Advice - conditional inclusion of pembrolizumab (Keytruda®) as an additional treatment of breast cancer prior to surgery
The National Health Care Institute has advised the Minister for Medical Care to reimburse pembrolizumab (Keytruda®) immunotherapy for the time being as an additional treatment prior to breast cancer surgery. The medicinal product may increase the chances of survival of young women with a certain type of breast cancer. Scientific evidence is still lacking. However, breast cancer experts consider this treatment to be promising. For this reason, the National Health Care Institute advises the Minister to grant pembrolizumab conditional access to the basic health care package. This should give room for further research into the treatment.
Pembrolizumab is intended for certain people with breast cancer
Pembrolizumab is the active substance. The brand name is Keytruda®. The medicinal product can be used as an additional treatment for adult patients with early stage breast cancer. It can be added to chemotherapy in 2 ways:
- Prior to surgery. This is called neo-adjuvant treatment.
- Before and after the operation. This is called perioperative treatment.
The medicinal product can be used for people with non-metastatic breast cancer. The condition is also called triple-negative breast cancer and is 3 times negative:
- 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.
Life expectancy is often worse with triple-negative breast cancer than with other types of breast cancer. People with this condition also have a higher risk of getting breast cancer again later on. This is called a high risk of recurrence. Other risk factors also play a role in determining the risk of recurrence. For example, tumour size and metastases in the lymph nodes in the armpit. In early-stage breast cancer, the cancer has not yet metastasised to the surrounding tissue or other parts of the body.
Advice from the National Health Care Institute on reimbursement of pembrolizumab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to conditionally include pembrolizumab (Keytruda®) to the basic health care package as a neo-adjuvant treatment. The assessment concludes that this treatment has no demonstrable added value for patients. No higher survival rate can be established based on the currently available scientific studies. However, breast cancer experts do see value in the treatment. They find the neo-adjuvant application of pembrolizumab promising. Conditional inclusion allows for more research into the use of the immunotherapy. The research should determine whether pembrolizumab is working and can be permanently included in the basic health care package for the neo-adjuvant treatment of women with breast cancer.
The National Health Care Institute also advises not to reimburse pembrolizumab as a perioperative treatment. The National Health Care Institute concludes that this treatment with pembrolizumab does not provide any added value for patients, because it is very uncertain that perioperative treatment leads to a higher survival rate for these patients, but the treatment can cause serious side effects.
More information or questions?
If you have any questions about this advice, please send them to the National Health Care Institute via Question regarding 'Package advice pembrolizumab (Keytruda®) as an additional treatment of breast cancer prior to surgery'. If you have questions about the reimbursement of a medicinal product, 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) advises the National Health Care Institute about the assessment. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.