1.1 Olaparib is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of BRCA mutation‑positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for olaparib are followed.
1.2 This recommendation is not intended to affect treatment with olaparib 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 currently no maintenance treatments for BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after a positive response to first-line platinum-based chemotherapy. Olaparib is currently recommended after 3 or more lines of platinum-based chemotherapy. Using olaparib earlier in the treatment pathway would be an important development because earlier use can achieve the greatest benefit and may have the potential to cure the disease.
An ongoing clinical trial shows that olaparib delays disease progression. But it is not known whether people having olaparib live longer because people in the trial have not been followed up for long enough. The currently available clinical trial evidence does not show a significant difference in overall survival between olaparib and placebo. This makes the estimates of cost effectiveness very uncertain. Therefore, olaparib is not recommended for routine use in the NHS.
If olaparib increases the length of time people live it has the potential to be cost effective, but more evidence from the ongoing trial is needed to address the uncertainties. Therefore, it is recommended for use in the Cancer Drugs Fund, while further data are collected.