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:
- Presenting convincing clinical data
- Conducting a systematic literature review (SLR)
- 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
- Clinical evidence
- Economic evidence & resource identification
- 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