[PMD122] A New Accelerated Early Access Process for Diagnostics in France

[PMD122] A New Accelerated Early Access Process for Diagnostics in France

2016 Value in Health

Hanna, E. | Azaiez, C. | Auquier, P. | Toumi, M. | Volume: 19, Issue: 7, Pages: A706,

OBJECTIVES: The fast development of precision medicine led to fast development of new diagnostic tools. New diagnostics face a complex access process delaying potential benefit to patients. France put in place an accelerated access process (AAP) for innovative diagnostics with immature data. This study objective is to describe AAP and analyse its potential impact on development and patient access to innovative diagnostics. METHODS: We reviewed the French regulation for AAP called Référentiel des actes Innovants Hors Nomenclature (RIHN): Instruction N° DGOS/PF4/2015/258, July 31st, 2015, and analysed potential implications on diagnostics manufacturers. RESULTS: In July 2015, the General directorate of health services (DGOS) established RIHN to support ongoing development of innovative laboratory medicine and pathology diagnostics. RIHN support evaluation of innovative diagnostics in “real life” before HTA assessment and pricing is issued. Payers support manufacturers by co-funding studies to collect clinical and economic data to prove efficacy and cost-effectiveness. Early dialogue with payers helps to increase diagnostic acceptability and chances of reimbursement. In parallel to study support, RIHN ensures a temporary reimbursement for 3 years; after what, there are 3 options: positive evaluation by DGOS and dossier transmission to HAS, negative evaluation and test withdrawal, unassessable evidence due to limited data and extension of the inclusion in RIHN for 2 additional years. RIHN endorsed tests are reimbursed on yearly basis to hospitals, retrospectively according to number of tests performed. CONCLUSIONS: After the Temporary Authorisations for Use (ATU) and “forfait innovation”, RIHN constitutes the third pillar to support early access to innovation in France. It aims to remove hurdles and facilitate access of innovative laboratory medicine and pathology tests onto French market by providing temporary funding. French payers are moving from a “see-to-pay” to “pay-to-see” strategy. France might now be considered an attractive market for launching new and innovative diagnostics.

https://www.doi.org/10.1016/j.jval.2016.09.2064