Developing a STA/HST submission to NICE

Developing a STA/HST Submission to NICE


What do NICE want to see in HTA submissions?

NICE require a broad range of evidence to be included within the reimbursement dossier, including clinical, economic and quality of life (QoL) data.

The 3 key considerations:

  1. Presenting convincing clinical data
  2. Conducting a systematic literature review (SLR)
  3. Developing a robust cost-effectiveness analysis (CEA)

Presenting convincing clinical data

  • The clinical effectiveness is reviewed to determine the additional benefit of the product versus the standard of care
  • Acquired through clinical trials preferable head-to-head with appropriate comparator
  • Real world data can be included if available
  • The clinical data should ideally reflect the outcomes outlined in the final scope by NICE

Conducting a systematic literature review (SLR)

  • The manufacturer has to conduct systematic literature reviews (SLRs) no more than 6 months prior to the submission
  • The SLRs have to be aligned with the NICE’s requirements
  • Typically 3 separate SLRs need to be conducted, although one general SLR might be accepted for rare diseases
    1. Clinical evidence
    2. Economic evidence & resource identification
    3. HRQoL

Developing a robust cost-effectiveness analysis (CEA)

  • Used to determine if the additional benefit of the drug is worth extra cost
  • Usually takes the form of cost-utility analysis of new treatment versus appropriate comparator
  • Having reliable QoL data is crucial for the development of a robust economic model (EQ-5D is considered gold standard)
  • A cost-effectiveness ratio below threshold will support a positive recommendation of the new drug

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