Resmetirom in Poland: How to get it before it’s available

According to the Polish Society of Hepatology, up to 6 million people in Poland may be suffering from fatty liver disease ¹. Most commonly, the condition is related to an unhealthy lifestyle and an inappropriate diet.

Until recently, there was no specific medicine for the treatment of fatty liver associated with metabolic disease (MASH/NASH) - especially for patients with liver fibrosis (scarring). However, in 2024, Rezdiffra (resmetirom) was approved in the USA as the first treatment for the condition.

What do approvals in the USA mean to patients in Poland? Here's what you should know about the availability of resmetirom in Poland.

What is resmetirom used for?

Rezdiffra (resmetirom) is a daily pill indicated for the treatment of nonalcoholic steatohepatitis (NASH) in patients with moderate to advanced liver scarring (fibrosis). NASH is since recently referred to as metabolic dysfunction-associated steatohepatitis (MASH). Rezdiffra is not applicable for patients with cirrhosis of the liver ².

How does resmetirom work for fatty liver disease?

De manier waarop Rezdiffra werkt is door het activeren van een schildklierhormoonreceptor die de ophoping van vet in de lever ² vermindert.

In a recent Phase 3 trial, resmetirom helped resolve NASH in about 26% of patients at a lower dose and 30% at a higher dose, compared to just 10% in those who received a placebo. It also improved liver scarring by at least one stage in 24% to 26% of patients, versus 14% with placebo ².

Where is resmetirom approved?

As of February 2025, Rezdiffra (resmetirom) only has an accelerated approval in the USA ³. In Europe, the medicine has been under review by the EMA since February 2024. However, as of February 2025, no decision has been made.

When will resmetirom be available in Europe (and Poland)?

Typically, EMA approval decisions take up to 210 days. However, in resmetirom's case, the process has stretched beyond this timeline. While it seems likely that Rezdiffra (resmetirom) will get EMA approval within 2025, it's difficult to provide a more specific timeline.

After resmetirom gets approved in Europe, it will not be immediately available in Poland yet. The local process of price negotiation, reimbursement decisions, and tenders (if applicable) takes on average 844 days in Poland.

Therefore, resmetirom will likely only be available in Poland around 2027.

Can doctors in Poland already prescribe Rezdiffra?

Technically, yes. Your treating doctor in Poland could make the decision to prescribe resmetirom on the basis of existing clinical trial results. Or, following a consultation with other doctors (i.e. in the USA) who have used the medicine in their clinical practice.

And if you're wondering what the use of a prescription is, if resmetirom is not available in Poland, here's what you should know - with a prescription, you can get the medicine right away.

How to get resmetirom in Poland before it's available

If you or a loved one are suffering from NASH/MASH and your doctor prescribes Rezdiffra (resmetirom), you don’t have to wait for regulatory approval in Poland. You can access it right away, thanks to a regulation known as Named Patient Import.

Order resmetirom for personal use

If your prescribed treatment with Rezdiffra (resmetirom) cannot wait, you are allowed to import the medicine from abroad for personal use. This process is called Named Patient Import. In order to get resmetirom in Poland via this route, you need a prescription from your doctor.

Already have a prescription? Share it with our expert Medicine Access team. We'll help you get Rezdiffra in Poland right away.

Referenties:

1. Choruje już sześć milionów Polaków. To obecnie największy problem hepatologiczny świata.  WP abcZdrowie, 26 March 2024.
2. MACMILLAN, CARRIE. FDA Approves Rezdiffra, the First Drug for NASH, a Form of Fatty Liver Disease. Yale Medicine, 24 March 2024.
3. FDA keurt eerste behandeling goed voor patiënten met leverlittekens als gevolg van leververvetting. FDA, 14 maart 2024.