HTA in Emerging Settings – Mapping Exercise and Toolbox · November 19th, 2015 . Final Conference – London . Jaime Espín, PhD – Professor. EASP . ADVANCE_HTA – WP6 Leader

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November 19th, 2015

Final Conference – London

Jaime Espín, PhD – Professor. EASP

ADVANCE_HTA – WP6 Leader

HTA in Emerging Settings – Mapping Exercise and Toolbox

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WP 6. Project Objectives

Research objectives:

1.To identify the use and capacity of HTA in emerging settings. This includes the identification of HTA mechanisms and techniques that apply in emerging countries of Europe and Latin America and the Caribbean.

2.To encourage the use of HTA for decision-making by developing appropriate tools for supporting the implementation of HTA in emerging settings.

3. To enable and facilitate exchange of HTA reports and economic evaluation, reducing efforts duplication, between EU countries with a strong HTA tradition and the Americas/Eastern Europe.

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WP 6. Project Activities

– 6.1a: Mapping exercise of the use of HTA (activities, networks

and capacity) in Emerging countries (18 Latin America and Caribbean Countries – LAC- & 24 Central, Eastern and South-Eastern Europe – CESEE-)

– 6.1b: Case studies on decision-making informed by HTA, with a view to producing recommendations for strengthening and implementing HTA as a decision-making tool

– 6.2: Toolbox outlining best practices and recommendations on HTA and decision-making

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CESEE • Albania • Belarus • Bosnia & Herzegovina • Bulgaria • Croatia • Cyprus • Czech Republic • Estonia • Greece • Hungary • Latvia • Lithuania • Macedonia • Moldova • Poland • Romania • Russian Federation • Serbia • Slovakia • Slovenia • Turkey • Ukraine

LAC • Barbados • Belize • Bermuda • Costa Rica • Dominica • Dominican

Republic • El Salvador • Guatemala • Guyana • Honduras • Jamaica • Nicaragua • Panama • St. Lucia • St. Maarten • Suriname • Trinidad & Tobago • Venezuela

Note: Tableau map created by author.

Mapping: countries included in the study

| Capacity to perform HTA systematically and regularly: refers to in opinion of the respondent his/her country has the capacity to perform HTA systematically and regularly.

Capacity perform

HTA

Funding limitation

Skills Training

Access to HTA network Institutional support Domestic International

Albania Yes 1 1 0 0 0 Belarus Yes 0 1 0 1 0 Bulgaria Yes 3 3 1 2 0 Croatia Yes 2 2 0 0 0 Czech R. Yes 2 0 1 0 0 Latvia Yes 0 0 0 0 0 Lithuania NO 3 3 0 0 2 Moldova YES 2 1 0 1 0 Poland YES 0 1 1 1 0 Romania NA 2 2 0 0 1 Russia YES 1 1 0 0 0 Slovenia NO 3 2 0 0 1 Turkey YES 1 1 0 0 0 Ukraine YES 1 1 0 1 0 Hungary YES 3 2 1 1 1

Total --- 24 21 4 7 5

Obstacles mentioned by respondents by countries

Capacity to perform HTA in CESEE

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Task 6.1. Mapping in Emerging Countries (CESEE & LAC)

Findings: Criteria for selecting Health Technology to be assessed

64%

64%

18%

36%

45%

18%

55%

36%

65%

65% 52%

43%

39%

39%

35%

30%

0% 10% 20% 30% 40% 50% 60% 70%

Prevalence/ Incidence

Burden of disease

Ethical, legal or social implications

Medical practice variations

Cost of illness

Public and media concern

Political concern

No Criteria

Other

LACCEE

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HTA and decisión making process

SK LV GR PL CZ CR LT RU EE SI BU HU RS

Legislation establishing HTA reports must be considered in the decision-making process as MANDATORY

√ √ √ √ √ √

Legislation establishing HTA reports should be considered to support coverage decisions as RECOMMENDATION

√ √ √

There no specific legislation, but HTA reports have been used to support policy making.

√ √ √ √

Decisions are not informed by HTA √

Link between HTAs and decision

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SK LV GR PL CZ CR LT RU EE SI BG HU

Pharmaceuticals (include vaccines and other biological products.) √ √ √ √ √ √ √ √ √ √ √

Medical devices (include diagnostic products) √ √ √ √ √ √ √

Medical procedures √ √ √ √ √

E-health technologies √

Public health interventions √ √ √ √

Technologies are assessed in HTA

Countries with HTA Guidelines: Slovakia, Latvia, Poland, Croatia, Estonia, Slovenia, Hungary Countries with Economic Evaluation Guidelines: Slovakia, Latvia, Poland, Checz Republic, Croatia, Bulgaria, Slovenia, Hungary

Use of HTA

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Internal reports produced

by the MoH, Social Security, or HTA agency

Reports commissioned externally by the Government

Information presented by the industry requesting the technology

SK Always Never Always LV Frequently Never Frequently GR NA NA NA PL Frequently Never Regulary CZ Always Never Frequently CR Alway Never Frequently LT Frequently Regulary NA RU NA NA Always EE Frequently Rarely Regulary SI Never Never Always

BU Always Regulary Always HU Regulary rarely Always RS Frequently NA Regulary

Decisiones are based on

HTA and decision-making

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Criteria used for priority setting/defining the benefits package. MEDICINES MEDICAL DEVICES INTERVENTIONS Explicit criteria Implicit

criteria No

criteria Explicit criteria

Implicit criteria

No criteria Explicit criteria Implicit criteria

No criteria

Efficacy (SK); (LV); (PO); (CZ); (CR); (RU); (ES); (BU);

(SI)

(SK); (PO); (CR); (ES); (HU)

(LV); (CZ) (SI) (LV); (PO); (ES); (HU)

(SK); (CZ) (SI)

Effectiveness (SK); (CR); (RU); (ES);

(HU); (SI) (LV); (PO); (CZ); (HU);

(BU)

(SK); (CR); (ES) (LV); (PO); (HU)

(CZ); (SI) (LV); (ES) (SK); (PO); (HU)

(CZ); (SI)

Safety (SK); (LV); (PO); (CZ);

(CR); (RU); (ES); (HU); (BU); (SI)

(SK); (PO); (CZ); (CR); (ES);

(HU)

(LV) (SI) (LV); (PO); (ES); (HU)

(SK); (CZ) (SI)

Quality of Life (SK); (CR); (RU); (ES); (BU); (SI)

(LV); (PO); (HU)

(CZ) (SK); (CR); (ES) (LV); (PO); (HU)

(CZ); (SI) (LV); (ES); (HU) (SK); (PO) (CZ); (SI)

Cost-Effectiveness

(SK); (LV); (PO); (RU); (ES); (HU); (SI)

(CZ); (CR); (BU)

(SK); (PO); (ES) (HU) (LV); (CZ); (CR); (SI)

(PO); (ES); (HU) (SK); (LV) (CZ); (CR); (SI)

Budget Impact (SK); (LV); (PO); (CR); (ES); (HU); (BU); (SI)

(CZ) (SK); (PO); (CR); (ES); (HU)

(CZ); (RU) (LV); (SI) (PO); (ES); (HU) (SK); (LV) (CZ); (SI)

Ethical, Equity, and Social Issues

(CR); (ES) (SK); (LV); (PO); (HU)

(CZ); (BU); (SI)

(ES) (SK); (PO); (HU)

(LV); (CZ); (SI)

(ES); (HU) (SK); (LV); (PO) (CZ); (SI)

Organizational Impact

(ES) (SK); (LV); (PO); (ES);

(HU)

(CZ); (BU); (SI)

(ES) (SK); (PO); (HU)

(LV); (CZ); (SI)

(ES); (HU) (SK); (LV); (PO) (CZ); (SI)

Innovation/Industrial Development/Technology transf

(SI); (SK); (LV); (PO); (CZ); (ES); (HU);

(BU)

(SK); (LV); (PO); (CZ); (ES); (HU);

(SI)

(SK); (LV); (PO); (CZ); (ES)

; (HU); (SI)

Geographical Budget Allocations

(HU); (SI) (SK); (LV); (PO); (CZ); (ES); (BU)

(HU) (SK) ; (LV) ; (PO) ; (CZ) ;

(ES); (SI)

(HU) (SK); (LV); (PO); (CZ); (ES); (SI)

Impact on Vulnerable Groups[1]

(ES) ; (SK); (LV); (PO); (CZ);

(HU); (BU); (SI)

(SK); (CZ); (ES); (HU)

(LV); (SI) (HU) (SK); (LV); (ES) (CZ); (SI)

Burden of Illness (LV); (PO); (CR);

(RU); (ES); (HU); (SI) (SK); (CZ) ; (BU) (PO); (CR);

(ES); (HU) (SK) ; (LV); (CZ);

(SI) (PO); (ES); (HU) (SK); (LV); (CZ); (SI)

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Type of study/type of evidence preferred or required for the decision-making process

SK LV PL CZ CR LT RU EE SI BU HU RS

Complete HTA

Rapid or mini-HTA

Comparative efficacy

Comparative effectiveness

Indirect comparison

Full economic evaluation

Cost-minimization

Cost analysis

Budget impact analysis

Systematic review

Meta-analysis

Epidemiological and other observational studies

Expert opinion

Group judgment

HTA and decision-making

AlwaysMost of the times Sometimes Rarely Never

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Question related to Economic Evaluation

Is an economic evaluation required for the decision-making process?

How often is an economic evaluation explicitly considered in the decision-making process?

Are there explicit ‘thresholds’ for cost-effectiveness? If not, what other approaches are used to decide whether an intervention is potentially cost-effective?

What is the perspective normally used of the economic evaluation?

SK It is mandatory

based on the law 363/2011.

Always WTP 1 is 24 x average monthly salary

€ / QALY; WTP 2 is 35 x average monthly salary € / QALY

Third-party payer

LV Yes Always

The ICER for an additionally obtained year of life or progression-free year of life shall not exceed the ICER of

pharmaceuticals already included in the Positive list.

Third-party payer

GR Not Yet. Rarely Not applicable Not definded yet

PO Yes Always (for

reimbursement submissions)

3x GDP per capita for ICUR/QALY or ICER/LYG Public Sector

CZ Yes ALWAYS NO( 3xGDP per QALY is used as reference) Third-party payer

CR NO. Only BIA NEVER No No answer LT No answer No answer No answer No answer RU Yes Frequently No Public Sector

EE Yes Always NO. (1-3 GDP per capita is used as reference) Third-party payer

SI No rarely Yes Third-party payer BU Yes Always No Third-party payer HU Yes Always Yes Third-party payer

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Limitations

Main barriers in the decision making process of evaluation of health technology

Organizational / Institutional

Economical / Financial

Information/ Comunication

Human Resources Other

BU √ √ √ √

CR √ √ (a)

CZ √ √ √

EE √ √

GR √ √ √

HU √ √ √

LT √ √

LV √

PO √ (b)

RU √ (c)

SI √ √ √ √ (d)

SK √

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Task 6.1. Mapping in Emerging Countries (CEE & LAC)

Conclusion: Lack of HTA capacity was identified in both

LAC & CEE countries Lack of Guidelines/ methodologies/ standard

procedures No legislagion that support HTA as formal a

tool for decision making

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Case Studies on decision-making informed by HTA

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Task 6.2. Case Studies on decision-making informed by HTA

• Objective: To produce recommendations for the strengthening and implementation of HTA as a decision-making mechanism in emerging settings.

• Methods: • Case study countries were benchmarked against advance HTA

setting countries. • What was compared?: Structure of HTA activities, Methods for

the conduct of HTA, Appropriate processes for the conduct of HTA and use of HTA in decision-making.

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Conceptual framework for the Case Study – LAC&CEE

•Medicine •Medical Device

•Vaccine

1 Product •2 LAC •2 CEE

Emerging Setting

•Canada •UK

Mature Setting


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STAGE 1. Countries and health technologies selection

LAC Canada, Brazil, Colombia, Mexico and Uruguay

CEE United Kingdom, Sweden, Scotland, France, Austria & Germany

Web searches of the technologies evaluated in the past 10 years

A. Technology selection

Comprehensive listing

“experienced” and “emerging” HTA countries

“experienced” HTA countries

First selection

First list of technologies Final decision

Selection of comparator (experienced HTA setting)

B. Country selection

Selection of emerging HTA setting (case studies)

Canada & UK (NICE & CADTH): Medicine & Medical DeviceJCVI: Vaccine

One vaccine

One medicine

One medical device

Invitation by email to key informants identified 7 EUNetHTA countries 8 Non EUNetHTA countries

First country selection Brazil & Colombia (LAC)

Polonia & Albania (CEE)

Incorporated: Estonia (CEE)


Method

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Sweden The Dental and Pharmaceutical Benefits Board (TLV)The Swedish Council on Health Technology Assessment (SBU)

Scotland

National Institute for Health and Clinical Excellence (NICE)

France The Haute Autorité de Santé (HAS) Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT)

Austria Ludwig Boltzmann Institut Health Technology Asessment (LBI-HTA)

Germany Institute for Quality and Efficiency in Health Care (IQWiG)

11 Medical Devices7 + 1 Medicines

10 Other technology

12 Medical Devices181 Medicines

1 Other TechnologyEngland

Scottish Health Technologies Group (SHTG)7 Medical Devices

5 Medicines11 Other Technology

7+49 Medical Devices1 Medicines

24 + 229 Other Technology

22 Medical Devices70 +6 Medicines

8 Other Technology


62 Other Technology

Canada Canadian Agency for Drugs and Technologies in Health (CADTH)4 Medical Devices

42 Medicines16 Other Technology

Colombia Instituto de Evaluación Tecnológica en Salud (IETS)

Mexico

Brazil Agência Nacional de Vigilância Sanitária (ANVISA)Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC)

Uruguay Fondo Nacional de Recursos


1 Other technology

Centro Nacional de Excelencia Tecnológica en Salud (CENETEC) 5 Medical Devices

6 + 26 Medical Devices6 + 63 Medicines


Method

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First selection






One vaccine

One medicine

One medical device






Method

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Indication COUNTRY / REGION

Europe Latin America UK FR SE AT GE SC CA BR CO UY MX

Medicines

RANIBIZUMAB Macular degeneration ● ● ● ●

BEVACIZUMAB Macular degeneration ● ●

INFLIXIMAB Rheumatoid arthritis ● ● ● ● ●

INFLIXIMAB Psoriatic arthritis ● ● ● TRASTUZUMAB Breast cancer ● ● ● ● ● ● ● ● VACCINE VPH

Cervical cancer ● ● ● ● ● ● ● ● ●

Medical devices

DRUG ELUTING STENTS

Coronary arteries diseases ● ● ● ● ● ● ● ● ●

IMPLANTABLE CARDIAC DEFIBRILATOR

Heart failure/ sudden cardiac death / arrhythmias

● ● ●

UK: United Kingdom; FR: France; SE: Sweden; AT: Austria; GE: Germany; SC: Scotland; CA: Canada; BR: Brazil; CO: Colombia; UY: Uruguay; MX: México

Method

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First selection






One vaccine

One medicine

One medical device






Method

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Structure and main questions Survey Items Corresponding to the principle of Drummond

Medicine Vaccine Medical device

1. Introduction General information about the assessment and final recommendation 1-3 1-3 1-2

Independent assessment; participation of experts 4-5 4-5 3-4 (2) HTA should be an unbiased and transparent exercise.

Publicity of the assessment and recommendations 6-7 6-7 5-6 (2) HTA should be an unbiased and transparent exercise.

- Link between scientific assessment and the appraisal decision - Transparent approach for weighing various considerations 8 8 7

(15) The link between health technology assessment and decision-making processes needs to be transparent and clearly defined.

- Institutions involved in the priority setting - Selection criteria for the technology - Evolutionary stage of the technology

9-11 9-11 8-10 (4) A clear system for setting priorities for HTA should exist.

Level of participation in the HTA process and type of stakeholder 12-13 12-13 11-12 (10) Those conducting HTAs should actively engage

all key stakeholder groups.

2. Structure and methods - The report include a scoping or background document - Detail of the information included 14-15 14-15 13-14 (1) The goal and scope of the HTA should be

explicit and relevant to its use.

Description of the decision problem 16-17 16 15 (3) HTA should include all relevant technologies.

- Clinical evidence used for the HTA report - Limitations found the review of the literature - Clinical endpoints included in the assessment

18-19 17-18 16-17 (6) HTA should consider a wide range of evidence and outcomes.

- Costs, benefits, and harms - Economic model and a systematic review of clinical evidence 20-22 19-21 18-20 (5) HTA should incorporate appropriate methods

for assessing costs and benefits.

- Types of costs considered in the HTA report - Costs in added years of life and endpoints 23-25 22-24 21-23 (7) A full societal perspective may be considered

when undertaking HTAs.

- The model uncertainties - Sensitivity analysis - Key deficiencies (or data limitations) - Key future research - Methods guidance for transferability issues

26-31 25-30 24-29

(8) HTAs should explicitly characterize uncertainty surrounding estimates. (9) HTAs should consider and address issues of generalizability and transferability.

The HTA organization monitor the impact of its recommendations 32 31 30 (12) The implementation of HTA findings needs to

be monitored.

3.Use of HTA in Decision Making Main source of information in which decisions were based on (reports and evidence) 33-34 32-33 31-32

- To make the decision rely on the conclusions of the assessment (Additional factors) - Threshold used to determine the cost-effectiveness - Planning to repeat or update the assessment in regular intervals - Communications plan

35-39 34-38 33-37 (13) HTA should be timely. (14) HTA findings need to be communicated appropriately to different decision makers.

Method

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•Medicine •Medical Device

•Vaccine

1 Product •2 LAC •3 CEE

Emerging Setting

•Canada •UK

Mature Setting

• Trastuzumab • Drug Eluting

Stent • Human

Papillomavirus Vaccine

1 Product

•Colombia & Brazil

•Poland, Albania & Estonia

Emerging Setting

•CADTH, INESSS, NACI/CIC

•NICE&JCVI

Mature Setting


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POLAND AOTM

Positive: An Immunization Program has been established in Poland. The vaccination is mandatory but not refunded by Minister of Health

Local governments may cover par t or total spending of their citizens on HPV immunization and they do it under local heal th programs

Restrictions & Comments

CANADA NACI & CIC

Positive: HPV vaccine (HPV2 or HPV4) is recommended for females between 9 and 26 years of age and for those between 14 and 26 years of age who have had previous Pap abnormalities, including cervical cancer and AGW

HPV vaccination may be admin istered to females over 26 years of age and is not recommended in females <9 years of age. It́ s expected to be implemented on a voluntary rather to a llow for parental and rel igious differences

Country Institution Recommendation

ENGLAND JCVI Positive: HPV vaccine into the routine national immunisation schedule

HPV vaccination programme was restricted to girls aged 12 to 13 years and targeted g irls up to age 18 and a time-limited ‘catch up vaccination of girls aged 13 to 17 years

BRAZIL CONITECPositive: HPV vaccine is administered through a national HPV immunization program.

Only on girls, age group 9-13 years o ld. With a gradual implementation of vaccine schedule: in 2014, female adolescents aged 11-13 years old, in 2015, will be adolescents aged 9-11 years o ld, and in 2016 girls aged 9 years o ld.

COLOMBIA CRESPositive: the HPV vaccine is part of a national immunization program for women from 9 years o ld and older

Main Results – Case Studies HPV vaccine

CEE Countries: England: (Joint Committee on Vaccination and Immunisation JCVI); P: Poland (AOTM) LAC Countries: Canada (NACI&CIC) B: Brazil (CONITEC); C: Colombia (CRES) *NACI: National Advisory Committee of Immunization (CANADA) CIC: The Canadian Immunization Committee (CANADA)

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Key principle: HTA should actively engage on key stakeholder groups

CEE Countries: UK: United Kingdom (NICE&JCVI); A: Albania (University Hospital) ; P: Poland (AOTM); ES: Estonia (EHIF) LAC Countries: CA: Canada (CCOHTA); Q: Quebec (INESSS); B: Brazil (CONITEC); C: Colombia (IETS);

Main Results – Case Studies

UK A P B C UK ES Q B C UK P CA B C

Patients groups

Clinical specialists

Technology manufacturers

Civil society

DES HPV vaccineTrastuzumabIn the Priority setting


Patients groups



Civil society

Trastuzumab DES HPV vaccineIn the submission or review of evidence

*INESSS process is very different now (the process reported is from 2004). Patients, clinical specialists and civil are taking part in all of the mentioned stages

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Key principle: HTA should actively engage on key stakeholder groups

Main Results – Case Studies


Patients groups



Civil society

Trastuzumab DES HPV vaccineIn the Appraisal

CEE Countries: UK: United Kingdom (NICE&JCVI); A: Albania (University Hospital) ; P: Poland (AOTM); ES: Estonia (EHIF) LAC Countries: CA: Canada (CCOHTA); Q: Quebec (INESSS); B: Brazil (CONITEC); C: Colombia (IETS);

*INESSS process is very different now (the process reported is from 2004). Patients, clinical specialists and civil are taking part in all of the mentioned stages


Patients groups



Civil society

Trastuzumab DES HPV vaccineIn the Final Decision

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Conclusions

Positive trends were identified among the reviewed countries regarding: scope, priorities, methodology, process and the impact of HTA.

The lack of transparency, as the HTA reports were not public, associated with the language barriers were the main difficulties to make a more complete case studies analysis of the use of HTA in CEE countries.

Despite the differences in the institutional contexts, the results showed in these case studies exercise are one of the bases for start preparing the toolbox. The toolbox will outline best practice, including recommendations, and providing advice for emerging countries in the use of HTA.

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Task 6.3. HTA Toolbox. Objective

To Develop adaptable toolbox for emerging countries to improve decision-making processes, outlining best practices, concrete examples and innovative approaches:

– Based on the current situation and the emerging changes captured in the mapping and lessons learned from case studies, this toolbox is developed with a set of recommendations for effectively implementing HTA in the priority setting process.

– Added value • Offer examples • Provide best practices developed by CEE & LAC countries • Its purpose is to serve as a support to other countries willing to

implement HTA as a tool to decision making.

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Task 6.3 HTA Toolbox: Outline

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HTA Toolbox

HTA & HEALTHCARE

SYSTEM

• PRIORITY SETTING IN HEALTH SERVICE - Definition of Health Service

- Definition of Universal Health Coverage - Defining population needs - Types of Priority Settings - Essential medicines List - Strategic Fund - Vaccination Program Strategies - Health Benefit Plan (health insurance schemes/ tax-funded systems) - Disinvestment/ Delisting Decisions - Concrete examples

• HTA - Purposes

- Fields of application - Role of HTA in the Decision Making Process

• EXAMPLES OF THE USE OF HTA IN THE DECISION MAKING PROCESS

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BUILDING THE HTA FUNCTION Examples of HTA bodies/Organizations

Types of HTA bodies/organizations and their responsibilities

Advantages of HTA-networking

HTA Toolbox

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BUILDING THE HTA FUNCTION

HTA Toolbox

• SOCIAL VALUES AND PERSPECTIVES OF DIFFERENT SOCIAL ACTORS IN DECISION MAKING

* Ethics in the decision process * Tools to include equity perspective - The Equity-Oriented Toolkit - INATHA’s ethics working group experience - the EuneHTA ethical analysis model - morally questions to assess HT * Participation of different social actors in the decision process * Transferability * Methods for ethical analysis * Examples of HT covered after ethical analysis

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Types of HTA - Advantages/ disadvantages - Fields of application (national, regional, hospital)

Guidelines based on HTA - Where can HTA/EE Guidelines be found: - in the America’s Region - in the CEE Region

Transnational HTA - Opportunities - Problems with transferability of HTA reports - Best Practices to address the transferability of HTA - Role of EUneHTA - Role of RedETSA - Role of INAHTA

HTA PRODUCTS

HTA Toolbox

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* Structure and content of a report * Scope * Efficacy, effectiveness, safety - Definition - Recommendations - Tools :

• Clinical endpoints • Composite endpoints • Surrogate endpoints • Safety • Health-related quality of life • Criteria for the choice of the most appropriate

comparator(s) • Internal validity • Applicability of evidence in the context of a

relative effectiveness assessment

* Systematic Review of clinical evidence - Definition - Recommendations - Best Practices examples - Tools: - for systematic reviews - for metanalisis/ Direct and indirec comparison

• ELEMENTS TO CONSIDER IN A REPORT OF HTA

HTA PRODUCTS HTA PRODUCTS

HTA Toolbox

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* Economic Evaluation of HT & BIA - Definition - Key issues in EE - Roles of modeling in HTA - Cost-effectiveness thresholds - Recommendations - Best Practices examples - examples of EE in decision-making - methodological guidelines - Tools: - For developing cost effectiveness analysis - For modeling - For adapting cost effectiveness analysis - To estimate the budgetary impact

• ELEMENTS TO CONSIDER IN A REPORT OF HTA

HTA PRODUCTS HTA PRODUCTS

HTA Toolbox

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HTA Toolbox

Beyond HTA: using MCDA to facilitate decision-making and priority setting

Figure 2. An overview of Multi-criteria decision analysis.

Source: Angelis & Kanavos 2015 (14).

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Task 6.3 The Toolbox

• CLINICAL PRACTICE GUIDELINES BASED ON HTA * Methodological aspects for the development of guides Adaptation of guidelines - Definition - Tools and checklists - Examples - Repositories Disinvestment / Reinvestment & Countries examples Monitoring and evaluation

V. IMPLEMENTATION OF THE DECISIONS

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Lessons Learnt (I)

Different/broad interpretation about what is HTA when asking is in the country they are performing HTA

– An affirmative answer goes from a “simple” HTA (literature review looking for evidence, for example) to a more complete HTA (Literature review + Cost effectiveness studies + BIA +…)

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Lessons Learnt (II)

Difficult to gathering information about the HTA and the decision making process in some countries

– Not clear steps of the process (sometimes is informal) – Lack of HTA regulatory framework

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Source: http://www.ispor.org/htaroadmaps/spain.asp

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Lessons Learnt (III)

Lack of transparency for getting the HTA reports (it is not only a problem of the language)

– NICE website as example of transparency

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Lessons Learnt (IV)

“Overall capacity is still limited” but with differences within the countries.

Capacity to perform HTA

N (%) yes 15 (55.6%) No 9 (33.3%) Missed data 3 (11,1%)

55.6% of the respondents affirmed that their countries have the capacity to perform HTA regularly and systematically.

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Lessons Learnt (V)

Most of the HTAs are made for medicines, so

what about other health technologies?

| Source: A comparative analysis of the role and impact of Health Technology Assessment: 2013. Charles River Associates

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Way Forward (I)

To make aware/advice to the payers that HTA is a important tool to make a efficient use of the health technologies (opportunity cost)

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Way Forward (II)

To improve the exhange of information between HTA bodies/institutions in order to avoid overlapping / contradiction in the HTA technical reports

but “Transferability should be assessed carefully” (Gulacsi 2014)

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Cross-border healthcare Directive

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Way Forward (III)

Need of a public guidelines of the HTA process that helps everyone to know the “rules”. Arbitrarity in the decision making is not a good reference.

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Way Forward (IV)

HTA as a tool for disinvestment – Re-evalution of medicines when there is new evidence

(MEA) – Evaluation of old medicines that are actually reimbursed and

that were not under a HTA process

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Any other proposal from you?

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Thanks for your attention!!!

Prof. Jaime Espín, PhD

Escuela Andaluza de Salud Pública – Andalusian School of Public Health

([email protected])

Documents

HTA in Emerging Settings – Mapping Exercise and Toolbox · November 19th, 2015 . Final Conference – London . Jaime Espín, PhD – Professor. EASP . ADVANCE_HTA – WP6 Leader