Question 20581 — pharmacy and medications

Summary

Ms. Agnès Firmin Le Bodo draws the attention of the Minister of Solidarity and Health to the urgency of adapting the drug evaluation system currently in force to allow patients to access innovative treatments and more broadly to ensure that France remains a land of innovation in health. The observation is as follows: the drug evaluation system, based on the actual benefit (SMR) and the improvement of the service medical rendering (ASMR) faces certain limitations. Indeed, the criteria currently used by the Transparency Commission of the High Health Authority prove to be poorly suited to certain disruptive innovations. Incremental innovations and products considered innovative are increasingly assigned an ASMR considered minor (ASMR IV) due to early and limited data and the absence of relevant comparison when the therapeutic need is not covered. Consequently, and in application of the ministerial guidance letter, the CEPS sets the price of these medicines taking into account the cheapest comparable medicine, or in its absence, the most economically relevant one with regard to medical knowledge. This diversion of scientific evaluation rules for purely budgetary purposes, namely reducing the security deficit in particular to finance innovation, produces in this case the opposite effect: slowing down patients' access to innovative treatments that save lives. The application by the CEPS of unsuitable comparators for budgetary purposes alone endlessly prolongs the duration of negotiations between biotechnology companies and the CEPS. The former wish to obtain a price reflecting the value of their therapies, while the The main objective of the second is to save money on medication. A study dated April 3, 2019 carried out by IQVIA, thus positions France 22nd out of 30 countries in terms of market access times compared to its European neighbors, with an average of 498 days between marketing authorization and patient access, compared to 119 in Germany in first position in the ranking. For orphan drugs specifically, France is 21st out of 30 countries, with an average of 551 days between marketing authorization and patient access, compared to 113 days for Germany which takes the lead in the ranking. Furthermore, the ATU system, designed to guarantee patients facing an unmet therapeutic need early access to innovation, is not a guarantee of lasting access in that it is often diverted from its intended purpose. initial. Designed for temporary application as its name indicates, it often replaces the negotiation between the CEPS and the laboratory so that the duration of its appeal becomes indeterminate. Thus, in 2017, out of 12 reimbursable medicines having benefited from an ATU, only one product was included on the community approval list, the other 11 reimbursable medicines remain under price negotiation (i.e. 92% of drugs having obtained an ATU evaluated in 2017, with a median delay to date of more than 500 days). In addition, the amendment to the framework agreement signed on April 24, 2019 between the CEPS and the LEEM which aims to reduce delays in administrative procedures for market access for medicines following the commitment made by the Prime Minister during the CSIS of July 10, 2018, seems totally insufficient to him. It aims in fact, through a game interrupting the calculation of negotiation time, to artificially reduce its duration. The consequences of this situation are very worrying. It is common knowledge that biotechnology companies are now hesitant to file their applications in France, favoring Germany, in particular, given the clearly defined deadlines and process for evaluating the benefits of pharmaceutical products by the Federal Committee (G-BA) and subsequent price negotiations with the National Association of Health Insurance Funds (GKV-SV) in accordance with the Medicines Market Reform Act (AMNOG), to reach an agreement within 12 months after submission of the dossier (6 months for the assessment of the G-BA + 6 months for the price negotiations with the GKV-SV). If this movement were confirmed, due to lack of rapid action by the Government, some patients could find themselves deprived of access to innovative treatments. Furthermore, and on another level, this situation harms the attractiveness of France. However, solutions exist to quickly remedy this situation: accelerate the implementation of the “Relative therapeutic value” at the drug evaluation stage, force the CEPS to accept new tailor-made conventional modalities making it possible to better promote real innovations and take into account budgetary constraints. Therefore, she asks it to specify what it intends to do concretely to remedy this situation in order to ensure patients' access to innovative therapies that save lives in France. She also wants to know when the VTR will be implemented and if she intends to constrain the CEPS in the next letter ministerial orientation to agree to explore new conventional modalities to help revive France's attractiveness in this area.

Machine translation from French. The official text remains authoritative.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

No documents linked.

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.