On behalf of the section of the alopecia community who are desperate for new treatment options to be made available, we are extremely disappointed, angry, and frustrated that NICE (National Institute for Health and Care Excellence) has dismissed Alopecia UK’s baricitinib appeal.

As such, NICE’s decision is to continue to not recommend baricitinib, currently the only licensed treatment in the UK, for the treatment of severe alopecia areata.

Our disappointment, anger, and frustration stem from the fact that the voices of patients and clinicians were included in this process, and the NICE committee agreed with us on several of our challenges, but that still wasn’t enough to change the outcome.

The NICE committee acknowledged that that the health-related quality of life tool EQ-5D ‘may not capture all the benefits of treatment for this condition’ but the absence of another tool led the committee to decide that it wasn’t unreasonable to base decision-making on EQ-5D data.

The NICE appeal panel agreed with Alopecia UK that ‘there is considerable unmet need for new treatments for alopecia areata’, noting the ‘profound impact that alopecia areata can have on quality of life, the lack of established care pathways for this condition, and the fact that baricitinib is the first licensed treatment for alopecia areata’.

Despite acknowledging that they agree with Alopecia UK that there are problems with the quality of life measure used, and that there are real treatment challenges for those with severe alopecia areata, it is incredibly frustrating to know this isn’t sufficient to change hearts and minds at NICE. We cannot help but conclude that the process has failed patients with severe alopecia areata.  

Dr Susan Holmes and Dr Leila Asfour supported our appeal to put forward the clinical perspective they see in their clinic. Dr Holmes described how those with severe alopecia areata are often neglected in NHS treatment. She explained there are no standard or managed pathways for treatment, no urgency in treatment, and provision for wigs varies geographically and is often inadequate.

Dr Holmes also explained how in comparison to the appraisal of baricitinib for atopic dermatitis, as baricitinib is the first in class technology to treat alopecia areata, there are no direct comparators to assist in assessing cost effectiveness.

Dr Asfour echoed this by describing those with severe alopecia areata as being penalised in the evaluation process due to lack of authorised comparators (in comparison with the relatively costly JAK inhibitors as comparators for treating psoriasis, for example).

Alopecia UK CEO Sue Schilling said:

“I am extremely frustrated that the committee acknowledge the challenges faced by those with alopecia areata but are unable to adopt a fit for purpose process, to ensure that this first licensed treatment is available to those who need it.

I had hoped that sense would prevail and that the appeal panel would consider alopecia areata as they would similar, non-life threatening, chronic lifelong dermatological conditions, such as atopic dermatitis (eczema) and psoriasis, I mention these two conditions as both have licenced medicines approved for routine commissioning by the NHS by NICE review, including baricitinib for atopic dermatitis. 

At Alopecia UK, a patient group, the health economics seems to be a game to us where the company comes in with a good cost effectiveness score and then the External Assessment Group (EAG) demonstrate why it’s not cost effective, and the two argue over the ‘fiction’ to be used in the calculation.

There are other JAK inhibitors in the pipeline. Hair loss researchers and pharmaceutical partners must now work together to overcome the challenges and evidence how new treatments improve quality of life, with the NICE feedback in mind. And we want to work alongside to support those efforts where we can.  If the sector cannot overcome these challenges, sadly, I fear we will see the same crushing outcome again.”

Although our appeal has been dismissed, and there is no possibility of a future appeal against this decision, we remain hopeful that Lilly will be able to do more to get a different outcome in the future.  Ultimately, it is up to them as the drug manufacturer to do the work required so that baricitinib is offered by the NHS. 

We call upon Lilly to revisit the submission, to provide the data that NICE need to demonstrate that baricitinib could improve the lives of some people affected by severe alopecia areata. We also call upon NICE to explore how alopecia areata is assessed and measured, to understand it more, and to move away from using EQ-5D for this condition, as it is not a representative tool.

Alopecia UK does not have the resources to pursue a High Court judicial review, and it is our opinion that the High Court would seek the same evidence that NICE was looking for from Lilly. This would therefore not be a prudent use of charity funds.

We know many of you will feel the same emotions that we are feeling today regarding this decision. We remain hopeful that there will be a different decision made at some point in the future for baricitinib and other JAK inhibitors which will follow a similar process.

We wish to acknowledge that when NICE guidance does not recommend a treatment, this is not the same as a ban on that treatment being provided by the NHS. If, having considered the guidance, a health professional considers that the treatment or procedure would be the appropriate options in a given case, there is no legal bar on the doctor recommending the treatment or on the NHS funding it.

Alopecia UK will continue to advocate for new treatment options to be made available. Although we are feeling let down by the NICE decision, we remain proud that we did the work to form an appeal. We were the only organisation to do so.  Alopecia UK may be a small charity but we believe our work to advocate for both fair treatment pathways, and for living well with alopecia, is vital.

We would like to take this opportunity to thank our trustee, Lynn, and volunteer, Emily, who not only volunteered their time to be part of this appeal, but also put so much of their personal experience and energy into this, which we know can have an emotional toll. Thanks also to Dr Susan Holmes and Dr Leila Asfour for supporting our appeal and putting forward the clinical perspective

You can read the full publication of the NICE Appeal Hearing here. 

Update - 7 November 2023 - Statement Received from Lilly

"Lilly shares the frustration and disappointment felt by Alopecia UK and people affected by NICE's decision not to provide reimbursement for this medicine, which is already deemed to be cost effective in other indications.

NICE did not fully agree with Lilly’s assessment of the impact baricitinib could have on health-related quality of life, or the current composition of best supportive care for people living with severe alopecia areata. As for any first-in-class medicine authorised in a specific indication, it is difficult to assess the true value for the NHS and patients, when there is no authorised alternative treatment from which to calculate the incremental value. At this time, NICE have deemed that baricitinib is not cost effective in this indication. In our view, collecting additional data would not provide the certainty they require to fundamentally change their decision."

Baricitinib petition

Dr Jemma Boyle set up a petition which needed 10,000 signatures by the 30th November 2023 in order to get a response from the Government. Jemma's petition received the necessary number to receive a response but sadly the Government response does not change anything. Their response begins with: "Decisions on medicines funding are rightly taken by NICE based on the available evidence. NICE was unable to recommend baricitinib as cost effective at the price proposed by the company." Read the Government response in full here.