The Accord Cadre is the framework agreement signed between the industry association of French pharmaceutical manufacturers (LEEM) and the CEPS (French pricing committee) that defines pricing regulation for both hospital and retail drugs. The agreement serves as a charter for pricing negotiations and is critical for ensuring transparency and consistency for the industry. The prior agreement was signed in December 2015 and was set to expire in December 2018, but was subsequently extended multiple times until a revised agreement could be negotiated. The new Accord Cadre, released in March, is organized into 5 chapters and 35 articles. It is similar to its predecessor, but with some important changes:
- Creation of a termination procedure for innovative drugs for which no agreement on price could be found
This concerns ASMR I-III drugs for which no price agreement is found after 10 rounds of negotiation. The CEPS can choose to enter into this termination procedure under which the manufacturer will then have 15 days to submit a new price proposal that the CEPS will then either accept or decline and make a last offer. If the last offer is not accepted by the manufacturer, negotiations will stop and cannot be re-opened for at least four months. - Changes to the EU price guarantee rules
The EU list price guarantee concept remains (i.e. list price cannot be lower than the lowest price among Germany, Italy, Spain, and the UK) with some slight changes, in both the rules and eligibility criteria. The drugs that can benefit from this mechanism are now:- ASMR I-III drugs. These drugs already had access to the price guarantee, but under the new agreement if the product is mainly produced in France its list price can then be set at the level of the highest of these EU4 list prices
- Eligibility of ASMR IV drugs which meet specific conditions has also been extended (e.g. if there is a high unmet need or a public health need and limited number of clinical comparators, if the drug has orphan designation or is a new product within a combination therapy, and other conditions detailed in the accord cadre)
- The duration and the factors influencing that duration have also changed and clarified with five years of price stability for ASMR I-III for both list and net prices, and three years otherwise, but can be reevaluated in some situations:
- At indication extension: variation of guarantee duration possible upon indication extension with a target population higher than the pre-existing one: increase by one year in case of ASMR I-III for the new indication, no change in duration with an ASMR IV and reduction by one year with an ASMR V
- CEESP evaluation outcome for ASMR I-III: five years duration can be reduced in case of major methodological reservation, high uncertainty in C/E, or target population evaluated significantly smaller vs. population of the indication – duration of the price stability is adjusted depending on the importance of the uncertainty identified
- Speeding up price negotiations and access to drugs via “fast track” procedure
In the previous Accord Cadre, only ASMR V drugs for which the requested daily price was inferior to the comparator price could benefit from the fast track pricing procedure within 15 days of application. This procedure has now been extended to:- ASMR I-III drugs showing improvement in cost-effectiveness and no major methodological reservations or high uncertainties in the analysis as determined by the CEESP
- ASMR IV meeting the same conditions as above and additionally demonstrating budget impact savings
- New pricing opportunities for high innovation therapies such as gene, cell, and tissue therapies
It is expressly recognized by the CEPS that these products frequently present unique types of challenges, including often single administration, promising long-term efficacy, uncertainties related to long-term safety and number of eligible patients. This new article outlines the need for flexibility when pricing these therapies with regards to the choice of comparator, higher acceptance of outcome-based contracts, need to set up unique contracts, and potentially also the need to have offer appropriate payment schedules, including openness to annuity payments pending implementation of a legal framework - Rewarding investment in France and EU
In recognition of the pharmaceutical sector’s role as a future industrial growth driver for France, the Accord Cadre includes a new chapter outlining advantageous conditions for products produced largely in the EU and especially in France. These include stability of list prices for up to five years, a process for price increases in case costs threaten production viability, and access to specific credits, among other measures.
The LEEM and the CEPS have communicated that the guiding principles of this new Accord Cadre are to speed up access for innovative therapies, ensure supply of currently marketed and efficacious drugs, reward innovation, increase the attractiveness of France for investment, and increase transparency in price setting.
