The National Institute for Health and Care Excellence (NICE) has recommended that a drug to treat severe alopecia in adults and adolescents be available on the NHS.
The approval of ritlecitinib (Litfulo, Pfizer) is the first time that the health regulator has sanctioned a licensed treatment for alopecia areata.
NICE estimated that up to 14,000 people in England and Wales could benefit from treatment with the one-a-day capsule.
Thursday's final draft guidance came after an appraisal committee rejected ritlecitinib in September 2023. NICE said that, since then, the manufacturer had offered a more generous price discount and provided additional evidence on the drug's longer-term effectiveness.
Ritlecitinib is a Janus kinase (JAK) inhibitor that downregulates the immune response at the hair follicles. Ritlecitinib received its marketing license from the Medicines and Healthcare products Regulatory Agency on 1 November 2023.
NICE said that evidence from the ALLEGRO clinical trials demonstrated that ritlecitinib is more effective than placebo at improving hair regrowth for up to 24 weeks and that response rates continued to improve for people taking ritlecitinib for up to 2 years.
Clinical experts said there is no evidence from the ongoing trials to show what happens to hair growth when ritlecitinib is stopped, but that further data might provide answers.
"Devastating Impact" of Severe Alopecia
Following a consultation, NICE concluded that there is no standard care for severe alopecia areata, that available treatments are not available equitably across England and Wales, and that there is an unmet need for new treatments. The committee took into account descriptions of "the devastating impact of severe alopecia areata which can lead to depression, anxiety, social isolation, and suicidal thoughts".
Ritlecitinib is indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older. The recommended dose is a 50 mg capsule taken daily. Side effects associated with ritlecitinib include acne in young people, and respiratory tract infections.
The list price for the drug is £949.41 per pack of 30 capsules. However, Pfizer has offered a discount to the NHS under the terms of a confidential agreement.
Final guidance from NICE is expected on 27 March 2024.
The drug's approval was welcomed by the charity Alopecia UK. Its CEO, Sue Schilling, said in a press release : "For far too long, patients with alopecia areata have gone without a licensed treatment option available via NHS pathways. If new treatments are only available privately, it becomes a case of the 'haves and the have nots'. This latest NICE recommendation will go some way to address this."