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Vitiligo is a skin disease characterized by more or less extensive depigmented areas. More than a million French people are affected. From July 27, they will be able to benefit from a new treatment reimbursed in city pharmacies: Opzelura (ruxolitinib).
Vitiligo, a disease that seriously affects quality of life
Vitiligo is a disease of the epidermis that corresponds to an acquired loss (not present at birth) of melanocytes, which results in depigmentation, that is, the appearance of white spots on the skin that affect different parts of the body, particularly the face, extremities, joints and areas of friction.
Of poorly understood origin, studies show that vitiligo corresponds to an alteration of the immune function triggered or aggravated by stress, but many other factors have been mentioned.
In France, vitiligo is estimated to affect between 0.5 and 2% of the population, or around 1 million people, one in two of whom are diagnosed before the age of 20. However, vitiligo can appear at any age and its progression is unpredictable. And until now, no treatment was approved to “repigment” patients with vitiligo, a chronic autoimmune disease that affects more than a million people in France.
Topical ruxolitinib: a long-term treatment
The cream – “Opzelura” – with a concentration of Ruxolitinib of 1.5% – is the only topical formulation of a JAK (Janus kinase) inhibitor. Manufactured by the company Incyte, the drug is intended for all patients aged 12 and over (adults and children) suffering from non-segmental vitiligo, a highly localized form of the disease. Before being marketed, it underwent numerous trials.
Today, the drug is approved for continuous topical use 2 times a day on the affected areas, on a limited body surface (up to 10%). However, be careful not to consider this drug as a miracle treatment: the body’s response to “topical Ruxolitinib” may be slow. It is therefore sometimes necessary to follow the treatment for more than 24 weeks before obtaining a response from the body.
Rapid availability of the drug
But in July 2022, the Food and Drug Administration made a big announcement by approving the marketing of the treatment Ruxolitinib in the United States. The European Commission, in turn, gave its approval on April 20, 2023, for the marketing of Opzelura (ruxolitinib) in Europe. In October 2023, the High Authority of Health issued a favorable opinion on its reimbursement. In January 2024, direct access to this drug was made possible via an exceptional procedure (without waiting for price negotiation between Health Insurance and the manufacturer), which required delivery of the drug through hospital retrocession pharmacies. Not necessarily the easiest for patients who live in remote areas or in the suburbs of large cities, far from hospital pharmacies.
But the situation is changing today with it being made available in local pharmacies like all medicines.
Access to city pharmacies from July 27!
THE Official Journal of July 23, 2024 published on July 23 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.
In concrete terms, this means that Opzelura will be available in pharmacies in the traditional way like all other medicines from July 27, 2024.
The drug is reimbursed at 65%. The remainder is normally covered by patients’ mutual insurance companies, as for other drugs. This availability means that negotiations on the price of the drug have been successful: the Economic Committee for Health Products and the laboratory Incyte Biosciences France have set, by agreement, the price of the 100g tube at 838.39 Euros including tax.