Case Study FIECON

Driving a >£1M ICER for a severe and debilitating rare disease to acceptable levels for reimbursement in England and Wales.

Case

  • Our client required support for a product undergoing a NICE HST appraisal for a severe and debilitating rare disease across England and Wales.​
  • Cost-effectiveness modelling developed by an external agency produced unacceptably high ICERs (>£1 million per QALY) for reimbursement.​
  • FIECON was brought in three months before the submission deadline to reduce the ICER and lead the NICE process.​

 

Action

Respecting the technical: A thorough review of the existing model was undertaken that identified implementation errors and other structural and context deficiencies resulting in an increased ICER. This meant that the model was not demonstrating the product’s true value.​

Delivering the practical:

  • Strategic recommendations were developed which identified methods to robustly reduce the ICER.​
  • Implementation errors were corrected and a complete re-analysis of the statistical modelling in the key areas identified was conducted. This included parametric modelling for mortality and treatment discontinuation, recalculating transition probabilities to highlight product effectiveness improved over time, compliance, and carer disutility.​
  • FIECON proposed and supported a patient/carer survey and Delphi panel to re-parameterise key inputs in the model.​

 

Results

  • A robust, well-written, and strategically thought-out submission was produced which allowed the product to demonstrate the potential to be cost-effective within the three-month deadline.​
  • The ICER was substantially reduced to <£150k per QALY using robust methodology for the next Committee meeting, which allowed a commercial agreement to be made between the manufacturer and NICE.
  • The NICE HEOR strategy has been rolled out as the Global HEOR strategy and has been implemented in country launches in Central Europe, Eastern Europe, and Canada.