Package advice on the lock procedure medicinal product olaparib (Lynparza®) for the treatment of hereditary breast cancer
The National Health Care Institute has assessed whether the medicinal product olaparib (Lynparza®) can be reimbursed from the basic health care package. Olaparib is used in the treatment of certain patients with hereditary triple-negative breast cancer. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products. The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse olaparib from the basic health care package for this condition after price negotiations. The National Health Care Institute investigated whether olaparib also works for another group of patients with hereditary breast cancer (HR+HER2- patients). The National Health Care Institute advises the Minister not to reimburse olaparib from the basic health care package for this group.
Condition for which reimbursement is requested
Olaparib can be used as adjuvant treatment for adult patients with hereditary triple-negative breast cancer. The product can also be used by itself. This is called monotherapy. Olaparib can also be used in combination with hormone therapy.
It is estimated that 5 to 10 percent of breast cancer patients have a hereditary predisposition to breast cancer. In those cases, it is caused by a faulty gene. This is called a mutation. The best-known gene mutation that increases the risk of breast cancer is the BRCA mutation. BRCA comes from BReast Cancer. The BRCA genes play a role in the development of breast cancer. A mistake in the BRCA1 or BRCA2 gene increases the risk of breast cancer and ovarian cancer. Women with a BRCA1 mutation or BRCA2 mutation have a 60 to 80 percent risk of developing breast cancer during their lifetime. For women without a hereditary predisposition, that risk is about 14%. Olaparib is reimbursed from the basic health care package for ovarian cancer treatment in patients with a BRCA1 or BRCA2 mutation.
Triple-negative means that the tumour has 3 negative properties:
- the tumour does not grow under the influence of the hormone oestrogen;
- the tumour does not grow under the influence of the hormone progesterone;
- the tumour is HER2-negative.
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 to reimburse olaparib for the condition mentioned from the basic health care package after price negotiations. We have prepared our advice in accordance with the guidelines of the physicians' association for the treatment of these patients. We conclude that olaparib meets the established medical science and medical practice for the treatment of hereditary triple-negative early breast cancer. This means that the treatment is effective. The price must not exceed that of the existing standard treatment with capecitabine.
The National Health Care Institute also investigated whether olaparib worked for another group of patients. These are adult patients with germline BRCA1/2 mutations who have early hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer (HR+HER2- patients). The National Health Care Institute advises the Minister not to reimburse olaparib from the basic health care package for this group. The National Health Care Institute has determined that olaparib does not work better than the current standard treatment in the Netherlands for these patients.
Lock procedure for expensive medicinal products
The Minister has placed olaparib 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.