Alopecia UK is deeply disappointed to learn that, in draft guidance, the National Institute for Health Care and Excellence (NICE) has not recommended baricitinib, a Janus Kinas Inhibitor drug (JAK inhibitor) for routine commissioning in the NHS for treating severe alopecia areata in adults.

Whilst we understand that many NICE technology appraisals do not approve treatments after the first step of the complex process, it is still frustrating to hear this initial rejection. We are hopeful that the drug manufacturer Eli Lilly and NICE can continue to work together, and for a different decision, after the second stage of the process which is not due to reach its final conclusion until 21 June 2023.

For many patients with severe alopecia areata, who could see their quality of life greatly improved if they had access to this drug, this will be hugely disappointing. Whilst JAK Inhibitor drugs, including baricitinib, have been approved for the treatment of other medical conditions, such as severe atopic dermatitis and rheumatoid arthritis, patients with alopecia areata remain without access to an effective licensed medication.

Alopecia UK is a Patient Organisation stakeholder in this process. We made a submission and attended the Committee Meeting at the beginning of February to ensure the patient experience was heard and understood. You can be confident that we are already developing further points of support for baricitinib to help it be approved for the treatment of severe alopecia areata. In the draft guidance report, we were pleased to see points that we made to the Committee were noted and considered, namely:

1. The difficulty that people with alopecia areata have in getting a dermatology appointment, the extremely long waiting times in some areas and the disparity of treatment options between hospitals. It really is a postcode lottery as to what a patient might be offered. And of the treatments that are currently offered via the NHS, none of them are licensed for the treatment of alopecia areata. All treatments currently offered to patients are prescribed off-license.
2. The devastating psychosocial impact and effects on patient quality of life, including absenteeism from university or work, difficulties with social interactions and relationships, anxiety and depression. (Please note, in our submissions we could only talk about adults with alopecia areata as this drug is only applying for a licence for the treatment of adults not children).

Why did NICE not recommend baricitinib for NHS commissioning?

The trials of baricitinib showed that it works for many patients, and hair regrowth is seen in about 50% people with severe alopecia areata and it has relatively few side effects. Baricitinib has been registered as a licenced, effective and safe treatment for severe alopecia areata in adults. It has registration with the MHRA in the UK, EMA across Europe and the FDA in America.

What NICE looks at is ‘cost effectiveness’ – so is it good use of money for the NHS to give to people with alopecia areata? In terms of considering cost effectiveness – NICE looked at two things:

1. The cost compared to the treatment people are getting now – This was a challenge when the committee looked at baricitinib, as many people with severe alopecia are not taking any treatments. They might have an annual appointment with a dermatologist to get a wig prescription but that’s it! So, today people with alopecia are not costing the NHS much money – as there are very few treatments for alopecia. So, if people start taking baricitinib – they do cost the NHS money and hence it’s a big difference in cost. You will see in the report NICE talks about ‘Best Supportive Care’ and acknowledges that many people are on ‘no active treatment’. The committee concluded that ‘there is an unmet need for safe and effective treatments for severe alopecia areata’ but concerns remain about cost-effectiveness.
2. Quality of life – The other big measure that NICE considers is how a treatment improves and helps quality of life. It is easier to demonstrate the improvement in quality of life in some medical conditions than others. For example, in severe arthritis taking a treatment means you walk better, can do more, can shower yourself, be in less pain, all considered easy to measure quality of life improvements. At Alopecia UK we hear from our community how hair loss affects quality of life – be that anxiety, depression, absenteeism from university or work, difficulties with social interactions & activities and relationships. Some of these impacts are harder to demonstrate with the Quality of Life Assessment tool that has been used in the trials. We were strong in the points we made in our submissions and at the committee meetings. The Committee acknowledged ‘that hair regrowth can have a profound impact on improving a person’s quality of life, but based on the data from the clinical trials, the extent of this improvement in quality of life is uncertain’.

Next steps

In the next four weeks, Alopecia UK will respond to a number of elements in the guidance. We will raise concerns around the Quality of Life Assessment tool – EQ-5D – that has been used in the trials, a tool approved by NICE. EQ-5D measures the impact of a health condition with dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and this is not the most appropriate tool for measuring the impact of alopecia areata on quality of life.

Alopecia UK is also concerned about the assessment of cost-effectiveness and the treatment comparator being used. We hope that NICE and Eli Lilly, will continue their discussions around cost-effectiveness.

We will submit our views on the current standard of care for alopecia areata patients, quality of life parameters, and we will firmly advocate that baricitinib should be made available as a treatment option. Living with severe alopecia areata is much more than a health-economic model.

Update at 24 March 2023: Alopecia UK has sent its response challenging the initial recommendations. We now await the further guidance in June. 

Your voice

There is an opportunity for your voice to heard as members of the general public can also make comments on the draft guidance. You can review the guidance and add your comments between 28^th February 2023 and 20^th March 2023.  

If you wish to add your comments, we suggest including details of the impact that alopecia areata has had on your quality of life. Also, if you were to be able to access this drug and it proves successful, the difference you believe this would make to your quality of life.

If you are already using baricitinib privately, you could add details of the difference that this has made to your life.

NICE’s appraisal consultation document can be found here.

Comments on this decision can be made by 20^th March. An explanation of how to add your comments can be found here.

Update at 24 March 2023: The opportunity for public comments has now closed. 

Key dates

Monday 20 March 2023 – Closing date for public comments. Now closed. 

Tuesday 4 April 2023 – 2^nd Committee Meeting to consider any new data from the drug manufacturer and comments from other stakeholders and general public.

Week commencing 15th May 2023 - We expect that NICE will make public the outcome of the 2nd Committee Meeting. This is subject to change but we have been told we can expect something during this week. 

Wednesday 21 June 2023 – Final guidance will be published.

Final thoughts

Whilst we remain hopeful that it will be a different outcome in June, if baricitinib is still not recommended for the treatment of severe alopecia areata, we know the drug manufacturer will continue to work on seeking approval at a future date. There is also a further JAK inhibitor drug, ritlecitinib (manufactured by Pfizer), going through the same consultation process later this year for the treatment of severe alopecia areata in people aged 12 years and over. Alopecia UK will be the Patient Organisation stakeholder in this technology appraisal too.

Finally, should bariticinib be approved for the treatment of severe alopecia areata, we recognise that not every patient would be willing or able to try this treatment option. Also, given the postcode lottery we already know exists across all medical treatments, if baricitinib was approved we do not believe it would be easily and readily available to all. We recognise there will still be barriers to access. However, the key thing is that a treatment option that has shown to be successful for many patients in clinical trials is approved so that patients have this choice. 

Further reading

Alopecia UK’s Research and Liaison Manager Niels Bootsma has written a more in-depth article about the consultation process, and the evidence behind baricitinib for alopecia areata, which you can read here.