The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse lutetium (177Lu)-vipivotide tetraxetan (Pluvicto®) injection from the basic healthcare package after price negotiations. This medicinal product can be used in certain patients with metastatic prostate cancer. The reason for this advice was the placement of the medicinal product in the ‘lock procedure for expensive medicinal products‘.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
The injection is intended for certain people with metastatic prostate cancer.
177Lu-PSMA-617 is the active substance. The brand name is Pluvicto®. The medicine is an injection given every 6 weeks.
It can be used to treat people with metastatic prostate cancer. Prostate cancer occurs when cells in the prostate begin to divide uncontrollably. In metastatic prostate cancer, the cancer is not only located in the prostate, but also in other parts of the body, such as the lymph nodes, bones or abdomen. If the prostate cancer is sensitive to testosterone, this is called hormone-sensitive prostate cancer. After several years, prostate cancer is often no longer sensitive to testosterone. This means that the prostate cancer continues to grow despite anti-hormone therapy. This is called castration-resistant prostate cancer.
The National Health Care Institute’s advice on reimbursement of injection Pluvicto®
The National Health Care Institute advises the Minister of VWS to reimburse lutetium (177Lu)-vipivotide tetraxetan (Pluvicto®) after price negotiations from the basic healthcare package for 2 different patient groups:
- Patients who have been treated with androgen receptor pathway inhibition (ARPI) and with 1 taxane-based chemotherapy and who are subsequently eligible for a second taxane-based chemotherapy. For this group, the medicine works as well as the current standard treatment cabazitaxel. Therefore, the National Health Care Institute recommends that these patients be reimbursed from the basic healthcare package, but the costs should not exceed those of cabazitaxel.
- Patients who have been treated with ARPI and 2 taxane-based chemotherapies or 1 taxane-based chemotherapy and who are no longer eligible for cabazitaxel therapy. The National Health Care Institute advises to reimburse the medicine from the basic healthcare package, but that can only be done if the minister negotiates a lower price with the marketing authorisation holder, making the medicine cost-effective. This means a reasonable costs-health gain ratio for patients.
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.
Explanation of lock procedure for expensive medicinal products
The Minister has placed 177Lu-PSMA-617 in the package lock procedure for expensive medicinal products for this indication. A medication in this lock procedure will not be eligible for reimbursement from the basic healthcare 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 marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.