1. Framework for HTA Implementation
Zoltán Kaló
Professor of Health Economics
1. Eötvös Loránd University (ELTE); 2. Syreon Research Institute
Framework for HTA Implementation
Dubai
18 September 2018

2. Starting points
Health technology assessment was introduced in developed countries
HTA implementation requires investment
What is the reality of HTA implementation in the near future in MENA countries?

3. Presentation Information
MENA countries
Few trained health economists
Low public budget for health technology assessment
Limited availability of local data
Methodologies are often too sophisticated for policy-makers
Frequent changes in policy leadership
MENA countries
cannot directly copy HTA implementation roadmap of developed countries
need more creativity to implement HTA 3
CONFIDENTIAL

4. Alice: Which way should I go?
Cat: That depends on where you are going.
Alice: I don’t know.
Cat: Then it doesn’t matter which way you go.”

5. Alice: Which way should I develop my HTA system?
Cat: That depends on how you want to use HTA.
Alice: I don’t know.
Cat: Then it doesn’t matter how you develop your HTA system.”

6. How to facilitate HTA implementation
Exploring current status
Setting preferred status in years
Publication on HTA roadmap ("where to go")
Coordinated action plan to reach target status
Monitoring
implementation of action plan
comparison of actual status to preferred status
HTA roadmap

7. HTA roadmap: major questions
Capacity building - human resources
HTA funding
HTA legislation (process and organisational structure)
Scope and depth of implementation
Decision criteria (categories and thresholds)
HTA quality, transparency and timeliness
Requirement and accessibility of local data
International collaboration
Ref: Kaló Z, Gheorghe A, Huic M, Csanádi M, Kristensen FB. HTA implementation roadmap in Central and Eastern European countries. Health Econ S1. 179–192.

8. HTA roadmap I. Human resources
Lack of trained professionals in MENA countries
limited number of trained professionals both in public and private sectors
demand in industry  brain drain from public sector
University training
training in developed countries – potentially different scope
local university training
trained trainers
long accreditation period

9. HTA roadmap I. Capacity Building
Regular short courses
Train the trainers
Academic HE/HTA courses to graduate and postgraduate students
Postgraduate program in Health Economics / Health Technology Assessment

10. HTA roadmap II. Funding different stages of HTA
Health Technology Assessment – funding?
public HTA office
academic researchers
pharmaceutical companies
consultants
Critical Appraisal of HTA – funding?
critical appraisal by public HTA office
opinion of clinical experts (and patients) is considered
decision by MoH / Health Insurance committee

11. HTA roadmap II. HTA funding
Reactive solution:
Only single TA funded from private resources
Fee for HTA services related to reimbursement submissions
Only for innovative pharmaceuticals (and potentially for hi-tech medical devices)
No budget for revision of previous decisions
Proactive solution:
Significant public funding: 0.1-1% of health care budget for health services research
Private resources: single TA funded from private resources
Public resources: multiple TA; horizon scanning; revision of previous decisions

12. HTA roadmap III. Transferability of international HTA recommendations
Motto: "you do not need to repeat what is already done by prestigious HTA agencies in WE“
Romanian HTA scorecard:
France HTA evaluation from HAS SMR: 15 points for SMR levels 1 or 2 (major/important) and 7 points for SMR levels 3 or 4 (moderate/low);
UK HTA evaluation from NICE or SMC: 15 points for a positive evaluation without any restrictions, 7 points for a positive evaluation with restrictions;
Germany HTA evaluation from IQWiG or G-BA: 15 points for a positive evaluation without any restrictions, 7 points for a positive evaluation with restrictions
Number of EU countries with a positive reimbursement status: 25 points for at least 14 EU countries, 20 points for at least 8 to 11 EU countries, 10 points for at least 3 EU countries, and 0 points for fewer than 3 EU countries;
Real-world data (RWD) study: 45 points if the manufacturer provides the real data collected for a period of at least 1 year in Romania
Budget impact analysis (only direct costs): 30 points for >5% savings; 15 points for neutral budget impact (±5%).
Ref: Radu CP, Chiriac ND, Pravat AM. The Development of Romanian Scorecard HTA System, ViHRI

13. HTA roadmap III. Transferability of international HTA recommendations
If HTA resources are limited, some decision-makers follow recommendations of prestigious HTA institutes in other countries.
Decision-makers may not understand the limitations of transferability
Incidence & prevalence
Higher disease progression  same relative risk reduction results in greater absolute risk reduction
Different mortality  cost-effectiveness of preventive medicine
Unit costs – cost of human resources  relative price of medicines
Resource utilization  effectiveness of primary care, nurse/physician ratio, availability of imaging diagnostics etc.
Different patient routes
Confidential price reduction of pharmaceuticals
Following international HTA recommendations may do more harm than good

14. HTA roadmap III. Legislation on the role of HTA process and recommendations in decision-making process
No formal role of HTA in decision-making
Dominantly international HTA evidence is taken into account in decision-making
International and additionally local HTA evidence is taken into account in decision-making
Local HTA evidence is mandatory in decision making

15. HTA roadmap III. Organisational structure
HTA Office or Special Committee?
One or several HTA agencies?
National or Regional/Local?
Collaboration of HTA agency with academic centers?
(Collaboration of HTA agencies within a country?)

16. HTA roadmap IV. Scope of HTA
Types of technologies
innovative pharmaceuticals
medical devices (including diagnostics)
surgical interventions
public health initiatives
investment decisions / infrastructure development
All or selected technologies
Every new technology?
Selected new technologies with significant budget impact?
Revision of reimbursement for technologies with significant budget impact?

17. HTA roadmap V. Verifiable criteria: cost-effectiveness criterion
Political attitude in lower income countries is based on implicit decision- making
How to interpret cost-effectiveness ratio?
no threshold
implicit threshold(s)
explicit soft threshold(s) – use HTA as a tool
explicit hard threshold(s) – use HTA as a rule
How many thresholds?
one
lower and upper
moving threshold according to disease severity
How to define threshold? (options: WHO proposal, GDP/average salary, dialysis, thresholds in benchmark countries, national poll, etc.)

18. HTA roadmap V. Verifiable criteria: budget impact; MCDA
Budget impact criterion:
In difficult economic periods policymakers may put more emphasis on budget impact analysis than cost-effectiveness analysis.
explicit limits (e.g. 0.2% of total budget)? different level of decision-making?
portfolio deal?
Multicriteria decision analysis
Composite HTA endpoint based on international studies
Composite HTA endpoint based on local and international studies

19. HTA roadmap VI. HTA quality
Standardization of HTA methodology
Methodological guidelines for economic evaluation and budget impact analysis
Regular follow-up research on HTA recommendations
Critical appraisal checklist (confidential or published?)

20. HTA roadmap VI. Transparency of HTA in policy decisions
Publication of
HTA reports
Critical appraisal of HTA reports
HTA recommendation
Reimbursement decisions
Transparent timelines of
HTA submission
critical appraisal
issuing recommendations

21. HTA roadmap VII. Limited availability of local data
There is no perfect data for health outcomes research and economic evaluation: the practical question is how wrong do they have to be to not to be useful
Even if local data is limited and low quality, we may start using it
Efforts to collect and use local data will teach us how to improve the quality

22. HTA roadmap VII. Local data
Requirement of using local data in technology assessment?
Investment into electronic health records, claims database and patient registries
Accessibility of publicly funded health care databases (payers’ databases data, registries etc.)
Data quality: use of real world data (payer’s database) improves the quality of data
Published list of most common cost and epidemiology data

23. HTA roadmap VIII. International collaboration in development or reuse of joint work
No involvement into joint work; and no reuse of joint work or national/regional HTA documents from other countries
Active involvement in joint work (e.g. INAHTA, EUnetHTA rapid REA, full core HTA)
National/regional adaptation (reuse) of joint HTA documents
National/regional adaptation (reuse) of national/regional work performed by other HTA bodies in other countries

24. Summary
Approach of developed countries for HTA implementation may not work in emerging economies, but MENA countries should learn from experiences in any other countries
Determining long-term objectives + creative and consistent HTA implementation delivers success over years
Key success factors:
Investment into training
Budget for HTA (incl. methodological research)
Political commitment