PMS69 Key Drivers for Pricing and Reimbursement for Biologic Drugs in France

Abstract

OBJECTIVES: In France, the reimbursement decisions and price negotiations for new drugs are highly influenced by the National Authority of Health (HAS) recommendations communicated in the formal health technology assessment (HTA). This study aimed to analyse past criterions and consider future possible requirements influencing future submissions. METHODS: A convenient internet literature review was conducted to identify categories for value drivers in the evaluation of the incremental medical benefit (ASMR) for a new product. An analysis of five biological products reviewed 2006-2012 for rheumatology disorders was conducted using these criterions. Based on the findings, exploratory interviews with two ex- HAS members were performed to gain insight into future potential evidence requirements. RESULTS: From the literature review three categories of evidence were developed. Firstly 'socioeconomics', to include the French payers' perspective of burden and cost of illness. The second category was 'clinical evidence', evaluating the added therapeutic value for a target population, the clinical efficacy and safety. The third category was 'real world data', to establish effectiveness and long-term safety post-launch. From the analysis it was demonstrated that only products targeting patients with an insufficient response to anti-TNFs were recommended a high -level II- ASMR. Only 2 of 14 phase III studies used an active comparator in Phase III superiority studies. Open label extension studies were commonly used to provide post-launch data. Findings of the interviews suggested that in the future superiority verses current standard of care in France for a clear target population would be the expectation for an ASMR = IV from the HAS. CONCLUSIONS: These findings emphasise the need to integrate payer evidence requirements into the clinical development strategy early on. Effort should be directed towards the identification of a clear target population demonstrating superior efficacy to standard of care.