What does it involve?
Identifying the processes that a product is expected to undergo in order to be considered for (and hopefully, achieve) reimbursement. Although we refer to it as 'reimbursement pathways', the review may also include evaluations conducted with respect to access, pricing and formulary decisions.
Why is it required?
Reimbursement pathways are unique to each individual market, indication and product type. Innovative treatments may require a new pathway to be defined and some organisations may review their methods from time to time. Understanding the reimbursement pathway at an early stage of development is critical for ensuring the required evidence is generated, and ensures there is sufficient preparation for each key milestone in the product lifecycle when the reimbursement pathway may change.
How could this information be used?
Understanding the exact HTA pathway is required for evidence generation plans and when preparing submission documents. As this information is often required at an early stage of development, or for innovative treatments where the pathway may be less clear, we find it useful to look at analogue products and apply our understanding of the changes to evaluation methods/approach. Further research can help to identify any changes that may be applied in the future, e.g. at the time of product launch.