1.1 Niraparib is recommended for use within the Cancer Drugs Fund as an option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults, only if:
they have a germline BRCA mutation and have had 2 courses of platinum-based chemotherapy or
they do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy and
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
People with relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer have a high unmet clinical need because the disease has a poor prognosis and chemotherapy is the only available treatment for many people. Niraparib appears to be a promising treatment for this disease. Olaparib may be another treatment option, but it is only recommended for people with a BRCA mutation who have had 3 or more courses of platinum-based chemotherapy.
A clinical trial shows that niraparib extends progression-free survival compared with routine surveillance, but the final results on overall survival are not available yet. Therefore, it's not clear whether niraparib will increase the length of time people live. Because of the uncertainty in the clinical evidence, the estimates of cost effectiveness are very uncertain. Therefore niraparib cannot be recommended for routine use in the NHS.
If niraparib increases the length of time people live, it may have the potential to be cost effective in 2 groups: people with a germline BRCA mutation who have had 2 courses of platinum-based chemotherapy, or people who do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy. More evidence is needed to address the uncertainties in the clinical and cost effectiveness for these groups. Niraparib is therefore recommended for use within the Cancer Drugs Fund as an option for treating relapsed, platinum-sensitive ovarian cancer in these 2 groups while further data are collected.