The UK National Institute for Health and Care Excellence (NICE) has recommended Pfizer‘s Ritlecitinib, marketed as Litfulo, as a new treatment option for severe hair loss associated with alopecia areata.

The approval marks the first time NICE has recommended a treatment for this condition on the National Health Service (NHS).

Intended to be used in patients aged 12 years and above, Ritlecitinib is a once-daily oral medication.

It has been shown to reduce the enzymes that contribute to inflammation and hair loss at the follicle.

Clinical trials have demonstrated its effectiveness over placebo in promoting hair regrowth, with improvements observed for up to two years.

The final draft guidance comes after NICE’s independent appraisal committee did not recommend the therapy in September 2023.

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However, after a public consultation and Pfizer’s submission of additional data and a revised discount offer, Ritlecitinib is now deemed both clinically effective and cost-effective for NHS use.

Alopecia areata is an autoimmune disorder that leads to hair loss when the immune system attacks hair follicles.

It can result in total hair loss across the body, not just the scalp, increasing susceptibility to infections and impacting body temperature regulation.

The condition can affect anyone at any age and while the hair follicles remain intact, the degree and duration of hair loss vary widely.

Pfizer has established a confidential commercial arrangement with the NHS which includes a simple patient access scheme, offering Ritlecitinib at a discounted rate.

NICE medicines evaluation director Helen Knight stated: “Our committee heard how severe alopecia areata can have a significant impact on people’s health and quality of life. I’m delighted that we are now able to recommend this innovative treatment, the first time a medicine for severe alopecia areata has been recommended by NICE for use in the NHS. 

“It is especially pleasing that we have been able to recommend Ritlecitinib just 16 weeks after it was granted a licence by the Medicines and Healthcare products Regulatory Authority, demonstrating NICE’s commitment to getting the best care to patients fast.”