Joy as NICE changes tack on first NHS vitiligo treatment

Tens of thousands of people living with the skin-lightening disorder vitiligo in the UK will soon be able to access an approved treatment for the first time.

Reimbursement authority NICE has said that Incyte's JAK inhibitor cream Opzelura (ruxolitinib) can be used to treat people aged 12 and over with vitiligo affecting the face, where off-label topical treatments, like steroids and immunosuppressants, have not worked or are unsuitable.

The health technology assessment (HTA) agency turned down the drug in initial guidance last year, after nearly two years of public consultation and review, and the change of heart has been celebrated by patient organisations.

It was also turned down by NICE's counterpart in Scotland, the SMC, in 2024. According to a spokesperson for Incyte, discussions are ongoing with the SMC regarding a potential re-submission later within the next few weeks.

There are believed to be around 80,000 people in England alone living with vitiligo, a chronic autoimmune disease that causes depigmentation of skin. It can affect any area of the body, but most commonly affects the face, neck, and hands.

While current drugs can slow down the skin lightening, they can cause significant side effects if used too much – including skin thinning – and do nothing to restore the usual skin colour.

Clinical trials have shown that around a third of patients treated with Opzelura twice-daily achieved 75% or more improvement from baseline in the facial vitiligo area scores. Overactivity of the JAK signalling pathway is believed to drive inflammation involved in the development and progression of vitiligo.

For many people, particularly those with darker skin tones, the visible changes can affect their confidence, social life, and mental health, said NICE.

"Today's approval of ruxolitinib represents a[n] historic milestone and the first time the NHS has recognised and funded a dedicated re-pigmentation treatment," commented Abigail Hurrell, chief executive of The Vitiligo Society.

"This decision acknowledges the significant psychological, social, and medical impact of vitiligo and marks a fundamental shift towards the equitable care our community has long deserved," she added.

One person who has been living with vitiligo for three decades, 47-year-old Gill from Preston in Lancashire, said she spends hours a week camouflaging her skin and the disorder "affects every part of my life, every single day."

While most people look forward to the summer months, Gill feels relieved when autumn arrives. She was devastated when, after waiting two and a half years for a dermatology appointment, she was seen for ten minutes and discharged after being told there was nothing that could be done.

"It's not just me it impacts," she said. "When the boys were younger, we couldn't just jump in the pool on holiday. I felt like I was restricting them, even though my husband says I haven't."

Although her husband is supportive, Gill says the condition has damaged her confidence. "He always says, 'I love you for who you are,' but it doesn't matter how many times he says it. I hate not being fully clothed."

While Opzelura is limited to people with facial vitiligo, Incyte is also testing an oral JAK inhibitor, povorcitinib, in phase 3 trials that could have a more widespread, systemic effect on the skin-lightening. The drug is already nearing regulatory filings for hidradenitis suppurativa, another inflammatory skin condition.

Meanwhile, other oral JAK inhibitors in late-stage testing for vitiligo include AbbVie's Rinvoq (upadacitinib), Eli Lilly's Olumiant (baricitinib), and Pfizer's Litfulo (ritlecitinib), while Clinuvel is running phase 3 trials of subcutaneously administered alpha-MSH agonist Scenesse (afamelanotide) in the skin disorder.

Photo by Maximus Mazar on Unsplash