1. National HTA strategies; the case of Hungary László Gulácsi PhD Chair Professor Corvinus University of Budapest Unit of Health Economics and Health Technology Assessment HunHTA Presented at the 7 th European Forum Gastein, 7 th October, 2004

2. HunHTA Unit of Health Economics and Health Technology Assessment The „New iron curtain” (standardised death rate, both sexes, 1990)

3. HunHTA Unit of Health Economics and Health Technology Assessment DEFICIT of the Hungarian National Health Insurance Fund (cont.)

4. HunHTA Unit of Health Economics and Health Technology Assessment Issues of the ‘Fourth Hurdle’ The first three hurdles, which already exist in most countries, require the demonstration of efficacy, safety and quality of manufacturer. Several countries have already introduced the ‘fourth hurdle’, namely a requirement for cost- effectiveness evidence prior to reimbursement of new drugs.

5. HunHTA Unit of Health Economics and Health Technology Assessment Issues of the ‘Fourth Hurdle’ (Cont.) Do we request evidence for all new drugs, or just some? How do we prioritize drugs for assessment? Does it make sense to assess several drugs in the same class together? How prescriptive, or flexible, should we be in specifying the data requirements? Should we be willing to accept data from other jurisdictions? If so, which?

6. HunHTA Unit of Health Economics and Health Technology Assessment ! 104 application between May 1th- September 1st, 2004 for HTA appraisal 105/89/EEC Transparency Directive

7. HunHTA Unit of Health Economics and Health Technology Assessment HTA settings and capacity HunHTA - INAHTA, Corvinus University of Budapest 4 staff - 4 trained (MD, economists) HTA assessment capacity / year: 4-5 HTA reports limitation: number of trained personnel budget for HTA: occasionally based on the given HTA project ESKI - Office of HTA National Institute for Strategic Health Research, Ministry of Health Social and Family Affairs 7 staff - 2 trained (2 MDs, 3 economists, 1 chemist) HTA assessment capacity / year: ? limitation: ? Budget for HTA: ? / not yet decided

8. HunHTA Unit of Health Economics and Health Technology Assessment Please notice … Manufacturers are unlikely to tailor many evaluations to the needs of the 10 ‘New’ EU member states.

9. HunHTA Unit of Health Economics and Health Technology Assessment Summary - Challenges Data shortage: no valid data available on morbidity, health status, risk, quality of life (measurement methodology is used in a very limited scale yet); registries are non-existing or inappropriately managed – real epidemiology is unknown. Cost & costing: costs are unknown or misleading (reimbursement), costing guideline has not established yet. The major constraint is the availability of trained personnel Standardisation of health economic analysis and HTA is needed in order to improve adaptability and transferability of the studies to other settings.