Package advice on zanubrutinib (Brukinsa®) for the treatment of Waldenström macroglobulinaemia (WM)

The National Health Care Institute advises the Minister to include zanubrutinib (Brukinsa®) in the basic health insurance package for the treatment of adult patients with Waldenström macroglobulinaemia (WM), provided that the price negotiations successfully deliver a net price that does not exceed that of the existing treatment with ibrutinib. The reason for this advice was the placement of zanubrutinib in what is known as the lock procedure for expensive medicinal products.

Registered indication

Reimbursement is requested for the treatment of adult patients with WM who have had at least one previous treatment or as first-line therapy for patients who are not suitable for chemo-immunotherapy. The National Health Care Institute has determined that the therapeutic value of this medicinal product is comparable to that of the medicinal product ibrutinib (Imbruvica®), which is already reimbursed.

Package advice

The National Health Care Institute advises the Minister to include zanubrutinib in the basic health insurance package for the stated indication, provided that the price negotiations successfully deliver a net price that does not exceed that of the existing treatment with ibrutinib. Given the equivalent value compared to ibrutinib, which is already being reimbursed, and that there are no indications that either product is preferable to the other, the National Health Care Institute advises the Minister to take the net price of ibrutinib and the expected patent expiry of ibrutinib in December 2026 into account during the price negotiations. We would like to point out that the Insured Package Advisory Committee has advised the National Health Care Institute in general terms that the price for a treatment should be reduced when several medicinal products are available for the same indication.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.