News & Events FDA Approves Baricitinib for Adults with Severe Alopecia Areata Yesterday (14 June 2022) history was made as the US Food and Drug Administration (FDA) approved a drug called baricitinib (brand name Olumiant™) for the treatment of alopecia areata, marking the first FDA-approved treatment for the condition. The news follows years of clinical trials of a class of medications called Janus kinase (JAK) inhibitors. It is anticipated that more treatment options are still to come, with baricitinib being one of a number of JAKs being trialled. The news of the FDA-approval was met with excitement in the press, on social media and in our private Facebook group, raising questions as to what it means for those in the UK. For drugs to be approved for use in the UK by the NHS, they need to be approved by the National Institute for Health and Care Excellence (NICE). The expected date for NICE to publish their advice on this drug as a treatment for Alopecia UK is 25 April 2023 – we do not understand this date to be set in stone and could be earlier or later. Alopecia UK is a stakeholder in the NICE consultation and has already attended scoping meetings. We are not permitted to discuss the specific details of the meetings but can assure our community that we are actively explaining the importance and urgency of new treatment options for alopecia areata. It is the pharmaceutical company, in this case Eli Lilly, who kick-start a process for NICE’s consideration- this is called the technology appraisal. NICE can only work as fast as the applications and UK-led clinical trial results come in. NICE then make a recommendation based upon the clinical evidence of how well the treatment works, and also the economics – does it represent good value for money. Alopecia UK are not a decision-maker in whether NICE approve baricitinib for the treatment for alopecia areata. Alopecia UK does not have a vote on whether JAKs will be offered as an NHS treatment. However, NICE are listening to Alopecia UK’s ‘patient voice’ and are taking seriously our advocacy for the importance of wider treatment options, but they will need to consider many factors outside of our control in their decision-making. The fact that baricitinib is approved by NICE for the treatment of severe rheumatoid arthritis and atopic dermatitis gives us hope that, if the clinical trials demonstrate efficacy for alopecia areata, it will be approved for alopecia areata. Alopecia UK’s CEO Sue Schilling says: “It is exciting to think that the current UK clinical trials may lead to further treatment options being offered to those struggling with alopecia areata. We will continue to ensure our voice is heard where appropriate and will try to demonstrate the psychological, social and financial impacts that alopecia areata can have to a person’s life to emphasise the importance of having access to treatments.” We want to end our update with some words of caution to anyone who may be considering accessing these drugs from anyone other than a registered UK doctor. We know some in the alopecia community are purchasing JAK inhibitor drugs from overseas pharmacies for a lower cost than can be found if purchasing from a private dermatologist*. We strongly urge that JAK inhibitor drugs are only taken under the strict supervision of a UK dermatologist. Without supervision from a clinician, there can be risks to health. *Some patients are being treated by private dermatologists on baricitinib ‘off-label’ i.e. without it having been approved by NICE. We understand the private cost of this to be in the region of £1,000 a month. We know other patients have sourced the drugs cheaper abroad and are under the supervision of a UK dermatologist to ensure their health is monitored.