The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) not to reimburse lecanemab (Leqembi ®) from the basic health care package. This medicine can be used for certain patients with early Alzheimer's disease. This is a form of dementia. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. Patients experience too little difference after treatment with the medicine and are at risk of severe adverse effects.
Current state of affairs: advice sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health care package.
Lecanemab is intended for certain people with Alzheimer's disease.
Lecanemab is the active substance. The brand name is Leqembi®. The medicine is an injection that is administered every 2 weeks in the hospital.
The medicine can be used in adult people with early Alzheimer's disease. In Alzheimer's disease, the brain is no longer able to process information properly. That is what we call a cognitive disorder. How they suffer from this varies from patient to patient. Common symptoms are: forgetfulness, confusion about time and place, and difficulty with language and speech. Alzheimer's disease is a progressive disease. Progressive means that the symptoms get increasingly worse.
Alzheimer's disease has different stages: from no symptoms to mild cognitive disorder to, ultimately, dementia. Dementia also has different forms: mild dementia, moderate dementia and severe dementia. If a patient has a mild cognitive disorder and mild dementia, we call it early Alzheimer's disease. This means that patients have difficulty remembering things, but they can still live at home, with the necessary adjustments and support if necessary.
The National Health Care Institute advice on the reimbursement of lecanemab
The National Health Care Institute advises the Minister not to reimburse lecanemab (Leqembi®) from the basic health care package. Research shows that the effect of lecanemab is so limited that patients do not notice sufficient improvement. They are still experiencing significant deterioration in their daily functioning and are at risk of serious side effects, such as brain haemorrhage and brain swelling. Patients often do not notice this, but in some cases, it causes serious symptoms such as paralysis, inability to speak or serious confusion. And in rare cases, the bleeding or swelling of the brain can also be fatal.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) advises the National Health Care Institute when issuing a reimbursement advice. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health care package.
Explanation of lock procedure for expensive medicinal products
The Minister has placed lecanemab for this indication in the lock procedure for expensive medicinal products. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health care package until:
- there is a positive reimbursement advice from the National Health Care Institute;
- there are agreements on appropriateness of use in place;
- price reductions have been successfully negotiated with the marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.