A New Accelerated Early Access Process for Diagnostics in France

Abstract

Objectives: In the Turkish medical device industry, budgetary concerns usually overweight other crucial issues like quality and effectiveness of medical devices on clinical and economical outcomes. Reimbursement application and assessment principles have not been regulated until very recently by the Social Security Institution (SSI), the only competent authority for reimbursement. After productive communications and collaboration between SSI and industry, the new directive, "Procedures and Principles of Medical Device Applications" and its guideline "Medical Device Application" has been published by SSI on Apr, 20th 2016,Objective of this study is to describe reimbursement application and assessment procedures for Medical Devices and the critical points of the guideline and the directive. MethOds: The Directive and Guidelines dated 20.04.2016 are analyzed. Results: Ministry of Health (MoH) registration is a prerequisite for reimbursement in Turkey. All medical devices are subject to specialty-based positive listing, consisting of generic definitions and codes with corresponding ceiling reimbursement prices set by SSI. For inclusion into the positive lists, the manufacturer/ distributor has to submit a "reimbursement dossier" to SSI. To get a new reimbursement code for innovative, first-in-it-class products (Type A) and for product differentiation in terms of size or specifications (Type B); high-level clinical evidence and local health economics and budget-impact analyses are required. C and D type applications are for matching to an existing code and getting reimbursement approval for new barcodes of the already reimbursed products. cOnclusiOns: Local economic analysis and information on reimbursement status in reference countries may seem challenging to companies, due to lack of local data and difference between Turkish and reference countries' healthcare systems. However, longwaited Directive regulates the decision mechanism of SSI and provides opportunity of fair competition to the industry. It may be seen as an evidence indicating the mindset shift of SSI towards the value based approach.