) they were aware of the Pharmaceutical Benefits Advisory Committee’s (PBAC’s) decision making processes for the subsidy of medicines (46%), while 19% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in four were ‘neutral’ (26%) and 10% said ‘unsure/not relevant’.

Figure 89: Awareness of PBACs decision making processes

Q14f. How strongly do you agree or disagree with the statement ‘I am aware of the Pharmaceutical Benefits Advisory Committee’s (PBAC’s) decision making processes for the subsidy of medicines’?


Page 111 of 137

Less than half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that biosimilar medicines will have a significant impact on how patients with their condition are treated (44%), while 9% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (32%) and 15% said ‘unsure/not relevant’.

Figure 90: Impact of biosimilars

Q14g. How strongly do you agree or disagree with the statement ‘biosimilar medicines will have a significant impact on how patients with [my/this] condition are treated’?


Page 112 of 137

About one in three consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that it would be appropriate for them to consider a biosimilar medicine if they had never taken the reference biologic (35%), while 12% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (37%) and 17% said ‘unsure/not relevant’. Carers were more likely to disagree overall (23%) compared to patients (10%).

Figure 91: Biosimilar medicine consideration

Q14h. How strongly do you agree or disagree with the statement ‘it would be appropriate for me to consider a biosimilar medicine if [I/the person I care for] had never taken the reference biologic’?


Page 113 of 137

Almost half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that it would be appropriate to switch from the reference biologic to the biosimilar if they were treatment stable (49%), while 9% disagreed overall (either ‘strongly disagree’ or ‘disagree’). Three in ten were ‘neutral’ (30%) and 13% said ‘unsure/not relevant’.

Figure 92: Biosimilars and biologic-treatment stable

Q14i. How strongly do you agree or disagree with the statement ‘it is appropriate to switch from the reference biologic to the biosimilar if [I/the person I care for] was treatment stable’?


Page 114 of 137

More than half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for other patient groups, who could then access PBS subsidy for the medicine (55%), while 5% disagreed overall (either ‘strongly disagree’ or ‘disagree’). Three in ten were ‘neutral’ (30%) and 11% said ‘unsure/not relevant’.

Figure 93: Biosimilars and cost-effectiveness

Q14j. How strongly do you agree or disagree with the statement ‘biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for other patient groups, who could then access PBS subsidy for the medicine’?


Page 115 of 137

About half of consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of the PBS (52%), while 6% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (31%) and 11% said ‘unsure/not relevant’.

Figure 94: Biosimilars and sustainability of the PBS

Q14k. How strongly do you agree or disagree with the statement ‘biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of the PBS’?


Page 116 of 137

Seven in ten consumers agreed overall (either ‘strongly agreed’ or ‘agreed’) that they would accept a biosimilar medicine if recommended by their doctor (71%), while 6% disagreed overall (either ‘strongly disagree’ or ‘disagree’). One in three were ‘neutral’ (31%) and 11% said ‘unsure/not relevant’.

Figure 95: Biosimilar medicine recommended by doctor

Q14k. How strongly do you agree or disagree with the statement ‘I would accept a biosimilar medicine if recommended by my doctor’?


Figure 96: Attitudes to biosimilar medicines – sub group differences


Consumers who were familiar with biologic medicines were more likely to agree that...

• They were generally comfortable with biologic medicines (64%). • They were disinclined to accept a new medicine until other people they knew with the same

condition recommend it (55%). • Medication access programs offered by pharmaceutical companies have an impact on

treatments available for their condition (59%). • Biosimilar medicines are essentially the same as generic medicines (59%). • They were aware of PBAC’s decision making processes for the subsidy of medicines (61%). • Biosimilar medicines will have a significant impact on how patients with the condition are treated

(61%). • It would be appropriate to consider a biosimilar medicine if the person I care for had never taken

the reference biologic (48%). • It would be appropriate to switch from the reference biologic to the biosimilar if the person was

treatment stable (70%).


Page 117 of 137


Consumers who were confident taking biosimilar medicines were more likely to agree that...

• They were generally comfortable with biologic medicines (60%). • They would accept a biosimilar medicine because they were confident in Australia’s regulatory

processes (76%). • Medication access programs offered by pharmaceutical companies have an impact on




treatment stable (66%). • Biosimilars will lead to a reduction in costs meaning the treatment is cost effective for other

patient groups, who could then access PBS subsidy for the medicine (67%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability

of the PBS (67%). • I would accept a biosimilar medicine if recommended by my doctor (79%).

Consumers who were confident switching to biosimilar medicines were more likely to agree that....

• They were generally comfortable with biologic medicines (57%). • They would accept a biosimilar medicine because they were confident in Australia’s regulatory

processes (72%). • Medication access programs offered by pharmaceutical companies have an impact on




treatment stable (60%). • Biosimilars will lead to a reduction in costs meaning the treatment is cost effective for other

patient groups, who could then access PBS subsidy for the medicine (63%). • Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability

of the PBS (63%). • I would accept a biosimilar medicine if recommended by my doctor (79%).

VIC/Tas consumers were more likely to agree that...

• Biosimilar medicines are essentially the same as generic medicines (48%). • That they were aware of PBAC’s decision making processes for the subsidy of medicines (57%). • That biosimilar medicines will have a significant impact on how patients with the condition are

treated (55%). • It would be appropriate to consider a biosimilar medicine if the person I care for had never taken

the reference biologic (47%). • I would accept a biosimilar medicine if recommended by my doctor (81%).

Consumers with ‘other conditions’ were more likely to disagree that...


Page 118 of 137

More likely to agree • It would be appropriate to switch from the reference biologic to the biosimilar if the person was

treatment stable (17%).

6.7 Intention to switch/use/accept biosimilar medicines 6.6.1 Confidence switching from a reference biologic medicine to a

biosimilar medicine Consumers were asked how confident they were in switching from a reference biologic medicine to a biosimilar medicine if prescribed by their doctor.

Three in four consumers were confident overall (‘totally confident’, ‘very confident’ and ‘confident enough to do so’ combined) to switch (75%).

Figure 97: Confidence switching

Q16. Which of the following best describes generally how confident you are in switching from a reference biologic medicine to a biosimilar medicine if prescribed by your doctor?


Figure 98: Confidence switching – sub group differences

Consumers

More likely to be confident • Consumers who had been diagnosed in the past three years were more likely to be confident

switching to a biosimilar medicine (83%).


Page 119 of 137

Consumers

• Consumers familiar with biologic medicines had higher confidence in switching (95%). • Those how had been on biologic (91%) or biosimilar (88%) medicines were more likely to be

confident. • Consumers who were confident taking biosimilars were more likely to be confident in switching

(96%).

6.6.2 Feelings about substitution Consumers were advised that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be available in the future. In this context, consumers were asked how they felt about pharmacists offering substitution (so offering the biosimilar medicine in the place of the reference biologic medicine).

Just over half were concerned overall (‘very concerned’, ‘concerned’ and ‘mildly concerned’ combined) about substitution (56%), while 34% were ‘neutral’ and 12% were ‘not concerned’.

Figure 99: Feelings about substitution - detail

Q18. You may or may not be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be available in the future. Which of the following best describes how you feel about pharmacists offering substitution (so offering the biosimilar medicine in the place of the reference biologic medicine)?


Page 120 of 137

Figure 100: Feelings about substitution - summary

Q18. You may or may not be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be available in the future. Which of the following best describes how you feel about pharmacists offering substitution (so offering the biosimilar medicine in the place of the reference biologic medicine)?


Figure 101: Feelings about substitution – sub group differences

Consumers

More likely to be concerned about substitution • Consumers with ‘other conditions’ were more likely to be concerned (72%). • Those familiar with biologic medicines had greater concerns (89%). • Those how had been on biologic (81%) or biosimilar (76%) medicines were more likely to be

concerned.

6.6.3 Additional comments about biosimilar medicines Consumers were asked if they had any specific additional comments that they wanted to make about biosimilar medicines. This was a fully open ended, free-text question.

Less than one in five consumers made comments (17%) with the most frequent being ‘generally positive comments related to biosimilars being a good idea and having value’ (4%).


Page 121 of 137

Table 15: Additional comments about biosimilar medicines


Patients (n=165) %

Carers (n=35) %

Additional comments made - total 17 16 20

General positive comments - good idea/see value/etc.

4 3 6

Substitution by the pharmacist should not be allowed

2 2 -

Concerns about adverse health outcomes/variances in efficacy

2 2 3

Concerns about quality/ingredients 2 2 3

Cost effective/will reduce costs 2 2 -

Support as long as regulations/restrictions in place

2 1 3

Would use on doctor's recommendation 2 2 -

More data/evidence/long-term monitoring needed

1 1 3

More information/education/marketing needed

1 1 -

Cost benefits must be matched by patient interests

1 1 3

Confusing for patients 1 - 3

Other 1 1 0

No comments 84 84 23

Q19. Do you have any specific additional comments that you would like to make about biosimilar medicines? OPEN ENDED

Due to the small number responding to this question, there were no sub-group differences.


Page 122 of 137

6.8 Understanding of the PBS 6.7.1 Confidence in the way medicines regulated in Australia Consumers were asked how confident they were in the way that medicines are regulated in Australia.

More than four in five consumers (87%) were confident overall (‘totally confident’, ‘very confident’ and ‘confident’ combined). Carers were significantly more likely to be ‘confident’ (69%) compared to patients (41%).

Figure 102: Confidence in medicine regulation

Q20. Thinking about the PBS now, how confident are you in the way that medicines are regulated in Australia?


Figure 103: Confidence in medicine regulation – sub group differences

Consumers

More likely to be confident overall • Carers (97%). • VIC/TAS consumers (95%). • Those familiar with biologic medicines (95%). • Those who had been on biologic medicines (94%). • Those confident taking (93%) or switching to (91%) biosimilar medicines.


Page 123 of 137

6.7.2 Need to increase the understanding of the PBS Consumers were asked how strongly they agreed or disagreed that there was a need to increase the understanding of the PBS amongst the general community.

Seven in ten agreed overall (‘strongly agreed’ and ‘agreed’ combined) that there was a need (72%), while a further 20% were ‘neutral’. Just 6% disagreed overall (‘disagreed’ and ‘strongly disagreed’ combined). There were no notable sub-group differences.

Figure 104: Need to increase understanding of the PBS

Q21. How strongly do you agree or disagree that there is a need to increase the understanding of the PBS amongst the general community?


Page 124 of 137

When asked the types of information consumers thought the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community, the most frequently mentioned issues to communicate were:

• ‘The role of the PBS in terms of providing affordable access to important and new medicines’ (61%)

• ‘The role of the PBAC in recommending medicine be listed on the PBS’ (54%) • ‘How you know when you’ve received a medicine subsidised through the PBS’ (51%) • ‘The importance of the PBS in the context of the overall health budget’ (49%)

As with professional stakeholders - general education and messages around sustainability and accessibility all appear to be important to consumers.

Table 16: Information the Australian Government Department of Health should communicate to increase understanding of the PBS


Patients (n=165) %

Carers (n=35) %

General education - total 78 81 66

The role of the PBAC in recommending medicine be listed on the PBS

54 55 46

How you know when you’ve received a medicine subsidised through the PBS

51 52 46

What co-payments are relative to the true costs of medicines

45 46 40

What the PBS is 43 45 31

Sustainability - total 70 70 71


61 61 60


42 46 23

Accessibility - total 59 65 29

The importance of the PBS in the context of the overall health budget

49 54 23


38 42 17


Page 125 of 137


Patients (n=165) %

Carers (n=35) %


No information needs to be communicated

1 1 3

Don't know 8 7 11

Q22.Which if any of the following do you think the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community? MULTIPLE RESPONSE


Page 126 of 137

7 Conclusions & Recommendations

This section highlights the key findings from the survey in terms of how they translate into recommendations for the (high level) content and dissemination channels of a communications initiative. Given the differences between the stakeholders groups in the survey results and associated implications, a separate diagram has been produced for each segment.


Page 127 of 137

7.1 Professional stakeholders 7.1.1 Specialists Given the high existing knowledge among specialists, communication is a relatively low priority with this professional group. However, the survey results indicate significant doubts around comparability between biosimilar medicines and the reference brand; and associated concerns in terms of patient outcomes. Moreover, specialists (particularly rheumatologists) tend to be reluctant to switch biologic-stable patients.

With this in mind, we recommend that the communication initiative focuses on addressing these concerns and reinforcing the benefits of switching. Given their channel preferences, communications through academic channels and word of mouth would appear to be most effective.

Figure 105: Specialist overview diagram


Page 128 of 137

7.1.2 GPs GPs have the least knowledge and also the lowest confidence levels in prescribing biosimilar medicines. Given this, and given that they represent such an important medium of information to consumers, a communications initiative targeting GPs is vital.

Its content should provide reassurance around patient outcomes and reinforce the financial benefits of biosimilar medicines; particularly in terms of the sustainability of the PBS. Channel preferences would suggest online and social media channels would be effective.

Figure 106: GP overview diagram


Page 129 of 137

7.1.3 Pharmacists Pharmacists have relatively high existing levels of knowledge around biosimilar medicines, and very high levels of confidence in dispensing and switching.

As such, the need for communications to encourage the use of biosimilar medicines is of lower relative priority. If pharmacists are to be targeted, reassurance around patient outcomes and discussion of patient incentives to switching will be important content. Given their channel preferences, academic sources and industry-specific publications would be most effective.

Figure 107: Pharmacist overview diagram


Page 130 of 137

7.2 Consumers Consumers have very low levels of awareness of biosimilar medicines, but relatively high confidence in taking them; particularly if recommended to do so by their doctor.

This highlights a need for a communications initiative targeted particularly at consumers. But it is also important to bear in mind that any initiative directed at providers will impact indirectly on consumers.

Given their concerns, the communications should cover patient outcomes and reassurance around the PBS and eligibility. Preference channels point to collateral through providers (e.g. at GP centres and pharmacies) and online.

Figure 108: Consumer overview diagram


Appendix A: Specialist questionnaire


3000290 Biosimilars Quantitative research, Specialist Questionnaire Department of Health July 2016

INTRODUCTION EMAIL

This survey is being conducted by ORC International on behalf of the Australian Government Department of Health.

The department is interested in obtaining feedback from specialists about their levels of awareness and knowledge of, and attitudes towards, biologic and biosimilar medicines.

We expect that this survey will take you about 15 minutes to complete, and in thanks of your participation you will receive $130 (which will be sent to you from EKAS via cheque, assuming that you qualify to participate). The closing date for this survey is [IF SAMPLE TYPE 1, 2, 3, 4 SAY August 18 / ALL OTHERS SAY SEPTEMBER 9]

Please be assured that all the answers you provide will be treated in the strictest of confidence and de-identified. This research is being conducted in keeping with the Australian Privacy Principles. Our privacy policy is available on our website (www.ORCInternational.com).

Should you have any questions or require further information about the survey please contact Katherine Tran at ORC International via [email protected] or 03 9935 5700.

Please work through this questionnaire by reading each question and clicking the most appropriate answer (or answers when multiple responses are allowed).

o Please use "Previous" button at the bottom of the page to review your responses in the previous pages.

o Each time you click "Next" at the bottom of your page, your responses will be saved automatically.

o When you have completed the survey, please click "Save and Exit" to submit your answers. Once submitted, you will not be able to return to the survey.

Please select the next button below to begin.

SCREENER NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

S1. First of all we need to know your area of specialisation. Please select this below.

SINGLE RESPONSE

Dermatologist 1

Continue (until Aug 18 when must be removed

from sample)

Immunologist 2

Rheumatologist 3

Paediatric rheumatologist 4

Gastroenterologist 5 Continue



Endocrinologist 6

Consultant physician in general or internal medicine specialising in gastroenterology

7

Oncologist 8

Nephrologist 9

Haematologist 10

Ophthalmologist 21 Only include in blast out after sample categories 1 to

10 exhausted and dept gives permission for

extension of sample and their inclusion

Neurologist 22

Fertility specialist 23

Respiratory physician 24

Other 96 Thank and Close

FAMILIARITY WITH BIOLOGIC AND BIOSIMILAR MEDICINES NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

ASK ALL

Q1. How familiar are you with biologic medicines? SR

Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4

Never heard of them before 5

ASK ALL

Q2. How familiar are you with biosimilar medicines? SR

Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4


Never heard of before 5

IF Q1 = 5 AND Q2 = 5, THANK AND CLOSE. RECORD TERMINATIONS.

AWARENESS AND KNOWLEDGE OF BIOLOGIC MEDICINES NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

ASK IF Q1 = 1 - 4, OTHERS GO TO Q5a

First we have some questions about biologic medicines.

Q3a. How did you find out about biologic medicines? PLEASE SELECT AS MANY SOURCES OF INFORMATION AS APPLY TO YOU. MR. RANDOMISE CODEFRAME.

National Prescribing Service (NPS) / NPS Radar email alerts 1

Communications from specialty associations (i.e. Australian College of...) 2

Conferences related to your area of specialisation 3

Word of mouth via colleagues 4

Medical journals / academic papers 5

University studies 6

Pharmaceutical company representatives 7

Online information from the Australian Government Department of Health 8

Brochures or pamphlets from the Australian Government Department of Health 9

State / Territory based government Department of Health 10

From hospital Drug and Therapeutics Committee (DTC) 11

Media (including social media) 12

General information online, but can’t recall specifically where 13

Other (please specify) 96

Don't know/Can't Say 99

ASK IF Q3a = 2+ ANSWERS GIVEN, OTHERS GO TO Q4

Q3b. And which was your most recent source of information about biologic medicines? SR. RANDOMISE CODEFRAME. ONLY DISPLAY CODES SELECTED AT Q3A


















Q4. Have you ever prescribed a biologic medicine to a patient? SR

Yes 1

No 2

AWARENESS AND KNOWLEDGE OF BIOSIMILAR MEDICINES NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

ASK IF Q2 = 1 - 4, OTHERS GO TO Q7

Now we have some questions about biosimilar medicines.

Q5a. How did you find out about biosimilar medicines? PLEASE SELECT AS MANY SOURCES OF INFORMATION AS APPLY TO YOU. MR. RANDOMISE CODEFRAME


















Q5b. And which was your most recent source of information about biosimilar medicines? SR. RANDOMISE CODEFRAME. ONLY DISPLAY CODES SELECTED AT Q5A







Pharmaceutical company reps 7










Q6. Have you ever prescribed a biosimilar medicine to a patient? SR


Yes 1

No 2

ASK ALL

Q7. Do you think there are any potential barriers to you prescribing biosimilar medicines? SR

Yes 1

No 2

IF Q7=2 GO TO Q9

Q8. Which of the following do you think are potential barriers to you prescribing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME

Immunogenicity concerns 1

Insufficient information on biosimilar medicines for patients and stakeholders 2

Insufficient information on biosimilar medicines for prescribers 3

Absence of incentives for patients to use biosimilar medicines 4

Absence of incentives for physicians to prescribe biosimilar medicines 5


6


7

Concern over the strength of pharmacovigilance activities 8

Concern about adverse outcomes for my patients 9

I don’t see the need to change what I prescribe 10


Q9. Do you think there are any potential benefits to you prescribing biosimilar medicines? SR

Yes 1

No 2

IF Q9=2 GO TO Q11


Q10. Which of the following do you think are potential benefits to you prescribing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLY TO YOU MR. RANDOMISE CODEFRAME

More affordable for the PBS 1

Treatment choice 2

More affordable for patients 3

More affordable for hospitals 4

Lower prices through competition 5

Advances in medicine technology 6

Positive impact on patient outcome 7

Mitigate against medicine shortages 8

Broadens access for patients at an earlier stage of disease 9

Improved manufacturing processes 10

Save taxpayers money 11

Enables more medicines to be listed on the PBS 12


ATTITUDES TOWARDS BIOLOGIC AND BIOSIMILAR MEDICINES, INCLUDING CONFIDENCE IN THEIR EFFICACY AND SWITCHING NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

ASK ALL

Q11. Which of the following best describes how confident you are personally in prescribing biosimilar medicines? SR

Totally confident 1

Very confident 2

Confident enough to prescribe biosimilar medicines 3

Little confidence 4

Not confident at all 5

Q12. Which of the following best describes how confident you are in the efficacy of biosimilar medicine? SR

Totally confident 1

Very confident 2



Little confidence 4


Q13. Which of the following best describes how confident you are that biosimilar medicines are comparable to the reference biologic medicine (i.e. the first brand to market)? SR

Totally confident 1

Very confident 2


Little confidence 4



Q14. Please rate how strongly you agree or disagree with each of the statements below.

SR FOR EACH STATEMENT. ROTATE ORDER OF STATEMENTS.

Please mark one answer for each statement

Strongly agree

Agree Neutral Disagree Strongly disagree

Unsure/not relevant

a. I am generally comfortable prescribing biologic medicines to my patients

1 2 3 4 5 9

b. I am disinclined to offer a new medicine to my patients until my colleagues recommend it

1 2 3 4 5 9

c. I would prescribe a biosimilar medicine to my patients because I am confident in Australia’s regulatory processes

1 2 3 4 5 9

d. Medication access programs offered by pharmaceutical companies have an impact on which treatments I offer to my patients

1 2 3 4 5 9

e. Biosimilar medicines are essentially the same as generic medicines

1 2 3 4 5 9

f. I am aware of the PBAC ‘s decision making processes for the subsidy of medicines

1 2 3 4 5 9

g. Biosimilar medicines will have a significant impact on my area of specialisation and how patients are treated

1 2 3 4 5 9

h. It is appropriate to offer a biosimilar medicine to a biologic-naive patient

1 2 3 4 5 9


instead of the brand name

i. It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine

1 2 3 4 5 9

j. Biosimilar medicines will lead to a reduction in costs meaning the treatment is cost-effective for other patient groups, who could then access PBS subsidy for the medicine

1 2 3 4 5 9

k. Biosimilar medicines will lower the prices of medicines which will contribute to the sustainability of the PBS

1 2 3 4 5 9

INTENTION TO SWITCH/USE/ACCEPT BIOSIMILAR MEDICINES NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that has demonstrable similarity in physiochemical, biological and immunological characteristics, efficacy and safety.

The active substances of biologic medicines and their complexity as well as the way they are produced may result in a degree of variability, between brands as well as between batches within a brand of the medicine.

Considering this, how confident do you feel about prescribing biosimilar medicines? SR

Totally confident 1

Very confident 2


Little confidence 4



Q16. Which of the following best describes generally how confident you are in switching a patient from a reference biologic medicine to a biosimilar medicine? SR

Totally confident 1

Very confident 2

Confident enough to switch a patient 3

Little confidence 4


Q17. How confident are you in counseling patients about biosimilar medicines? SR

Totally confident 1

Very confident 2

Confident enough to do so 3

Little confidence 4


Q18. You may or may not be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future.

Which of the following best describes how you feel about pharmacists offering substitution? SR

Very concerned 1

Concerned 2

Mildly concerned 3

Neutral 4

Not concerned at all 5

Q19. Do you have any specific additional comments that you would like to make about biosimilar medicines? OE

<ENTER OE RESPONSE>

No answer


AWARENESS/KNOWLEDGE OF THE PBS NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

Thinking about the PBS now…

Q20. How confident are you in the way that medicines are regulated in Australia? SR

Totally confident 1

Very confident 2

Confident 3

Little confidence 4


Q21. How strongly do you agree or disagree that there is a need to increase the understanding of the PBS amongst the general community? SR

Strongly agree 1

Agree 2

Neutral 3

Disagree 4

Strongly disagree 5


Q22. Which, if any of the following do you think the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME

What the PBS is 1

The importance of the PBS in the context of the overall health budget 2


3

The role of the PBAC in recommending medicine be listed on the PBS 4

What co-payments are relative to the true costs of medicines 5

How you know when you’ve received a medicine subsidised through the PBS 6


7


8



No information needs to be communicated 97


DEMOGRAPHICS NOTE TO PROGRAMMER DO NOT DISPLAY TITLE

ASK ALL

D1. How long have you personally been working as a specialist in this area…? SR

Less than five years 1

Five to 10 years 2

11 to 19 years 3

20 years or longer 4

Prefer not to answer 98

D2. In what state do you work…? SR

Australian Capital Territory 1

New South Wales 2

Northern Territory 3

Queensland 4

South Australia 5

Tasmania 6

Victoria 7

Western Australia 8


D3. Do you mainly work in a…? SR

Metropolitan capital city 1

Outside of the capital city 2


THANK & CLOSE


That was the final question. Thank you for your time and assistance with this important survey which has been conducted by ORC International on behalf of the Australian Government Department of Health.

As a reminder, please be assured that all the answers you have provided will be treated in the strictest of confidence and de-identified. This research is being conducted in keeping with the Australian Privacy Principles and the industry Privacy Code.

Our privacy policy is available on our website (www.ORCInternational.com). Should you have any questions or require further information about the survey please contact Katherine Tran at ORC International via [email protected] or 03 9935 5700.

Quota

Type Target Source

Specialists 200 EKAS Sample



Appendix B: GP questionnaire


3000290 Biosimilars Quantitative research, GP Questionnaire Department of Health July 2016

INTRODUCTION EMAIL


The department is interested in obtaining feedback from General Practitioners about their levels of awareness and knowledge of, and attitudes towards, biologic and biosimilar medicines.

We expect that this survey will take you about 15 minutes to complete, and in thanks of your participation you will receive $50 (which will be sent to you from EKAS via cheque, assuming that you qualify to participate). The closing date for this survey is September 9.









S1. Are you currently working as a General Practitioner?

SINGLE RESPONSE

Yes 1 Continue

No 2 Thank and Close


ASK ALL




Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4


ASK ALL


Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4








Communications from specialty associations 2










REMOVED

















REMOVED






Q4. Have you ever prescribed a biologic medicine to a patient? SR

Yes 1

No 2
















REMOVED














Pharmaceutical company reps 7




REMOVED 11






Q6. Have you ever prescribed a biosimilar medicine to a patient? SR

Yes 1

No 2

ASK ALL

Q7. Do you think there are any potential barriers to you prescribing biosimilar medicines? SR

Yes 1

No 2

IF Q7=2 GO TO Q9

Q8. Which of the following do you think are potential barriers to you prescribing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME


Insufficient information on biosimilar medicines for patients 2




Concern over the delay of biosimilar medicines due to legal / International Patent issues

6



7



I don’t see the need to change what I prescribe 10


Q9. Do you think there are any potential benefits to you prescribing biosimilar medicines? SR

Yes 1

No 2

IF Q9=2 GO TO Q11

Q10. Which of the following do you think are potential benefits to you prescribing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLY TO YOU MR. RANDOMISE CODEFRAME


Treatment choice 2














ASK ALL

Q11. Which of the following best describes how confident you are personally in prescribing biosimilar medicines? SR

Totally confident 1

Very confident 2


Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4






Strongly agree


Unsure/not relevant

a. I am generally comfortable prescribing biologic medicines to my patients

1 2 3 4 5 9


1 2 3 4 5 9

c. I would prescribe a biosimilar medicine to my patients because I am confident in Australia’s regulatory processes

1 2 3 4 5 9

d. Medication access programs offered by pharmaceutical companies have an impact on which treatments I offer to my patients

1 2 3 4 5 9


1 2 3 4 5 9

f. I am aware of the PBAC ‘s decision making processes for the subsidy of medicines

1 2 3 4 5 9

g. Biosimilar medicines will have a significant impact on how patients are treated

1 2 3 4 5 9

h. It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference

1 2 3 4 5 9


biologic medicine

i. It is appropriate to switch a biologic treatment-stable patient to the biosimilar medicine

1 2 3 4 5 9


1 2 3 4 5 9


1 2 3 4 5 9


Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that is demonstrably similar in physiochemical, biological and immunological characteristics, efficacy and safety.


Considering this, how confident do you feel about prescribing biosimilar medicines? SR

Totally confident 1

Very confident 2


Little confidence 4




Totally confident 1

Very confident 2


Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4


Q18. You may, or may not, be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable; following the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future.

Which of the following best describes how you feel about pharmacists offering substitution? SR

Very concerned 1

Concerned 2

Mildly concerned 3

Neutral 4



<ENTER OE RESPONSE>

No answer





Totally confident 1

Very confident 2

Confident 3

Little confidence 4


Q21. How strongly do you agree, or disagree, that there is a need to increase the understanding of the PBS amongst the general community? SR

Strongly agree 1

Agree 2

Neutral 3

Disagree 4

Strongly disagree 5


Q22. Which, if any, of the following do you think the Australian Government Department of Health should communicate to increase the understanding of the PBS amongst the general community? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME

What the PBS is 1



3





7

Responsibility to the taxpayer in light of the ageing population and increased incidence of chronic disease

8






ASK ALL

D1. How long have you been working as a General Practitioner? SR


Five to 10 years 2

11 to 19 years 3





New South Wales 2


Queensland 4

South Australia 5

Tasmania 6

Victoria 7

Western Australia 8






THANK & CLOSE





Quota

Type Target Source

General Practitioners

100 EKAS Sample



Appendix C: Pharmacist questionnaire


3000290 Biosimilars Quantitative research, Community Pharmacists Questionnaire Department of Health July 2016

INTRODUCTION EMAIL


The department is interested in obtaining feedback from pharmacists about their levels of awareness and knowledge of, and attitudes towards, biologic and biosimilar medicines.

We expect that this survey will take you about 15 minutes to complete, and in thanks of your participation you will receive $50 (which will be sent to you from EKAS via cheque, assuming that you qualify to participate). The closing date for this survey is September 9.









S1. In the past 12 months have you worked as a pharmacist in a community pharmacy?

SINGLE RESPONSE

Yes 1 Continue

No 2 Thank and Close


ASK ALL




Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4


ASK ALL


Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4









Conferences/Symposiums 3


Journals / academic papers 5







Continuing professional development (CPD) activities 14























Q4. Have you ever dispensed a biologic medicine to a patient? SR

Yes 1

No 2








































Q6. Have you ever dispensed a biosimilar medicine to a patient? SR

Yes 1

No 2

ASK ALL

Q7. Do you think there are any potential barriers to you dispensing biosimilar medicines? SR

Yes 1

No 2

IF Q7=2 GO TO Q9

Q8. Which of the following do you think are potential barriers to you dispensing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME



Insufficient information on biosimilar medicines for pharmacists 3



Absence of incentives for pharmacists to dispense biosimilar medicines 11

Concern over the delay of biosimilar medicines due to legal / international 6


patent issues


7



I don’t see the need to change what I dispense 10


Q9. Do you think there are any potential benefits to you dispensing biosimilar medicines? SR

Yes 1

No 2

IF Q9=2 GO TO Q11

Q10. Which of the following do you think are potential benefits to you dispensing biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLY TO YOU MR. RANDOMISE CODEFRAME


Treatment choice 2











Larger profit margin for pharmacies 13

Lower stock holding costs for pharmacies 14





ASK ALL

Q11. Which of the following best describes how confident you are personally in dispensing biosimilar medicines? SR

Totally confident 1

Very confident 2

Confident enough to dispense biosimilar medicines 3

Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4






Strongly agree


Unsure/not relevant

a. I am generally comfortable dispensing biologic medicines to my patients

1 2 3 4 5 9


1 2 3 4 5 9

c. I would dispense a biosimilar medicine to my patients because I am confident in Australia’s regulatory processes

1 2 3 4 5 9

d. REMOVED 1 2 3 4 5 9


1 2 3 4 5 9

f. I am aware of PBAC ‘s decision making processes for the subsidy of new medicines

1 2 3 4 5 9

g. Biosimilar medicines will have a significant impact on how patients are treated

1 2 3 4 5 9

h. It is appropriate to offer a biosimilar medicine to a biologic-naive patient instead of the reference biologic medicine if a-flagged on the PBS

1 2 3 4 5 9

i. It is appropriate to offer a biosimilar medicine to a 1 2 3 4 5 9


treatment-stable patient on a reference biologic if a-flagged on the PBS


1 2 3 4 5 9


1 2 3 4 5 9


Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that is demonstrably similar in physiochemical, biological and immunological characteristics, efficacy and safety.


Considering this, how confident do you feel about dispensing biosimilar medicines? SR

Totally confident 1

Very confident 2


Little confidence 4




Totally confident 1

Very confident 2


Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4


Q18. You may, or may not, be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable; following the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be listed on the PBS in the future.

Which of the following best describes how you feel about offering substitution? SR

Very concerned 1

Concerned 2

Mildly concerned 3

Neutral 4



<ENTER OE RESPONSE>

No answer





Totally confident 1

Very confident 2

Confident 3

Little confidence 4



Strongly agree 1

Agree 2

Neutral 3

Disagree 4

Strongly disagree 5



What the PBS is 1



3





7

Responsibility to the taxpayer in light of the ageing population and increased incidence of chronic disease

8






ASK ALL

D1. How long have you been working as a pharmacist…? SR


Five to 10 years 2

11 to 19 years 3





New South Wales 2


Queensland 4

South Australia 5

Tasmania 6

Victoria 7

Western Australia 8






THANK & CLOSE





Quota

Type Target Source

Community Pharmacists

100 EKAS Sample



Appendix D: Consumer questionnaire


3000290 Biosimilars Quantitative research, Patients Questionnaire Department of Health July 2016

INTRODUCTION EMAIL


The department is interested in obtaining feedback from patients and eligible carers about their levels of awareness and knowledge of, and attitudes towards, biologic and biosimilar medicines.

We expect that this survey will take you about 15 minutes to complete, and in thanks of your participation you will receive the incentive specified by SSI. The closing date for this survey is September 9.






o When you have completed the survey, please click "Save and Exit" to submit your answers. Once submitted, you will not be able to return to the survey. Then please wait to be redirected to SSI to claim your incentive.



S1. Do you have any of the following conditions? PLEASE SELECT AS MANY AS APPLY TO YOU PERSONALLY

MULTIPLE RESPONSE

Ankylosing spondylitis 1

Continue Crohn’s disease 2

Diabetes 3

Treatment of anaemia in renal 4



disease

Chronic lymphocytic leukaemia (CLL)

5

Juvenile idiopathic arthritis 6

Psoriatic arthritis 7

Rheumatoid arthritis 8

Active polyangiitis 9

Chronic plaque psoriasis 10

Malignant melanoma 11

Metastatic colorectal cancer 12

Age-related macular degeneration (AMD)

21

Only include after sample categories 1 to 12

exhausted and dept gives permission for extension of sample and their inclusion

Atypical haemolytic uraemic syndrome

22

Cystic fibrosis 23

Diabetic macular oedema 24

Short stature and slow growth requiring access to growth hormone

25

Idiopathic thrombocytopenic purpura (ITP)

26

Multiple sclerosis 27

Osteoporosis 28

Retinal vein occlusion 29

Severe allergic asthma 30

Stage IV HER2 +ve adenocarcinoma stomach or gastro-oesophageal junction

31

Systemic anaplastic large cell 32


lymphoma

Anovulatory infertility or undergoing Assisted Reproductive Technologies or In-vitro Fertilisation (IVF)

33

None of the above 96 ASK S2

ASK S2 IF S1 = 96, OTHERS GO TO Q1

S2. If you are responsible for the:

care of a child aged under 18 with one of these conditions (and therefore you attend all medical appointments and are fully informed about their medical care); OR

care of a close relative with one of these conditions who is incapable of managing their own healthcare (and therefore you attend all medical appointments and are fully informed about their medical care)

Please select the condition(s) below. PLEASE SELECT AS MANY AS APPLY

MULTIPLE RESPONSE

Ankylosing spondylitis 1

Continue

Crohn’s disease 2

Diabetes 3

Treatment of anaemia in renal disease

4

Chronic lymphocytic leukaemia (CLL)

5

Juvenile idiopathic arthritis 6

Psoriatic arthritis 7

Rheumatoid arthritis 8

Active polyangiitis 9

Chronic plaque psoriasis 10

Malignant melanoma 11

Metastatic colorectal cancer 12


Age-related macular degeneration (AMD)

21

Only include after sample categories 1 to 12

exhausted and dept gives permission for extension of sample and their inclusion

Atypical haemolytic uraemic syndrome

22

Cystic fibrosis 23

Diabetic macular oedema 24

Short stature and slow growth requiring access to growth hormone

25

Idiopathic thrombocytopenic purpura (ITP)

26

Multiple sclerosis 27

Osteoporosis 28

Retinal vein occlusion 29

Severe allergic asthma 30

Stage IV HER2 +ve adenocarcinoma stomach or gastro-oesophageal junction

31

Systemic anaplastic large cell lymphoma

32

Anovulatory infertility or undergoing Assisted Reproductive Technologies or In-vitro Fertilisation (IVF)

33

None of the above 96 THANK AND CLOSE

PROGRAMMER NOTE: THE WORDING WITHIN THE SURVEY IS TO STREAM BASED ON WHETHER THE RESPONDENT HAS THE CONDITION (NOT 96 AT S1) OR SOMEONE THEY CARE FOR HAS THE CONDITION S2 CODES 1-12 OR 21-33) – SEE [ ]

IF RESPONDENT IS A CARER FOR SOMEONE WITH CONDITION (SO WAS ASKED S2 AND RESPONDED 1-33) ASK S3.

S3 Is the person (or people) that you care for with [INSERT CONDITIONS FROM S2] a…?

MULTIPLE RESPONSE.


Child under 18 1

Close relative (not a child aged under 18) who is too sick to manage their own healthcare

2

Close relative who is elderly and unable to manage their own healthcare 3


PROGRAMMER NOTE – WHEREVER “REFERENCE BIOLOGIC MEDICINE” APPEARS IN THE SURVEY, PLEASE HAVE HOVER OVER SAYING “FIRST BRAND OF THE MEDICINE TO MARKET”


ASK ALL


Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4


ASK ALL


Very familiar 1

Familiar 2

Somewhat familiar 3

Unfamiliar 4








REMOVED 1

Communications (including pamphlets and brochures) from national patient peak bodies related to your condition or the person you care for (i.e. Arthritis Australia, Diabetes Australia, Crohn’s and Colitis Association, etc.) or their state arms

2

Specialist 14

General practitioner 15

Pharmacist 16

Nurse 17

Word of mouth 4



Patient support groups that I attend 18



Information sources from State / Territory based Health Departments 10

REMOVED 11


Online forums that I participate in 19







REMOVED 1


2

Specialist 14


Pharmacist 16

Nurse 17

Word of mouth 4







REMOVED 11







Q4. [Are you / Is a person you care for] currently on or have [you/they] previously been on a biologic medicine? MR

Yes – currently on 1

Yes – previously on (but not currently) 3

No 2

Don’t know 9






REMOVED 1


2

Specialist 14


Pharmacist 16

Nurse 17

Word of mouth 4







REMOVED 11









REMOVED 1


2

Specialist 14


Pharmacist 16

Nurse 17

Word of mouth 4







REMOVED 11







Q6. [Are you / Is a person you care for] currently or have [you/they] previously been on a biosimilar medicine? MR

Yes – currently on 1

Yes – previously on but not currently 3

No 2

Don’t know 9

ASK ALL


Q7. Do you think there are any potential barriers to [you/a person you care for] taking biosimilar medicines? SR

Yes 1

No 2

Don’t know 9

IF Q7=2 OR 9 GO TO Q9

Q8. Which of the following do you think are potential barriers to [you/a person you care for] taking biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLIES TO YOU. MR. RANDOMISE CODEFRAME

Immunogenicity concerns PROGRAMMER NOTE – INCLUDE DEFINITION WITH WORD: IMMUNOGENICITY - the ability of a substance to trigger a response from your immune system

1






6

REMOVED 7


Concern about adverse outcomes for [me/the person I care for] 9

I don’t see the need to change what [I/the person I care for] take/s 10

Concern about having a fail and this counting against [me/the person I care for] in terms of PBS subsidised access to biologic medicines in the future

11


Q9. Do you think there are any potential benefits to [you/a person you care for] taking biosimilar medicines? SR

Yes 1

No 2

Don’t know 9

IF Q9=2 OR 9 GO TO Q11


Q10. Which of the following do you think are potential benefits to [you/a person you care for] taking biosimilar medicines? PLEASE SELECT AS MANY RESPONSES AS APPLY TO YOU MR. RANDOMISE CODEFRAME

More affordable for the Pharmaceutical Benefits Scheme (PBS) 1

Treatment choice 2













ASK ALL

Q11. Which of the following best describes how confident you are personally [in taking/in a person you care for taking] biosimilar medicines? SR

Totally confident 1

Very confident 2

Confident enough to take biosimilar medicines 3

Little confidence 4


Q12. Which of the following best describes how confident you are in the effectiveness of biosimilar medicine? SR

Totally confident 1

Very confident 2



Little confidence 4



Totally confident 1

Very confident 2


Little confidence 4


Q14. Please rate how strongly you agree, or disagree, with each of the statements below.



Strongly agree


Unsure/not relevant

a. I am generally comfortable with biologic medicines 1 2 3 4 5 9

b. I am disinclined to accept a new medicine until other people I know with the same condition recommend it

1 2 3 4 5 9

c. I would accept a biosimilar medicine because I am confident in Australia’s regulatory processes

1 2 3 4 5 9

d. Medication access programs offered by pharmaceutical companies have an impact on treatments available for [my/this] condition

1 2 3 4 5 9



1 2 3 4 5 9

f. I am aware of the Pharmaceutical Benefits Advisory Committee’s (PBAC ‘s) decision making processes for the subsidy of medicines

1 2 3 4 5 9

g. Biosimilar medicines will have a significant impact on how patients with [my/this] condition are treated

1 2 3 4 5 9

h. It would be appropriate for me to consider a biosimilar medicine if[ I/the person I care for] had never taken the reference biologic

1 2 3 4 5 9

i. It would be appropriate to switch from the reference biologic to the biosimilar if [ I/the person I care for] was treatment stable

1 2 3 4 5 9


1 2 3 4 5 9


1 2 3 4 5 9

l. I would accept a biosimilar medicine if recommended by my doctor

1 2 3 4 5 9


INTENTION TO SWITCH/USE/ACCEPT BIOSIMILAR MEDICINES

Q15. A biosimilar medicine is a version of an already registered biologic medicine (the reference medicine) that is demonstrably similar in chemical and biologic characteristics, effectiveness and safety.


Considering this, how confident do you feel about [taking/the person you care for taking] biosimilar medicines? SR

Totally confident 1

Very confident 2


Little confidence 4


Q16. Which of the following best describes generally how confident you are in switching from a reference biologic medicine to a biosimilar medicine if prescribed by your doctor? SR

Totally confident 1

Very confident 2


Little confidence 4


Q17 REMOVED

Q18. You may, or may not, be aware that there is currently one biologic medicine on the PBS where the biosimilar medicine is considered substitutable, which follows the same process as for generic medicine substitution. It is possible that more biosimilar medicines that can be substituted will be available in the future.

Which of the following best describes how you feel about pharmacists offering substitution (so offering the biosimilar medicine in the place of the reference biologic medicine)? SR

Very concerned 1

Concerned 2

Mildly concerned 3


Neutral 4


Q19. Do you have any specific additional comments that you would like to make about biologic or biosimilar medicines? OE

<ENTER OE RESPONSE>

No answer




Totally confident 1

Very confident 2

Confident 3

Little confidence 4



Strongly agree 1

Agree 2

Neutral 3

Disagree 4

Strongly disagree 5



What the PBS is 1




3

The role of the Pharmaceutical Benefits Advisory Committee (PBAC) in recommending medicine be listed on the PBS

4




7

Responsibility to the taxpayer in light of the ageing population and increased incidence of chronic long term illnesses

8





ASK ALL

D1 How long ago were [you/the person you care for] diagnosed with the condition/s [DISPLAY CONDITIONS SELECTED AT S1/S2 AS APPROPRIATE]?

If [you have/a person/people you care for has/have] more than one condition, please answer in relation to the length of time since diagnosis for the condition [you/they] have had the longest.

Less than 12 months 1

1 to 3 years 2

4 to 5 years 3

6 to 10 years 4

11 to 15 years 5

16 to 20 years 6

More than 20 years 7


Don’t know 99


D2. In what state do you live…? SR


New South Wales 2


Queensland 4

South Australia 5

Tasmania 6

Victoria 7

Western Australia 8


D3. Do you live in a…? SR




THANK & CLOSE




Quota

Type Target Source

People (and/or their carers) with associated conditions

200 SSI


Documents

Market Research for the Pharmaceutical Benefits Schedule ...File/market-research-report-09-2016.pdf · Market Research for the Pharmaceutical Benefits Schedule (PBS) and Biosimilar