Ritlecitinib Update - July 2024

Following the final decision back in March by NICE to recommend the JAK inhibitor medicine ritlecitinib (Litfulo) for routine commissioning from the NHS, for the treatment of severe alopecia areata in patients aged 12 and over, we wanted to provide a further update.  

From the final NICE guidance publication date of 27th March 2024, NHS England had 3 months in which to comply with NICE’s recommendations (2 months for NHS Wales). The SMC in Scotland followed with the same recommendation as NICE for NHSScotland, and Northern Ireland was expected to follow NICE guidance.  

As the 3-month deadline has now expired, we expect to see ritlecitinib being made available to patients across the country. However, progress has been slower than many patients were hoping for. Unfortunately, as anticipated by Alopecia UK, we are already seeing inconsistent approaches to prescribing ritlecitinib across the NHS in the UK. We are hearing that some people in our community are being added to waiting lists to start the medicine when it becomes available, some are being told that ritlecitinib will not be available at their hospital, and small numbers have managed to get a prescription.  

A common thing we are hearing from people is that their dermatologist does not feel confident enough to prescribe the medicine as they don't feel the NICE guidance gives enough detail about when to prescribe and when not to prescribe, when to start treatment, when to stop.  

The British Association of Dermatologists (BAD), with support from Alopecia UK, has taken the additional step of publishing a supplementary guidance note to help dermatologists with the prescribing of ritlecitinib with severe alopecia areata. This guidance is supplementary to NICE’s guidance and is not endorsed by NICE. You can find BAD’s supplementary guidance here.  

If patients are met with feedback from doctors along the lines of “We are waiting to see if NICE issue some additional guidance” or “We are unclear on qualifying criteria for prescribing ritlecitinib”, be sure to let them know about the supplementary guidance published by BAD. This might give more dermatologists the confidence to prescribe ritlecitinib and/or have conversations about adding the medicine to your hospital’s formulary (if it’s not already on there).  

Whilst we will continue to do what we can to advocate for fairer patient pathways, it is clear that people affected by alopecia are also going to need to advocate for themselves. We will try our best to provide you with the information you need to do this and we recommend reading our ritlecitinib announcement, from earlier this year along with all the further information links provided at the bottom of our news item, if you have not done so already. There is a lot of information provided within, but we urge anyone considering ritlecitinib (or any medical treatment) to understand all you can about that treatment before embarking on it. Read our earlier announcement, and the further information links, here.  

Another link that you might find helpful when advocating for yourself to access ritlecitinib is this page from NICE’s website all about compliance with NICE Technology Appraisals (TA). Their FAQs document contains some particularly helpful information which we believe might be helpful in pushing back on any initial rejection from dermatologists to prescribe ritlecitinib.

We are starting to receive questions from our community asking if it’s possible to be referred to a different NHS Trust if their NHS Trust says no to prescribing ritlecitinib. We currently do not have a clear answer on this and are trying to find out more. However, we believe that the information from NICE is clear that commissioners have a statutory responsibility to make funding available for a drug of treatment recommended by a NICE technology appraisal (TA) – as is the case for ritlecitinib for severe alopecia areata for people aged 12 and over – within the timeframe recommended in that guidance. In the case of ritlecitinib, TA 958 guidance was published on 27th March 2024 and section 4.1 of this “requires integrated care boards (ICB), NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication”, i.e. by 27th June 2024.

NICE state that, “In practical terms, the effect of this legal obligation and the NHS consultation is that all NICE-approved treatments must be included in local formularies for use in line with the technology appraisal recommendations and with no additional funding or formulary restrictions.” The latter part of this statement may be a point to emphasise should you be told by your doctor that there is no funding available, or ritlecitinib has not been added to the formulary. 

Section 4.3 of the TA 958 guidance says that “When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has severe alopecia areata and the doctor responsible for their care thinks that ritlecitinib is the right treatment, it should be available for use, in line with NICE's recommendations.”.

This means that to be effective in advocating for yourself with the hospital, Trust or ICB, it is important for you to understand if your dermatologist thinks that ritlecitinib is the right treatment for you even if they are struggling to prescribe it because of limitations within the clinical environment. 

If you continue to be told no, consider whether you can use information within the NICE documents linked above to advocate for a different decision.

We are also seeking to find out if there is a way for your clinicians to escalate within their ICB or NHS Trust to overcome their internal challenges.

If you come across challenges in your Trust/ICB, then please let us know. Please understand that we cannot fix the problem on an individual basis but we are building a picture to support our conversations within the wider NHS. It would be useful for us to hear the following; 

• What NHS Trust your hospital is part of

• If the dermatologist has confirmed that you are eligible for ritlecitinib 

• What reason they gave you for not being able to prescribe ritlecitinib 

• If they have agreed to see you for a follow up appointment in the hope that they will be better placed to prescribe in the future 

If you are successful in advocating for yourself to be prescribed ritlecitinib, please also get in touch with us to share your experience so we can perhaps learn from it and share that learning with others.  

We want to reiterate that we are supported by many dermatologists who are doing the best they can to support their patients with alopecia. Empowering people in our community to self-advocate is by no way a slight upon the discipline of dermatology. We hope that when clinicians and patients align and work together, these challenges can be overcome.