The National Health Care Institute has advised the minister of Health, Welfare and Sport (VWS) not to reimburse setmelanotide (Imcivree®) for certain patients with obesity due to Bardet-Biedl syndrome. It has not been demonstrated that this medicinal product has an added value for this patient group.
Current state of affairs: advisory report 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 healthcare package.
Setmelanotide is intended for certain patients with obesity caused by Bardet-Biedl syndrome
Setmelanotide is the active substance. The brand name is Imcivree®. The medicinal product is a subcutaneous injection.
The medicine can be used in people with obesity due to Bardet-Biedl syndrome. Obesity is another word for being severely overweight. Bardet-Biedl syndrome is a rare hereditary disorder. Patients with Bardet-Biedl syndrome are often overweight due to increased hunger sensation. They also have an increased risk of becoming blind. The marketing authorisation holder has requested reimbursement for the treatment of patients with obesity due to Bardet-Biedl syndrome.
National Health Care Institute advice on setmelanotide reimbursement
The National Health Care Institute advises the Minister of VWS not to expand the reimbursement conditions of setmelanotide (Imcivree®) and thus not to reimburse the medicinal product for certain patients with obesity due to Bardet-Biedl syndrome. The medicine is currently only included in the Medicine Reimbursement System (GVS) for a specific patient group.
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 about the assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Setmelanotide is an extramural medicinal product. Extramural means: medicines for home use that can be obtained at the pharmacy with the prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.