Direct access device for certain health products

2023-07-21 08:57:03

In order to strengthen the rapid and secure access of patients to the medicines allowed by the early access reform, the government has proposed a measure, voted in the law on financing social security (LFSS) for 2022, to test a new “direct access” system allowing coverage for certain drugs as soon as the opinion of the High Authority for Health is obtained (HAS).

It’s regarding a two-year experimentin order to analyze the effects of such an early management plan, before a possible generalization.

The experiment allows direct reimbursement from the publication of the HAS opinion, for hospital medicines eligible for the list in addition, or city medicines not reimbursed elsewhere, when their evaluation mentions a significant medical service as well as a improvement of this at least minor medical benefit (from level I to IV).

Context and objective

Article 62 of the LFSS for 2022 drew the outlines of a new experimental mechanism for early reimbursement of certain drugs. It provides for the establishment of a two-year experiment, known as a direct access device. The objective is to provide patients and manufacturers with early access to the market compared to the 180 regulatory days and to ensure a connection with common law in the event of an exceptionally long negotiation period. This device is intended as a complement to early access.

This experimentation thus enables certain medicinal products to benefit, in a given indication, from 100% covered by Health Insurance for a maximum period of one year, upon publication of the opinion of the Transparency Commission (CT) of the High Authority for Health (HAS).

Eligibility requirement for direct access support

The products concerned are pharmaceutical specialties not subject to in a particular indication of an early access authorization but having a marketing authorization (AMM) in the requested indication, without being already registered in other indications on the “city” list or covered under compassionate access and dispensed in community pharmacies as such.

Coverage of a specialty by the compulsory health insurance schemes, for a given indication, is subject to the following criteria:

• The request for reimbursement under direct access is submitted by the operator to the ministers responsible for health and social security. in the month following the publication of the opinion of the CT (on the request for registration on one of the “city”, “retrocession”, “local authorities” lists) and no later than July 17, 2025;
• If the specialty comes under the hospital reserve, it fulfills the eligibility criteria for registration on list it in your. A request for inclusion on this list is sent to the ministers responsible for health and social security at the same time as the request for reimbursement under direct access;
• The level of actual benefit (SMR) of the specialty in the indication(s) considered, assessed by the TC is at least major or important ;
• The level ofimprovement of this actual benefit (ASMR) of the specialty in the indication(s) considered, assessed by the TC is at least minor (from level I to IV);
• The operator undertakes to ensure continuity of treatment patients initiated during the direct access scheme as well as for a minimum period of one year from the end of reimbursement under this scheme, unless the specialty, in the indication concerned, is the subject of a marketing discontinuation for serious reasons relating to patient safety. If the company does not ensure continuity of treatment, it may suffer a penalty.

Coverage under direct access is granted for the pharmaceutical specialty in the indication(s) considered for a maximum period of one year and may be subject to conditions (for example, special conditions of prescription, dispensation, use; coverage only if the prescriber mentions on the prescription elements relating to the circumstances and indications of the prescription).

This care is provided in certain health establishments, mentioned in Article L. 162-22-6 of the Social Security Code, establishments with a pharmacy for internal use (PUI) or in certain army hospitals; without waiting for price negotiation with the Economic Committee for Health Products (CEPS).

No registration of the proprietary medicinal product on the “city”, “retrocession” or “community” reimbursement lists may take place during the direct access period in an indication other than the indication in question. The specialty can be purchased, provided, and used by public authorities without appearing on the “authorities” list.

Procedure

The request for reimbursement under direct access is submitted by the operator to the ministers responsible for health and social security on the AccessMed platformno later than one month following the publication of the opinion rendered by the HAS CT on the application for inclusion on the common law lists.

The application is accompanied by a file containing the information necessary to assess compliance with the conditions of eligibility for direct access reimbursement. The list of documents making up the claim file for reimbursement of a pharmaceutical specialty under the direct access system is fixed as follows, for each indication considered individually for the specialty:

1. The name and address of the operator;
2. A letter of request for support under the direct access device;
3. The opinion issued by the committee mentioned in Article L. 5123-3 of the Public Health Code on the application for inclusion on one of the lists mentioned in Article L. 162-17 of the Social Security Code and Article L. 5123-2 of the Public Health Code in the indication(s) considered;
4. The UCD codes of the different presentations;
5. Economic data including:
   1. where applicable, the prices charged and the sales volumes recorded in France for the indications of the specialty already covered by health insurance;
   2. three-year sales forecasts for the indication for which coverage is requested under the direct access scheme as well as, where applicable, for each of the indications already covered;
   3. when the specialty is not marketed in France, the compensation that will be claimed by the holder of the exploitation rights or his agent under a direct access management agreement;
   4. the sale price to healthcare establishments by UCD code when the specialty does not have a price or a tariff set pursuant to Articles L. 162-16-5 or L. 162-16-6 of the Social Security Code;
6. An estimate by the company of the number of patients likely to be treated in this indication and the forecast turnover by indication, for the coming year;
7. Extensions of indication likely to be covered within two years of the request, as well as their provisional marketing schedule;
8. Information on any research involving humans for commercial purposes in progress in other indications, in particular the protocols, timetables, indications concerned, lists of French centers that are co-investigators and comparators;
9. The laboratory’s commitment to ensure the continuity of the treatments initiated for the duration of the direct access device and for a minimum period of one year from the end, in the indication concerned, of the reimbursement under this device, unless the specialty, in this indication, is the subject of a marketing discontinuation for serious reasons relating to patient safety;
10. When the specialty has been classified in the category of medicinal products reserved for hospital use, a copy of the application for inclusion on the list mentioned in Article L. 162-22-7 of the Social Security Code.

The link to the AccesMed platform and the support request file is available in the “useful documents” section at the bottom of the page.

Coverage is granted by order of the ministers responsible for health and social security. The decree may specify, where applicable, the special conditions of prescription, dispensation and use.

The prescriber mentions on the prescription: “Prescription for direct access” and informs the patient of the conditions of coverage, by Health Insurance, of the prescribed specialty.

Financing of specialties benefiting from direct access

Specialties are 100% covered by compulsory health insurance schemes in addition to hospitalization benefits as soon as their authorizations are granted. They are provided to the health establishment by the operator, free of charge or in return for compensation, the amount of which is freely set by the laboratory (excluding the case where the drug already benefits from an administered price, i.e. a price negotiated or set by the CEPS, or a maximum intra-GHS price, if applicable, this price applies).

Coding by indication

As for early and compassionate derogatory access, the procedures for collecting and transmitting data relating to medicines under direct access are implemented. A code must be transmitted at the time of invoicing.

Thus, the repository dedicated to direct access lists the UCD codes and drug indication codes, includes the list of specialties subject to reimbursement under direct access and specialties for which this reimbursement has ended, for each specialty, the indications concerned.

These codes are accessible in the repository in the “useful documents” section at the bottom of the page.

End of support

In each indication considered, reimbursement under direct access ends no later than one year following the date of the reimbursement decision. It may also end before this deadline, if:

• The indication is listed for reimbursement under its Marketing Authorization (on one of the “city” / “local authorities” lists in the indication in question) and, where applicable, that the notice setting the liability tariff or the price is published;
• The operator requests the withdrawal of support under direct access ;
• The operator withdraws his refund registration request ;
• The specialty is refused registration for reimbursement in the indication in question.

Beyond stopping direct support:

• When the specialty which has benefited from the reimbursement is registered on one of the “city”, “retrocession” or “local authorities” lists in the indication in question, the conditions of dispensation and coverage for registration on these lists apply.
• When the specialty has not been registered on these lists, the last dispensing conditions are maintained. The operator then allows the purchase of the specialty for continued treatment at a price that does not exceed the reference price set by the Committeeif necessary by means of discounts (price capping).

Continuities of treatment

Article 62 of the LFSS 2022 aims to commit the operator, who benefits from direct access and the associated management in a particular indication, to ensure the continuities of treatments initiated for a minimum period of one year from the end of treatment.

Failure by a laboratory to fulfill these obligations may lead the Economic Committee for Health Products to pronounce a financial penalty.

In the event that the proprietary medicinal product is discontinued for serious reasons relating to patient safety, there is no continuity of treatment.

Useful links and documents

• Link to the Accesmed website:
  
  accesmed.sante.gouv.fr (“Experimental support” section and “Direct access” sub-section)

• The list of products subject to direct access authorization:
  
  Reference table to come

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