How to get donanemab in Poland (before it’s approved or available)?

For patients with early-stage Alzheimer's, a number of new treatment options have emerged in the last 5 years - including Aduhelm, Leqembi, and now Kisunla (donanemab).

While patients in the USA, the UK, and other countries, have access to all three medicines, patients in the EU (including Poland) are still in the waiting room ¹. The EMA approval of Leqembi has been in limbo since 2024, and donanemab is still awaiting an approval decision.

Is there a way for Alzheimer's patients in Poland to get donanemab before it's approved by the EMA? Here's what you need to know.

Who should take Kisunla (donanemab)?

It's important to note that Kisunla (donanemab) is not a cure for Alzheimer's. However, it is indicated for patients in the early stage of the disease, and aims to delay its progression. This means that those who have mild cognitive impairment and have just been diagnosed, may be good candidates for treatment with donanemab ².

To be sure that the medicine applies to you, you should always consult with your treating doctor.

How does Kisunla work?

Kisunla (donanemab) is a beta-amyloid-directed antibody. It works by attaching to beta-amyloid proteins in the brain. In this way, it helps the immune system break down beta-amyloid plaques in the brain. Lower levels of beta-amyloid may help slow the progression of Alzheimer's disease ³.

How good is Kisunla (also compared to Leqembi)?

Based on the reported results of the Phase 3 TRAILBLAZER-ALZ 2 study, Kisunla (donanemab) has demonstrated significant efficacy for early symptomatic Alzheimer's disease. 

In the study, donanemab treatment resulted in a 35% slowing of clinical decline compared to placebo, and a 40% reduction in the decline of daily living activities ⁴.

Is Kisunla better than Leqembi?

This is not a straightforward comparison to make. However, one criterion to look at are the clinical trial results. 

• In the Phase 3 Clarity AD trial, Leqembi (lecanemab) achieved a 27% reduction in clinical decline over 18 months. A July 2024 report on the results after 3 years of treatment demonstrated that 51% of patients with no or low tau accumulation showed improvement in cognition and daily functioning ⁵.
• Both treatments have been associated with amyloid-related imaging abnormalities (ARIA), such as brain swelling and bleeding. In the donanemab trial, 24% of participants experienced side effects, including ARIA. Similarly, lecanemab's trial reported ARIA in nearly 13% of participants.
• Regarding administration, donanemab is given via intravenous infusion every four weeks, while lecanemab requires bi-weekly infusions.

Is Kisunla available in Poland?

No. It will only be available in Poland after it gets EMA approval. Even then, the period from EMA approval to local availability can stretch up to 844 days ⁶. 

While this may not sound encouraging, considering the progressive nature of Alzheimer's disease, there is good news. You do not have to wait for donanemab to be approved or available in Poland in order to start your treatment. Here's what you can do. 

How to get donanemab in Poland before it's available

In almost every country in the world, Poland included, patients have the right to buy and import medicines for personal use, if they are not available to them locally. This is called the Named Patient Import regulation. In order to be eligible for it, this is required:

• you have a prescription for a medicine;
• the medicine is for a life-threatening, chronic, or debilitating disease;
• the medicine is not approved or available in your country;
• there are no treatment alternatives available locally.

In other words, if your treating doctor believes that donanemab could benefit your condition, they have the right to prescribe it to you, before it's EMA approved or available in Poland. And with the prescription, you can buy donanemab right away. Our expert team at Everyone.org will help you out in getting the medicine to Poland right away. Simply click the button below to get started. 

Questions about accessing Kisunla (or other Alzheimer's medicines) in Poland? Get in touch. We're here to help. 

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References:

1. Leqembi | European Medicines Agency (EMA). European Medicines Agency, Accessed 4 February 2025.
2. HIGHLIGHTS OF PRESCRIBING INFORMATION. FDA.gov, Accessed 4 February 2025.
3. Kisunla (donanemab-azbt). Medical News Today, Accessed 4 February 2025.
4. Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. Lilly Investors, Accessed 4 February 2025.
5. New Clinical Data Demonstrates Three Years of Continuous Treatment with Dual-Acting LEQEMBI® (lecanemab-irmb) Continues to Significantly Benefit Early Alzheimer's Disease Patients Presented at The Alzheimer's Association International Conference. Biogen | Investor Relations, 30 July 2024.