Advice - Reimburse voclosporin (Lupkynis®) for the treatment of rare kidney inflammation (lupus nephritis)

The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse voclosporin (Lupkynis®) from the basic health care package. This medicinal product can be used in certain patients with rare kidney inflammation. If the Minister adopts our advice, voclosporin will be entered into the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the health care insurer's basic health care package. We do recommend additional conditions for reimbursement. 

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 this medicinal product from the basic health care package.

Voclosporin is intended for certain people with kidney inflammation

Voclosporin is the active substance. The brand name is Lupkynis®. The medicinal product is a capsule that you swallow. Voclosporin is used in combination with mycophenolate mofetil (MMF). Treatment with voclosporin becomes an option if previous treatment with other medicinal products was not effective. These are MMF, prednisone or cyclophosphamide.

The medicinal product can be used for people with lupus nephritis. This is the medical term for a rare kidney inflammation. This inflammation is caused by the autoimmune disease systemic lupus erythematosus (SLE). In this autoimmune disease, the body's immune cells are responsible for damaging various organs. When these immune cells damage the kidneys, it is known as lupus nephritis.

Advice from the National Health Care Institute on reimbursement of voclosporin

The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse voclosporin (Lupkynis®) from the basic health care package under certain conditions. The recommendation is to include the medicinal product in List 1B of the GVS. Certain additional conditions, the so-called List 2 conditions, apply for Lupkynis®.

For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of extramural drugs (GVS)’.

Conditions for reimbursement of voclosporin

The following conditions apply for reimbursement. 

The National Health Care Institute advises to include voclosporin in List 1B and List 2 in the GVS, provided that the (net) price of a treatment with voclosporin does not exceed that of a treatment with tacrolimus. 

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, personal expenses or whether you should pay a contribution, you could 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.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.