End of early access authorization and continuity of treatment 

While drugs are automatically reimbursed at 100% by the French health insurance system as soon as they are granted early access authorization (AAP), the end of this system raises essential questions about the continuity of treatment.

In particular, it raises questions about the continuation of coverage, whether during the reimbursement waiting period or in the event of non-inclusion on the list of specialties reimbursable by social security.

The interministerial information note of February 5, 2025 on the end of PAAs, repealing the circular of July 8, 2014, specifies these conditions and their information procedures.

Treatment management after the end of the PAA

As a reminder, the aim of the AAP system is to enable the reimbursement of new molecules that meet an unmet medical need, before they are granted marketing authorization or reimbursed under ordinary law.

It applies exclusively to drugs intended to be marketed by the laboratory for the indication in question.

The interministerial information memorandum of February 5, 2025 specifies the procedures applicable in the two possible situations:

- the end of PAAs not included on the list of reimbursable specialties and,

- the end of the PAA with the inclusion of the specialty concerned on this list.

^1st case: end of PAA without inclusion on the list of reimbursable specialties

‍On thecontinuity of post-PAA treatments

In accordance witharticle D. 163-3 of the French Social Security Code, coverage of a product under the early access program is conditional on a commitment by the laboratory providing the product to ensure continuity of treatment for at least one year from the date on which coverage ceases.

Compliance with this commitment guarantees continued coverage by the Assurance Maladie for the first three months.

Once this three-month period has elapsed, the laboratory is responsible for supplying the speciality to the patients concerned, possibly free of charge, for the remaining nine months.

Please note: only patients treated during the early access phase can benefit from this continuity of care.

‍Surles modalités d'information de la poursuite des traitements post-AAP

Information on treatment continuity, provided by the operating laboratory, will henceforth be included in the reference system for derogatory access , which lists all early-access drugs.

Only "special" situations will be covered by interministerial information notes distributed to healthcare establishments by the ARS and published in the Bulletin Officiel - Santé.

^2nd case: end of PAA with inclusion on the list of reimbursable specialties

The information note provides for a 15-day period between the publication in the Journal Officiel of registration orders and notices relating to prices and rates of co-payment by the insured, and their effective date for dispensing these specialties in pharmacies.

This measure enables PUIs to clear their stocks and prepare for the transition to the pharmacy circuit, thus ensuring continuity in the dispensing of medicines.

Watch out for penalties!

Failure by the laboratory to comply with the obligation to maintain continuity is punishable by a penalty of up to 30% of pre-tax sales made in France for the speciality concerned, over the 24 months preceding the observation of the breach.

Vigilance is also required with regard to stock-outs: medicines available in post-marketing AP, i.e. with a marketing authorization, are subject to the regulatory obligations applicable to MITMs in terms of managing and preventing stock-outs. 

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