Introduction
Why conduct a HTA review?
Reviewing previous Health Technology Assessment (HTA) submissions, particularly for drugs in the same therapy area, can provide valuable insights that can help manufacturers prepare for the launch of a new product. In particular, previous HTAs are a good way of identifying payers’ evidence needs and learnings from previous submissions can be applied to provide the new product with the best possible chance of gaining reimbursement.
Three key considerations:
- Population restrictions
- Payer perception of study design
- Payer perception of economic approach
Population restrictions
Not all drugs will receive reimbursement for their full licenced indication. Did previous analogues receive a restricted recommendation for reimbursement? If so, what were the reasons for this? Were their clinical trials deemed not sufficiently robust to provide the level of evidence needed in all subgroups? Was the evidence of effectiveness much weaker for some subgroups than others?
Identifying reasons for previous products’ restrictions can help manufacturers to identify ways to meet payers’ evidence requirements and increase the likelihood of their product gaining reimbursement for the full licenced indication.
Payer perception of study design
Each market varies in its value drivers. Assessing the acceptability of previous submissions’ clinical data packages is useful in planning for clinical trials, key aspects to consider are:
- Clinical comparators
- Study patient population
- Acceptability of trial endpoints
- If surrogate endpoints are used are these accepted by payers?
- Study duration
- It is also key to consider how previous manufacturers may have successfully justified and applied mitigation strategies to overcome weaknesses in the evidence
Payer perception of economic approach
As part of an HTA, economic evaluations may be undertaken to support reimbursement or coverage decisions.
Previous economic models should be assessed in an HTA review, including payer perceptions of the model structure, any assumptions used to inform the model, and where applicable the acceptability of any published sources to derive calculations. Findings can be used to inform the development of a robust economic model bespoke to your product.