The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to not reimburse osimertinib (Tagrisso®)
from the basic health insurance package. This medicine can be used for certain patients with locally advanced non-small cell lung cancer. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. The medicine is proven to be effective, but certain information from the marketing authorisation holder was insufficient. As a result, the National Health Care Institute cannot determine a reasonable price for this medicinal product. A reasonable price is necessary for reimbursement from the basic health insurance package, in order to prevent an excessively high price from displacing other good care.
Current state of affairs: advice 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 insurance package.
Osimertinib is intended for people with a certain form of non-small cell lung cancer
Osimertinib is the active substance. The brand name is Tagrisso®. The medicinal product is a tablet that you swallow.
The medicinal product can be used after chemotherapy treatment for people with locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. That is what is called non-resectable. In lung cancer, there is a malignant tumour in the lungs. We can divide lung cancer into 2 types: small cell and non-small cell. NSCLC is non-small cell lung cancer. The cells usually grow slowly. The tumour may have been in the body for years before it is detected. In half of the cases, this lung cancer has metastasised when it is detected.
In locally advanced NSCLC, the tumour is in stage 3. At this stage, the tumour is often larger than in earlier stages. It may have spread to the lymph nodes in the chest cavity, but not yet to other organs or tissues outside the chest. In this evaluation, the patients in question are patients with non-small cell lung cancer with specific genetic abnormalities: to exon-19 or exon-21 (L858R). The full indication for which reimbursement is requested can be found in the drop-down menu.
Osimertinib (Tagrisso®) is indicated for the treatment of adult patients with locally advanced, non-resectable NSCLC whose tumours exhibit EGFR exon-19 deletions or exon-21 (L858R) substitution mutations and whose disease has not progressed during or after platinum-based chemoradiotherapy.
The National Health Care Institute advice on reimbursement of osimertinib
The National Health Care Institute advises the Minister of VWS not to reimburse osimertinib (Tagrisso®) from the basic health insurance package. The medicine is proven to be effective, but the marketing authorisation holder’ economic analysis was not good enough. As a result, the National Health Care Institute cannot determine a reasonable price for this medicinal product. However, this information is essential for a possible price negotiation by the Minister of VWS for reimbursement of the medicinal product. The National Health Care Institute has requested the marketing authorisation holder to provide more information.
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 Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing package advice. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health insurance package.
Explanation of the package lock procedure for expensive medicinal products
The Minister has placed osimertinib 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 health insurance 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’.