Medico-economic Evaluation of Health Products in the Context of the Social Security Financing Act for 2012 - 08/07/16
participants of round table N°6 of Giens Workshops XXVIII:
Véronique Ameye 4, Pierre Angot 5, Antoine Audry 6, Laurent Becquemont 7, Thomas Borel 8, Béatrice Cazeneuve 9, Jocelyn Courtois 10, Bruno Detournay 11, Pascal Favre 12, Muriel Granger 13, Anne Josseran 14, Catherine Lassale 15, Olivier Louvet 16, Jean Pinson 17, Gérard de Pouvourville 18, Lise Rochaix 19, Catherine Rumeau-Pichon 19, Rima de Saab 20, Mickaël Schwarzinger 21, Aristide Sun 22, †pages | 5 |
Iconographies | 0 |
Vidéos | 0 |
Autres | 0 |
Abstract |
The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico-economic evaluation of health products published a few days earlier (02 October 2012). The medico-economic evaluation (MEE), becomes an additional determinant for fixing the prices of health products by the Health products economic committee (Comité économique des produits de santé, CEPS) via the hierarchisation of treatment strategies, and thus modifies the market access conditions.
Limiting the analysis to medicinal products and medical devices for which a major, important or moderate improvement in the medical service rendered (ASMR) or of the expected service (ASA) has been requested and presenting a significant budget impact on the Social Security expenses, excludes health products with ASMR or ASA with a lower level requested which often create complex price fixing problems and often have a major budget impact. This latter concept remains to be defined in detail. The MEE envisaged for the first registration must include the need to confirm or refute the initial hypotheses especially concerning the actual position in the therapeutic strategy at the time of renewal of the registration. For the first registration, the conventional reference to European prices guaranteeing a minimum price to innovative medicinal products, the medicoeconomic models submitted by the industry to the French Drug Authority (Haute autorité de santé, HAS) must be used to guide the compilation of new data to be requested at the time of the registration renewal and to negotiate the level of the discounts in the framework of a price-volume agreement, if applicable. The MEE will allow comparing the result of the analysis to the model hypothesis at the time of the renewal of the registration, which may contribute to the renegotiation (either up or down) of the price of health goods.
The costs related to obtaining new data must be controlled. In order for the MEE to allow confirming the relationship between the price requested and the benefit expected, the group privileges the definition of reference values with an indicative and non-normative value, likely to evolve with time rather than a threshold.
Concerning the evaluation procedure: the time to market access must not be lengthened; while the possibility of regular meetings between the industry and the HAS is recommended to avoid methodological divergences. A transitory period should allow the implementation of the entire evaluation procedure which must also take into account the specificities of health products registered before the 3 October 2013.
Le texte complet de cet article est disponible en PDF.Keywords : medico-economic evaluation, price of medicinal products and medical devices, reimbursement, innovative medicinal products, innovative medical devices, budget impact, efficiency, cost-efficacy ratio, guidelines, acceptability threshold, Economic and Public Health Evaluation Commission, market access
Abbreviations : AMNOG, ASA, ASMR, CEEPS, CEPS, CNEDIMTS, CT, HAS, LEEM, LFSS, MA, MEE, NHS, QALY, SNIIRAM
Plan
Vol 68 - N° 4
P. 259-263 - juillet 2013 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’achat d’article à l’unité est indisponible à l’heure actuelle.
Déjà abonné à cette revue ?