2023-05-15 14:26:02
Announced by the President of the Republic during the Strategic Committee for Health Industries (CSIS) in 2021, the so-called “Direct Access” experiment to shorten the time between the approval of innovative treatments and their availability for patients has been concretized by the Minister of Health and Prevention with the publication in the Official Journal on May 14 of a decree issued pursuant to Article 62 of the Social Security financing law for 2022.
Set up for a period of two years, this experiment aims to accelerate and facilitate patient access to innovative drug treatments to better meet the urgent health needs and medical challenges of today. Long-awaited, this decision is fully in line with the desire of the President of the Republic and the Government to guarantee all of our fellow citizens faster and more efficient medical care – a priority reaffirmed today by the actors of the world. of health and international investors on the occasion of the 6th edition of the “Choose France” Summit organized in Versailles.
Thanks to this experimentation, patients will be able to benefit more quickly from medicines recognized as “innovative” by the French National Authority for Health (HAS) and which have demonstrated their efficacy and safety during rigorous clinical trials.
In concrete terms, the experiment will now allow certain drugs to benefit, in a given indication, from reimbursement by the Health Insurance as soon as the opinion of the HAS is published, for a period of one year. Patients will thus be able to benefit from early access to the market, without waiting for the finalization of all the formalities allowing official access to the market (in particular price negotiation).
Eligible drugs
Planned as a complement to the already existing early access system, this experiment specifically targets all drugs deemed innovative by the HAS and not eligible for early access. Thus, innovative and expensive hospital medicines eligible for the so-called “in addition” list or community medicines not reimbursed elsewhere are concerned, when their evaluation by the HAS recognizes a significant level of medical service rendered (SMR) and a improvement of this actual benefit (ASMR).
The laboratory must also undertake to ensure continuity of treatment for patients benefiting from this experimental device for one year. The law provides that the price of these products is freely set by the manufacturer (unless it is already set under other indications). The treatment is 100% covered by the Health Insurance, with no remaining charge for the patients or for the establishments that treat them.
The direct access discount grid
At the end of the direct access system, depending on the price negotiated with the Economic Committee for Health Products (CEPS), the operator may be required to pay additional discounts or benefit from a transfer from Health Insurance , on the basis of a grid fixed by order of the ministers. It is a question of fixing by decree the rates of rebates by bracket of turnover.
The content of the decree and in particular the discount schedule was the subject of an agreement very recently between the Minister of Health and Prevention and the players in the sector. It will be published by the end of May.
The launch of the “Direct Access” experiment reaffirms the commitments of the Minister of Health and Prevention and of the entire Government in favor of medical innovation and better access to care for patients. The results of this initiative will serve as a basis for evaluating the effectiveness and relevance of this measure with a view to possible generalization in 2025.
For more information and to consult the decree in full, please visit the Légifrance website.
Contacts presse
Office of Mr. François Braun
[email protected] – 01 40 56 60 60
1684208677
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