When will Opzelura be available in the UK (and what to do in the meantime)?

Last updated: 15 January 2024

After its EMA approval in April 2023, Opzelura (ruxolitinib) was also granted marketing authorization by the MHRA in the UK in July 2023 ^1,2. This was an important milestone in vitiligo treatment, as Opzelura is the first and only approved non-segmental vitiligo medicine for skin repigmentation.

However, patients eager to start treatment with Opzelura in the UK may need a bit more patience. It can still take some time before the medicine is available on the UK market.

Is Opzelura (ruxolitinib) available in the UK?

As of August 2023, Opzelura is approved but not yet available on the UK market.

This is the normal situation with newly approved medicines. From the moment they get the MHRA's approval until the moment a doctor can prescribe them to you, a number of additional steps need to be taken. These include assigning a local distributor, deciding on the price of Opzelura in the UK, and more.

When will Opzelura be on the UK market?

There's no clear timeline for Opzelura's availability on the UK market.

According to the standard medicine approval procedure in the UK, getting the MHRA's green light is only the first step ³. Before Opzelura can be available to prescribe to patients, it needs to also go through these steps:

Initial pricing decisions. After the MHRA’s approval, the medicine's manufacturer, Incyte, has to make a decision on Opzelura's price in the UK.
Decision on NHS availability and funding. As a UK patient, you're likely wondering if Opzelura (ruxolitinib) is available on the NHS. This decision is to be made by the National Institute for Health and Care Excellence (NICE). The decision process is currently underway, and there is no specific timeline for its completion.
Market availability. If NICE approves Opzelura for NHS funding, Opzelura should be made available on the UK market within 3 months of the approval date.

Based on the process outlined here, it may still take a few months before you can access Opzelura in the UK.

Opzelura

What can you do until Opzelura is available in the UK?

If you're a vitiligo patient and your doctor recommends treatment with Opzelura, you're probably wondering about your options. Can you use Jakavi instead of Opzelura in the meantime? Or, should you accept the frustrating wait? The good news is, you don't have to.

When a medicine is unapproved in a patient's country, or it's approved but not yet available (as in Opzelura's case in the UK), you can access it via the Named Patient Import regulation.

Everyone.org is specialized in helping people access the latest medicines via this regulation. If you have a prescription from your treating doctor for Opzelura, you're impatient to start your treatment plan, and would like us to help you access the medicine immediately, contact us.

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