The Clinical and Cost Effectiveness of Aflibercept in Combination with Irinotecan and Fluorouracil-Based Therapy (FOLFIRI) for the Treatment of Metastatic Colorectal Cancer Which has Progressed Following Prior Oxaliplatin-Based Chemotherapy: a Critique of the Evidence.

摘要: The National Institute for Health and Care Excellence (NICE) invited the manufacturer of aflibercept (Sanofi) to submit clinical cost-effectiveness evidence in combination with irinotecan fluorouracil-based therapy [irinotecan/5-fluorouracil/folinic acid (FOLFIRI)] treatment metastatic colorectal cancer which has progressed following prior oxaliplatin-based chemotherapy, as part Institute’s Single Technology Appraisal process. Centre Reviews Dissemination Economics at University York were commissioned act independent Evidence Review Group (ERG). This article provides a description company submission, ERG review resulting NICE guidance TA307 issued March 2014. critically reviewed presented manufacturer’s submission identified areas requiring clarification, provided additional evidence. effectiveness data derived from one good-quality double-blind randomised controlled trial (RCT), VELOUR trial, compared plus FOLFIRI placebo FOLFIRI. RCT found small but statistically significant increase overall survival (OS); difference median OS was 1.44 months (13.5 months group 12.06 months group). There also progression-free (PFS) aflibercept; PFS 2.23 months (6.9 months 4.67 months However, grade 3–4 adverse events more frequent than group: 83.5 % 62.5 %. Treatment-emergent led permanent discontinuation 26.8 % patients 12.1% group. included an estimation mean benefit based on extrapolation data, considerably longer reported (4.7 vs. 1.44 months). considered this be over estimate. base-case incremental ratio (ICER) population by £36,294 per quality-adjusted life-year (QALY). After correcting model programming updating include ERG’s preferred parameter estimates, ICER alternative base case £54,368 QALY. curves key driver major source uncertainty model. Additional scenarios related undertaken resulted ICERs between £62,894 £92,089 consideration critique, submissions other stakeholders, Committee concluded that could not cost effective use Service resources treating is resistant or after oxaliplatin-containing regimen. Aflibercept recommended regimen TA307.