TIME TO MARKET ACCESS FOR INNOVATIVE DRUGS IN THE UK, FRANCE, AND BELGIUM
Author(s)
Maervoet J1, Toumi M21Deloitte, Diegem, Belgium, 2University Claude Bernard Lyon 1, Lyon, France
Presentation Documents
OBJECTIVES: It is often considered that the UK grants access to new medicines upon marketing authorisation (MA) approval, while patients in countries such as France or Belgium gain access only after significant delays. The objective is to quantify differences in time to market access between the UK (excluding Scotland), France and Belgium and to identify contributing factors. METHODS: We reviewed submission and approval dates for all new chemical or biological entities that were granted a MA by the European Commission (EC) between August 2006 and July 2011. Generics, fixed dose combinations, new formulations, and vaccines were excluded. Information was collected from official health authority sources (i.e. regulatory, health technology assessment, and pricing agencies; official journals; national formularies). Results are presented as median days pre- and post-marketing authorisation (MA was defined as day 0). RESULTS: For the 111 drugs we identified, EC approval was granted a median of 428 days after submission of the application and 64 days after the Committee for Medicinal Products for Human Use issued a positive opinion. A first analysis suggested more drugs were marketed in England (n=97), than in France (n=74) or Belgium (n=62). NICE guidance, however, was only issued for 29 products (21 positive opinions) after a median of 399 days following MA. In France and Belgium, ministerial reimbursement decisions were published in the Official Journal after 279 and 348 days, respectively. The time needed for Belgian companies to submit a reimbursement dossier was variable (median: 68 days; IQR: 21-235 days after MA). CONCLUSIONS: As product uptake is negligible until NICE issues a positive guidance, English patients have access to only a limited number of innovative drugs. French authorities appear to grant access to more products and have shorter review timelines than their Belgian and English counterparts. Dossier submission timelines may contribute to delays in Belgium.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PHP132
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases