The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) not to reimburse abemaciclib (Verzenios®) from the basic healthcare package. This medicine can be used in the treatment of certain patients with breast cancer. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products’. This is a reassessment of an earlier advice from 2023.
Abemaciclib is intended for certain people with breast cancer
Abemaciclib (Verzenios®) can be used after surgery to treat men and women with early-stage breast cancer. It is an additional treatment, also called adjuvant treatment. These are people whose cancer has spread to the lymph nodes, referred to as node-positive cancer. The cancer also has other features that indicate a higher risk of the cancer recurring. Abemaciclib should only be used if the cancer cells have certain types of receptors on their surface called hormone receptors. In that case, the cancer is called HR positive. The cancer cells must also not produce abnormally large amounts of another receptor called HER2. In other words, the cancer must be HER2 negative. Abemaciclib should be used in combination with endocrine therapy. Endocrine therapy is hormone therapy given in hormone-sensitive breast cancer. In those cases, the breast cancer is sensitive to sex hormones.
The treatment applies to a certain group of patients. The complete indication can be read in the drop-down menu.
Abemaciclib, in combination with endocrine therapy, is indicated as adjuvant treatment of adult patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer with a high risk of recurrence.
People with HR-positive, HER2-negative, node-positive breast cancer are at greater risk of the breast cancer coming back later. We call this high risk of recurrence. Other risk factors also play a role in determining the risk of recurrence. For example tumour size and the spread of the tumour to lymph nodes in the armpit. In early breast cancer, the cancer has not spread to other parts of the body.
Previous assessment 2023: No higher survival rate or better quality of life
In December 2023, the National Health Care Institute advised the Minister of VWS not to reimburse abemaciclib (Verzenios®) from the basic healthcare package.
Read the advice on abemaciclib (Verzenios®) from December 2023.
We concluded then that the medicinal product does not lead to a higher chance of survival or a better quality of life for people with HR-positive, HER2-negative, node-positive, early-stage breast cancer. The marketing authorisation holder filed an interim injunction against the National Health Care Institute after this advisory report. The court concluded that the 2023 package advice was not sufficiently substantiated in a number of respects. That is why the National Health Care Institute has performed a new assessment with a new assessment team. The marketing authorisation holder has submitted new study results.
Advice from the National Health Care Institute on the reimbursement of abemaciclib
The National Health Care Institute advises the Minister of VWS not to reimburse abemaciclib (Verzenios®) from the basic healthcare package. In the reassessment, the National Health Care Institute found that abemaciclib does not meet the legal criterion of 'established medical science and medical practice' for the group of patients mentioned. In other words, it has not been sufficiently demonstrated that the treatment works better than the current treatment, which is the criterion that healthcare must meet in order to be reimbursed from the basic healthcare package. Treatment with abemaciclib does not increase survival, but it does cause side effects.
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) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing package advice. The final decision as to whether or not reimbursement from the basic healthcare package will take place lies with the Minister.
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’.