Can I get lecanemab in the UK? MHRA approval timelines and how to avoid waiting.
Last updated: 28 August 2024
You can legally access new medicines, even if they are not approved in your country.
Learn howSince its first global approval in 2023, Leqembi (lecanemab) has received a lot of attention from Alzheimer's specialists and patients alike. Although not yet a cure for Alzheimer's disease, Leqembi has been the first medicine to show evidence of slowing down cognitive decline 1. For patients with early stage Alzheimer's, any extension in the time they can live independently can be a win.
However, Leqembi is still awaiting EMA approval, which has dampened the initial excitement surrounding its launch. Luckily, since August 2024, lecanemab is now approved in the UK.
What does that mean for Alzheimer's patients in the UK? Find out when Leqembi will be available to you and where you can get Leqembi earlier.
Why did it take so long for lecanemab to be approved in the UK?
Simply, the MHRA and NICE needed more time to make a decision on Leqembi's marketing authorization application, which was submitted in May 2023 2.
When considering approval for a medicine such as Leqembi, multiple practical factors come into play, beyond clinical benefits. For example, patients require close monitoring, as well as regular infusions by a medical professional - at least until Leqembi can be administered at home. These are resource requirements that may put additional strain on the already short-staffed NHS.
The MHRA had included Leqembi in its Innovative Licensing and Access Pathway. The pathway is intended to fast-track the time to market for innovative medicines 3. Possibly, this helped Alzheimer's patients in the UK access Leqembi sooner than patients acoss the EU, where Leqembi has not been authorized yet.
When will Leqembi be available in the UK?
Now that the MHRA has approved lecanemab, it should be available to UK patients soon.
However, as of August 2024, there is no decision by NICE on incliding lecanemab on the NHS. A review by NICE is already underway, with an expected draft guidance publication date in mid-September 2024 5.
If NICE gives its green light, it's possible that Leqembi will be available on the NHS at the beginning of 2025.
Can doctors in the UK already prescribe Leqembi (lecanemab)?
Yes. Even though Leqembi is not yet available on the NHS, your treating doctor has the authority to prescribe it to you. However, it may be a bit more challenging to fill the prescription since it typically takes some time between the date of marketing authorization and the date when the medicine is available in the pharmacy network. Also, for the time being, you would need to cover the medicine costs out of pocket.
Where can I get Leqembi in the UK?
You should ideally be able to get Leqembi from any pharmacy in the UK, as long as you have a prescription. However, in practice it can take some time until an approved medicine is available to patients. If you find yourself in this grey area of time, don't worry. Thanks to the Named Patient Import regulation, patients can import locally unavailable medicines for their personal use, as long as they have a doctor's prescription.
This means that you don't have to wait the NICE appraisal or for lecanemab to be made available acoss the UK in order to start your treatment. All you need is your doctor's support.
How much is Leqembi out of pocket?
To give you an idea of Leqembi costs without NHS coverage, a single-dose vial (200 mg/2 mL) costs around GBP 893. Typically, you would require two vials per month, unless otherwise prescribed by your doctor. Assuming that NICE will recommend lecanemab for NHS coverage, you will hopefully only need to finance the few months of treatment until then.
In addition to the medicine costs, you should keep in mind that shipping or importation costs may also apply, as Leqembi is currently not available from suppliers in Europe.
Have you and your doctor discussed Leqembi and are you looking to start your treatment as soon as possible? Send your prescription to our team at Everyone.org and we will help you buy lecanemab in the UK at the time when you need it - now.
References:
- Gray, Afsaneh. Would UK approval of lecanemab be a game changer for people with Alzheimer's disease? The Pharmaceutical Journal, 20 July 2023.
- Pearce, Naomi, and Sian Hope. Eisai submits MAA in UK for LEQEMBI® (lecanemab) for early Alzheimer's. Lexology, 21 May 2023.
- MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease, Pharmaceutical Technology, 6 April 2023.
- UK marketing authorisation. Stevens & Bolton LLP, 18 August 2023.
- Project information | Lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease [ID4043] | Guidance. NICE, Accessed 23 January 2024.