1.1 Niraparib is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment for advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after response to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for niraparib are followed.
1.2 This recommendation is not intended to affect treatment with niraparib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
There are no maintenance treatments routinely available for advanced ovarian, fallopian tube or peritoneal cancer that has responded to first-line platinum-based chemotherapy. For some people, maintenance treatment is available through the Cancer Drugs Fund.
Clinical evidence comes from PRIMA, an ongoing clinical trial, which shows that niraparib delays disease progression. But it has not shown whether people having niraparib live longer, because they have not been followed up for long enough.
Because of the clinical uncertainty, the cost-effectiveness estimates are very uncertain. They may be higher than what NICE normally considers an acceptable use of NHS resources. So, niraparib cannot be recommended for routine use in the NHS.
Longer follow-up data from PRIMA could help address the uncertainty about the clinical effectiveness of niraparib in this population. Niraparib has the potential to be a cost-effective use of NHS resources. So, it is recommended for use in the Cancer Drugs Fund while more data from the trial are collected.