A first treatment for vitiligo available in France

Patients suffering from vitiligo, an autoimmune disease which causes progressive depigmentation of the skin, will benefit from a first authorized treatment reimbursed by Health Insurance, according to a decree published Wednesday in the Official Journal.

This treatment concerns Opzelura cream, developed by the American laboratory Incyte Biosciences, to treat “non-segmental vitiligo with facial involvement in adults and adolescents over 12 years of age”, according to the text. It intervenes within the framework of a so-called “direct access” system, an experimental measure included in the social security financing law since 2022 so that certain medicines reach French patients more quickly.

Vitiligo causes a progressive breakdown of the cells producing skin pigments (melanocytes) which leads to depigmentation in the form of white spots on the face and body. The French Vitiligo Association estimates that around 1 to 2% of the world's population is affected by this very visible chronic disease which can lead to a "significant alteration in the quality of life, in relationships with others and with oneself" . More than a million people in France are affected by this pathology, according to Incyte Biosciences, which employs 2,500 employees, including 50 in France.

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Opzelura received marketing authorization valid throughout the European Union in April. In October, the High Authority of Health issued a favorable opinion for its reimbursement. The pharmaceutical company then turned to the Ministry of Health to request direct access, that is to say without waiting for price negotiation. The Opzelura treatment is already available in the United States, Germany and Austria. “The patient will have to obtain the treatment in a hospital pharmacy” during the direct access period, the manufacturer's spokesperson in France, Claire Lhériteau-Calmé, told AFP.

By applying the cream twice a day, “the patient will see repigmentation gradually until almost 75% repigmentation after six months for the most part,” she added. In December, a treatment for hemophilia B, marketed under the name Hemgenix by the CSL Behring laboratory, was the first indication to obtain coverage in France via direct access.