It intervenes within the framework of the so-called “direct access” system, an experimental measure included in the social security financing law from 2022 so that certain medicines reach French patients more quickly.
Vitiligo causes progressive breakdown of the skin’s pigment-producing cells (melanocytes) leading to depigmentation in the form of white patches on the face and body. The French Vitiligo Association estimates that around 1 to 2% of the world’s population is affected by this highly visible chronic disease that can lead to “significant changes in quality of life, relationships with others and with oneself”. According to Insight Biosciences, which employs 2,500 staff, including 50 in France, more than a million people in France are affected by this pathology.
Opzelura received a valid marketing authorization throughout the European Union in April. In October, the High Authority of Health issued a favorable opinion for its reimbursement. The pharmaceutical company then requested the Ministry of Health for direct access, i.e. without waiting for price negotiations. Opzelura treatment is already available in the United States, Germany and Austria.
During the direct access period “the patient will have to receive the treatment in the hospital pharmacy”, the manufacturer’s spokeswoman in France, Claire Lherito-Calme, indicated. By applying the cream twice a day, “the patient will gradually see repigmentation,” she added, referring to the results of a phase III study that ultimately showed improvement in the face. Six months of treatment for about 31% of patients.
