The National Health Care Institute has advised the Minister of Health, Welfare and Sport (hereinafter also “VWS”) to reimburse trastuzumab-deruxtecan (Enhertu®) from the basic healthcare package. This medicinal product can be used in certain patients with breast cancer. This advisory report is about a specific form: HER2-low breast cancer. The medicine is already reimbursed for certain patients with a type of breast cancer that closely resembles it, HER2-positive breast cancer. The reason for this advisory report was the medicinal product being placed in what is known as the ‘lock procedure’ for expensive medicinal products.
Current state of affairs: advisory report sent to the minister
The National Health Care Institute has sent this advisory report to the Minister of Health, Welfare and Sport. The minister makes the final decision on whether or not to reimburse the medicinal product from the basic healthcare package.
Trastuzumab-deruxtecan is intended for certain people with breast cancer
Trastuzumab-deruxtecan is the active substance; the brand name is Enhertu®. The medicinal product is administered by intravenous infusion.
The medicinal product can be used for people with HER2-low breast cancer at an advanced stage. A breast cancer cell that has more HER2 protrusions on its exterior than normal means that the tumour is said to be HER2-positive, otherwise it is HER2-negative. In HER2-low breast cancer, protrusions are also present but there are fewer than in HER2-positive breast cancer. The drug molecules attach to the HER2 protrusions on the cancerous cells and can thus target the cancer. It can be used when the cancer has spread or when it cannot be removed surgically. The full indication for this group of patients is given in the drop-down menu.
Trastuzumab-deruxtecan is indicated for the treatment of adult patients with non-resectable or metastatic HER2-low breast cancer who have previously received chemotherapy for the metastatic disease or whose disease has recurred during adjuvant chemotherapy or within 6 months of completing it.
Advice from the National Health Care Institute on the reimbursement of trastuzumab-deruxtecan
The National Health Care Institute advises the Minister of VWS to reimburse trastuzumab-deruxtecan (Enhertu®) from the basic healthcare package. The medicinal product has added value for patients compared to the current standard treatment. The National Health Care Institute advises the minister that the medicine can only be reimbursed after successful price negotiations of substantially more than 68%.
Trastuzumab-deruxtecan is already reimbursed for other breast cancer patients
Trastuzumab-deruxtecan (Enhertu®) is already reimbursed for patients with HER2-positive breast cancer. This advisory report is therefore about extending the indication for use of the medicine. That the medicine can now be used for people with HER2-low breast cancer is partly due to better tissue examinations. As a result, the HER2 protrusions are now nevertheless visible on breast cancer cells in 60-65% of people with HER2-negative breast cancer, whereas previously this could not be detected. Because there are fewer protrusions in these cases than in HER2-positive breast cancer, it is called HER2-low breast cancer.
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 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 trastuzumab-deruxtecan for this indication in the ‘lock procedure for expensive medicinal products’. A medicine in this lock procedure will not be eligible for reimbursement from the basic healthcare package until:
• there is a positive package recommendation 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’.