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)

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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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