Dear Clients,

MedPass is pleased to inform you of two significant developments for the reimbursement of innovative implantable medical devices, in-vitro diagnostic solutions & medical procedures in France.

A new Decree (Décret n°2015-117 du 16 février 2015) opening an early-access reimbursement pathway has just been published for immediate application. This text defines eligibility rules and submission procedures for innovative technologies to benefit from Coverage with Evidence Development under a revamped “Innovation Funding” (L.165-1-1, Forfait innovation). Please find attached a summarized note as well as the original decree.

In addition, a second Decree (Décret n°2015-188 du 18 février 2015) is intended to enforce existing regulations in order to expedite the registration and tariff fixation process for medical and diagnostic procedures with strong added clinical value

MedPass, whose Market Access & Reimbursement group supports 2 of the 4 technologies retained in the pilot phase of the “Forfait innovation”, confirms that the reform should significantly improve the accessibility of this program, especially to SMEs. Medical procedures and diagnostic solutions are especially expected to benefit from both evolutions, streamlining their evaluation and reimbursement process.

Our team is looking forward to building on its expertise with these reforms in order to facilitate the access of innovative medical technologies to the French market.

For more information, please contact us www.medpass-NBD@medpass-dev-medpass.pf2.wpserveur.net