Incyte Biosciences UK has reported that the National Institute for Health and Care Excellence (NICE) has authorised the reimbursement of Opzelura (ruxolitinib) cream 15 mg/g for qualifying patients with non-segmental vitiligo through the NHS.
In a statement, the company said the news was the result of more than two years of negotiation and sustained engagement by the patient and clinical communities.
This decision follows the publication of the Final Draft Guidance (FDG) for the topical treatment of adults and adolescents aged 12 years and older with non-segmental vitiligo involving the face.
Ruxolitinib cream, a topical formulation of a Janus kinase (JAK) 1/2 inhibitor, is the first and only approved treatment in England to offer eligible patients with vitiligo support for re-pigmentation.
Vitiligo is a chronic autoimmune condition in which areas of skin depigment or lose their colour due to the progressive destruction of pigment-producing cells known as melanocytes.
Around 1 in 100 people in the UK develop vitiligo, with approximately 8 in 10 affected by non-segmental vitiligo, in which symmetrical white patches affect both sides of the body.
Anyone can develop vitiligo, but it appears more pronounced in people with darker skin. It has a significant psychosocial impact, which can negatively affect the quality of life of people living with the condition.
Abbie Hurrell, CEO, The Vitiligo Society said: "This decision is a significant milestone for our community and we are hugely excited by how the approval of Opzelura will potentially transform treatment for people living with non-segmental vitiligo."
"Vitiligo is a condition that has psychologically devastating effects on people living with it. Our own research showed that 80% of patients said vitiligo negatively impacts their appearance and almost half (46%) have suffered with feelings of isolation and depression."
That is why we remained committed to campaigning for the approval of the first topical innovative treatment option, which means the community now has an opportunity to access treatment options in a way they never have before, addressing this area of historical high unmet medical need.
Dr Viktoria Eleftheriadou, Consultant Dermatologist, Walsall Healthcare & The Royal Wolverhampton NHS Trusts, said: "On behalf of the clinical community, we are delighted that NICE is recommending this treatment option for patients."
"A topical treatment, Opzelura has the potential to enhance patient and clinical outcomes and serves a huge need in the dermatology community."
For the first time, people living with vitiligo will have equitable access to a clinically proven therapy that can meaningfully restore skin pigmentation and potentially improve their quality of life.
"For many patients with vitiligo, their conditions are mentally and socially challenging and this brings renewed hope for effective treatment."
"This decision recognises the power of innovation and will minimise the need for burdensome monitoring or frequent in-patient care appointments. We are pleased to see this underserved patient community receive access to a promising treatment that they can apply themselves to and that has clinically impressive outcomes."
Pete Williams, General Manager, Incyte Biosciences UK and Ireland, added: "Incyte is proud that patients in the UK will now be able to receive the first and only approved treatment for non-segmental vitiligo."
This decision is the result of two years of negotiation with NICE and NHSE and significant collaboration with the patient community to ensure their interests remained at the forefront of decision-makers' minds.
This approval is based on data from the pivotal Phase III TRuE-V clinical trial programme (TRuE-V1 and TRuE-V2), which evaluated the safety and efficacy of ruxolitinib cream versus vehicle in more than 600 people with nonsegmental vitiligo aged 12 and older.
In the studies, treatment resulted in significant improvements in VASI scores, representing improvements in facial and total-body repigmentation at Week 24 (primary analysis) compared with vehicle (non-medicated cream) and in an open-label extension at Week 52.