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 zoltan.kalo@syreon.eu

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?

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

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.”

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.”

How to facilitate HTA implementation Exploring current status Setting preferred status in 5-10-20 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

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. 2016. 25. S1. 179–192.

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

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

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

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

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. 2016. 10. 41-47.

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

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

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?)

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?

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.)

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

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?)

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

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

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

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

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