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 Crohn's disease. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’.
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 people with Crohn's disease
Guselkumab is the active substance. The brand name is (Tremfya®). The product is administered in 2 parts. The first part is administered via an IV. The second part is done with subcutaneous injections.
The medicinal product can be used in adults with moderately to severely active Crohn's disease. Crohn's disease is a chronic inflammatory disease of the intestines. Chronic means it does not go away. Active disease means that patients suffer from symptoms and disease attacks, such as flare-ups. In patients with Crohn's disease, the small intestines, the large intestines or the rectum are inflamed. The most common symptoms are abdominal pain, diarrhoea and fatigue.
Advice of the National Health Care Institute on the reimbursement of guselkumab
The National Health Care Institute advises the Ministry of Health, Welfare and Sport to reimburse guselkumab (Tremfya®) from the basic healthcare package. This is reimbursement for people with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant toa biological. Intolerant means that patients have an adverse reaction to it. A condition is that the medicinal product should not 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’.