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New HTA Decisions in England
January 2020
Drug name
LYNPARZA® (olaparib)
Company
AstraZeneca
Decision date
29/11/2019
Therapeutic area
Cancer
Therapeutic sub area
Ovarian cancer
Decision
Recommended with restrictions
Indication
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. It is also recommended for use within the CDF with extended restrictions.
Decision Detail
Olaparib is recommended 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. Olaparib is recommended for use within the Cancer Drugs Fund 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.
Summary
The clinical trial evidence came from double-blind randomised placebo-controlled trials (study 19 and SOLO 2). The committee concluded that olaparib improved progression-free survival irrespective of BRCA mutation status, and generally people with a BRCA mutation had greater benefit. However, the size of the difference in the benefit compared with the overall population was still uncertain. 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 (OS) 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 OS 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. The committee concluded that the ERG's and the company's ICERs for this subgroup (£47,935 and £16,877 per QALY gained respectively) provided a good estimate of the plausible ICER range.