[PHP322] French Health Policies: Front Runner for Early Access to Innovation

[PHP322] French Health Policies: Front Runner for Early Access to Innovation

2016 Value in Health

Rémuzat, C. | Thivolet, M. | Kornfeld, A. | Toumi, M. | Volume: 19, Issue: 7, Pages: A496-A497,

OBJECTIVES: While regulators are increasingly focused on accelerating access to innovative drugs, payers tend to limit access of medicines with immature data. France appears to be an exception with a well-established regulation offering opportunities for early market access to innovative products. The objective of this research was to describe the French regulation for early access of health products. METHODS: A literature review was conducted in French public health authorities’ websites and in grey literature to identify funding processes for early access of innovative health products. RESULTS: Three key pillars exist in France to get early access to innovative health products: 1) For medicines, Temporary Authorisation for Use procedure (ATU) is in place since 1994 and widely used to grant access to drugs without any marketing authorisation. It is issued by the French Drug Agency (ANSM). Prices are freely set during ATU but adjusted backward based on final negotiated price once product is approved; 2) For new innovative medical devices and medical procedures which are no part of any past or current public funding, ‘forfait innovation” has been introduced in 2009. It is a temporary funding conditioned by setting up of a clinical or health economic study. Eligibility assessment is made by the French health technology assessment body (HAS) and final funding decision lies on the Ministry of Health. It covers partial or total costs of medical procedure/medical device and hospitalisation; 3) For innovative biology and anatomo-cytopathology medical procedures not yet reimbursed, a temporary funding has been introduced in 2015, known as RIHN, conditional to the conduct of prospective and comparative data collection. Additional funding options are available through translational, clinical or health economic research programs. CONCLUSIONS: French policy makers have developed an effective armamentarium of procedures to allow early access to innovation with immature data and to collect additional data supporting further coverage decisions.

https://www.doi.org/10.1016/j.jval.2016.09.870