case study
South Korea – Reimbursement Submission Strategy & Premium Benchmarking for a Medical Device
  • Objective

    Develop an evidence-based strategy to support the HIRA submission for a medical device, including justification for a premium reimbursement level, selection of an appropriate comparator and identification of evidence requirements to demonstrate clinical, quality-of-life and economic value.

  • Approach

    Conducted a review of 19 HIRA valuation cases from 2018–2023, identifying products that achieved premiums of 30% or more and analysing evidence & factors associated with higher valuations. Assessed appropriate comparator and reimbursement grouping for the medical device and reviewed an existing premium submission to identify transferable evidence.

  • Deliverables

    Developed a predicate-case benchmarking analysis highlighting HIRA premium precedents, including recommendations on comparator selection, reimbursement classification and evidence generation, including clinical outcomes, patient quality of life and healthcare financial impact.

  • Outcome

    Provided a strategic evidence roadmap for the HIRA submission, enabling the client to strengthen the case for premium reimbursement by linking clinical and quality-of-life improvements to cost-effectiveness and potential healthcare expenditure savings, while aligning the submission with precedents recognized by HIRA.