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FINDING A WAY WITHOUT MATURE OS DATA

 

  • Supporting a product undergoing a NICE STA to launch a product for the treatment of ovarian cancer with and without BRCA mutations across England and Wales
CHALLENGE
  • Demonstrate cost-effectiveness at a commercially acceptable price despite the fact that mature OS data was not available, and evaluate the appropriate route for access for treatment in light of an upcoming competitor relaunch
Action
Respecting the technical:
  • Having reviewed an existing global partitioned survival model developed by an external agency (the usual structure adopted for oncology treatments) we identified two key issues:
    • The existing model failed to capture our product’s broader indication and observed PFS benefits (instead simply assuming equivalent OS between treatments)
    • Survival extrapolations did not follow NICE DSU guidelines, and multiple calculation errors were identified

Delivering the practical:
  • We developed a decision analytic model, based on a structure previously accepted by NICE, driven by establishing a relationship between mean PFS benefit and mean OS benefit, based on the competitor’s pivotal trial publication
  • We delivered internal training sessions and made strategic recommendations for global and UK-specific HEOR and NICE strategy to support important access and pricing decision-making

result
  • The ICER was significantly reduced, with model results were ratified with a clinical expert
  • FIECON represented the client at NICE committee and CDF meetings, providing compelling evidence that the product was cost-effective based on the PFS benefit observed, successfully defending the methods against significant challenge from the ERG
  • The product was recommended by the CDF at a commercially acceptable price for the full licensed indication, negotiations with the CDF used the manufacturer’s base case as a starting point

Acronyms: CDF - Cancer Drugs Fund; DSU Decision Support Unit; ICER - Incremental Cost-Effectiveness Ratio; NICE - National Institute for Health and Care Excellence; OS - Overall Survival; PFS - Progression-Free Survival; STA - Single Technology Appraisal; HEOR - Health Economics and Outcomes Research; ERG - Evidence Review Group