The medicines concerned are Xenpozyme (olipudase alfa), Carvykti (ciltacabtagene autoleucel), and Enhertu (trastuzumab deruxtecan) for the treatment of HER2-low breast cancer. Enhertu remains reimbursed for the treatment of HER2-positive breast cancer.

Intensive negotiations

Despite intensive negotiations, no agreement has been reached on a price that aligns with the underlying recommendations of the Healthcare Institute. The Healthcare Institute concluded that the medicines do have added value for treatment, but the expected health benefits do not outweigh the high price. The requested prices are far from what we in the Netherlands consider socially acceptable for the health benefits of these medicines.

Minister Bruijn: “It is difficult for me to have to make this decision. I fully realize that these medicines can provide health benefits. I understand that this decision is very disappointing for patients and their loved ones who have placed their hopes on these medicines. But the prices of these medicines must be proportional to the health benefits they provide. If not, it is not a responsible use of the healthcare budget. In that case, I cannot explain to all patients and premium payers why I include the medicine in the basic package. The high prices requested by these suppliers put the solidarity of our healthcare system under pressure. If we do not control spending on these expensive medicines, it will eventually mean we can no longer afford other effective and efficient care. I must also consider the consequences for (future) patients who depend on that care.”

The medicine lock

The medicine lock (the lock) is an instrument to temporarily exclude expensive new medicines from the basic package when expected expenditures are too high. During this period, experts from the Healthcare Institute assess whether the medicine meets four so-called package criteria: effectiveness (does the medicine work at least as well for the patient as the standard treatment in the Netherlands?), cost-effectiveness (is the price proportional to the health benefits gained from using the medicine?), necessity (is it necessary to reimburse the medicine from basic insurance due to the medicines cost and the severity of the disease?), and feasibility (is it practically feasible to reimburse the medicine?).

Based on the Healthcare Institutes advice, the minister negotiates with the supplier about the price. Only when socially acceptable agreements have been made can the medicine be taken out of the lock and included in the basic package.

Social support

Recent research from the Socially Acceptable Expenditure Medicines program (MAUG) shows that Dutch people believe the government should be critical when reimbursing expensive medicines. If the effectiveness is limited or the price socially unacceptable, reimbursement should be refused. People also indicate that transparency in pricing and a good justification for why the manufacturer asks a certain price for a new medicine are very important.

Minister Bruijn remains willing to reconsider the lock placement of the 3 medicines if suppliers come to a socially responsible price.