Advice - reimburse upadacitinib (Rinvoq®) for the treatment of Crohn's disease
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse upadacitinib (Rinvoq®) from the basic health care package after price negotiations. This medicinal product can be used in certain patients with Crohn's disease. The reason for this advice was the placing of the 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 health care package.
Upadacitinib is intended for people with Crohn's disease
Upadacitinib is the active substance. The brand name is Rinvoq®. The medicinal product can be used in people 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. In most patients with Crohn's disease, the small intestines, the large intestines or the rectum are inflamed. But the rest of the digestive tract can also be inflamed. These different inflammation sites may also cause different symptoms. The most common symptoms are abdominal pain, diarrhoea and fatigue. The severity of the symptoms depends on disease activity. In the calm phase (remission), symptoms are mild and not always present. During a flare-up, symptoms can suddenly become very severe. Complications can also occur at this stage.
Upadacitinib is an immunosuppressive medicinal product. It inhibits the action of the enzymes involved in the inflammation process in Crohn's disease. By blocking these enzymes, the inflammation and therefore the symptoms are reduced.
National Health Care Institute advice on reimbursement of upadacitinib
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse upadacitinib (Rinvoq®) from the basic health care package after price negotiations. The price should not exceed the standard treatment with vedolizumab or ustekinumab.
Conditions for reimbursement of upadacitinib
The following conditions apply for reimbursement.
For the treatment of patients with moderately to severely active Crohn's disease who have responded inadequately or have not responded, or who are intolerant to treatment with a biological product.
More information or questions?
If you have any questions about this advice, please send them 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 can ask your health insurance provider.
Lock procedure for expensive medicinal products
The Minister has placed abemaciclib for this indication in the lock procedure for expensive medicinal products. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health care 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 manufacturer.
For more information, see the page ‘Lock procedure for expensive medicinal products’.
The Scientific Advisory Board (WAR) advises the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.