Informing future evidence generation through literature review and landscape analysis
Insight and direction for strategic development plans to optimise market access and returns on investment
Our client had an established treatment for which they were evaluating life cycle management in new indications. They were planning phase III studies and developing evidence for HTA submissions and payer bodies, but had limited knowledge of the market landscape in the new target indication. They sought our help in identifying the unmet need in order to:
- Inform the product’s development programme.
- Ensure that it delivered value for money.
- Ensure successful reimbursement in key markets.
We conducted a thorough literature and landscape review to understand the burden of illness along with the clinical and economic evidence of current treatments. It was important to capture real world evidence and patient reported outcomes to identify the unmet need and determine opportunities for the client to differentiate their product.
Alongside this, we critically reviewed HTA appraisals for products in the relevant indications to understand the potential weaknesses of competitor submissions and inform a robust reimbursement strategy.
Our research provided evidence of the unmet need across the indications and highlighted that previous products had been criticised on the appropriateness of their study design during HTA appraisals.
We established the existing evidence gaps and identified a number of factors for effective market access. As a result, we made recommendations on trial design, reimbursement submission content and communication strategies to best support future market access.
Value to the client
Our evidence-based approach, combined with our knowledge of the payer and reimbursement landscape, enabled our client to make informed decisions on the design of their phase III trials, approach to reimbursement submissions and communication strategies.