PHP115 The Sharp Decrease of Drug's Access to Reimbursement in France in 2011

Abstract

In France, all drug's indications are listed for reimbursement according to the advice of the Haute Autorité de Santé (HAS), which assesses the SMR level (Service Medical Rendu) – linked to the future drug reimbursement level, the ASMR (comparative added value) – linked to the future price and “official” target population. Until last year, 90-95% of SMR levels allowed reimbursement, hence a significant manufacturer focus on ASMR level (which actually is the basis for reimbursed drugs price fixation). Following the “Mediator affair” in 2010, the HAS perceived high percentage of positive recommendations for reimbursement have been challenged by multiple administrative and political reports. We investigated the 2011 HAS recommendations for reimbursement of new drugs/indications. We considered all complete procedures for a first inscription or line extension with an HAS opinion published between Jan and Dec 2011. We also considered applications which have been withdrawn by companies (no HAS advice). We focused our analysis on the SMR level, indication by indication, and compared it to 2010 HAS opinions. Sixty-two HAS opinions have been published in 2011: 30% less than in 2010 (85 opinions in 2010). Regarding the SMR and considering it is granted indication by indication: out of 81 SMRs granted for a first indication reimbursement, 30% (24) were considered “insufficient” (no reimbursement)–in 11 of these cases companies withdrew their applications. In 2010, the SMR “insufficient” represented only 11% of all the published advices (which was already higher than 2009: 6%). The number of positive recommendations for reimbursement has sharply decreased in 2011 versus 2010, going from 6-10% in previous years to over 30%. A qualitative analysis shows that the HAS seems to have evolved the assessment criteria used for SMR.