Package advice on the lock procedure medicinal product abemaciclib (Verzenios®) for the treatment of breast cancer
The National Health Care Institute has assessed whether the medicinal product abemaciclib (Verzenios®) can be reimbursed as an additional treatment for adults with a specific type of early breast cancer. The reason for this advice was the placement 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 not reimburse abemaciclib from the basic health care package for the mentioned patient group. The addition of abemaciclib to the standard treatment of this type of breast cancer does not appear to lead to a higher survival rate and better quality of life.
Condition for which reimbursement is requested
Abemaciclib can be used as an add-on treatment for adults with HR-positive, HER2-negative, gland-positive early breast cancer. Abemaciclib can be added to standard endocrine therapy after surgery. This is a hormone therapy given in hormone-sensitive types of breast cancer. The full indication for which reimbursement has been requested can be found in the drop-down menu.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport not to include abemaciclib in the basic health insurance package as an additional treatment for the aforementioned form of breast cancer. This conclusion is drawn from the results of a large international scientific study and the assessment criteria used by oncologists. This is because adding abemaciclib to standard endocrine therapy does not increase the survival rate or improve the quality of life for people with HR-positive, HER2-negative, node-positive, early breast cancer. The study also shows that abemaciclib results in a high risk of side effects for those patients, such as diarrhoea and infections. Many people who participated in the study discontinued treatment because of these side effects. The National Health Care Institute does not consider the additional treatment with abemaciclib to be appropriate care for the group of patients mentioned. Long-term use of the medicinal product does not provide a cure and may adversely affect their quality of life.
Lock procedure for expensive medicinal products
The Minister has placed abemaciclib for this indication 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;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the manufacturer.
For more information, see the page ‘Lock procedure for expensive medicinal products’.
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.