Trogarzo in FranceIt looks like the drug is approved for the ATU program in France, It seems the commercialization is done by a third party called Inresa Pharma.
INRESA TROGARZO 200 mg/1,33 ml, solution injectable ibalizumab 1,000.000 €
"ATU - Temporary Use Authorizations
published on07.01.21
In France, by derogation from the procedure for issuing an AMM, obtaining a temporary authorisation for use (ATU) issued by the National Agency for the Safety of Medicines and Health Products (ANSM) allows the exceptional use of pharmaceutical specialties that do not benefit - or not yet - from AMM.
There are two types of
- ATU: the so-called "cohort" ATU, which involves drugs whose efficacy and job security are strongly presumed and intended for a group or subgroup of patients treated and monitored according to criteria defined in a protocol for therapeutic use and information collection;
the so-called "nominal" ATU issued for a single named patient who cannot participate in biomedical research, at the request and under the responsibility of the prescribing physician, as long as the drug is likely to be of benefit to that - patient.
During the entire period during which a drug is granted an ATU, the laboratory operating the drug may supply the atU drugs to health facilities, free of charge or for compensation, the amount of which is freely set by the manufacturer who is required to declare it to the CEPS.
When a drug with an ATU obtains marketing authorization, the ATU ends and the drug enters a transitional "post-ATU" regimen. This system ensures continuity of access to treatment until a final decision on the assumption or reimbursement under its MMA is made, i.e., if necessary, until the publication of the price of the specialty by the CEPS and its inclusion in reimbursement by health insurance.
Under Section L. 162-16-5-1 of the Social Security Code, CEPS makes public the maximum amount of compensation that laboratories can claim from health facilities for ATU or post-ATU products.
https://solidarites-sante.gouv.fr/ministere/acteurs/instances-rattachees/article/atu-autorisations-temporaires-d-utilisation