POSSIBLE EXPLANATIONS AS TO WHY EFFECTIVE PRODUCTS STILL DON'T HAVE A PRICE IN FRANCE
Author(s)
Peirone V1, Houzelot D1, de Paz B1, Toueg R2
1PRIORITIS Market Access, Paris, France, 2Paris Descartes University, MALAKOFF, France
OBJECTIVES: Price negotiations are known to be a long and arduous process between companies and health agencies. We attempted to shed the light on the international status of products that were still in price negotiations in France for more than a year. METHODS: We chose to investigate all products within the past five years that were evaluated as “effective” (ASMR ≥ IV, compared to existing alternatives) by the Transparency Commission and that still have no price at the national level. Furthermore, we compared these products (n=9) with their status in other health agencies across the world (NICE, SMC, CADTH, TLV and PBAC). RESULTS: In more than half of cases (55%), products were evaluated as not cost-effective and rejected in at least one HTA agency. This therefore questions their cost-effectiveness in France. On one hand, this could be explained by the ATU status (temporary use authorization in France before the MA) which favours the company during negotiations since these products fill a therapeutic and are priced freely in France. Our data shows that almost all products (80%) with the ATU status were evaluated by at least four HTA agencies, underlining that therapeutic need. On the other hand, this could be explained by the conditional MA that leads to uncertainties concerning the real efficacy of the product, and hence its cost-effectiveness. Half of the products with a conditional MA only obtained negative recommendations due to cost-effectiveness issues. CONCLUSIONS: Two parameters caught our attention. First, the ATU status, translating a therapeutic gap, seems to play in favor for multiple and positive evaluations. Second, conditional MAs favor negative evaluations due to the uncertainty associated to efficacy and cost-effectiveness. These results must however be confirmed with a larger sample including products that obtained prices after long negotiations.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PSY152
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology, Rare and Orphan Diseases