Belzutifan approval in the UK & Ireland: What's the status and what does it mean for you?
Last updated: 15 January 2024
You can legally access new medicines, even if they are not approved in your country.
Learn more »Belzutifan (commercially sold as Welireg) was first approved by the FDA in the USA in 2021 1. Until today, Welireg is still the first and only oral treatment option for adult patients with tumors related to the von Hippel-Lindau (VHL) disease 2.
This is a big milestone for patients with VHL-related tumors anywhere. However, patients in the UK and Ireland, who are eager to start their treatment, may need a bit more patience.
It can still take some time before belzutifan is available on the UK and Irish markets.
Is belzutifan approved in the UK?
Welireg (belzutifan) is approved in the UK as an orphan drug. This means that it's only available for a specific group of patients, and isn't widely available on the market.
Currently, the MHRA has approved belzutifan for the treatment of adults with VHL-associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), for whom localized procedures are unsuitable 3.
Importantly, this indication only applies to patients for whom surgery is considered too dangerous. Use of belzutifan as a way to delay or avoid surgery in patients who don't require surgery yet, is not currently approved in the UK 4.
Is belzutifan approved in Ireland?
With Ireland still in the EU, it remains dependent on the medicine approval processes and timelines of the EMA.
Currently, Welireg (belzutifan) does not have marketing authorization by the EMA. As a result, it is also not approved in Ireland.
Is belzutifan available on the NHS?
Unfortunately, not yet. The MHRA's orphan designation is not equivalent to approval for reimbursement. Such an approval can be granted by NICE (National Institute for Health and Care Excellence).
The NICE's decision on making belzutifan available on the NHS is expected by the end of January, 2024. If positive, the treatment should be made available to patients within 3 months after that.
In the meantime, patients in England may have a small possibility of accessing Welireg (belzutifan) via an individual funding request to the NHS. Please note, however, that according to the VHL UK/Ireland organization, this route is rarely successful 4.
When will belzutifan be available in the UK?
Receiving the MHRA's approval is only the first step of making belzutifan available on the UK market. Before the medicine can be accessible to patients, the NICE's decision on NHS reimbursement needs to be made official. If positive, belzutifan should be made available on the UK market within 3 months.
In other words, the best case scenario for belzutifan's availability in the UK is around May, 2024.
When will belzutifan be available in Ireland?
Market availability in Ireland is likely to be a much slower process than in the UK. The main reason is that belzutifan doesn't have the EMA's marketing authorization yet.
The average time needed from the moment a medicine is approved by the EMA to the moment it's available on the market varies a lot per country. In Ireland, the average time to availability is 661 days 5.
In other words, VHL patients in Ireland may have to wait for years to begin belzutifan treatment.
Or, not necessarily.
What can you do until belzutifan comes to the UK & Ireland markets?
A few months can make a big difference to an oncological patient. The good news is, you don't have to wait.
Are you a VHL patient in the UK or Ireland with RCC, pNET or central nervous system hemangioblastoma? If your doctor thinks Welireg (belzutifan) might help you, you can get it right away through the Named Patient Import rule.
Everyone.org is specialized in helping people access the latest medicines via this regulation. If your doctor prescribed Welireg (belzutifan) and you need help getting the medicine, contact us.
