PARP inhibitors are medicines used to treat various types of cancer. For a number of PARP inhibitors, the National Health Care Institute has reassessed whether they can still be reimbursed from the basic healthcare package. These include olaparib (Lynparza®), niraparib (Zejula®) and talazoparib (Talzenna®). Olaparib and niraparib for the treatment of advanced or recurrent ovarian cancer. And olaparib and talazoparib for the treatment of metastatic breast cancer. The National Health Care Institute concludes that longer survival has been demonstrated only for patients with ovarian cancer with a BRCA mutation. Reimbursement remains available for these patients. However, for breast cancer, reimbursement is terminated because the treatment has not been shown to ensure longer survival.
The change in reimbursement will be in effect on 18 June 2025.
Stakeholder reactions in the addendum
The addendum to the reassessment of PARP inhibitors contains the consultation reactions of the stakeholders and our responses to them. The consultation period was in October-November 2024. The stakeholder reactions have been carefully considered and, where possible, incorporated into the position statement.
Reason for reassessment of PARP inhibitors
PARP inhibitors are cancer medicines that prevent damaged tumour cells from repairing themselves. This kills the tumour cells. This group of medicines is used to treat patients with ovarian cancer, pancreatic cancer, breast cancer or prostate cancer. A number of treatments with PARP inhibitors are reimbursed from the basic healthcare package. More effectiveness data have become available since the inclusion in the basic healthcare package. Therefore, the National Health Care Institute has re-evaluated when PARP inhibitors are sufficiently effective for reimbursement from the basic healthcare package.
Summary of position statement: change reimbursement for 6 treatments
Based on the new data, we have performed 6 reassessments. Our conclusion is as follows:
- For people with recurrent ovarian cancer with a BRCA mutation, treatment with olaparib (Lynparza®) or niraparib (Zejula®) has added value. It can lead to longer survival. Therefore, the reimbursement will be continued. However, for patients without a BRCA mutation, treatment has not shown any added value. The reimbursement for that treatment is therefore stopped.
- For people with advanced ovarian cancer with a BRCA mutation, treatment with olaparib (Lynparza®) has added value. It can lead to longer survival. Therefore, the reimbursement will be continued.
- For people with advanced ovarian cancer, niraparib (Zejula®) treatment has shown no added value. It does not lead to longer survival or a better quality of life. The reimbursement is therefore stopped.
- For people with metastatic breast cancer, treatment with olaparib (Lynparza®) or talazoparib (Talzenna®) has not shown any added value. It does not lead to longer survival or a better quality of life. The reimbursement is therefore stopped.
Transitional scheme for ongoing treatment of patients
The change in reimbursement will take effect on 18 June 2025. However, patients who are already receiving treatment with one of the mentioned PARP inhibitors at that time may complete that treatment. Patients can discuss with their physician whether the treatment is working well enough for them to continue within this scheme.
Procedure followed
Only healthcare that has added value should be part of the basic healthcare package. This is defined by the legal term 'established medical science and medical practice'. Often it is clear whether care from the basic healthcare package can be reimbursed, but not always. In such cases, the National Health Care Institute can decide for itself whether such care is eligible for reimbursement. The outcome of the assessment is called a position statement.
A position statement taken by the National Health Care Institute immediately provides clarity. The Minister for Health, Welfare and Sport has no further say in this.
In drawing up this position statement, we consulted patient organisations, healthcare providers, healthcare insurers and marketing authorisation holders. The National Health Care Institute has also sought advice from the Scientific Advisory Board (WAR). This board includes independent scientists, physicians, pharmacists, methodologists and health economists. We have carefully considered all these reactions and then formulated the position statement.
PARP inhibitors on the package agenda for appropriate care
The subject of 'reassessment of expensive medicinal products - PARP inhibitors' is on the appropriate care agenda 2023-2025. The National Health Care Institute has drafted this agenda together with healthcare providers, patient organisations and healthcare insurers. The agenda includes topics that should promote appropriate care and prevent inappropriate care. The implementation of the package agenda is also a joint effort. This is agreed in the Integrated Care Agreement (IZA).
Read more about appropriate care on the page 'What are we doing for appropriate care?'.
More information or questions?
If you have any questions about this position statement, you can send these to Hedy Maagdenberg by e-mail at warcg@zinl.nl.
Frequently Asked Questions and Answers
The PARP inhibitor you are now taking will continue to be available to you for the duration of treatment agreed with your physician.
If you have not yet started treatment with a PARP inhibitor, this treatment will unfortunately no longer be reimbursed from the basic healthcare package. This is because the assessment by the National Health Care Institute has shown that in your situation, treatment with PARP inhibitors does not lead to a longer survival or an improvement in the quality of life. You can discuss your new treatment plan with your medical specialist.
A treatment already started can be continued. The treatment may be reimbursed with a transitional scheme. The news article by Zorgverzekeraars Nederland (ZN) tells you how to claim reimbursement for the treatment. If you have any questions about the reimbursement, please contact ZN. Of course, you can also decide to stop, in consultation with the patient.
There was little information previously available on the effect of PARP inhibitors on survival for the assessed indications. It was therefore necessary to look at information that could predict longer survival. That information looked promising and therefore reimbursement was made. Now that new data on survival is available, the National Health Care Institute concludes that it is not as good as expected. In some cases, longer survival has not been demonstrated. That is why the National Health Care Institute has now reached a different conclusion.
The reassessment of expensive medicinal products follows from the Integrated Care Agreement (2022). In it, healthcare providers, patient associations, health insurers and government parties stated the ambition that expensive medicinal products should be periodically reassessed after inclusion in the basic healthcare package. This is because of concerns about the ever-increasing cost of expensive medicinal products, which puts further pressure on regular healthcare in hospitals. It is important that medicines provide a cure, a prolongation of life or a better quality of life. In the initial assessment of whether a medicinal product is eligible for reimbursement from the basic healthcare package, in many cases not all the information is yet available to determine this properly. As a result, there may still be uncertainty about the effect of the treatment. It is important to reassess when more information becomes available.