Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
NPS MedicineWise experience
with HTA evidence dissemination
…and implementation
Belo Horizonte
November 2014
NPS MedicineWise , Melbourne N
PS
foo
tbal
l
ten
nis
arts
ce
ntr
e
Outline
Australian healthcare system
Role of NPS MedicineWise
NPS approach
The range of strategies used
Example of activities
Successes and challenges
Terms and synonyms
medicine
= drug
= pharmaceutical
= medication
rational use of medicines (RUM)
= quality use of medicines (QUM)
= better use of medicines (_UM)
Health technology assessment (HTA) evidence
- knowledge translation
- dissemination
- implementation
Population: 23.5 million Multicultural Ageing population: 13% >65 years Life expectancy: 78-83 years
Australians
Health priorities in Australia
Arthritis and
musculoskeletal conditions
Asthma
Cancer control
Cardiovascular health
Dementia
Diabetes mellitus
Injury prevention and
control
Mental health
Obesity
Australian health system
Universal health care scheme
Public-private partnership
Pharmaceuticals, pathology and radiology, medical
practitioners, and hospital care
Funding is from both Federal and State Governments
Private health insurance also available for hospital and
allied health care
Health expenditure as % of GDP
0
2
4
6
8
10
12
14
16
18
20
UnitedStates
Euro area World Brazil Australia Argentina LatinAmerica &Caribbean
Sub-SaharanAfrica
Europe &Central Asia
Middle East& North
Africa
East Asia &Pacific
South Asia
Who pays?
Pharmaceutical expenditure as
a percentage of total health expenditure
Source: WHO Global Health Expenditure Database; OECD Health Database, 2012
MEDICINES IN AUSTRALIA
National Medicines Policy
Quality, safety and efficacy of medicines
- Therapeutic Goods Administration
Equitable access
- Pharmaceutical Benefits Scheme
Responsible and viable industry
- Pharmaceutical industry
Quality use of medicines
- NPS MedicineWise
National Medicines Policy
PH
AR
M
NPS
Equitable access:
Pharmaceutical
Benefits Scheme
Prof Lloyd Sansom, Former Chair of Pharmaceutical Benefits Advisory Committee
Pharmaceutical Benefits Scheme (PBS)
Timely access to medicines,
at a cost individuals and the community can afford
Began
1947
1960s
Co-payments
Safety net
1980s
1990s
Formal economic analyses
Pharmaceutical Benefits Scheme (PBS)
>750 drug substances
~1970 forms and strengths
- ~4500 products
>197 million prescriptions/2013
- 1.2% > 2012
AUD 9 billion/year (= BRL 19.7b)
- 2.1% < 2012
Patient co-payment
- Concession AUD 6.00 (= BRL 13)
- General AUD 36.90 (= BRL 81)
Assessment of medicines for
reimbursement
Pharmaceutical Benefits Advisory Committee (PBAC)
Statutory committee established under the National
Health Act
Health minister cannot list a medicine under the scheme
without a positive recommendation from the PBAC
Assessment of medicines for
reimbursement
Sponsor (usually industry) makes requests for listing,
including type of listing (e.g. generally available,
restricted or prior authorisation)
In assessing medicines for listing, the PBAC is required
by legislation to consider:
- Comparative efficacy
- Comparative safety
- Cost-effectiveness (mandatory since 1993)
Cost-minimisation assessment or cost-effectiveness
assessment, includes whole of health costs
- Budget impact
Listings types
Unrestricted
- available to everyone
Restricted
- available only for specific indications
Require prior authorisation
- tiered approach to prior authorisation
streamlined approval
telephone approval
written approval
Process for listing on the
Pharmaceutical Benefits Scheme
registration
economic analysis
utilisation estimates
PBS listing criteria
price
Overall PBS costs
0
1
2
3
4
5
6
7
8
9
10
Government PBS expenditure ($ billions)
Patient
contributions
~$1.6 billion
Medicine utilisation changes
(government reimbursed only)
0
10
20
30
40
50
60
70
80
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
Co
un
ts (
mill
ion
s)
Alimentary Tract andMetabolism
Anti-Neoplastic andImmunomodulating Agents
Cardiovascular System
General Anti-Infectives forSystemic Use
Nervous System
Respiratory System
Medicine expenditure changes
(government reimbursed only)
0
0,5
1
1,5
2
2,5
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
Co
st (
bill
ion
s $
AU
D)
Alimentary Tract andMetabolism
Anti-Neoplastic andImmunomodulating Agents
Cardiovascular System
General Anti-Infectives forSystemic Use
Nervous System
Sensory Organs
Policy measures to ensure PBS
sustainability
Pharmacoeconomic analysis
- pay what the drug is worth with respect to health outcomes
Monopsony buying power
- counter monopoly power of pharmaceutical companies during patent
protection
Reference pricing
- subsidise only the lowest price product in a generic group and in some
therapeutic classes
Risk sharing arrangements
- such as price-volume and rebate agreements
Increased patient co-payments and safety net limits
Generic substitution for interchangeable medicines
Policy measures to ensure PBS
sustainability
Creation of 2 separate formularies on the PBS.
- Formulary One (F1): drugs where there is only one brand
- Formulary Two (F2): drugs where there are 2 or more brands
Mandatory 12.5% price reduction
- in the price paid for all interchangeable drugs in a therapeutic class
when the first generic brand in that class appears.
Price disclosure system for all F2 drugs
- Required to provide information about the prices at which drug sold.
- A ‘weighted average disclosed price’ (WADP) is calculated that reflects
the price at which the drug is being supplied in the market.
- If WADP >10% below PBS price, then PBS price is reduced to WADP.
QUM programs (NPS MedicineWise)
National Medicines Policy
PH
AR
M
NPS
Why do we need activities
to improve medicine use?
Medication safety
- Avoidable adverse drug events are common
Clinical benefit
- Prescribing is often suboptimal
Value for money
- Sustainability of PBS
Why do we need activities
to improve medicine use?
Decision making is difficult
- risks of harm versus benefits of therapy
- negotiating complexity, uncertainty and ambiguity
The medicines situation keeps changing
- new evidence
- changing drug availability
Abundance of information
- poor quality and/or biased information
Patients are demanding access to trusted information
Health professionals need support
Proliferation of expensive new drugs
Category Number %
Major advance 7 0.2%
Real advantage 78 2%
Some advantage 227 7%
Nothing new 2789 69%
Not acceptable 106 3%
Judgement reserved 128 4%
A French review of 3335 new drugs from 1981-2005 (La Revue Prescrire)
PHARMA-doctor interaction correlates with:
Preferences for new products that have no benefit over existing ones
Decreased prescribing of generic drugs
A rise in both and irrational and incautious prescribing
Rising prescription expenditures
Suboptimal prescribing
Prescribing not consistent with best practice
Under use of medicines
- beta blockers for heart failure
- adequate dosage of ACE inhibitors in heart failure
- metformin for diabetes
Over use of medicines
- antibiotics for upper respiratory tract infections
- benzodiazepines for sleep disorders
- antihypertensives and lipid lowering drugs in place of lifestyle
modification
Using second line before first line therapy
- aspirin versus clopidogrel
- broad spectrum versus narrow spectrum antibiotics
The role of formularies & treatment
guidelines Common diseases & complaints
Treatments of choice
Use to identify & solve problems
Improved availability & use
Harvey K, Dartnell J, Hemming M. Improving antibiotic use: 25 years of antibiotic guidelines and related initiatives. Commun Dis Intell 2003; 27 Suppl: S9–S11
Australian Medicines Handbook
Therapeutic Guidelines series
HTA, evidence and medicine policy
Evidence question Who Outcome
•Safety? •Efficacy? •Product quality?
Therapeutic Goods Administration
•Registration and marketing
•Comparative efficacy? •Comparative safety? •Cost effectiveness? •Budget impact?
Pharmaceutical Benefits Advisory Committee
•Availability on Pharmaceutical Benefits Scheme
•Best practice in real world?
Therapeutic Guidelines •Standard treatment guidelines
•What is practice in real world?
NPS MedicineWise •Program design •Program evaluation •Policy change
HTA evidence to practice pipeline
Paul Glasziou. Bond University. Australia
National Medicines Policy
PH
AR
M
NPS
Who is NPS MedicineWise?
Established as the National Prescribing
Service Limited in 1998
Largely funded by the Australian
Government
Independent, not-for-profit organisation
Membership based
Work in partnership
- consumers
- health professionals
- government
- industry
Dr Lynn Weekes
Chief Executive Officer,
NPS, since 1998
OUR PURPOSE
To achieve better health and economic outcomes
Enable people to make better decisions about medicines and other medical choices
health professionals consumers
QUALITY USE OF MEDICINES
Selecting treatment options wisely - including non
medicine options
Choosing suitable medicines, if a medicine is deemed
necessary
Using medicines safely and effectively (including
prescription, non-prescription and complementary
medicines)
..AND QUALITY USE OF MEDICAL TESTS
How do we work?
Who are our audiences?
Health professionals
- general practitioners
- medical specialists
- pharmacists
- nurses (primary health care)
- students
Consumers
- communities
- mass audience
Government
Industry Dr Janette Randall, Chair of
NPS Board and general
practitioner
Promotion
PBS
Registration
Social marketing
STG
Drug information
Reframing
decision making
When decisions are made
Immediate impact
Between decision making
Intermittent impact
Teaching how to make decisions
Enduring impact
Building the evidence base
? Impact
Decision support tools
Guideline support
Medicine information
Academic detailing
Peer group discussion
Audit and feedback
Continuing education
Undergraduate
education
Research
NPS interventions and activities
Drug and therapeutic information
resources
http://www.nps.org.au/health_professionals/publications
NPS RADAR
New drugs on PBS
Timely
- coincides with PBS updates
Independent
- evidence-based, review process
Reach
- >60,000 health professionals including
almost all GPs
website
Email subscription
Prescribing software
Review process
Expert advisory group members
- information needs, key points for consumer information, place in
therapy, practice points
External clinical expert
- clinical management of condition, use in practice
- conflicts of interest considered
Department of Health
- details of PBS listing
Sponsor
- interpretation of clinical and economic evidence, launch dates,
issues that may arise after publication
NPS MedicineWise approach to
implementation
consumer
identify problem
clinical issues
barriers + enablers
evidence based
messages
mix of inter-
ventions
across disciplines + sectors
evaluate
Understand barriers to change
Awareness, knowledge
Beliefs, attitudes
Skills
Systems, practicalities
Motivation, readiness for change
External environment
Analysis of needs and barriers (formative research)
• Literature reviews
• Surveys
• Key informant interviews
• Data analysis / audits
• Phone line questions
• Environmental and market analyses
• Previous evaluation results
• Advisory groups
Consider possible interventions
Educational materials
Educational meetings
Clinical audit & feedback
Reminder systems
Educational visiting
Patient mediated strategies
Map interventions to barriers
• Required change
• Evidence for interventions
• Active v/s passive engagement
• Multi-faceted approach
• What will work (or not work) in general practice
Opinion leaders
Consumers: gateways and influences
Family & friends
General practitioner
Specialist
Pharmacist Internet
Media
Non-medical prescriber
Family & friends
General practitioner
Specialist
Pharmacist Internet
Media
Non-medical prescriber
Web
Social media
Radio
SMS
Telephone support
Smart phone apps
Media releases
TV
Delivering our programs
Products and services created and packaged for target
audience and target problem
Multiple-channel strategy
Fit-for-purpose delivery
General practice programs
Face-to-face educational visits
- academic detailing
- GPs and practice staff
Data review and feedback
- Self audits
- Comparison with national data,
practice data, MedicineInsight network
Peer group discussions
- based on case studies
Voluntary participation
- Quality Practice and professional development incentives
Recent therapeutic programs
Lipid management and cardiovascular risk
Vitamin D testing
Osteoporosis
Antipsychotics
Heart failure
Generic medicines
Antibiotics in respiratory infections
Depression
Headache
Diabetes
Oral anticoagulants
Health checks
Medicines in older people
Diabetes programs
Diabetes has been an Australian national health priority.
Several new oral antidiabetic drugs and insulins have
become available in recent years.
There are established guidelines1 in Australia for the
management of type 2 diabetes.
Metformin is an established cost-effective oral
antidiabetic drug and recommended as first-line therapy.
Management has not been optimal.
1. RACGP and Diabetes Australia. Diabetes management in General Practice. 2009/10. Diabetes Australia
Diabetes program schedule
NPS MedicineWise implemented national programs to
improve management of type 2 diabetes in primary care:
1. 2001–03
2. 2005–06
3. 2007–08
4. 2012-13
Key messages
Key messages focused on encouraging lifestyle
interventions, management of risk factors, and first-line
use of metformin, for example:
- Early and continuing lifestyle interventions decrease disease
progression.
- Use metformin as initial drug therapy and ensure is part of
ongoing therapy.
- Consider early use of insulin if oral therapy is unsatisfactory.
- Manage cardiovascular risk factors.
- Consider glitazones only if combination therapy fails and review
use in heart failure and ischaemic heart disease.
Interventions
For each program, NPS deployed a range of activities to
deliver key program messages:
- Academic detailing: NPS facilitators based in local areas
conducted face-to-face visits with practitioners and small group
case study discussions.
- Clinical audits with feedback were available to help clinicians
reflect on their practice.
- Information resources on the management of diabetes were
distributed to support good decisions by health professionals and
consumers.
- Self management tools for diabetes were distributed to support
consumers
Academic detailing (educational outreach)
Educational
facilitators across
Australia
Face-to-face, one-
to-one visits with
GPs
Trained
facilitators, usually
pharmacists
Targeted and
general messages
Good evidence
that is effective at
changing practice
Clinical self audits
Completed by general
practitioners.
Self-audits of records (paper
or electronic).
Assesses practice in
comparison with evidence-
based guidelines (using
indicators of quality
prescribing).
Feedback is given on their
practice in comparison with
their peers.
Drug and therapeutic information resources
NPS News
- program key messages
Prescribing Practice
Review
- prescribing feedback
NPS RADAR
- New drug updates
Australian Prescriber
- reviews and updates
http://www.nps.org.au/health_professionals/publications
GP participation
Year Educational visit
Small group
GP clinical audit
Case study
Interactive workshop
Total unique GPs
2001-03 4211 1535 1626 1673 - 6,704
2005-06 3922 2699 1769 1603 131 6,965
2008-08 5963 4921 2073 1467 353 8,756
2012-13 6233 4689 640 935 11,362
0
2.000
4.000
6.000
8.000
10.000
12.000
14.000
0
2
4
6
8
10
12
14
16
18
DD
D/
100
0 p
op
ula
tio
n p
er
day
Actual
Estimated with NPS Intervention
Estimated without NPS intervention
Cumulative count participating GPs
Cu
mu
lati
ve
GP
co
un
t C
Impact on prescribing
Metformin DDD/1000/population per day (concessional scripts only)
7% increase in metformin prescriptions (2009-11)
Impact on prescribing
Glitazones: rate of prescribing per 1000 GP consultations
↓13% in 2008 & ↓ 16% in 2009
Cost consequence analysis: modelling logic
All diabetes patients in Australia (AIHW)
Patients managed by participating GPs (NPS data)
Patients managed by GPs with improved prescribing (NPS DU analysis)
Patients reached HbA1c target (clinical audit)
Patients with less complications (international)
Process to determine the patient population and health and economic
outcomes
e-Audit: 1378 GPs completed; 27,679 patients
19% patients (n = 5030) achieved chosen target HbA1c (%)
NPS program: 9496 unique GPs; Type 2 patients
treated by NPS GPs = 290,897
19% patients “better controlled”,
i.e., achieved 1% HbA1c reduction
(n = 56,285)
10yr incidence rates and associated risk reduction with 1% reduction in HbA1c (from the literature)
Consequences: type & number of
sequelae avoided over 10yr follow-up period
Costs of delivering NPS 2008 program
DU Study: Metformin 7% PBS Rxs increase
DU Study: Insulin add-on 7% PBS Rxs increase
Diabetes sequelae: Eg., myocardial infarction, retinopathy, etc.
CONSEQUENCES COSTS
Number of sequelae avoided x unit cost =
Total cost per sequela avoided
Cost consequence summary
20% of the diabetic patient population managed by the GPs who
participated in the program would benefit from improved glucose
control
5,745 avoided cases of complications over a ten-year period
- Lower extremity amputations (477 cases)
- Cataract extraction (950 cases)
- Major cardiovascular events (2,602 cases)
- Retinopathy or nephropathy (1,529 cases)
Direct hospital costs potentially avoided totalling AU$36.5 million (in
addition to the AU$46.4 million of cost-saving to the PBS)
Extending evaluation of NPS program beyond prescribing change
MedicineInsight: real world data
First Australian large scale general practice
longitudinal data platform for policy and
practice improvement
De-identified patient data collected from
general practices across Australia
Links information on patient diagnosis to the
medicines prescribed, the health services
provided and clinical and patient
characteristics
Practice profile data (target 500 practices,
2500 GPs)
Clinical encounter data (target 2.0-2.5 million
patients)
MedicineInsight data flow
MedicineInsight
Live laboratory with real world data
Greater insights into how medicines are used in practice
- when, what dose, and for what type of patient medicines are
being used
- the effects of a medicine(s) on an individual
- how new medicines are adopted once released
- alignment with recommended best practice
- adverse events
- monitor effects of policy changes
Improve policy and PBS decision making
Better program design and evaluation
Improve clinical practice
Why invest in national programs to improve HTA
evidence dissemination and implementation?
Adds value to registration (TGA) and
subsidisation (PBS) processes.
Valued by health professionals
Demonstrated changes in
attitudes and practice
Savings on medicines and
medical tests for Australian
Government >AUS$660 million.
Contributes to better health and
economic outcomes.
QUESTIONS?
www.nps.org.au
Dementia program
Around 200,000 Australians have dementia with the
most common being Alzheimer’s disease (50% to 70%
of cases).
Cholinesterase inhibitors and memantine commonly
cause adverse effects and benefits are small.
Difficult to objectively assess the efficacy.
Pressure from carers to prescribe and continue therapy.
Program goal to improve decision making regarding use
of non-pharmacological and pharmacological
management.
Key messages
Use non-pharmacological strategies at all stages.
Benefits of cholinesterase inhibitors and memantine, if any, are likely
to be small and adverse effects are common.
Monitor and objectively assess the effectiveness of cholinesterase
inhibitors and memantine if they are to be used.
Trial a withdrawal of antipsychotics if there are no clear beneficial
effects.
Plan to review medications regularly as well as opportunistically.
Counsel patients and their carers on the limited benefits of drug
therapy.
Prescription expenditure: cholinesterase inhibitors & memantine
Model of actual data over time with the NPS intervention
Model of data over time with the NPS intervention effect removed (predicted)
PBS cost-savings achieved by
reducing volume or expenditure on
prescriptions following the NPS
intervention
National Prescribing Curriculum
Web-based interactive
modules
WHO Guide to Good
Prescribing
Case-based topics
Diagnosis provided –
focus on prescribing
Medical, pharmacy,
nurse practitioner and
dentistry students
Development of the National Prescribing
Curriculum
Case based topics informed by survey of final year Australian medical students during 1999*
Process of development, writing and review governed by a committee of clinical pharmacologists
Biennial review of content – review evidence and update resources
Concordance with national guidelines and formulary
links to Therapeutic Guidelines, Australian Medicines Handbook, Australian Prescriber
Local champions from ten medical schools involved as authors and reviewers
* Rolfe, I., et al., Identifying medical school learning needs: a survey of Australian
interns. Education for Health, 2001. 3: p. 395 - 404.
Examples of topics
• Chronic obstructive
pulmonary disease
• Peptic ulcer disease
• Hypertension
• The confused patient
• Seizures
• Acute chest pain
• Acute otitis media (child)
• Heart failure
• Anticoagulation
• Postoperative pain and
vomiting
• Polypharmacy
• Intern orientation
Introduction
+ Learning
Objectives Case Study +
Context
Defining the
patient problem
Review
Therapeutic
Goals-voting
Specify
therapeutic
objective
Therapeutic
Goals
Feedback
Specify
therapeutic
objective
Non Drug
Treatment +
Feedback-Q&A
Choose a
treatment Drug
Treatment
Choose
treatment +
P-drugs
Verify
Suitability
Verify
suitability
Start
treatment
Write
Prescription
Prescription
Feedback
Start
treatment
Monitor
Treatment
Monitor
treatment
Provide
Information +
Feedback-Q&A
Monitor
treatment
NPC Virtual Tour