Early Access Schemes and Pricing Strategies: A Case Study on Temporary Authorization for Use in France from 1994 to 2016
Setti Rais Ali
(1, 2, 3)
,
Véronique Raimond
(4)
,
Albane Degrassat Degrassat-Théas
(5, 6, 7, 8)
,
Laurie Rachet Jacquet
(1, 9)
,
Lise Rochaix
(1, 2, 3)
,
Xiaoyan Lu
(1, 2)
,
Pascal Paubel
(5, 7, 6, 8)
1
Hospinomics
2 PSE - Paris School of Economics
3 PJSE - Paris Jourdan Sciences Economiques
4 HAS - Haute Autorité de Santé [Saint-Denis La Plaine]
5 AGEPS - Agence Générale des Equipements et Produits de Santé [Paris]
6 IDS - U1145 - Institut Droit et Santé
7 UPD5 Pharmacie - Faculté de Pharmacie de Paris - Université Paris Descartes
8 USPC - Université Sorbonne Paris Cité
9 University of York [York, UK]
2 PSE - Paris School of Economics
3 PJSE - Paris Jourdan Sciences Economiques
4 HAS - Haute Autorité de Santé [Saint-Denis La Plaine]
5 AGEPS - Agence Générale des Equipements et Produits de Santé [Paris]
6 IDS - U1145 - Institut Droit et Santé
7 UPD5 Pharmacie - Faculté de Pharmacie de Paris - Université Paris Descartes
8 USPC - Université Sorbonne Paris Cité
9 University of York [York, UK]
Setti Rais Ali
- Fonction : Auteur
- PersonId : 827348
- ORCID : 0000-0002-3371-4769
- IdRef : 194643220
Véronique Raimond
- Fonction : Auteur
- PersonId : 795704
- ORCID : 0000-0002-0331-4991
Lise Rochaix
- Fonction : Auteur
- PersonId : 1356826
- IdHAL : lise-rochaix
- ORCID : 0009-0005-2822-7439
Résumé
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.
Domaines
Economies et financesFormat du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
Early Access Schemes and Pricing Strategies: A Case Study on Temporary Authorization for Use in France from 1994 to 2016
|
Résumé |
en
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.
|
Auteur(s) |
Setti Rais Ali
1, 2, 3
, Véronique Raimond
4
, Albane Degrassat Degrassat-Théas
5, 6, 7, 8
, Laurie Rachet Jacquet
1, 9
, Lise Rochaix
1, 2, 3
, Xiaoyan Lu
1, 2
, Pascal Paubel
5, 7, 6, 8
1
Hospinomics
( 476518 )
- France
2
PSE -
Paris School of Economics
( 301309 )
- 48 boulevard Jourdan 75014 Paris
- France
3
PJSE -
Paris Jourdan Sciences Economiques
( 578027 )
- 48 boulevard Jourdan 75014 Paris
- France
4
HAS -
Haute Autorité de Santé [Saint-Denis La Plaine]
( 184290 )
- 2, avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex
- France
5
AGEPS -
Agence Générale des Equipements et Produits de Santé [Paris]
( 458678 )
- 7, rue du Fer à Moulin – 75005 Paris
- France
6
IDS - U1145 -
Institut Droit et Santé
( 247290 )
- Centre Universitaire des Saints-Pères
45 rue des Saints-Pères
75270 Paris Cedex 06
- France
7
UPD5 Pharmacie -
Faculté de Pharmacie de Paris - Université Paris Descartes
( 461721 )
- 4, avenue de l'Observatoire - 75270 Paris Cedex 06
- France
8
USPC -
Université Sorbonne Paris Cité
( 303171 )
- Université Sorbonne Paris Cité | 100-104, avenue de France | 75013 Paris
- France
9
University of York [York, UK]
( 124942 )
- Heslington, York, YO10 5DD
- Royaume-Uni
|
Langue du document |
Anglais
|
Nom de la revue |
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Date de publication |
2018-06
|
Volume |
2018/3
|
Page/Identifiant |
69-89
|
Domaine(s) |
|
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