Package advice sacituzumab govitecan (Trodelvy®) for the treatment of inoperable or metastasized triple-negative breast cancer

The National Health Care Institute advises the Minister to include sacituzumab govitecan (Trodelvy®) in the basic health care package.  Sacituzumab govitecan is indicated for the treatment of adult patients with inoperable or metastasized triple-negative breast cancer. The reason for this advisory report was the placing of sacituzumab govitecan in the ‘lock procedure’ for expensive medicinal products.

Registered indication

Reimbursement is requested for the treatment of adult patients with inoperable or metastasized triple-negative breast cancer (mTNBC) who have previously received systemic therapies 2 or more times, including at least 1 for advanced disease. 

Package advice

Sacituzumab govitecan complies with the established medical science and medical practice for the treatment of adult patients with inoperable or metastasized triple-negative breast cancer who have previously received systemic therapies 2 or more times, including 1 line of therapy containing a taxane and at least 1 for advanced disease. The medicinal product has therapeutic added value compared to chemotherapy, in terms of both overall survival and progression-free survival. 

The National Health Care Institute advises the Minister to include sacituzumab govitecan in the health insurance package for the specified indication. Based on the conservative estimate of cost-effectiveness, the National Health Care Institute believes that a discount of at least 75% should be appropriate. During the negotiations, we advise the Minister to take into account the fact that expansions of the indications for sacituzumab govitecan are to be expected and also that new treatments for this group of patients may become available. The National Health Care Institute hopes that all parties, given the poor prognosis for this group of patients, are committed to ensuring that this medicinal product becomes available to Dutch patients quickly.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.