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
SLOVAKIA LATVIA GREECE POLANDCZECH
REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA
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
SLOVAKIA LATVIA GREECE POLANDCZECH
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.
SLOVAKIA LATVIA GREECE POLANDCZECH
REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA
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.
Third-party payer (i.e. public
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.
Third-party payer (i.e. public
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
REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA
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
REPUBLICCROATIA LITHUANIA RUSSIAN ESTONIA
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
Country Eunetha HTA Guideline Body responsible for HTA Decision maker - Reimbursement
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)
CEE Countries Overview
Country Eunetha HTA Guideline Body responsible for HTA Decision maker - Reimbursement
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
CEE Countries Overview
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.
Advance HTA: Case Study
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).
Advance HTA: Case Study
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.