Olaparib for Maintenance Treatment of BRCA 1 or 2 Mutated, Relapsed, Platinum-Sensitive Ovarian, Fallopian Tube and Peritoneal Cancer in People Whose Relapsed Disease has Responded to Platinum-Based Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Paul Tappenden (), Sue Harnan, Shijie Ren, Praveen Thokala, Ruth Wong, Clara Mukuria, Clare Green, Simon Pledge and John Tidy
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Paul Tappenden: ScHARR, University of Sheffield
Sue Harnan: ScHARR, University of Sheffield
Shijie Ren: ScHARR, University of Sheffield
Praveen Thokala: ScHARR, University of Sheffield
Ruth Wong: ScHARR, University of Sheffield
Clara Mukuria: ScHARR, University of Sheffield
Clare Green: Southampton General Hospital and Hampshire Hospitals Foundation Trust
Simon Pledge: Sheffield Teaching Hospitals NHS Foundation Trust
John Tidy: Sheffield Teaching Hospitals NHS Foundation Trust

PharmacoEconomics, 2017, vol. 35, issue 1, No 8, 97-109

Abstract: Abstract As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of olaparib (AstraZeneca) to submit evidence on the clinical and cost effectiveness of olaparib for the maintenance treatment of BRCA1/2 mutated (BRCAm), platinum-sensitive relapsed (PSR) ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy. The Evidence Review Group (ERG) produced a critical review of the evidence contained within the company’s submission (CS) to NICE. The clinical evidence related to one phase II, double-blind randomised controlled trial that recruited 265 patients with PSR serous ovarian cancer (OC) regardless of BRCAm status. Patients received olaparib 400 mg twice daily (b.i.d.) or matched placebo. In the whole population, the primary endpoint of progression-free survival (PFS) was met (hazard ratio [HR] 0.35; 95 % confidence interval [CI] 0.25–0.49, p

Date: 2017
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DOI: 10.1007/s40273-016-0440-x

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