hta in emerging countries: examples for eastern europe …€¦ · wp 6. project objectives...

HTA in emerging countries:

Examples for Eastern Europe

and Latin America

Jaime Espín, PhD

Professor

Presentation Outline

• ADVANCE_HTA - Introduction

• WP - objectives and tasks.

• Current findings: Mapping exercise in

Central and Eastern European countries

and Latin America & Caribbean.

• Case study framework and current

progress.

WP 6. Project Objectives

Research objectives:

1. To identify the use and capacity of HTA in emerging

settings (around 40 countries). This includes the

identification of HTA mechanisms and techniques that apply

in emerging countries of Europe and Latin America and the

Caribbean.

WP 6. Project Tasks

• Task 6.1: Mapping exercise of existing HTA activities, networks and capacity in Central and Eastern Europe and Central American and Caribbean countries.

• Review and evaluate all the previous mappings that were undertaken related to HTA and decision-making process, and the ones that are currently being developed (e.g. mapping of the members of the HTA Network of the Americas RedETSA; EUnetHTA for Central and Eastern European Countries; NICE Int.)

• Develop and validate a survey to collect the information in the selected countries;

• After receiving the answers to the survey, to interview key decision-makers in the selected countries if some information needed to be clarified

Mapping Exercise

• 1. Mapping exercise comprised of 2 surveys on decision-making and capacity building to analyze the current HTA situation in CEE and LAC countries.

• 2. Survey data collected was supplemented with information gathered through web searches and literature reviews.

Advance HTA: WP 6

Mapping HTA in CEE

CEE NOT covered by

EUnetHTA

Albania, Bosnia-Herzegovina,

Kosovo, Macedonia,

Montenegro, Serbia, Belarus,

Moldova and Ukraine

Countries CEE covered by EUnetHTA

Estonia, Latvia, Lithuania, Poland, Czech

Republic, Slovakia, Hungary, Romania,

Bulgaria, Slovenia, Croatia and Russia

Plus

Greece, Cyprus and Turkey

Advance HTA: Regional Overview

CEE Countries

Advance HTA CEE Countries by Income Classification

9 Upper middle income

11 High income (nonOECD)

2 Lower middle income

Source: Country classification based on World Bank Income Classification.

Advance HTA: WP 6

Mapping HTA in the Americas

Advance HTA countries:

1. Central America: Belize, Costa

Rica, El Salvador, Guatemala,

Honduras, Nicaragua, Panama.

2. Caribbean: Dominica, Dominican

Republic, Barbados, Jamaica, St.

Lucia, St. Maarten, Trinidad and

Tobago.

3. South America: Venezuela,

Guyana, Surinam.

Advance HTA: Regional Mapping

LAC Countries Overview

Advance HTA LAC Countries by Income Classification

Source: Country classification based on World Bank Income Classification. Note: High-income countries: Barbados, Bermuda, St. Martin, and Trinidad & Tobago.

4 High income

9 Upper middle income

5 Lower middle income

Advance HTA: Mapping

Exercise Task D6.1 A mapping exercise of existing HTA activities, networks, and capacity in 40 emerging HTA countries.

CEE • 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.

WP 6: Progress to date in 2014

• Draft – Report

Method

• The mapping exercise encompassed the design of two surveys on:

(i) HTA and the decision-making process and

(ii) diagnosing capacities in HTA

Surveys were sent to 24 European countries (including Cyprus, Russia, and Turkey) • An initial first step prior to survey design was to conduct a literature review to identify available information on the use of HTA in the region.

To gain a better understanding of HTA in South and East european countries with an emerging HTA setting

to identify key institutions such as Ministries of Health (MoH), HTA bodies, and other institutions that could be included in the target group of survey respondents

Results - Literature Review-

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Albania

Bosnia-Herzegovina

Bulgaria

Croatia

Cyprus

Czech Republic

Estonia

Greece

Hungary

Latvia

Lithuania

Poland

Republic of Belarus

Republic of Moldova

Republic of Serbia

Romania

Russian Federation

Slovakia

Slovenia

Turkey

Ukraine

Literature Review

Results - Literature Review +Decision Making Process Survey -

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Albania

Bosnia-Herzegovina

Bulgaria

Croatia

Cyprus

Czech Republic

Estonia

Greece

Hungary

Latvia

Lithuania

Poland

Republic of Belarus

Republic of Moldova

Republic of Serbia

Romania

Russian Federation

Slovakia

Slovenia

Turkey

Ukraine

Literature Review Decision making in HTA Survey

Results - Literature Review +Decision Making Survey + Capacity Building Survey

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Albania

Bosnia-Herzegovina

Bulgaria

Croatia

Cyprus

Czech Republic

Estonia

Greece

Hungary

Latvia

Lithuania

Poland

Republic of Belarus

Republic of Moldova

Republic of Serbia

Romania

Russian Federation

Slovakia

Slovenia

Turkey

Ukraine

Literature Review Decision making in HTA Survey Capacity in HTA Survey

Results - Survey on diagnosing Capacities in HTA-

Country Emails

gathered Emails sent

Responses

Albania 7 4 1 (2,77%)

Belarus 10 9 1 (2,77%)

Bulgaria 15 10 3 (8,33%)

Croatia 17 14 2 (5,55%)

Czech Republic 15 13 2 (5,55%)

Greece 11 7 3 (8,33%)

Latvia 4 3 1 (2,77%)

Lithuania 17 17 4 (11,11%)

Macedonia 13 10 1 (2,77%)

Moldova 8 8 2 (5,55%)

Poland 12 11 2 (5,55%)

Romania 18 14 4 (11,11%)

Russia 7 7 1 (2,77%)

Serbia 11 8 1 (2,77%)

Slovakia 12 10 1 (2,77%)

Slovenia 16 10 2 (5,55%)

Turkey 14 13 2 (5,55%)

Ukraine 6 5 1 (2,77%)

Hungary 19 17 2 (5,55%)

Total 232 190* 36 (100%)

*The difference between emails gathered and emails sent are the emails available, refers to problems occurred with that emails; † The percentage refers to the total of questionnaires received.

A very low response rate was observed

(18%). A great heterogeneity was observed in

relations with the characteristics of the

respondents (institution, responsibility, HTA

experience, etc.).

One results of the bibliographic search was

the unequal amount of information

obtained related with the countries.

The results allowed to identify different

institutions that perform HTA in the selected

countries.

N (%) Systematic Review 14 (51.9%) Economic Evaluation 5 (18.5%) Clinical Practical Guideline 5 (18.5%) Technical report/working document 15 (55.6%) Other 5 (18.5%) * Critical review of Economic evaluation, Rapid REA and Full Core HTAs, rational pharmacotherapy guidelines, etc.

Main type of reports produced

Technical Reports (55.6%) and Systematic Review (51.9%) are the

most frequently HTA products.

Training activities and dissemination strategies

40,7% of the respondents have affirmed that they have training activities for

external participants and 66.7% of the HTA institutions/bodies have strategies for

dissemination of HTA reports.

N (%)

Systematic Review 14 (51,9%)

Economic Evaluation 14 (51,9%)

Clinical Guideline 5 (18,5%)

Technical report/working document 15 (55.6%)

Other* 5 (18,5%)

Obstacles mentioned by the respondents by countries (for those that perform or not HTA)

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.

Countries

Capacity to perform HTA

systematically and regularly

Sources of funding

Skills training

Access to domestic HTA

networking

Access to International

HTA networking

Institutional support

Other

Albania Yes √ √ Bulgaria Yes √ √ √ √ Croatia Yes √

Czech R. No √ Greece Yes √

Hungary Yes √ √ √ √ √ Poland Yes √ √ √ √ √ Latvia Yes √ √

Lithuania No √ √ √ Slovenia NA √ √ √ Russia Yes Serbia NA √ √ Turkey - √ √ √ Ukraine Yes Belarus Yes √ √

Moldova Yes Romania NA √ √ √ √

Results - Survey - HTA and the decision-making process

Four Sections

•Use of HTA

•Decision-making process

•Implementation

•Future Challenges

Use of HTA Criteria for selecting technologies to be assessed using HTA

SLOVAKIA LATVIA GREECE POLANDCZECH

REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA

ESTONIA

II

Frequency of the clinical condition

(Prevalence, incidence)

Burden of disease (mortality, morbidity

and quality of life related to a clinical

condition (DALY, QALY)

Cost of illness (the direct cost of the health

care of a patient per year)

Medical practice variations (those not

related to demographic differences)

Political concern (Information needs of the

policy maker)

Public and media concern (social interest in

the management of a specific clinical

condition

Ethical, legal or social implications (equity

criteria included)

No criteria

Other: a d b e

d submission of manufacturer of drug/medical device/food supplement

e new emerging technologies

a To obtain reimbursement MOH submits an application to NHS, indicating the price along with economic evaluation of a pharmaceutical compared with

other available treatments. The reimbursement decision is taken according to therapeutic and economic evaluation of a pharmaceutical

b Obligatory in case of new drug indication

c Clinical and practical efficacy, safety, BIA, recommendations in other countries, the HTA criteria are used for every new one INN

Technologies are assessed in HTA



ESTONIA

II

Pharmaceuticals (include vaccines and

other biological products.)

Medical devices (include diagnostic

products)

Medical procedures

E-health technologies

Public health interventions

Other, (a)

a National and Local Government Health Care Programs

Use of HTA

Decision Making Process


REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA ESTONIA II

There is legislation establishing that HTA reports must

be considered in the decision-making process

(mandatory)

? (a)

There is legislation establishing that HTA reports

should be considered to support coverage decisions

(recommendation)

?

There is no specific legislation at the present time

stating that coverage decisions should be informed by

HTA reports, but HTA reports have been used to

support policy making in this area.

There is no link and the decisions are not informed by

HTA c)

(a)

(b)c)

How HTAs are ultimately linked to decision-making and priority setting

The existing legislation for the positive reimbursement list (Official Gazette 2912 B/30.10.2012 article 2, paragraph 6) mentions that a MAH could submit as supporting material HTAs from other EU HTA

bodies like NICE. Additionally, in Official Gazette FEK 2219 B/9.09.2013 is defined as reimbursement condition for products having a MA after 01.01.2012 the reimbursement by the 2/3 of EU countries

where the product is marketed or the reimbursement at least in 12 Member States, after assessment through respective HTA organizations.It differs: in pharmaceuticals, HTA report must be delivered (but need not be considered), there is legislation that decisions have be evidence based, medically effective, cost-effective, affordable within social insurance system

Questions related to the decision-making process for health technologies that are publicly funded

a reports made by AOTM

b (not by Government, sometimes by AOTM)

c

d (evaluation reports that are based on the evidence collected during an administrative procedure)

Pharmaceutical manufacturers applying to the MoH for reimbursement (if active substance has not been funded earlier)

have to submit full HTA report for AOTM assessment

Decisions are based on

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 being publicly

subsidized or incorporated in

a benefits package

SLOVAKIA Always Never Always

LATVIA Frequently Never Frequently

GREECE Not aplicable Not aplicable Not aplicable

POLAND frequently (a) Never (b) regulary (c )

CZECH REPUBLIC Always (d) Never Frequently

CROATIA rarely rarely REGULARY

LITHUANIA Frequently regulary No answer

RUSSIAN __ __ always

ESTONIA frequently rarely regularly

ESTONIA II always rarely regularly

Explicit

criteria

Implicit

criteriaNo criteria

Explicit

criteria

Implicit

criteriaNo criteria

Explicit

criteria

Implicit

criteriaNo criteria

Efficacy(SK) (LV) (PO)

(CZ) (CR) (RU)

(ES)

(SK) (PO) (CR)

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

Effectiveness(SK) (CR) (RU)

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

Safety(SK) (LV) (PO)

(CZ) (CR) (RU)

(ES)

(SK) (PO) (CZ)

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

Quality of Life(SK) (CR) (RU)

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

Cost-Effectiveness(SK) (LV) (PO)

(RU) (ES) (CZ) (CR) (SK) (PO) (ES) (LV) (CZ) (CR) (PO) (ES) (SK) (LV) (CZ) (CR)

Budget Impact(SK) (LV) (PO)

(CR) (ES)(CZ)

(SK) (PO) (CR)

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

Ethical, Equity, and Social Issues (CR) (ES) (SK) (LV) (PO) (CZ) (ES) (SK) (PO) (LV) (CZ) (ES) (SK) (LV) (PO) (CZ)

Organizational Impact (ES)(SK) (LV) (PO)

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

Innovation/Industrial

Development/Technology Transfer(SK) (LV) (PO)

(CZ) (ES)

(SK) (LV) (PO)

(CZ) (ES)

(SK) (LV) (PO)

(CZ) (ES)

Geographical Budget Allocations(SK) (LV) (PO)

(CZ) (ES)

(SK) (LV) (PO)

(CZ) (ES)

(SK) (LV) (PO)

(CZ) (ES)

Impact on Vulnerable Groups[1] (ES)(SK) (LV) (PO)

(CZ) (SK) (CZ) (ES) (LV) (SK) (LV) (ES) (CZ)

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

(RU) (ES) (SK) (CZ) (PO) (CR) (ES) (SK) (LV) (CZ) (PO) (ES) (SK) (LV) (CZ)

INTERVENTIONSMEDICINES MEDICAL DEVICES

Criteria used for priority setting/defining the benefits package.

(CR) ; no complete information

(RU) no complete information

GR, LI, MO No answer

[1] Vulnerable groups include the elderly, the mentally and physically disabled, at-risk children and youth, ex-combatants, internally displaced people and returning refugees,

HIV/AIDS-affected individuals and households, religious and ethnic minorities, in some societies women.



Does the HTA organization encourage or

require submissions of evidence from

stakeholders?

YES YES N/A YES YES YES Unsure NO

depends on

the HTA

process

Does the HTA organization allow

stakeholders to comment on HTA at the

draft stage?

No NO N/A NO YES NO Unsure NO

depends on

the HTA

process

Does the HTA organization allow

stakeholders to appeal against

recommendations/decisions?

Yes YES N/A NO YES NO UnsureNO,

UNSURE

depends on

the HTA

process

Is the decision-making process (including

the rationale behind technology

reimbursement decisions) open to public

scrutiny?

Yes YES N/A YES (a) YES NO NO NO NO

aonly HTA process is partially open (“confidential” information may be hidden by applicant, what sometimes stays for huge part

of HTA analysis), as descripted above

Question related to the Stakeholder involvement in HTA process

Is an economic evaluation required for

the DM?

How often is an

economic evaluation

explicitly considered in

the DM?

Are there explicit ‘thresholds’ for

cost-effectiveness?

What is the perspective

normally used of the economic

evaluation?

SLOVAKIAYes, It is mandatory based on the law

363/2011.ALWAYS.

Yes, Thresholds within the Slovak

Republic. WTP1: 24 x average

monthly salary € / QALY; WTP2: 35 x

average monthly salary € / QALY

Third-party payer (i.e. public

insurer). For the reimbursement

process from public funds the PE

perspective of health insurance

companies is accepted.

LATVIA YES ALWAYS

YES; The ICER shall not exceed the

ICER of pharmaceuticals already

included in the Positive list.


insurer)

GREECE

NOT YET. However the MAH could

included an EE to the submission file for

the Positive Reimbursement Committee

for Pharmaceuticals

Rarely Not applicable Not definded yet

POLAND YES

Always (for

reimbursement

submissions)

YES. There is an explicit CE threshold

of 3 x GDP per capita for ICER, which

in 2014 is approximately EUR 26,520.

Public Sector *

CZECH

REPUBLIC

YES; For new technologies, new

indications or in case of an increase in

the current reimbursement level.

ALWAYS

NO, they use 3xGDP per QALY as a

basic threshold with a correction

based on the other parameters -

burden of illness, comparative

effectiveness,BIA, unmet clinical

need.


insurer)

Question related to Economic Evaluation

Is an economic evaluation

required for the DM?

How often is an economic

evaluation explicitly

considered in the DM?

Are there explicit ‘thresholds’

for cost-effectiveness?

What is the perspective

normally used of the economic

evaluation?

CROATIA NO. Only BIA NEVER NO No answer

LITHUANIA No answer No answer No answer No answer

RUSSIAN YES Frequently NO Public Sector

ESTONIA yes AlwaysNO, 1-3 GDP per capita is used

as reference

Public Sector; Third-party

payer (i.e. public insurer)

Question related to Economic Evaluation

Implementation SLOVAKIA LATVIA GREECE POLAND

CZECH


Are there monitoring and

evaluation mechanisms for

assessing uptake of technical

advice/recommendations

based on HTA?

Yes YES Not applicable yet NO UNSURE NO YES No YES

Are the clinical guidelines

mandatory or advisory

recommendations for the

doctors in the public health

system?

Yes NO

YES. There are therapeutic

protocols that will be

mandatory for doctors in the

public health system.

Additionally, a national

committee for monitoring the

implementation of the

therapeutic protocols has

been recently being

established.

Unsure UNSURE YES No answer No They are advisory.

How are the clinical guidelines

disseminated to users and in

the public health system?

Email; Website;

Other:

publication

WebsiteThrough the system of e-

prescription

Probably by the

websites of main

medical

associations;

dissemination of a

clinical guideline

doesn’t belong to

AOTM tasks and

responsibilities.

Website

and Clinical

guidelines

are

provided by

Medical

experts

societies to

their

members.

Website No answer Website

WEBSITE. : Each

clinical guideline

has an

implementation

plan, which

includes guideline

specific activities,

including

trainings

Is there a national strategy for

the implementation of health

technologies?

No No answer NO Unsure UNSURE Yes No answer NO NO

Question related to Implementation of decision based on HTA

SLOVAKIA LATVIA GREECE POLAND CZECH


Organizational /

institutional

Economical /

Financial

Information /

comunication

Human Resources

Other

Lack of

national

data

Legal

framework;

political issue

Lack of

political

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

Country Eunetha HTA Guideline Body responsible for HTA Decision maker - Reimbursement

Albania NO no National Centre of Quality, Safety and

Accreditation of Health Institutions (NCQSA)

MoH and Health Insurance Institute (HII)

Belarus NO no Unit in the MoH

Bosnia-Herzegovina

NO no Health insurance Fund Health insurance Fund

Bulgaria yes no

Posivie Drug list Committe (NPRC); National Center of Public Health and Analisys (NCPHA); Other: Center for Health Technology Assessment and

Analysis;

National Pricing and Reimbursement Council (NPRC)

Croatia yes YES Agency for Quality and Accreditation in

Health Care and Social Welfare

CIHI Board (medicines); MoH (health policy, public health

program); Hospital Management (medical device)

Cyprus yes NO Drug committe (MoH) MoH

Czech Repulbic

yes NO No institution. MAH carry out CEA and BIA MoH

CEE Countries Overview


Hungary yes Economic Evaluation Guideline

Technology Appraisal Head Department in the National Insitute for Quality and

Organisational Development in Healthcare and medicinies)

National Health Insurence Fund Administration

Latvia yes yes Center of Health Economics NHS

Lithuania yes no Reimbursement committe MoH

Macedonia NO NO

Moldova NO no Medicine Agency MoH

Poland yes YES AHTAPol MZ

Romania yes no MoH

Russia yes no

Department of the Establishment for Higher and Continuous Education for Civil

Servants founded by the Presidential Administration (RANE)

MoH

Serbia NO no National Health insurance fund (RZZO) National Health insurance fund

(RZZO)



Slovakia yes EUnetHTA Working Group for Pharmacoeconomics, Clinical Outcomes and HTA of the MoH

MoH

Slovenia yes no Slovenia Health Insitute

Turkey yes no Social Security Insitution Social Security

Institution, SSK drug committee,

Ukraine NO no Ukraine Agency of Health Technology

assessment


LAC Countries Overview Quick overview of established HTA agencies in the

region.

Country

Formal

HTA

Agency

Performs

HTA Institution

Barbados X N/A N/A

Belize X X ..

Bermuda X ✔

MoH/Bermuda

Health Council

Costa Rica X ✔ MoH/SS

Dominica X X ..

Dominican

Republic X ✔ MoH

El Salvador X ✔ MoH/SS

Guatemala X X ..

Guyana X X ..

Honduras X ✔ MoH

Jamaica X ✔ MoH

Nicaragua X X ..

Panama X X ..

St. Lucia X X ..

St. Maarten X X ..

Suriname X ✔ MoH

Trinidad &

Tobago X ✔ MoH

Venezuela TBD TBD TBD

Findings:

None have a formal

HTA agency.

8 out of 18 perform

HTA.

8 do not perform

HTA.

2 no data

available/TBD.

LAC Countries

Table 3. Criteria for selecting Technologies to be assessed in HTA

Barbados Belize Bermuda

Costa

Rica Dominica

Dominican

Republic

El

Salvador Guatemala Guyana Honduras Jamaica Nicaragua Panama St. Lucia

St.

Maarten Suriname

Trinidad

& Tobago Venezuela

Frequence of the

clinical condition N/A

Burden of disease

Cost of illness

Medical practice

variations

Political concern

Public and media

concern

Ethical, legal, or

social implications

Other

Source: All data in table is based on question #13 of HTA Decision-Making Survey.

Advance HTA: Survey Findings

LAC Countries

Table 4. Technologies assessed in HTA

Barbados Belize Bermuda

Costa

Rica Dominica

Dominican

Republic

El

Salvador Guatemala Guyana Honduras Jamaica Nicaragua Panama St. Lucia

St.

Maarten Suriname

Trinidad

& Tobago Venezuela

Pharmaceuticals N/A

Medical devices

Medical procedures

E-health

technologies

Public health

interventions

Other

Source: All data in table is based on question #15 of HTA Decision-Making Survey.

Advance HTA: Survey Findings- LAC Countries

Table 6. Snapshot on HTA decision-making process in select LAC countries

HTA Process

Costa

Rica

El

Salvador Bermuda

Trinidad

& Tobago Honduras Jamaica

Decisions based on internal

HTA reports Regularly Regularly Frequently Never No Regularly

Economic evaluation

required

Not

always Yes n/a No No No

Final assessment

Yes/MoH

and CCSS Yes/MoH Yes Yes/MoH No Yes/MoH

Incorporation of health

technologies Yes/MoH Yes/MoH

Yes/MoH

& Health

Technolog

y Review Yes/MoH Yes/MoH Yes/MoH

Stakeholder involvement Not sure Yes Yes Unsure No Yes

Appeals against a decision

by manufacturer Yes No Yes Yes No Yes

Monitoring & evaluation

mechanism Not sure No Yes No No Unsure

Notes: All information comes from Advance HTA surveys; countries not included skipped survey questions or failed to complete survey.

Advance HTA: Case Study

Framework

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

Instrument: Case study countries will be benchmarked against “advance/mature” HTA setting countries.

What will be 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.


Framework

Step-by-step process:

Review of health technologies evaluated in the last 10 years.

LAC: Canada, Brazil, Colombia, Mexico & Uruguay.

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

1st selection of health technologies based on those technologies more frequently evaluated (broader selection).

One technology selected for each category of a medicine, vaccine, and medical device.

Country selection (mature – benchmarking – reference countries): Canada & United Kingdom (CADTH & NICE).


Framework

Selection of the HTA inventory conducted in select EU and LAC countries.

Source: Countries websites

COUNTRY / REGION Europe Latin America Indication

UK France Sweden Austria Germany Scotland Canadá Brazil Colombia Uruguay México

RANIBIZUMAB Macular

degeneration ● ● ● ●

BEVACIZUMAB Macular

degeneration ● ●

INFLIXIMAB Rheumatoid

arthritis ● ● ● ● ●

INFLIXIMAB Psoriatic arthritis

● ● ●

Medicines

TRASTUZUMAB Breast cancer ● ● ● ● ● ●

Vaccines VPH ● ● ● ● ● ●

DRUG ELUTING

STENTS

Coronary arteries diseases

● ● ● ● ● ● ● ● ● Other

technologies IMPLANTABLE

CARDIAC

DEFIBRILATOR

Heart failure/ sudden cardiac

death / arrhythmias

● ●

●

Case Study Framework

• To study the decision-making process of 3 products in a total of 6 countries. • Research outputs: 18 country mini-studies.

•Medicine

•Medical Device

•Vaccine

1 Product •2 LAC

•2 EE Emerging

Setting 2

Benchmark Mature Setting

Trastuzumab

HPV Vaccine

Drug eluting stents

Next step: research product in benchmark country

LAC: Colombia & Brazil

EE: Poland & Albania or Serbia

Select 2 “mature” countries: UK & Canada

Research Outputs •3 Products •Regional sampling: •2 LAC •2 EE •2 “Mature”

Case Study Framework

Roadmap of how each technology has been evaluated by CADTH and NICE International.

Case study survey: a survey has been designed to help us understand the decision-making process in CEE and LAC countries*.

Part 1. Introduction

Introduction HTA should be an unbiased and transparent exercise

Part 2. Structure and methods

The goal and scope of the HTA should be explicit and relevant to its use HTA should include all relevant technologies HTA should consider a wide range of evidence and outcomes HTA should incorporate appropriate methods for assessing costs and benefits A full societal perspective should be considered when undertaking HTAs HTAs should explicitly characterize uncertainty surrounding estimates HTAs should consider and address issues of generalizability and transferability The implementation of HTA findings needs to be monitored

Part 3. Use of HTA in Decision Making

HTA should be timely HTA findings need to be communicated appropriately to different decision makers The link between health technology assessment and decision-making processes needs

to be transparent and clearly defined

Next Steps

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

• Toolkit outlining best practices and recommendations on HTA and decision-making

Thank you very much for your attention.

[email protected]

hta in emerging countries: examples for eastern europe …€¦ · wp 6. project objectives...

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