Research Research Home Research Aims Funded Projects Participate in Research Lay Research Panel Research Committee For Researchers Blogs JAKs - Where are we now and where might we be heading? October 2022 Janus Kinase Inhibitors (JAK inhibitors) are a hot topic within our community peer support spaces, as well as making their way into national media headlines. Our staff team is continuing to field questions via email and phone, so we wanted to provide an update regarding the current position re JAK inhibitor drugs as a potential treatment for alopecia areata. Rather than explaining again at length what JAK inhibitors are, we recommend having a read of our blog from 2021 which provides an explanation of JAK inhibitors and why they are being considered as a treatment option for alopecia areata here. What is the position with any approval of JAK inhibitors for the treatment of alopecia areata? The US Food and Drug Administration (FDA) approved a JAK inhibitor called ‘baricitinib’ for the treatment of alopecia areata in June 2022. You can read our commentary from that time here. In addition, in September 2022 the FDA accepted a New Drug Application for a JAK inhibitor called ‘ritlecitinib’ for adults and adolescents 12 years and older with alopecia areata. The FDA decision is expected by mid-2023. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Olumiant (baricitinib) for the treatment of alopecia areata in October 2022. The MHRA authorisation determines that a product is safe and effective. However, in the UK for drugs to be purchased & supplied by the NHS, they need to be approved by the National Institute for Health Care and Excellence (NICE). This requires a consultation process. What is happening with the NICE consultation processes, and can I get involved? Alopecia UK will be representing the patient voice at the NICE appraisals for the JAK inhibitor drugs - baricitinib (Eli Lilly) and ritlecitinib (Pfizer). This involves attending facilitated NICE meetings and completing written submissions for committee meetings. We have shared a lot of information on the debilitating psychosocial and economic impact, and inconsistent care practices within the NHS. Where available, we’ve quoted academic papers to underpin the credibility of our opinion. Our CEO Sue Schilling will be attending the appraisal committee meetings to represent the patient voice. Based on the research we have seen to date, and an unmet need in the NHS (no on-label JAK product for alopecia), our strong view is that these much-needed treatments will improve the quality of life for those that want to take them. One of our Trustees, Lynn Wilks, is working on gathering feedback from those people who are already taking baricitinib and ritlecitinib (prescribed from clinical trials or privately) to support our preparation for this meeting. Are you currently taking a JAK Inhibitor? Or perhaps you have experience of them in the past? If you would be happy to have a chat and provide feedback to Lynn, please email [email protected] with your preferred contact details and a brief summary of your experience with JAKs. Please note, depending on how many people get in touch, Lynn may not be able to contact each person who volunteers to share their experience with JAK inhibitors. There are currently no other opportunities for patients with alopecia to be involved in this consultation process but please be assured that Alopecia UK is representing those within the alopecia community who are keen to see JAK inhibitor drugs available for the treatment of alopecia areata. Is there a target date for when NICE will make their decision on these JAK inhibitors? Regarding the timeline, it is led by the timings set by both the MHRA (Medicines & Healthcare products Regulatory Agency), who will decide if it is safe to use, and then NICE who will decide if it is good value for money within the NHS. These two central processes run concurrently, with MHRA approval being conditional for the decision at NICE. In the 4 nations of the UK the process differs slightly. What we have described here is for England. We hope to be involved in the process with the relevant bodies in the rest of the UK in the future. MHRA approval was given for baricitinib on 3rd October 2022. The expected date for NICE to publish their advice on this drug as a treatment for alopecia areata is 25th April 2023. You can follow progress here. MHRA have yet to give their approval for ritlecitinib, with this likely to take place in mid-2023. The expected date for NICE to publish their advice on this drug as a treatment for alopecia areata is 13th September 2023. You can follow progress here. We do not understand any of the above dates to be set in stone and they could be earlier or later depending on the efficacy of the trials and the evidence that the pharmaceutical companies present to NICE. If a JAK inhibitor is approved by NICE, there is still more time to wait. Each NHS England Trust will make its own decision about what to offer in its area and how much of its budget to spend on These treatments, in line with the care pathway. This is true of every single medicine and treatment and is the reason that nationally we talk about inequality and a postcode lottery in healthcare in England. We are told that each NHS Trust can take months to make their mind up. Sadly, this suggests that even if JAK inhibitors are approved there will still be work to do, and this will be an important time for people like you to raise your voice in your local Trust with your Patient Advice and Liaison Service (PALS) teams. Can I join a JAK inhibitors clinical trial? From time to time, Alopecia UK is asked to help researchers recruit for trials. At present, no one is engaging us to promote new, or ongoing JAK inhibitor trials. We understand that the current clinical trials have recruited the patients they need. If Alopecia UK is made aware of any new opportunities, we will share details to those registered to hear about ‘Research Opportunities’. Sign up here. If JAK inhibitors are approved by NICE for the treatment of alopecia areata, will every patient with the condition be able to access these treatments? No, JAK inhibitors will not be offered to every patient with alopecia areata if approved by NICE. As mentioned, individual NHS Trusts decide what to offer and how much of its budget to spend on every drug/treatment. Also, baricitinib is under consultation for the treatment of severe alopecia areata in adults and ritlecitinib is under consultation for the treatment of moderate to severe alopecia areata in people aged 12 years and over. It is unlikely that it will be offered to patients with small patches of alopecia areata. We are unclear at this point what the criteria will be in terms of what is determined ‘severe’ or ‘moderate’ hair loss. Whilst we remain hopeful that NICE will approve these JAK inhibitor drugs as treatments for alopecia areata, there is no guarantee this will happen or will lead to them being offered via the NHS. We hope this will be the case, but currently we do not know what will happen. It is a case of waiting to see what the outcome is in 2023. Another point to note is that we do not expect that the NHS will adopt JAK inhibitors as a first-line treatment for alopecia areata. We expect that patients will be expected to try other treatments prior to embarking on JAKs. This is what is seen with other medical conditions that have JAK inhibitor drugs as a treatment option. Can I access JAK inhibitors privately? Yes, we are already aware of people with alopecia areata who are accessing JAK inhibitor drugs via private dermatologists. We understand the cost in the UK to be in the region of £1,000 a month. Some patients are purchasing JAK inhibitor from overseas pharmacies for a lower cost. We cannot emphasise enough the importance of ensuring you only take JAK inhibitor drugs under the close supervision of a UK-registered doctor. These drugs have possible side effects, and it is crucial that your health is monitored to ensure your safety. Managing expectations As a small charity in touch with thousands of people affected by this condition, we know that from some people in the alopecia community there is a real excitement for these drugs to be made available. As such, we recognise some of what is included in this update is not what many people with alopecia areata want to hear. As an alopecia charity, with a team made up of some people with alopecia areata themselves, we are also enthusiastic for there at last to be treatment options that are approved for the treatment of alopecia areata. It will be the first time we have treatments that have officially gone through rigid clinical trials and specifically approved for our condition. But there have been many media headlines suggesting that these drugs will be a cure for alopecia areata and we need everyone to understand that this is not the case. We hope JAK inhibitor drugs, including baricitinib, ritlecitinib and any others that might be approved, will be treatment options. However, we know that whilst the clinical trials show success for some of those taking part, there are still plenty of trial participants that did not get the desired results. It is important that anyone embarking on these treatments, goes in with open eyes and realistic expectations. Whilst these JAK inhibitor drugs are a giant leap forward in the treatment of alopecia areata, they do not represent the cure that many are hoping for. We hope to hear good news in 2023 regarding NICE and NHS approval of these drugs for the treatment of alopecia areata but, right now, we do not know what the outcome will be.