REAL™ reports for landscape assessment

A fundamental element of any market access strategy is an understanding of the competitive landscape – both current and future. Rapid Evidence review and Assessment of Landscape (REAL™) provides our clients with a robust overview of a specific indication across markets.

Our REAL™ reports provide a valuable overview to inform lifecycle strategy and decision making for evidence generation and to highlight appropriate opportunities for competitor differentiation. By identifying the gaps and potential opportunities we can help you devise and execute a plan to generate the required evidence for optimum product development and commercialization. Based on our robust evidence review processes, REAL™ reports are built on a modular approach tailored to each disease area.

Rapid review of published literature covering epidemiology, burden, clinical pathway and unmet need

Flexible coverage of HTA decisions and potential analogous scenarios

Key competitor profiling through research, interpretation and communication of the competitor landscape

Multi-perspective visualisation of the access landscape

Option for primary research into payer expectations and current/future drivers of value

View a case study on a previous REAL™ report for landscape assessment project

Landscape assessment to identify existing clinical outcome measures and regulatory and payer perceptions

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Value Insight & Communiction

Click here for details of our wider expertise and our database of published research and conference presentations

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Landscape assessment to identify existing clinical outcome measures and regulatory and payer perceptions

Insight and direction for strategic outcome assessment to optimise the clinical development program of an early phase asset through synthesising previous payer and regulatory insights.

The challenge

Our client had an early phase asset for use in cystic fibrosis and bronchiectasis. They sought our help in identifying:
> The management of the respiratory conditions of interest with a focus upon clinical outcome assessments (COAs) used to assess symptoms, impact function and general health-related quality of life.
> Appraisal of different COAs from stakeholders at both regulatory and Health Technology Assessment (HTA) levels.

The solution

We conducted a thorough literature and landscape review to understand and explore existing outcome measures available for these respiratory conditions. Alongside this, we critically reviewed HTA appraisals and regulatory documents for products in the relevant indications to understand the potential weaknesses of competitor outcome assessments and inform a robust outcome assessment strategy.

Key results

Our research provided evidence for the COAs used across the indications and highlighted where previous products have been criticised on the appropriateness of their outcome assessments during regulatory and HTA appraisals. Findings were synthesised into a detailed technical report, a digestible summary slide deck and a userfriendly database that could be easily updated as the landscape emerged. Our research highlighted the most commonly used outcome measures across the indications of interest and provided recommendations for our client for the outcome assessment strategy to best support future market access.

Value to the client

Our evidence-based approach, combined with our knowledge of the regulatory and payer landscape, enabled our client to make informed decisions on the choice of outcome measures for their clinical development program for an early-stage asset, helping prepare them for future market access.