Ritlecitinib is not recommended by NICE in draft guidance Alopecia UK is, yet again, extremely disappointed to learn that the National Institute for Health and Care Excellence (NICE) has produced draft guidance that does not recommend a licensed medication for the treatment of severe alopecia areata. This latest guidance relates to a drug called ritlecitinib which is manufactured by Pfizer. This follows the dismissal of our appeal for NICE to reconsider their decision not to recommend baricitinib for the treatment of patients with severe alopecia areata. (Find out more about the baricitinib appeal here). On 1 November 2023, ritlecitinib was given a marketing license by the Medicines and Healthcare products Regulatory Authority (MHRA) for the treatment of severe alopecia areata in adults and adolescents 12 years and older. NICE held the first appraisal committee meeting for ritlecitinib on 5 September 2023, with Alopecia UK attending to represent the patient experience and advocate for this new treatment to be made available to those who need it. Ritlecitinib is a JAK inhibitor drug, but unlike baricitinib (which was already licensed to treat other conditions before it went though clinical trials for alopecia areata), ritlecitinib does not have a license from the MHRA for any condition other than alopecia areata. Like the clinical trials for baricitinib, the clinical trials for ritlecitinib showed positive results with a higher percentage of people experiencing regrowth than those on a placebo. As with similar drugs, it is clear from the clinical trials that this medication isn’t a cure that will work for all but the trial data does point to this being another treatment option that could result in significant regrowth for some who opt to try it. NICE’s draft guidance to not recommend ritlecitinib is hugely disappointing. The NICE committee acknowledged the severe distress and profound impact on quality of life that alopecia areata can cause, as well as recognising that there is currently no standard treatment and that access to treatments varies widely across England and Wales. NICE even noted that ritlecitinib is 'innovative' and acknowledged the patient expert comments that there is ‘no current pathway for treatment of alopecia areata’. Yet, having acknowledged all those points it was still a no from NICE because: · It is not clear how much ritlecitinib improves quality of life – this comes from the clinical trial data, along with the weaknesses of the EQ-5D quality of life measure. · The most likely cost-effectiveness estimates for ritlecitinib are higher than what NICE normally considers an acceptable use of NHS resources. · The NICE committee are comparing the cost of ritlecitinib to ‘Best Supportive Care’, which currently only includes the cost of wigs, psychosocial support and GP/Dermatology appointments. If there was another licensed treatment for alopecia areata being routinely used by the NHS, the cost-effectiveness calculations may be different. As you will be able to see from the draft guidance (pg 23), the NICE committee has asked to see further evidence and analyses from Pfizer. We hope that Pfizer provide what is needed to satisfy the committee’s need for this data, and hope the committee will focus on the key points of; the psychosocial impact of alopecia areata on patients, the lack of patient pathway or current licensed treatments, and the innovation of ritlecitinib. Alopecia UK remains firm in our belief that the quality of life tool ‘EQ-5D’ does not capture all the benefits of treatment for alopecia areata and that a condition-specific measure is needed, and that the lack of any other licensed treatments mean there are no direct comparators to assist in assessing cost-effectiveness. Whilst NICE continues to rely on ‘EQ-5D’ as a quality of life measure, and continues to compare the cost of new licensed treatments with ‘no treatment at all’, it feels that the answer is going to continue to be no. We urge NICE and drug manufacturers, in the case of ritlecitinib, Pfizer, to not give up on patients with severe alopecia areata. We want to remind everyone of the significant impacts that alopecia areata can have on those affected. We plead with these parties not to give up on a group of patients who deserve the chance to try a treatment which might mean they do not have to struggle on with the severe emotional and psychological impacts that some people with alopecia areata experience. The draft guidance not to recommend ritlecitinib is particularly disappointing for families of adolescents with severe alopecia areata, as this is currently the only treatment licensed for people aged 12 and over. We worry what further rejection from NICE means for our community of patients with alopecia. We believe we are at risk of entering a future of ‘haves and have nots’, in which the only people who can access treatment are those who can afford to purchase medication privately (which we know is already happening) whilst those who rely on treatment via the NHS miss out on these novel treatments. This would be completely unfair and inequitable and a disgraceful situation for those already struggling with alopecia areata to find themselves in. Call to action We urge you to become a patient advocate and tell NICE what you think of this draft guidance. As somebody affected by alopecia areata, you can help by sharing your experiences. Feedback needs to be submitted by 15th December 2023, with the second committee meeting likely to take place on 16th January 2024. Please note, the second committee meeting is usually closed to the public. From previous community feedback, we recognise that the NICE website, and the questions asked/language used, are not the easiest to navigate, but we encourage you not to be put off by this. Even if you just put your views forward to the question ‘Are the recommendations sound and a suitable basis for guidance to the NHS?’. This question provides you with an opportunity to challenge NICE’s point about the unclarity of how much the treatment improves quality of life. You could do this by explaining to NICE how hair regrowth, or a treatment that provides the chance of hair regrowth, would affect your quality of life. If you are someone who has tried a JAK inhibitor drug for your alopecia areata, please consider submitting your views on how this has affected your quality of life. Provide your feedback to NICE here.