Alzheimer's drugs approved in the EU - A new world opens up for future dementia care

On April 16, the European Commission approved the antibody treatment developed in Sweden by Professor Lars Lannfelt and his research team, which is already in use in the United States, Japan, South Korea, Israel and the United Arab Emirates.

This is a so-called 'brake' medicine that slows down the disease process, but it should be noted that it will take time to reach Sweden and is not suitable for everyone. It will therefore initially be offered to a limited group of patients at an early stage of the disease.

The major focus in the coming years will therefore be, among other things, to learn how to identify those suffering from the early stages of Alzheimer's disease, preferably those who have not even started to show symptoms.

In addition, in a first phase, the medicine will NOT be offered to those who have two copies of the ApoE epsilon 4 variant as this combination has been shown to significantly increase the risk of serious side effects.

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When will the medicine be available?

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It will probably be a couple of years before Leqembi, as the medicine is called, can be used in Swedish healthcare.

The reason is that the process takes several steps:

1. Sweden's council for new therapies, the NT Council, has agreed that Leqembi will be introduced in healthcare through so-called nationally organized introduction. The purpose of such an introduction is to make the use of Leqembi as value-creating and equal as possible across the country.
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2. An initial step in this process is for the NT Council to commission a health economic assessment from the Dental and Pharmaceutical Benefits Agency (TLV).
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3. The health economic assessment - once in place - is then used as the basis for negotiations on the pricing of the drug in Sweden.
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4. Once negotiations are complete, the NT Council makes a balanced assessment and formulates a recommendation to the regions on the use of the medicine.

Issues to be resolved:
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The approval is a clear milestone in the future treatment of dementia diseases such as Alzheimer's. But several questions remain:

- Which patients should be prioritized for treatment?
- How big should the effect be for that treatment to continue? And for how long?
- How to effectively identify these patients if they are at an early stage of the disease process where symptoms are not always very pronounced?
- How will the healthcare system deal with the increased pressure for early screening and risk assessment that will be required to identify suitable patients for treatment?