The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) not to change the reimbursement conditions for ofatumumab (Kesimpta®). This medicinal product can be used to treat adult patients with relapsing forms of multiple sclerosis (RMS). Ofatumumab is already in the Medicine Reimbursement System (GVS) and is reimbursed from the basic healthcare package. It is listed on List 1A of the GVS, in a cluster together with natalizumab (Tysabri®). Additional conditions apply for reimbursement. Medicinal products listed on List 1A have a reimbursement limit. Medicinal products listed on List 1B do not have a limit. The National Health Care Institute recommends keeping ofatumumab in the cluster on List 1A with the existing reimbursement conditions.
Current state of affairs: advisory report sent to the minister
The National Health Care Institute has sent this advisory report to the Minister of VWS. The Minister makes the final decision whether or not to move the medicinal product from List 1A to List 1B of the GVS.
Reason: request from marketing authorisation holder to place ofatumumab on List 1B
The marketing registration holder of the medicinal product has requested that ofatumumab be relisted on List 1B based on new research. According to the marketing authorisation holder, this new information would indicate that ofatumumab (Kesimpta®) is no longer interchangeable with natalizumab (Tysabri®).
Ofatumumab is intended for adults with relapsing multiple sclerosis (RMS)
Ofatumumab is the active substance. The brand name is Kesimpta®. The medicinal product is an injection under the skin that you can give yourself with a pre-filled pen or syringe.
Multiple sclerosis (MS) is a condition in the brain and spinal cord in which the body’s own immune system attacks certain nerve cells. This causes inflammation in different locations. People with MS can get all kinds of symptoms, such as problems with movement, talking, vision, concentration and memory. The symptoms vary from person to person.
The medicinal product can be used in people with active relapsing multiple sclerosis (RMS). Relapsing means that patients have periods of inflammatory attacks.
The National Health Care Institute advice on reimbursement conditions for ofatumumab (Kesimpta®)
The National Health Care Institute advises the Minister of VWS to keep ofatumumab (Kesimpta®) in the cluster on List 1A with the existing reimbursement conditions. These are the so-called List 2 conditions. The National Health Care Institute concludes that ofatumumab is interchangeable with the medicinal product natalizumab, also an injection. Therefore, both medicinal products can remain together in a cluster on List 1A. The additional data submitted by the marketing authorisation holder does not sufficiently show that the medicinal products are different.
For more information on the GVS and lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines’.
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 Minister of VWS asks the National Health Care Institute to make an assessment. The Minister makes the final decision whether or not to move the medicinal product.
Explanation about the reimbursement of medicinal products
Ofatumumab is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.