The wait was great! The Official Journal of July 23, 2024 has just published the Order of the Ministry of Labor, Health and Solidarity, signed on July 18, 2024, which formalizes the inclusion of Opzelura on the list of drugs reimbursable to social security beneficiaries.
It therefore allows Opzelura to be made available in pharmacies in the traditional way like all other medicines. The price and availability will be effective 4 days after the publication of the decree in order to allow the implementation of supply circuits, and therefore from July 27, 2024.
© Copyright: French Vitiligo Association
A reimbursement rate of up to 65%, the remaining cost covered by your mutual insurance
In the same issue of the Official Journal, the participation rate that remains the responsibility of social security beneficiaries is also made official at the rate of 35% ( 65% of the price is therefore covered by Social Security under national solidarity). This is the highest rate for this type of medication due to the Improvement of Medical Service Rendered (ASMR 4) which was issued by the High Authority of Health (HAS). Vitiligo patients with mutual insurance should normally have this remaining charge completely taken into account by their mutual insurance , as for other prescribed medications.
The Economic Committee for Health Products (CEPS, a state body composed of several ministries including Finance, Health and Social Security, etc.) and the laboratory Incyte Biosciences France have set, by agreement, the price of the 100g tube at 838.39 Euros including tax . This price was published by notice in the Official Journal of July 23, 2024, and is therefore now official .
A price negotiated with the health authorities
Some people wonder about the set price , which they consider to be high, or even too high. But this is often without taking into account, or with poor knowledge of, the investments required in the development and development of new molecules, the costs relating to clinical research prior to making them available, or even the monitoring throughout the life of a drug. In addition, let us have confidence in the discussions and negotiations of the health authorities for all drugs, their monitoring and management throughout the year for a price set as fairly as possible : this guarantees access to medical innovation and the protection of social security coverage for all patients in France and overseas territories.
Fast access for vitiligo patients
We were able to quickly benefit from access to Opzelura and use this first drug with a marketing authorization (MA) against vitiligo, with direct access since January 2024. However, this exceptional procedure required the drug to be dispensed through hospital pharmacies. Not easy, when the vast majority of patients with vitiligo live in remote areas or in the suburbs of large cities, far from hospital pharmacies.
Today, what was a supply nightmare will be behind us from Sunday, July 27, 2024: the medicine will be made available in local pharmacies , in the traditional way.
Reminder of the active ingredient of the drug and its marketing authorization
Opzelura must be prescribed by a private or hospital dermatologist, during a consultation, after diagnosis; its active ingredient is a molecule that inhibits the Janus Kinase enzyme (or anti-jak) which regulates the inflammatory system . These new molecules and different anti-jak are used for chronic diseases , systemically or topically such as for vitiligo (in order to facilitate its use and their activation in skin affected by vitiligo, the molecules are in fact contained in a cream).
Opzelura cream has a Marketing Authorization (MA) for the treatment of non-segmental vitiligo with facial involvement (i.e. located on both sides of the body, and with vitiligo on the face) in adults and adolescents over 12 years of age . The total surface area treated should not exceed 10% of the body (1% of body surface area corresponds approximately to 1 hand), application twice a day , morning and evening. As an indication, 1 tube may be suitable for covering 1% of skin surface over 6 months; the dermatologist must indicate “to be renewed” as well as the number of tubes planned per month (“either for 1 year…” or “or for 6 months…” for example).
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