Package advice for lock procedure medicinal product darolutamide (Nubeqa®) for the treatment of metastatic prostate cancer
The National Health Care Institute has assessed whether the medicinal product darolutamide in combination with docetaxel and androgen deprivation therapy (Nubeqa®) can be reimbursed from the basic health care package. This medicinal product is used to treat certain patients with metastatic hormone-sensitive prostate cancer (mHSPC). The reason for this advice was the placing of the medicinal 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 darolutamide in combination with docetaxel and androgen deprivation therapy from the basic health care package for the mentioned condition after price negotiations.
Indication for which reimbursement is requested
Darolutamide can be used for the treatment of adult patients with metastatic hormone-sensitive prostate cancer. Treatment with darolutamide takes place in combination with chemotherapy (docetaxel) and androgen deprivation therapy (ADT, hormone treatment).
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include darolutamide in combination with docetaxel and androgen deprivation therapy 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 darolutamide does not exceed the lowest net price of the medicinal product abiraterone.
Lock procedure for expensive medicinal products
The Minister has placed eptinezumab 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;
- arrangements and safeguards have been made for the appropriate use;
- price reductions have been successfully negotiated with the manufacturer.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise 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.