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Master Thesis

L’impact de l’évaluation médico-économique dans la fixation du prix des médicaments en France : bilan de son utilisation de 2015 à l’accord cadre de 2021 et perspectives

Abstract : Cost-effectiveness analysis are used to compare the relative cost and outcomes of several several therapeutic strategies. In France, the CEESP commission is responsible for the methodological evaluation of pharmaceutical companies models. Until March 2021, in the absence of a major methodological reservation, the 2015 framework agreement guaranteed a face price for ASMR I to III drugs that was at least equal to the lowest price charged in Germany, the United Kingdom, Italy and Spain. In a context of challenging about the place and use of HEOR, its use has been requalified in the framework agreement of March 2021. The objective of this thesis is to determine the impact of the HEOR in the determination of the face price by the CEPS for products with a primary listing, an ASMR I to III (or even IV) and an evaluation by the CEESP. An exploratory analysis of the conditions of access to fast-track, a new measure of the March 2021 framework agreement will also be carried out. The first part of this thesis is the description of the HEOR, the regulatory and conventional contexts that govern its use in France. The second is a retrospective descriptive analysis of 12 drugs that had an AMSR I to III (or even IV) between August 2015 and March 2018 and an evaluation by the CEESP. The impact of the HEOR will be assessed through its role on access to the European price corridor, time period to define the price and price differential between the claimed price and the price published in the JORF. Finally, based on interviews with health system experts from the CEPS, pharmaceutical companies and the CEESP, the impact of the HEOR between 2015 and March 2021 will be discussed in the third part. A sub-section of this third part will also be devoted to an analysis of the prospects offered by the new 2021 framework agreement for the use of HEOR.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03366270
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Submitted on : Tuesday, October 5, 2021 - 3:51:12 PM
Last modification on : Wednesday, October 27, 2021 - 3:22:53 AM

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Marie-Natacha Marquet. L’impact de l’évaluation médico-économique dans la fixation du prix des médicaments en France : bilan de son utilisation de 2015 à l’accord cadre de 2021 et perspectives. Sciences du Vivant [q-bio]. 2021. ⟨dumas-03366270⟩

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