**Disclaimer – this blog article represents my own personal opinions and views and should not be interpreted as medical advice. Please consult your GP or Dermatology specialist for any personal medical advice regarding your hair loss.
Thursday 22nd February 2024 (incidentally 22/2 for anyone sharing my similar penchant for angel numbers) is a day that will be engrained in my memory forever. And here is why.
I woke up to an Instagram message from one of my wonderful fellow alopecians sending a link to an Alopecia UK Press Release for the approval of Ritlecitinib (Pfizer brand name LITFULO). Immediately, I felt the adrenaline kick-in, and my brain turned to mush. I could NOT believe what I was seeing. The flood gates opened, and I cried tears containing a tangle of happiness, relief, and utter disbelief.
So WHY is this news such a monumental moment for the Alopecia community?
1. JAK inhibitors are the first licensed treatments for severe Alopecia Areata
Let’s rewind back to October 2022. Prior to this, there were NO licensed treatments for Alopecia Areata. There were treatment options that many of us might have tried, for example, steroid creams, steroid injections, and more traditional immunosuppressant medications such as methotrexate, ciclosporin and azathioprine. However, these medications do not have a solid evidence base (e.g., medical trial results) for use in Alopecia Areata.
Put simply this means that, prior to JAK inhibitors, there were no treatments specifically for Alopecia Areata.
In October 2022, Baricitinib (commonly recognised through the Eli Lilly brand name Olumiant) became the FIRST licensed treatment for severe Alopecia Areata. This was a hugely pivotal moment because it meant that for the first time ever there was a medication that could be specifically used for severe Alopecia Areata. Beyond that, it was a medication that had been through formal medical trials with promising results.
Having had Alopecia Areata since I was 10 years old, news of these medications marked a HUGE moment for me. Living with a condition that affects you in such a profound way every single day and knowing that there aren’t any effective treatments available is really difficult to come to terms with. These medications brought me the hope I had been desperate to have for decades of my life.
2. Baricitinib was licensed in 2022 but did NOT get approved for NHS use.
The licensing of Baricitinib did not automatically mean that it was going to be available on the NHS.
Let’s break down what this meant:
LICENSING = this is granted by a regulatory authority e.g.,
o Medicines and Healthcare products Regulatory Agency (MHRA)
o European Medicines Agency (EMA)
o U.S. Food and Drug Administration (FDA)
What is the licensing process? This means that the regulatory authority has reviewed the clinical research (e.g., medical trial results) to ensure that the drug is effective, safe, and meets manufacturing quality standards.
In the UK, the MHRA licenses treatments for England, Scotland, and Wales. The EMA licenses treatments for Northern Ireland.
What does it mean when a treatment is licensed? Once a marketing authorisation or license has been given, the treatment can be sold by the licence holder in the particular regions covered by the regulatory authority that gave the licence.
This meant that although Baricitinib was “licensed” it had to now be “approved” for use on the NHS.
To break down the approvals process:
If a drug is licensed, why is it not immediately available on the NHS?
Once a new medicine has been licensed, it has to be reviewed by the bodies that decide whether it is a cost-effective treatment to provide on the NHS.
Who are these bodies?
o ENGLAND = National Institute for Health & Care Excellence (NICE)
o WALES = NICE and All Wales Medicine Strategy Group (AWMSG)
o SCOTLAND = Scottish Medicines Consortium (SCM)
o NORTHERN IRELAND = Department of Health (DoH)
In February 2023, Baricitinib was not recommended for routine commissioning in NHS England.
In August 2023, the SCM followed suit and also did not recommend Baricitinib for use within NHS Scotland.
Despite being licensed, Baricitinib was not able to get approval for routine commissioning on the NHS and this was confirmed in August 2023.
3. Lack of availability of medications for severe Alopecia Areata via the NHS generates significant inequity in care.
Practically speaking, this meant that until Baricitinib had this approval it could only be obtained via a private prescription, rather than being available through standard NHS routes.
Trying to obtain Baricitinib through the private route has significant financial implications. In my personal experience, the costs I was quoted for obtaining this medication via private prescription varied from around £450 up to around £1,300 per month depending on where it was sourced from.
In addition to this, there are the added costs of seeking private healthcare e.g., paying for private dermatology appointments, getting the tests done that are required before you start this medication, and paying for blood tests every 3 months to monitor you whilst you are on the medication.
Clearly, this is not a feasible option for everyone and generates a huge disparity in care. On top of this, due to the lack of NHS approval, dermatologists are not obliged to consider prescribing this medication.
4. A further appeal for Baricitinib to be approved for use in NHS England was also dismissed.
In October 2023, an appeals process for Baricitinib was also rejected. This was incredibly frustrating for a whole plethora of reasons but namely:
1. For the first time there was a licensed treatment, but not everyone could access it.
2. This medication was already available on the NHS for other medical conditions including eczema and rheumatoid arthritis.
3. The discrepancy between being told this medication is not deemed “cost-effective” but knowing with every ounce of my being how life-changing this medication could be for many people, including myself.
5. Ritlecitinib (brand name LITFULO) was the second JAK inhibitor licensed for severe Alopecia Areata but also initially did NOT get NHS England approval.
In November 2023, NICE made a draft decision to not approve Ritlecitinib for routine NHS use.
Personally, this draft rejection of Ritlecitinib felt worse than that for Baricitinib, and this is why:
1. This was now the second medication that had not been approved.
2. Ritlecitinib is the FIRST treatment that is solely designed for severe Alopecia Areata and not used for any other medical conditions, so it felt more personal.
3. Ritlecitinib is the FIRST treatment to be licensed for younger people with severe Alopecia Areata. This means that the medication has been deemed safe for use in those aged 12 years and over.
Thursday 22nd February 2024
Yesterday, the news broke that Ritlecitinib has (finally) been recommended for routine commissioning on the NHS. This marked a monumental moment for the alopecia community because, as detailed above, this has been anything but an easy process.
For some reason, it can feel like every aspect of living with Alopecia Areata is a constant fight. And, for me, this represents what I hope is the first of many wins for our community. I am not naïve enough to think that this is the end of the fight as there remain a huge number of issues with our care processes and I suspect that approval of this medication may actually end up highlighting these issues more clearly. But, for now… we should relish in this moment because it is a gigantic push forwards for our community.
Finally, I would like to thank every single person who has worked tirelessly for this cause and, in particular, Alopecia UK who have advocated and fought for us to be heard.
There is a huge amount to unpick with this latest news and I will be writing some further blog posts exploring this. Follow me on Instagram and/or subscribe to my Blog to keep up to date.
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