HTA/Pre-Phase III Planning
- Why do you need to plan for your HTA submission?
- How do you know what relevant data is required for your HTA submissions to NICE and SMC?
- Are your Phase III trials designed to collect the appropriate data?
- Who do you consult to advise you on which data to collect that will be relevant for your HTA submissions?
NICE and SMC evaluation programmes require certain types of evidence about the technology being appraised. In order to plan market access for your product, you may wish to seek strategic advice to ensure your proposed development plans can produce relevant data/evidence for future HTA evaluations. An appropriate time for requesting specific advice is pre Phase III clinical trials. This will enable you to design your studies to capture the relevant data required for NICE and SMC submissions.
At Tolley Health Economics, we can offer you tailor-made strategic advice to help you collect the clinical and economic evidence you need to prepare for your future submissions to NICE and SMC.
Systematic review design considerations:
- Framing questions for a review
- Identifying relevant work
- Assessing the quality of studies
- Summarising the evidence
- Interpreting the findings
Economic evaluation design considerations:
- form of evaluation and approaches to benefit measurement
- modelling versus trials
- relevant trial(s) for economic evaluation
- approaches to the generation of quality-adjusted life years (QALYs).
- selection of instruments or research to derive QALYs
- extrapolation of long-term outcomes
- planning for indirect comparisons including Mixed-treatment comparisons (MTC).
- adapting economic models so they are fit for purpose
- expected value of perfect information (EVPI)
- calculations to highlight greatest areas of uncertainty and assist with trial design
- Bayesian simulations.
Clinical study design considerations:
- study population
- appropriate comparator(s)
- study endpoint.