Temporary reimbursement: Vo I going Dutch;

1. Temporary reimbursement: VoI going Dutch; Erasmus MC Department of Medical Psychology and Psychotherapy De Viersprong Viersprong Institute for Studies on Personality Disorders (VISPD) Jan J.V. Busschbach

2. Temporary reimbursement Start reimbursement at T0 Evaluate at T3 Since 2006 T3 is ‘temporary’ T4 First T4 at December 2010 39 application between T0 and T3 (T4)

3. When applicable? Expensive hospital drugs > 0.5% of total national budget > € 2.500.000 per year Orphan drug in academic hospital setting > 5% of academic hospital medication budget € 600.000 < prevalence 5 / 10.000 < 8000 patients in the Netherlands A ‘cost effectiveness indication’ must be provided ?? ….. An cost effectiveness estimate

4. Why? Officially problem: Medication comes late on the market As research is to expensive given the budget Medication does not come on the market Unofficial problem: Difficulty in denying health care when: High burden of disease Highly exposed diseases Lack of arguments As no trials are running Although expensive, low budget impact Because of low prevalence in orphan drugs

5. Paradox Officially argument ‘no evidence’ But many applications are clearly not cost effective > € 80.000 per year Why no rejecting: no threshold value in NL Cost effectiveness research is necessary Not cost effectiveness… Clear roles for assessment No clear roles for appraisal Anyway:… no effect data as well

6. Who wants it? We all love temporary reimbursement… Manufacturers Patient Clinicians Policy makers It looks humane It looks like policy Scientist The promises of research in between

7. There scientist who object… Why are we going to do it, if we know the out come at forehand…. € 80.000 per year will never be cost effective It is extremely difficult to get drug of the market If you think research is to expensive: VoI Well a cost ‘effectiveness indication’ must be given at T0 What is a cost effectiveness indication

8. A cost effectiveness ‘indication’ 1. Definition of research question Literature investigation Rational Plan for ‘outcome investigation’ 2. An estimate of the CE-ratio Model, a description of a model, only a description An indication of the ‘critical parameters’ 3. According to national CE guidelines 4. rational of additional data collection ‘outcome research’ (Budget estimates)

9. Funds available Fund for evaluation research Not for the cost effectiveness indication Only for period between T0 – T3 Aimed at: hospitals, health care professional organizations and patient organizations Matched funding Not really clear if industry may benefit Through third party?

10. Temporary… After three years (T3 …. Ehh T4) Budget impact Effectiveness Cost effectiveness Along normal guidelines Rightful (target) population If not, reimbursement stops

11. The scientist who where hoping on new research… Clinical investigators Setting up registers and database investigation Effectiveness Seen as substitute for CE Rightful (target) population Seen as substitute for CE Health economist Full model at T3 Value of information at TO

12. Scientist had difficulty understanding each other… Health economists What is the point in collection data is you know that it not going to be cost effective in the first place What else (should) you do than a VoI Clinical scientist Cost per QALY are bad thing anyway… What is VOI?

13. Guideline for outcome research

14. Guideline Pragmatic Unclear quality for the research… Understandable is funding is limited A strange mix of clinical outcome Data base building Data base analysis Health economics

15. Changes Start with a VoI Get funding Get your medication reimbursed For at least 3 years Not cost effective? Will they be able to stop reimbursement? Why not start all over again for another period of three years…