Package advice on the lock procedure medicinal product trastuzumab-deruxtecan (Enhertu®) for the treatment of HER2-positive breast cancer
The National Health Care Institute has assessed whether the medicinal product trastuzumab-deruxtecan (Enhertu®) can be reimbursed from the basic health insurance package. This medicine is used in palliative treatment of adult patients with HER2-positive breast cancer at an advanced stage. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medications. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to reimburse Enhertu from the basic health insurance package only after a price reduction is negotiated with the marketing authorisation holder. This advice is based on interim research results. Once the finalised research results of the medicinal product are made available, the National Health Care Institute, at the request of the Minister of Health, Welfare and Sports, can re-assess the advice on the reimbursement of Enhertu.
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Indication for which reimbursement is requested
Breast cancer occurs in the milk ducts or mammary glands of the breast. HER2 is a protein on the surface of breast cancer cells thatregulates their growth and cell division. In HER2-positive breast cancer, there is an excess of HER2 present on the cancer cells. As a result, the tumour grows rapidly and aggressively. In a (very) advanced stage, the tumour has metastasised to other parts of the body. Surgery is no longer useful. Patients will receive palliative treatment, as recovery is no longer possible. They receive life-prolonging treatment with medicinal products that inhibit tumour growth.
Enhertu is one such medicinal product. It can be used in the treatment of adult patients with untreatable or metastatic HER2-positive breast cancer. Patients must have already received one or more anti-HER2 treatments.
Enhertu damages the cancer cells or clears them up without seriously damaging healthy cells, thereby inhibiting the growth and further metastasis of the tumour.
Recommendations from the National Health Care Institute
The National Health Care Institute concludes that there are still uncertainties about the effect of Enhertu on overall survival. This is the period from first administration of treatment until death. There are also uncertainties about the effect on the quality of life of patients with HER2-positive breast cancer. Partly due to these uncertainties, the National Health Care Institute believes that the current price for the product is too high. Therefore, we advise the Minister to reimburse the product from the basic health insurance package only after a price reduction is negotiated with the marketing authorisation holder. Once more mature study results become available, the National Health Care Institute can reassess Enhertu at the request of the Minister, The National Health Care institute can then advise the Minister again on the reimbursement of this medicinal product.
Lock procedure for expensive medicinal products
The Minister has placed trastuzumab-deruxtecan (Enhertu) for this indication in the ‘lock procedure for expensive medicinal products’. A medication 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.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The Minister ultimately decides whether or not to reimburse the medicinal product from the basic health care package.