Early access schemes and pricing strategies: A case study on temporary authorization for use in France from 1994 to 2016 (notice n° 551532)

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041 ## - LANGUAGE CODE
Language code of text/sound track or separate title fre
042 ## - AUTHENTICATION CODE
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100 10 - MAIN ENTRY--PERSONAL NAME
Personal name Raïs Ali, Setti
Relator term author
245 00 - TITLE STATEMENT
Title Early access schemes and pricing strategies: A case study on temporary authorization for use in France from 1994 to 2016
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Date of publication, distribution, etc. 2018.<br/>
500 ## - GENERAL NOTE
General note 47
520 ## - SUMMARY, ETC.
Summary, etc. 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.
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Raimond, Véronique
Relator term author
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Degrassat-Théas, Albane
Relator term author
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Jacquet, Laurie Rachet
Relator term author
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Rochaix, Lise
Relator term author
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Lu, Xiaoyan
Relator term author
700 10 - ADDED ENTRY--PERSONAL NAME
Personal name Paubel, Pascal
Relator term author
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Note Revue française des affaires sociales | - | 3 | 2018-11-07 | p. 69-89 | 0035-2985
856 41 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="https://shs.cairn.info/journal-revue-francaise-des-affaires-sociales-2018-3-page-69?lang=en&redirect-ssocas=7080">https://shs.cairn.info/journal-revue-francaise-des-affaires-sociales-2018-3-page-69?lang=en&redirect-ssocas=7080</a>

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