The National Health Care Institute has concluded that pembrolizumab (Keytruda®) can be reimbursed from the basic health care package. This medicinal product can be used in certain patients with early-stage (non-metastatic) breast cancer. This is the second time the National Health Care Institute has assessed the medicinal product. The marketing authorisation holder has shared new data on the effect of the medicinal product on the survival of these patients. These data were not available at the time of the initial assessment.
Brexucabtagene autoleucel is intended for certain people with acute lymphoblastic leukaemia
Pembrolizumab is the active substance. The brand name is Keytruda®. The medicinal product is an injection.
The medicinal product can be used as an additional treatment before and after breast cancer surgery in patients with early-stage breast cancer. In early-stage breast cancer, the cancer has not yet spread to the surrounding tissue or other parts of the body.
Treatment with pembrolizumab consists of a course of medication prior to surgery to stimulate the immune system to attack the cancer cells and a course of medication after surgery to reduce the chance of the disease recurring. The pre- and post-treatment together is called a perioperative treatment.
The medicinal product can be used for people with triple-negative breast cancer. This means that:
- 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 to lymph nodes in the armpit.
Explanation from the National Health Care Institute on the reimbursement of pembrolizumab
The National Health Care Institute concludes that pembrolizumab (Keytruda®) can be reimbursed from the basic health care package for this group of patients. The new data from the marketing authorisation holder show that the perioperative treatment with pembrolizumab in these patients complies with the ‘established medical science and medical practice’. In addition, the National Health Care Institute supports the position of Dutch breast cancer specialists to apply the post-operative treatment with pembrolizumab only to patients whose cancer has not completely disappeared after surgery. The National Health Care Institute also supports the plan of the breast cancer specialists to carry out further research into the treatment.
Previous advice pembrolizumab not adopted
In its advice of 23 May 2024, the National Health Care Institute concluded that perioperative treatment (before and after surgery) with pembrolizumab did not meet the legal criterion of 'established medical science and medical practice'. However, because it is a promising medicinal product, the National Health Care Institute recommended that it should be admitted conditionally to the basic health care package. In June 2024, the then Minister for Medical Care decided not to adopt the advice of the National Health Care Institute and wanted to wait for new data from the marketing authorisation holder.
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) advises the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.