The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse guselkumab (Tremfya®) from the basic healthcare package. This medicinal product can be used in certain patients with ulcerative colitis, a chronic inflammation of the colon. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products’. This is the eleventh medicinal product that the Medicines Evaluation Board (CBG) and the National Health Care Institute have assessed in a parallel procedure.
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.
Guselkumab is intended for certain people with ulcerative colitis
Guselkumab is the active substance. The brand name is Tremfya®. The product is administered in 2 phases. In the first phase it is administered via an IV. In the second phase is done with subcutaneous injections.
The medicinal product can be used in people with moderate to severe active ulcerative colitis. Ulcerative colitis is a chronic inflammation of the colon. Patients may have periods when the disease is more or less active. They may experience diarrhoea, abdominal pain, weight loss and a general feeling of discomfort. If the inflammation does not decrease, it may be necessary to remove parts of the intestine.
The manufacturer has requested reimbursement for adult patients who have responded inadequately to, stopped responding to, or are intolerant to a biological (often a TNF-alpha inhibitor). These patients are unable to control the disease with a TNF-alpha inhibitor.
Advice of the National Health Care Institute on the reimbursement of guselkumab
The National Health Care Institute advises the Minister of VWS to reimburse guselkumab (Tremfya®) from the basic healthcare package. A condition for this is that the medicinal product cannot be more expensive than the standard treatment already being reimbursed.
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 Health, Welfare and Sport (VWS) asks the National Health Care Institute to carry out an assessment. The final decision as to whether or not reimbursement from the basic healthcare package will take place lies with the Minister.
Explanation of the package lock procedure for expensive medicinal products
The minister has placed guselkumab in the 'lock procedure for expensive medicinal products' for this indication. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic healthcare package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness 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’.
Parallel procedure Medicines Evaluation Board-National Health Care Institute
The assessment of guselkumab took place in the parallel procedure of the CBG and the National Health Care Institute. In this procedure, they simultaneously assess a medicine’s admission to the Dutch market and the reimbursement from the basic healthcare package. This will give patients access to new medicines as soon as possible.