Updated 21st August 2023

We are extremely disappointed and dismayed that the draft final guidance from The National Institute for Health and Care Excellence (NICE) is not to recommend baricitinib for routine commissioning on the NHS for the treatment of severe alopecia areata.

Please be reassured that we will still be fighting and advocating, to enable people with alopecia areata to be able to access new treatments, including JAK inhibitor drugs, from the NHS. Unfortunately, it is going to be a long battle.

Baricitinib is the only treatment licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) for severe alopecia areata. It seems particularly unfair and inequitable that NICE did not recommend baricitinib for alopecia areata when they have recommended it for use in atopic dermatitis (eczema). This seems as though there is a suggestion that alopecia areata does not impact patients as much as another skin condition like eczema. We question the cost-effectiveness comparators that justify this inequality, and ask NICE to look further than the numbers.

Next steps, including Updates

We have until 5pm on 2nd June 2023 to submit an appeal, and while the grounds for an appeal are difficult to meet, we are still going to lodge our comments and reasons. UPDATE: We submitted our appeal to NICE and you can read a copy here.

UPDATE: On 12 June 2023, we received confirmation that NICE have determined four of our appeal points have been determined as valid appeal points. We now expect to be invited to an appeal meeting later in the Summer, but don't have a firm date at this stage. 

UPDATE: On 26 June 2023, we received confirmation that the NICE appeal meeting will take place on 12 September 2023. The appeal hearing is not a re-hearing of the evidence presented to the committee, it’s about process. This means the appeal will not overturn the previous NICE decision to not recommend baricitinib. Rather, it instructs the committee to review how it operated.  If our appeal points are upheld, the final draft guidance is returned to the appraisal committee to assess if the decisions originally made are impacted by the upheld points.

UPDATE: August 2023, Members of the public can attend the virtual appeal hearing webinar. Public observers will be able to listen to the business of the hearing but will not be able to participate in the discussions or ask questions or put views to members of the appeal panel. Registration will close at 4pm on Tuesday 5th September 2023. For details, including how to register, click HERE. 

You can also be sure that Lilly, the drug manufacturer, will not give up and will no doubt submit additional health economic data at a later date. We will be urging Lilly to do all they can to ensure baricitinib is made available to patients with alopecia areata who need it. While the price of baricitinib for the NHS is at a higher price than you may be able to source generic medicines from abroad*, as Lilly stated at the second NICE committee meeting: ‘Even if we gave away baricitinib at no cost it would still not be classed as cost effective by NICE’.

*We know some patients are accessing JAK inhibitor drugs from online overseas pharmacies. We continue to urge all patients to ensure their health is monitored by a UK doctor to ensure patient safety.

There may also be other routes to try and get the NHS to provide baricitinib and for NICE to approve baricitinib for a select group of patients or in further ‘managed access’ trials. We will be continuing to press our case with the clinical experts, Lilly, the NHS and NICE and trying any angle we can to gain approval for the use of baricitinib for NHS patients.

On the near horizon, there is another JAK inhibitor for NICE to consider. We are now working on our case for support for ritlecitinib (a Pfizer drug), which will be assessed by NICE in September 2023. Please be confident that we will be lobbying Pfizer, clinical experts, NHS and NICE for this drug to made available to patients with alopecia areata who are seeking treatment.  

Why do we think that NICE did not recommend baricitinib?

Our understanding is that NICE rejected baricitinib on the following points – neither of which we accept as fair:

- Not a strong enough improvement in quality of life

NICE assess ‘cost effectiveness’ as what it costs to save a life, cure a patient, or in this case improve a patient’s quality of life. While we understand the great difference it would make to the quality of life of some patients with severe alopecia areata to have their hair regrowing again, unfortunately NICE only look at the clinical trials data that Lilly submitted, which did not show a great improvement in quality of life. We challenged the trial data, the quality-of-life measure used, and how the calculation was made, but to no avail. We put forward all the data we have. There were also two dermatologists as clinical experts, who also put forward strong points and data, but at the end of the day – the NICE committee did not accept our arguments.

- Confusion over Best Supportive Care and the comparator medicine

When NICE reviewed baricitinib for atopic dermatitis (eczema), they compared the costs and results to another eczema medicine (dupilumab). In this case, the cost of baricitinib and the other NICE-approved medicine were similar in some ways and NICE put certain conditions on which patients with atopic dermatitis could receive baricitinib, and when. While for severe alopecia areata, NICE and Lilly were arguing over what is best supportive care and which medicines are currently being used for severe alopecia areata.

Both Lynn Wilks (AUK Trustee) and Sue Schilling (AUK CEO) fought strongly here, at the NICE second committee meetings and in the Alopecia UK comments on the draft guidance, that currently most patients with severe alopecia areata just get ‘abandoned’ by the NHS, and that is if patients even get referred to dermatology in the first place. We argued, that as there are no other effective, licenced treatments for severe alopecia areata, baricitinib should be considered, as an innovative ‘first’ real medicine. Baricitinib is the first, and currently only, drug to be licenced by the MHRA for the treatment of severe alopecia areata.

NICE have stated that the committee’s preferred assumptions include the use of ‘no active treatment’ as the comparator.  We do not agree and feel that patients with alopecia areata have been unfairly treated in this consultation. This is because, if an expensive, effective, licensed treatment was already approved for severe alopecia areata and baricitinib was compared against that, would it have been approved, as in the case of atopic dermatitis (eczema).

What is happening in other areas of the UK?

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 asked Alopecia UK to be the patient organisation stakeholder, to bring the patient voice to their committee. 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.  

UPDATE: Alopecia UK attended the SMC appraisal meeting for baricitinib on 4 July 2023. The meeting was very patient-focused and the SMC representative did a good job of showcasing Alopecia UK's written submission, which included some quotes from our community. We believe the SMC will publish their decision on baricitinib in early August and we will provide updates as soon as we are able to. 

UPDATE: On 7 August 2023, SMC confirmed their advice is not to recommend bariticinib for use within NHS Scotland. Their reason was that "the pharmaceutical company's justification of the treatment's cost in relation to its health benefits was not sufficient and the company did not present a sufficiently robust economic analysis to gain acceptance from SMC." You can find further details of their decision here.

We are very disappointed by this decision. We do not have the option to appeal this decision and it is up to the manufacturer Lilly to continue their work to get this drug accepted for patients with severe alopecia areata. 

What can you do?

Please join us as advocates for yourself and other people with alopecia. If you feel strong enough to make a public stance, please raise awareness of this rejection of baricitinib by NICE.

• Contact your local MP and explain in your own words how you feel abandoned by the NHS and disappointed by the decision from NICE not to approve baricitinib for patients with severe alopecia areata. We have provided some tips for contacting your local MP here.
• Consider contacting your local newspaper, TV and radio stations – but only if you feel confident enough about being in the public eye. Feel free to use the content of this article in your own communications. We have provided some tips for speaking with the media here. You may also find it helpful to read our Press Release here and our Media Factsheet here. 
• We are looking for one volunteer patient expert to provide a patient voice in the NICE consultation for ritlecitinib later this year. Find out more here. UPDATE: position now filled. 
• Sign this petition created by one of our community members and, if you feel passionately about this issue, ask your family and friends to sign too.