Can I get lecanemab in the UK? MHRA approval timelines and how to avoid waiting.

Last updated: 23 January 2024

Since 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 and is currently unavailable in the UK, which has dampened the initial excitement surrounding its launch.

What does that mean for Alzheimer's patients in the UK? Find out when Leqembi will be available in the UK, and where you can get Leqembi earlier.

Why is lecanemab not available in the UK?

Simply, the MHRA and NICE have not yet made 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 good news is that the MHRA included Leqembi in its Innovative Licensing and Access Pathway. The pathway is intended to fast-track the time to market for innovative medicines ³. Hopefully, this will help Alzheimer's patients in the UK access Leqembi soon after a positive decision by the MHRA.

When will Leqembi be available in the UK?

Unfortunately, the MHRA has not provided a decision timeline on Leqembi's marketing authorization application. Typically, such decisions can take up to 210 days ⁴. This timeline excludes any pauses taken by the medicine manufacturer to provide additional information or data to the MHRA, if requested.

To be included on the NHS, Leqembi will require not only the MHRA's approval, but also a positive assessment by NICE. A review by NICE is already underway, with an expected decision publication date in mid-July 2024 ⁵.

Assuming both the MHRA and NICE give their green light, it's possible that Leqembi will be available in the UK somewhere in the second half of 2024 or early 2025.

Can doctors in the UK already prescribe Leqembi (lecanemab)?

Technically, yes. Even though Leqembi is not yet approved or available in the UK, your treating doctor has the authority to prescribe it to you. They can do so on the basis of clinical trial results data, as well as the fact that Leqembi is already approved by the FDA in the USA.

But where can you fill a prescription for a medicine that isn't yet approved in the UK? Luckily, there are ways to access Leqembi in the UK before it's locally available.

Where can I get Leqembi in the UK before its MHRA approval?

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 for the MHRA or NICE in order to start your treatment with Leqembi. All you need is your doctor's support.

The downside of importing Leqembi before it's approved in the UK is that you won't be able to benefit from NHS coverage. Instead, you will need to pay for the medicine out of pocket.

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.

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.