Package advice niraparib (Zejula®)
Zorginstituut Nederland has completed its assessment whether niraparib (Zejula®) can be included in the insured package. Niraparib is indicated for the maintenance treatment of adult patients who have a specific form of ovary cancer. The reason for this advice was the placing of the above-mentioned medicinal product in the so-called lock procedure or ‘sluice’ for expensive medications.The Zorginstituut advises the Minister to include niraparib in the insured package for a subgroup of the mentioned indication.
Niraparib (Zejula®) is indicated for the maintenance treatment of adult patients with advanced, epithelial, high-grade ovary, Fallopian tube or primary peritoneal cancer, who respond fully or partially to platinum-based chemotherapy.
The Zorginstituut advises the Minister to include niraparib in the package for a subgroup of the mentioned indication: for patients without proven BRCA1/2 mutation. For this patient group, niraparib has added value compared to active monitoring. Thus niraparib meets the established medical science and medical practice for patients without proven BRCA1/2 mutation.
For patients who have a proven BRCA1/2 mutation, it cannot be determined whether niraparib has at least an equal value compared to olaparib. Thus, for patients with proven BRCA1/2 mutation, niraparib does not meet the established medical science and medical practice.
Niraparib is an effective medicinal product with a favourable cost-effectiveness to which patients require rapid access. The Zorginstituut will review its advice when the data on overall survival become available if the provisional positive advice of the BOM committee becomes a negative advice.