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Early Access Schemes and Pricing Strategies: A Case Study on Temporary Authorization for Use in France from 1994 to 2016

Abstract : Early access schemes for pharmaceuticals have been increasingly implemented worldwide with the objective of satisfying unmet medical needs or facilitating market access for certain innovative drugs. It allows for pharmaceuticals which have not yet obtained their marketing authorization (MA) to be administered and reimbursed to a pre-defined population of patients. Under the French regulatory framework, this scheme consists in a window of unregulated prices, which stands in contrast with the system of administered prices for reimbursed pharmaceuticals. Our study aims at filling a gap in the literature by analyzing the French Temporary Authorization for Use (TAU) scheme since its implementation in 1994 up to 2016. This long time span allows to document and describe the TAU scheme and its impact on prices. In this article, we review the price difference between the freely set price under TAU and the post-MA price, after negotiation with the French Pricing Committee. Our main result shows that the 2007 regulatory change, which compelled pharmaceutical companies to reimburse the difference between the TAU price and the post-MA price, is significantly correlated with decreasing or stable post-MA-to-TAU price ratios.
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https://halshs.archives-ouvertes.fr/halshs-02096440
Contributor : Caroline Bauer <>
Submitted on : Thursday, April 11, 2019 - 12:46:26 PM
Last modification on : Wednesday, October 14, 2020 - 4:13:57 AM

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  • HAL Id : halshs-02096440, version 1

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Setti Rais Ali, Véronique Raimond, Albane Degrassat-Théas, Laurie Rachet Jacquet, Lise Rochaix, et al.. Early Access Schemes and Pricing Strategies: A Case Study on Temporary Authorization for Use in France from 1994 to 2016. Revue française des affaires sociales, La documentation française, 2018, 2018/3, pp.69-89. ⟨halshs-02096440⟩

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