DOES THE ATU PROCESS HAVE AN IMPACT ON TIME TO MARKET LAUNCH?
Author(s)
Houzelot D1, Heng C1, Brun-Fain E2, Joubert S2, Guigand G2, Ghazouani A2, Fares A2
1PRIORITIS Market Access, Paris, France, 2Université Paris-Dauphine, Paris, France
OBJECTIVES: In order to launch a reimbursed drug in France, products with marketing authorization (MA) are firstly assessed by the Transparency Committee (CT, Commission de la Transparence) and then undergo pricing negotiations with the Pricing Committee (CEPS, Comité Economique des Produits de Santé). This process has an impact on time to market launch (ML). The Temporary Authorization for Use (ATU) allows early access of drugs to patients before MA and could reduce time to ML. Our aim was to compare the time from MA to ML between ATU and non-ATU drugs. METHODS: Using the Prismaccess database, research was carried out to identify ATU and non-ATU drugs to calculate their time to ML from January 2013 to June 2015. Mean total time (MA-ML) and mean intermediate times (MA-CT opinion and CT opinion-ML) were compared between groups using Mann-Whitney test (α=0.05). RESULTS: French health authorities assessed 7 ATU and 18 non-ATU drugs during the reviewed period. The mean total time (MA-ML) was shorter for ATU drugs compared to non-ATU drugs (281±58 versus
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP74
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Reimbursement & Access Policy
Disease
Multiple Diseases