[Hybrid medicines in France. Hybrid medicines: Overviews in France and in Paris Public Hospitals].

Les médicaments hybrides en France. État des lieux des médicaments hybrides en France et à l’Assistance Publique–Hôpitaux de Paris.
Assistance Publique–Hôpitaux de Paris Economic issues Enjeux économiques Hybrid medicines Intérêts thérapeutiques Médicaments hybrides Paris Public Hospitals Risk Risques Therapeutic value

Journal

Annales pharmaceutiques francaises
ISSN: 0003-4509
Titre abrégé: Ann Pharm Fr
Pays: France
ID NLM: 2985176R

Informations de publication

Date de publication:
Nov 2021
Historique:
received: 15 11 2020
revised: 28 03 2021
accepted: 05 04 2021
pubmed: 23 4 2021
medline: 16 11 2021
entrez: 22 4 2021
Statut: ppublish

Résumé

The aim of this study is to give an overview of hybrid medicines, term introduced in France by the Social Security Financing Act for 2019, with special attention to those available in Paris Public Hospitals (AP-HP), and to analyze their therapeutic values and economic issues. Research by keywords on European and French health authorities' websites was done to provide a list of hybrid medicines. Then, an analysis of their profile and of their differences from reference medicinal products was done. A reflection on hybrid medicines likeness to "new medicines" or to "generic medicines" was carried out. Lastly, their therapeutic interests, their risks and their costs were assessed. In France 85 hybrid medicines were identified, including 41 commercialized, and 21 available in AP-HP. Six different types of differences from the reference medicinal product were found out. Over 90% of hybrid medicines show at least one interest compared to the reference medicines, even if it is not a major innovation. However, more than a third of hybrid medicines are associated to a risk in case of drug substitution with the reference medicinal product. Hybrid medicines costs appear to be lower than reference medicines, but with smaller discounts than what is usually observed with generic medicines. Hybrid medicines constitute a very heterogeneous population, whether in terms of differences from reference medicines, of interests or risks. Common rules development for all hybrid medicines may be complex and would require taking every couple hybrid/reference medicines specificities into account.

Identifiants

pubmed: 33887249
pii: S0003-4509(21)00061-4
doi: 10.1016/j.pharma.2021.04.001
pii:
doi:

Substances chimiques

Drugs, Generic 0

Types de publication

Journal Article

Langues

fre

Sous-ensembles de citation

IM

Pagination

664-689

Informations de copyright

Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Auteurs

E Leclerc (E)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer à Moulin, 75005 Paris, France. Electronic address: lec.elisabeth@gmail.com.

I Fusier (I)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer à Moulin, 75005 Paris, France.

P Paubel (P)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer à Moulin, 75005 Paris, France; Faculté de pharmacie, université de Paris, 4, avenue de l'Observatoire, 75006 Paris, France; Institut droit et santé, Inserm UMRS 1145, université de Paris, 45, rue des Saints-Pères, 75006 Paris, France.

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Classifications MeSH