Advice - reimburse sacituzumab govitecan (Trodelvy®) for the treatment of breast cancer (re-evaluation)
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse sacituzumab govitecan (Trodelvy®) from the basic health care package after price negotiations. This medicinal product can be used in certain patients with breast cancer. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. This is a reassessment of an earlier advice from 2022.
Trodelvy® is intended for certain people with breast cancer
Sacituzumab govitecan is the active substance. The brand name is Trodelvy®. The medicinal product is administered by infusion.
The medicinal product can be used for people with inoperable or metastatic triple negative breast cancer. In this form of breast cancer, targeted treatment and cure is no longer possible. Triple-negative means that the tumours have 3 negative properties:
- the tumour does not grow under the influence of the hormone oestrogen;
- the tumour does not grow under the influence of the hormone progesterone;
- the tumour is not HER2 positive.
This means that the cancer cannot be treated with targeted treatment. Hormone therapy is an example of such treatment. The manufacturer has applied for reimbursement for adult patients with inoperable or metastatic triple-negative breast cancer who have received 2 or more prior systemic treatments, including at least 1 for advanced disease. Systemic treatment works on the whole body.
Previous assessment 2022: failed price negotiation
In July 2022, the National Health Care Institute advised the Minister of VWS to reimburse sacituzumab govitecan (Trodelvy®) from the basic health care package.
Read the advice on sacituzumab govitecan (Trodelvy®) from July 2022.
At the time, we concluded that the medicinal product is effective and provides health benefits for patients. People treated with Trodelvy® live on average 5.4 months longer than patients treated with chemotherapy. However, our conclusion was also that the asking price was too high. That is why we recommended a price reduction of 75% to the minister. Only then would it be socially responsible to reimburse the medicine from the basic health care package, since reimbursement of overpriced treatments is at the expense of appropriate care for other patients. Because the manufacturer was not prepared to offer a discount, the minister decided not to include Trodelvy® in the basic health care package. The manufacturer has now asked the National Health Care Institute for a reassessment of the advice, as new data on the medicinal product have become available.
Advice 2024 from the National Health Care Institute on the reimbursement of Trodelvy®
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse sacituzumab govitecan (Trodelvy®) from the basic health care package, on the condition that the minister and the manufacturer can agree on a socially acceptable price. Based on the new study data, the National Health Care Institute determines that a discount of at least 55% on the asking price is necessary to justify the reimbursement of Trodelvy® from the basic health care package.
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 advises the National Health Care Institute about the assessment. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.
Lock procedure for expensive medicinal products
The Minister has placed sacituzumab govitecan 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’.