Package advice for the lock procedure medicinal product zanubrutinib (Brukinsa®) for the treatment of chronic lymphocytic leukaemia (CLL)
The National Health Care Institute has assessed whether the medicinal product zanubrutinib (Brukinsa®) can be reimbursed from the basic health care package. This medicinal product is used to treat certain patients with chronic lymphocytic leukaemia (CLL). This is a form of blood cancer. The reason for this advice was the placing of the product in the so-called ‘lock procedure for expensive medications’. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to reimburse zanubrutinib (Brukinsa®) from the basic health care package for the mentioned condition after price negotiations.
Condition for which reimbursement is requested
Zanubrutinib can be used for the treatment of adult patients with CLL. CLL is a form of blood cancer. It is the most common form of leukaemia. In CLL, malignant white blood cells, the B-lymphocytes, accumulate in the body. This can cause symptoms. CLL is a chronic disease, which means that the disease almost never goes away. However, people can often live with it for many years, even decades. The disease is not treated until the patient starts having symptoms.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include zanubrutinib in the basic health care package for the above indication. The price negotiations with the marketing authorisation holder should ensure that the net price of zanubrutinib does not exceed the lowest net price of any of the pre-existing treatments: ibrutinib or acalabrutinib.
Lock procedure for expensive medicinal products
The Minister has placed zanubrutinib for this indication in the lock procedure for expensive medicinal products. A medication 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;
- price reductions have been successfully negotiated with the marketing authorisation holder.
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.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.