Biogen share: Alzheimer’s middle Lecanemab now also in Germany

Austria and Germany are the first EU countries in which the funds distributed under the name Leqembi are available, the pharmaceutical companies involved said Biogen from the USA and Eisai from Japan. The therapy approved after long hesitation can only help a small part of around one million people who are affected by Alzheimer’s in Germany alone. Lecanemab is administered as an intravenous infusion every two weeks.

Admission with restrictions

In April, the EU Commission Lecanemab approved for the treatment of mild cognitive impairment (memory and thinking disorders) in the early stage of Alzheimer’s disease. As an early Alzheimer phase, Johannes Levin from the German Center for Neurodegenerative Diseases (Dzne) must be evaluated for the first three years. In Germany, this probably affects around 250,000 people.

However, there is another restriction: The remedy should only receive those Alzheimer’s patients who have only one or no copy of Apoe4 – a variant of the GES for the protein apolipoprotein E. The likelihood of certain side effects – swelling and bleeding in the brain – is lower than in humans with two apoe4 copies. According to the Dzne, people with only one or no APOE4 copy make up about 80 percent of Alzheimer’s patients in Germany.

High costs – negotiations run

The Eisai company puts the manufacturer’s price at 310 euros per 2-milliliter pack and 615 euros per 5 milliliter pack. According to the Federal Association of German Pharmacists’ Associations (ABDA), the sales price for the small pack is initially 403.27 euros and 788.86 euros for the large pack. For how many infusions the quantities were enough, an Eisai spokesman said.

The ABDA calculates that about 7 milliliters of concentrate – a large and a small pack – would be required for a 70 kilogram person per infusion. According to the manufacturer Eisai, this would amount to medication costs of 24,050 euros per year with regard to the manufacturer’s price.

This coincides with the estimate of the General Secretary of the German Society for Neurology, Peter Berlit, who also expects around 24,000 euros in costs for the medication per year. The cost of testing, carrying out therapy and surveillance could amount to around 10,000 euros.

According to the Alzheimer Research Initiative, the costs are initially covered by the health insurers. At the same time, the Federal Joint Committee will examine the benefits of the funds compared to previous therapies. The result of this exam is the basis for the price negotiations between manufacturers and health insurance companies.

Challenge for the clinics

Before therapy can begin, Alzheimer’s patients must first be demonstrated by biomarker tests, followed by a genetic test on APOE4. The costs for the genetic test are also a cash benefit, since this is an examination mandatory for the treatment, according to Alzheimer’s Research Initiative.

Frank Jessen, director of the Clinic for Psychiatry and Psychotherapy of the University Hospital Cologne and dementia researchers, sees the hospital outpatient clinics “fundamentally well positioned in order to start therapy with Leqembi next week”. In concrete terms, however, this also depends on the capacities of the individual centers – for example in view of personnel, MRI and infusion places.

According to dpa information, the start in some clinics could also be delayed because of the high costs for the clinics that have to shoulder because the price negotiations are still running.

Jessen explains that the costs for the treatment of health insurance patients are usually initially billed via outpatient flat rates that have to be negotiated. “The hospitals now have to find a regulation internally.”

No healing in sight

Previous Alzheimer’s therapies only treat symptoms of the disease, not caused processes in the brain. This is different with Lecanemab: the antibody is directed against amyloid deposits in the brain and is supposed to slow down the course of the disease by a few months. However, this active ingredient is not about healing or improvement, such a means is still not in sight.

Due to the side effects such as swelling and micro bleeding in the brain, Lecanemab was still rejected during a first exam of the EU drug authority EMA. At a new exam, however, the authorities came to the conclusion that the benefits for the aforementioned sub-group of Alzheimer’s patients exceed the risks.

To ensure that only those patients come to the remedy who also have a benefit, there will be an EU-wide register of all patients.

/SWE/DP/ZB

Berlin (dpa-Afx)

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