LEEM, CEPS Framework Agreement Focuses on Innovative Drugs (ASMR 1-3), Stabilizing Prices

Date: March 8, 2021 | Country: FRANCE | Region: EUROPE | Type: Policy | Keywords: #ceps #drugsupply #fasttrack #frameworkagreement #innovation #investment #leems 
#netprices #pricestabilization #pricetransparency #pricingandreimbursement #r&d #risksharing

PRICENTRIC BRIEF:

  • After multiple delays mainly due to the COVID-19 pandemic, the French Pharmaceutical Companies Association (LEEM) and France’s Economic Committee for Health Products (CEPS) have concluded negotiations for their framework agreement on the setting and regulation of drug prices in France, which will last for the next three years until 2024
  • Today’s announcement is welcomed by all stakeholders, especially considering the framework’s five main objectives—speeding up deadlines, promoting patient access to innovation, stimulating investments and exports, promoting the supply of drugs that meet public health need, and strengthening transparency—which aim to nurture innovation and make pricing more attractive for drugmakers so that they invest in France
  • Notably, the framework will have France establishing fast-track procedures that allow for access within 15 days for drugs rated ASMR 1-3 based on efficacy, ASMR 4 drugs primarily based on efficacy but also savings, and ASMR 5 drugs when priced at a lower price than the comparator; providing the possibility of assigning higher prices than those found in the UK, Germany, Italy, and Spain to ASMR 1 to 3 drugs if the main manufacturing steps occur in France; and stabilizing net prices for the first five years of marketing for the most innovative drugs (those ranked as ASMR 1 to 3), with valid medico-economic evaluation, as well as prices for ASMR 4 drugs if there is a public health need and an insufficient supply

 

THE DETAILS

PARIS, France – After multiple delays mainly due to the COVID-19 pandemic, the French Pharmaceutical Companies Association (LEEM) and France’s Economic Committee for Health Products (CEPS) have concluded negotiations for their framework agreement on the setting and regulation of drug prices in France, which will last for the next three years until 2024.

Their initial framework agreement was set to expire December 31, 2018; however, it was extended an additional year. But due to the COVID-19 pandemic, their efforts to renegotiate the framework experienced three additional delays, pushing framework negotiations back by at least 19 months.

Today’s announcement is welcomed by all stakeholders, especially considering the framework’s five main objectives—speeding up deadlines, promoting patient access to innovation, stimulating investments and exports, promoting the supply of drugs that meet public health need, and strengthening transparency—which aim to nurture innovation and make pricing more attractive for drugmakers so that they invest in France.

The framework will have France establishing fast-track procedures that allow for access within 15 days for drugs rated ASMR 1-3 based on efficacy, ASMR 4 drugs primarily based on efficacy but also savings, and ASMR 5 drugs when priced at a lower price than the comparator.

Likewise, France is increasing access to innovation by stabilizing net prices for the first five years of marketing for the most innovative drugs (those ranked as ASMR 1 to 3), with valid medico-economic evaluation. Further, there will be accountability measures such as risk-management contracts put into place that consider uncertainty, discounts, and splitting payments, and additional doctrines released focused on innovative drugs—in particular, cell and gene therapies. There will also be an opportunity for renegotiating discount conditions in the event target populations change.

Of note, for the first time the LEEM-CEPS framework includes provisions aimed at promoting investment and exports for France’s pharmaceutical companies, encouraging investments in production, digital solutions, and research & development (R&D). A specific chapter focused on investment and export will soon come into fruition.

France will provide the possibility of assigning higher prices than those found in the UK, Germany, Italy, and Spain to ASMR 1 to 3 drugs if the main manufacturing steps occur in France, and when it comes to exports, these products will be guaranteed price stability for two years, renewable once for products that are primarily manufactured in France and for which more than 60% of production is exported.

To stabilize the drug supply, LEEM and CEPS agreed that ASMR 4-rated products can access a “European price” if there is a public health need and an insufficient supply, and ASMR 4 and 5 drugs will have price stability for three years, with a two-year gap between price reductions.

Companies need to report to CEPS the amount of public investment they received for R&D, as well as contributions made to public entities, and they will also need to present to CEPS therapeutic innovations planned for the next five years, which will be gathered in part by LEEM through horizon scanning.

Touting the modernization of the framework and the opportunities it provides to companies, Philippe Bouyoux, President of CEPS, said, “Above all, it [the framework] seeks, in concrete terms, to promote innovation and encourage investment which contributes to better availability of drugs. With this framework agreement and recent ministerial guidelines, CEPS has a new roadmap. It is ambitious, clear and shared with manufacturers.”

Frédéric Collet, President of LEEM, added, “This new framework agreement incorporates very strong measures, adapted to the challenges of the drug in the period which opens today. It takes into account both the therapeutic innovations which are arriving at a sustained rate for the benefit of patients and the desire of the public authorities to make France a major drug-producing country again. Companies have a clear instrument for the regulation and governance of conventional policy, the result of quality work carried out jointly with the CEPS.”

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