We are extremely disappointed that a new drug that could improve the lives of over 1 million sufferers will not be made available through the NHS.

The National Institute for Health and Care Excellence (NICE) has announced this week that it will not approve the new drug, Ruxolitinib, for use through the NHS on prescription.

We have been advocating for improved treatments for vitiligo since the 1980s and we will continue to fight to ensure that people living with vitiligo will be able to access new treatments, including JAK inhibitor drugs, from the NHS. Frustratingly, this is going to be an even longer battle.

Ruxolitinib is currently the only treatment for non-segmental vitiligo licenced by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. NICE’s decision not to recommend this treatment seems to suggest that vitiligo does not impact patients significantly enough to justify the cost of the drug, despite all the research and patient testimonies our charity shared during the appraisal process.

Currently there are no licensed treatments for non-segmental vitiligo available through the NHS. Instead, treatment guidelines suggest the use of unlicensed treatments used with the aim of restoring the skin’s colour (repigmentation). These treatments are corticosteroids and calcineurin inhibitors (creams) and they are used on the skin. After trying these, some people then try treatment with light (phototherapy).

Unlike these options, Ruxolitinib cream is a licensed treatment for non-segmental vitiligo that affects the face. Ruxolitinib is available in the UK on private prescription, despite not being available on the NHS.

The NICE technology appraisal (TA) guidance makes recommendations on the clinical and cost-effectiveness of medicines and treatments. It helps to ensure that the NHS uses its resources fairly and effectively.

It our understanding that whilst the clinical-trial evidence submitted did show that ruxolitinib cream increases re-pigmentation and reduces how noticeable vitiligo patches are compared with placebo (a cream that does not contain any of the drug), the evidence submitted during this appraisal left too much uncertainty in trying to demonstrate how well ruxolitinib cream works compared with unlicensed, available treatment such as phototherapy.

NICE also concluded that it was uncertain, based on the evidence submitted, whether treatment with ruxolitinib cream would improve people’s quality of life. Finally they concluded that the cost-effectiveness estimate would be higher than what they would consider an acceptable use of NHS resources.

We are devastated by this decision, but we also recognise that this was a first attempt to get a licenced treatment for vitiligo available on the NHS. There are numerous treatments in development by different companies (such as Upadacitinib, Povorcitinib and Ritlecitinib) so this is by no means the end of the battle. We are committed to learning from this experience and doing everything we can to ensure our community have access to the best possible range of treatment options. Scroll down to read what’s next and how you can support us.

Raising awareness of of the decision: Our first priority is to inform our community of this decision, it’s never been more important for us to come together and raise awareness of how important treatment options are for vitiligo. We have released a press statement to the media, and across all our communication platforms.

Appeal the decision: On 30th July 2024 we summited an appeal with NICE, see update below.

Campaigning for access: In case an appeal is not possible, our Chairperson has drafted a petition against the decision which we will be sharing with our community. We have also prepared campaign tools that you can use to help us lobby for change -scroll down for more information.

Exploring other routes to access: Incyte, the drug manufacturer, are also committed to ensuring patients have access to this treatment. We will be urging Incyte to do all they can to ensure that Ruxolitinib is available to patients in the UK who need it. There may be other routes to try to get the NHS to provide access to this treatment and we will be working with the NHS, NICE and Incyte to explore every possible route.

NICE guidelines are evidence-based recommendations for health and care in England. In Scotland, it is the Scottish Medicines Consortium (SMC) who review new treatments. The SMC have recently also reached the decision not to approve this treatment on the NHS, read more here. We expect that Wales and Northern Ireland will follow NICE’s technology appraisal decisions. Find out more about the relationship between NICE and Welsh Government/NHS Wales here, and Northern Ireland here.  

We believe it is important to work through the appeals process first, but if this is unsuccessful, and you feel strong enough to make a public stance, then please see the below steps to help raise awareness of this rejection of Ruxolitinib by NICE. It has never been more important for our community to come together, so please join us as advocates for yourself, your loved ones and for all other people affected by vitiligo.

Write to your local MP: Explain in your own words how you feel disregarded by the NHS and devastated by the decision from NICE not to approve Ruxolitinib for vitiligo patients. We have provided a template letter and guidance here.

Contacting local press: Local newspapers, radios and TV are an excellent way to raise awareness if you feel confident to be in the public eye. We have provided some helpful tips on how to speak to the media here, and you can also use our Press Release and Media Factsheet.

Sign a petition: Our Chairperson has drafted a petition ready to submit should the appeals route not be an option or be successful for us. We will need to wait for the new government to appoint their Petitions Committee in order to proceed. We will circulate a link to it once it is live.

Become a Member of our Society: Our staff member and volunteer team have spent 100s of hours working to try to get this treatment approved, and we are gearing ourselves up for a big fight to appeal the decision. Please consider joining our charity as a member or making a one-off donation to support our work – we need support now more than ever.

NICE has received 4 appeals, that fall within one or more of the two strictly limited grounds for appeal, against the Final Draft Guidance on the above technology from the following organisations:

The appeal panel will convene on Friday 11 October at 10:00am via Zoom to hear oral representations from the appellants. Members of the public, including consultees and commentators for this appraisal, and the press, may request to attend the hearing. Where possible, requests to attend should be made using the registration link that will be available on the NICe website from 14 August 2024. The registration period for this appeal will end at 4:00pm on Friday 4 October. Further details relating to public attendance at this appeal are available on the same webpage as above.

As you may be aware NICE (the regulatory body which decides whether a treatment should be made available on the NHS) decided earlier this year not to recommend Ruxolitinib (Opzelura) for use in the NHS. As one of the largest and longest established vitiligo charities in the world we felt it was essential to do everything in our power to contest this decision. We have been campaigning hard on behalf of patients for better treatment options for years, and this process represents a turning point for our work. The Appeal Hearing was held last Friday 18th October and we want to publicly thank all the experts and patients who contributed to the meeting. We also want to thank those who dialled to listen to us and the other appellants make our cases.

Our Appeal points were in relation to the fact that NICE consistently failed to act fairly in the manner by which they engaged with our organisation throughout this process. We believe that as a result of this: NICE did not hear from key groups of individuals who statistically feel the burden of vitiligo the greatest; which resulted NICE not being able to understand the impact of the disease as a whole; and so NICE were not in a position to fairly assess the impact that this treatment could have.

Our charity holds recent and comprehensive data from the largest ever survey of people living with vitiligo in the UK, and we believe it is a significant failing that we were not given a fair platform to share this information which would have provided a critical and powerful quantitative data relating to the devastating psychological effects that vitiligo can cause.

We were extremely grateful that NICE recognised their failings publically in this meeting, and acknowledged the lack of time we were given to adequately respond to consultation. There was also a public acknowledgment that NICE could have included more patient representation in key meetings, and were unable to justify their decision to only invite two individuals to speak at key meetings. In addition, there was a recognition that there was no representation or consideration given to young people throughout the process – a key group of patients who our research shows are more statistically likely to significantly struggle with the condition.

We want to thank everyone for their kind words of support following the meeting. It was a privilege to be present to represent vitiligo patients and we thank everyone who helped shape our opening and closing statements – it was a real community effort. We also want to thank all those who supported us with a donation after the event – an incredible testament to how our words resonated with so many people listening in.

The Appeal Hearing will not result in the decision being overturned, the best possible outcome is that one or more of the appeal points are upheld and final draft guidance is returned to the NICE Appraisal committee. We hope to be able to communicate the outcome with you all in a couple of weeks.

For too long the vitiligo community has felt unheard, unseen and dismissed by the medical and scientific community. The most important thing we took away from the meeting was that there are a number of incredible organisations, experts and individuals who are trying to change this. The hope for the vitiligo community rests in our ability to work in collaboration to ensure the best possible outcomes for everyone affected by this devastating condition.

For more information on the Appraisal Process: https://vitiligosociety.org/…/nice-ruxolitinib…/

Donate to support our work: https://vitiligosociety.org/donate/

¹ In the largest ever UK survey of vitiligo (more than 700 people) 80% said vitiligo negatively impacts their appearance, and almost half (46%) felt isolated and depressed. The #LetsTalkVitiligo campaign was launched by The Vitiligo Society to raise awareness and understanding among healthcare professionals and the public. The independent study, commissioned by the UK charity that supports those with vitiligo, found that just 15% of those diagnosed felt informed about vitiligo, with a third of people feeling dismissed and confused when first speaking to their GP or healthcare professional. 

Funding disclosure:
The Vitiligo Society has project work supported by an educational grant from Incyte Biosciences UK Ltd. The Vitiligo Society maintains full control over the all project management and content, ensuring independence and impartiality in its work. When it comes to any external funding we follow the current guidance and rules as set out by the Charity Commission and the Fundraising Regulator. We report any research collaborations and/or financial contributions received from industry in our annual reports and accounts as well as being transparent about our partnerships on our website.