Advice - Adjustment of reimbursement conditions for lenacapavir (Sunlenca®)
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to adjust the conditions of lenacapavir (Sunlenca®), enabling the use and reimbursement of the combination of lenacapavir and fostemsavir (Rukobia®) from the basic health care package. This treatment can be used in HIV patients who have multiple-drug resistance. Lenacapavir is already included in the Medicines Reimbursement System (GVS) with additional conditions for reimbursement. If the Minister adopts our advice, these reimbursement conditions will be extended.
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 amend the conditions of reimbursement.
Lenacapavir with fostemsavir is intended for HIV patients with very extensive resistance
Lenacapavir is the active substance. The brand name is Sunleca®. This medicinal product can be used in combination with fostemsavir (Rukobia®) in HIV patients who have multiple-drug resistance. These are patients with a very extensive resistance who otherwise cannot be treated.
Advice from the National Health Care Institute on adjustment of the reimbursement conditions for lenacapavir
The National Health Care Institute advises the Minister of Health, Welfare and Sport to adjust the reimbursement conditions for lenacapavir (Sunleca®). These are the so-called List 2 conditions.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of extramural drugs (GVS)’.
Conditions for reimbursement of lenacapavir
Since 22 September 2022, the following conditions for reimbursement apply:
We advise the Minister of Health, Welfare and Sport to adjust the second condition as follows:
Only for an insured person:
- with a multi-drug resistant human immunodeficiency virus-1 (HIV-1) infection who cannot otherwise be treated with a suppressive antiviral regimen,
- who does not use this medicinal product as a pre-exposure prophylaxis to reduce the risk of infection with the human immunodeficiency virus.
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 drug, the personal expenses or whether you should pay a contribution, please visit our information page on personal expenses and contribution. Or 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. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.