1 Recommendations

1 Recommendations

1.1 Olaparib is recommended as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if:

  • they have a BRCA1 or BRCA2 mutation

  • they have had 3 or more courses of platinum-based chemotherapy and

  • the company provides olaparib according to the commercial arrangement.

1.2 Olaparib is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if:

  • they have a BRCA1 or BRCA2 mutation

  • they have had 2 courses of platinum-based chemotherapy and

  • the conditions in the managed access agreement for olaparib are followed.

1.3 These recommendations are not intended to affect treatment with olaparib that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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

Clinical trials show that olaparib extends the time until the cancer progresses compared with routine surveillance, regardless of whether the person has a BRCA mutation. But the company has offered a commercial arrangement that applies to olaparib tablets when used for people with a BRCA mutation who have had 2 or more courses of platinum-based chemotherapy. This means that olaparib is cost effective only when used for the subgroup of people with a BRCA mutation.

For people with a BRCA mutation who have had 3 or more courses of platinum-based chemotherapy, olaparib meets NICE's end-of-life criteria. It is cost effective for this group of people and is therefore recommended for routine use in the NHS.

For people with a BRCA mutation who have had 2 courses of platinum-based chemotherapy, olaparib does not meet NICE's end-of-life criteria. The cost-effectiveness estimates are uncertain because overall survival data from the most relevant clinical trial are not yet available. Olaparib has the potential to be cost effective if further data confirm the overall survival benefit estimated using the company's alternative model. Olaparib is therefore recommended for use within the Cancer Drugs Fund, for people with a BRCA mutation who have had 2 courses of platinum-based chemotherapy, while more data are collected.

  • National Institute for Health and Care Excellence (NICE)