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- W2002929016 abstract "From October 2013, some pharmaceutical products will be required to undergo a medico-economic evaluation in France. The aim of this study was to interview key stakeholders involved in this conceptual change in order to understand how this reform will be implemented and how it will affect market access in France. Primary research was conducted between April and June 2013 with stakeholders from the French National Authority for Health (HAS), the Economic and Public Health Evaluation Commission (CEESP), the Transparency Commission (TC) and relevant French ministries. Interviews lasted between 45 and 75 minutes and focused on the methodology for medico-economic assessment and its implications on the French pharmaceutical pricing and reimbursement (P&R) process. Medico-economic evaluation in France will be based on cost-utility or cost-effectiveness analyses, depending on whether or not quality of life is an important outcome. Cost-utility analyses will rely on QALYs (quality-adjusted life years), whereas cost-effectiveness analyses will rely on survival. The medico-economic assessments will inform pricing negotiations, on the one hand, and potentially the development of prescribing guidelines, on the other. Medicines will be subjected to a medico-economic assessment based on their level of innovation and/or on their financial impact on the health care budget. France is formally introducing the QALY into its P&R system; however, this reform will come with a twist on the Anglo-Saxon approach, as there will be no associated ICER (incremental cost-effectiveness ratio) above which the medicine will not be reimbursed. While there is still some level of uncertainty with regards to the medicines that will be subjected to this assessment (as stakeholders have yet to put a quantitative value on a “significant impact” on the health care budget), the direction of travel is toward greater pressure on pharmaceutical prices." @default.
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- W2002929016 date "2013-11-01" @default.
- W2002929016 modified "2023-09-30" @default.
- W2002929016 title "Medico-Economic Evaluation in France: Methodology and Impact on the Pricing and Reimbursement System" @default.
- W2002929016 doi "https://doi.org/10.1016/j.jval.2013.08.766" @default.
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