NICE has published draft guidance which does not recommended olaparib (Lynparza) tablet as a maintenance treatment for adults with relapsed, platinum-sensitive ovarian, fallopian tube, and peritoneal cancer.
NICE guidance currently recommends olaparib as a capsule formulation for maintenance treatment of relapsed, platinum-sensitive, ovarian, fallopian tube, and peritoneal cancer that is BRCA mutation-positive, after response to second-line or subsequent platinum-based chemotherapy. When that appraisal was done, olaparib was licensed for use only in people with BRCA mutation-positive ovarian cancer. However the marketing authorisation has since been extended to cover a broader population, irrespective of BRCA mutation status.
The current appraisal considers a new tablet formulation that, according to the manufacturers, will eventually replace the capsule formulation. The new formulation allows a regimen of four tablets per day instead of 16 capsules and does not have any fasting restrictions.
The clinical trial evidence supporting the application was derived from the double-blind randomised placebo-controlled study 19 and SOLO‑2 trial. In study 19 there was a statistically significant improvement in progression-free survival (PFS) in the overall population compared with placebo - 8.4 months vs 4.8 months (HR 0.35; 95% CI 0.25-0.49).
SOLO‑2 also found a statistically significant benefit with olaparib vs placebo for mutation-positive disease, a median difference of 13.6 months (HR 0.30; 95% CI 0.22-0.41).
However, at a list price of £4635 per 28-day cycle, the incremental cost-effectiveness ratios substantially for olaparib tablets substantially exceeded the threshold normally considered a cost-effective use of NHS resources and hence was not approved. The treatment was also found not to meet the criteria for end-of-life treatment or inclusion in the Cancer Drugs Fund.
The draft guidance is now open for public consultation until 30 November 2018. Final guidance is expected to be published in April 2019.