An amendment to the Accord-Cadre agreement (which provides the framework for pharmaceutical policy, including in relation to pricing and reimbursement) regarding the pricing conditions for orphan drugs has been signed by the President of the Pricing Committee (Comité économique des produits de santé, CEPS), Philippe Bouyoux and the Chairman of the research-based pharmaceutical industry association (Leem), Frédéric Collet.
The amendment includes a number of articles which aims to “streamline the negotiation of the price conditions for orphan drugs”. Specifically the amendment states that:
- The price conditions for orphan drugs are negotiated according to the rules of the Accord-cadre, most notably in relation to their improvement in medical benefit (amélioration du service medical rendu, ASMR). For indications with an ASMR of I-IV, comparators used for determination of the price must have marketing authorisation in the indication in question and be branded drugs without generic competition/original biological drugs without biosimilar competition.
- In the absence of an agreement and if the estimated annual cost per patient exceeds €50,000, either CEPS or the manufacturer can propose – in return for a price “coherent” with international levels – that the company supplies the drug to all patients eligible for treatment in exchange for a “contractually negotiated limited amount of total turnover”. The cap on turnover may be revised based on actual sales volumes.
- At the request of either the manufacturer or CEPS “pricing conditions are adapted […] as soon as possible for any change in the target population”.
- In specific circumstances, the Committee may adapt pricing conditions on the basis of “population data transmitted by the company (from, for example, a register or epidemiological data or data from medico-administrative databases)”.
- The company can request a hearing between CEPS and one or more medical experts as part of pricing negotiations.
www.leem.org, “Le Leem se réjouit de la signature d’un nouvel article conventionnel concernant les medicaments orphelins”, 18th April 2022
https://solidarites-sante.gouv.fr,”Avenant à Accord-cadre du 05/03/2021 entre le Comité économique des produits de santé et les entreprises du médicament (Leem)”, 7th April 2022