News
NICE guidance on olaparib for maintenance treatment of patients with relapsed, platinum-sensitive, BRCA mutation-positive ovarian cancer On Jan 27, 2016, the National Institute for Health and Care Excellence (NICE) published guidance1 recommending olaparib as a treatment option for patients with relapsed, platinumsensitive ovarian cancer, fallopian tube cancer, or peritoneal cancer who have BRCA1 or BRCA2 mutations and whose disease has responded to subsequent plantinum-based chemotherapy. Olaparib was recommended only for people who have had three or more courses of platinum-based chemotherapy and if the cost of olaparib for patients who remain on treatment after 15 months is met by the company. NICE appraised olaparib as a single technology appraisal. AstraZeneca (London, UK) submitted evidence for the clinical and cost-effectiveness of olaparib,2 which was reviewed by an independent academic evidence review group, the School of Health and Related Research (ScHARR) at the University of Sheffield. 3 An independent appraisal committee met three times to develop the guidance. Clinical specialists, patient experts, and company representatives attended the committee meetings. The key clinical evidence came from an international, multicentre, double-blind, randomised, placebocontrolled trial by Jonathan Ledermann and colleagues, 4 which included 265 patients with platinum-sensitive epithelial ovarian cancer (including fallopian tube cancer and peritoneal cancer). Olaparib was associated with a statistically significant improvement in the primary outcome of progressionfree survival for the whole trial population and for the subgroup of 136 patients with BRCA gene mutations (the BRCAm subgroup). For the whole population, median progressionfree survival was 8·4 months in the
olaparib group and 4·8 months in the placebo group (hazard ratio [HR] 0·35 [95% CI 0·25–0·49]; p
NICE guidance on olaparib for maintenance treatment of patients with relapsed, platinum-sensitive, BRCA mutation-positive ovarian cancer On Jan 27, 2016, the National Institute for Health and Care Excellence (NICE) published guidance1 recommending olaparib as a treatment option for patients with relapsed, platinumsensitive ovarian cancer, fallopian tube cancer, or peritoneal cancer who have BRCA1 or BRCA2 mutations and whose disease has responded to subsequent plantinum-based chemotherapy. Olaparib was recommended only for people who have had three or more courses of platinum-based chemotherapy and if the cost of olaparib for patients who remain on treatment after 15 months is met by the company. NICE appraised olaparib as a single technology appraisal. AstraZeneca (London, UK) submitted evidence for the clinical and cost-effectiveness of olaparib,2 which was reviewed by an independent academic evidence review group, the School of Health and Related Research (ScHARR) at the University of Sheffield. 3 An independent appraisal committee met three times to develop the guidance. Clinical specialists, patient experts, and company representatives attended the committee meetings. The key clinical evidence came from an international, multicentre, double-blind, randomised, placebocontrolled trial by Jonathan Ledermann and colleagues, 4 which included 265 patients with platinum-sensitive epithelial ovarian cancer (including fallopian tube cancer and peritoneal cancer). Olaparib was associated with a statistically significant improvement in the primary outcome of progressionfree survival for the whole trial population and for the subgroup of 136 patients with BRCA gene mutations (the BRCAm subgroup). For the whole population, median progressionfree survival was 8·4 months in the
olaparib group and 4·8 months in the placebo group (hazard ratio [HR] 0·35 [95% CI 0·25–0·49]; p
