Les médicaments hybrides en France. État des lieux des médicaments hybrides en France et à l’Assistance Publique–Hôpitaux de Paris

Abstract

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.