Early-Stage Value & Evidence Strategy Planning

The Brief

An early-stage pharmaceutical company based in the US had a product completing Phase II clinical trials in a rare autoimmune condition. They requested our support with developing the global access strategy for their product, including the design and facilitation of an internal strategy workshop, critique of available evidence, and development of early value materials.

Approach

• Literature review and early value proposition: We initially conducted an in-depth review of available evidence provided by the client and supplemented the evidence with targeted literature searches. We developed draft value messages that best reflected the unmet needs in the disease area that the drug would most effectively address, from both a patient and clinical perspective
• Gap analysis and evidence generation recommendations: We then conducted a gap analysis using the draft value proposition to form a framework. We developed a pre-specified scoring system that allowed identification of areas of the value proposition supported by higher and lower quality evidence. In collaboration with our real-world evidence team, we prepared recommendations for evidence generation activities to strengthen areas of lower quality evidence. We provided strategic input to the client on the pros and cons of different activities, both from a logistical perspective, and considering payer perspectives on different categories of evidence
• Internal value workshop: We designed and facilitated a whole-day, in-person workshop to achieve alignment on the access strategy for the product. We provided recommendations to the client on how to maximise the value of each workshop session, ensuring discussions would build on existing work and would lead to tangible outputs. Cross-functional participants mapped best- and worst-case scenarios for the future positioning of the product, and stress-tested the value proposition from the perspective of payers in priority markets including the US, Japan and Germany. The value proposition was subsequently updated based on stakeholder feedback
• External validation of updated value proposition: We developed questionnaires and facilitated interviews via teleconference with clinical and payer experts, to generate feedback on the strengths and weaknesses of the value proposition. We tailored the wording and framing of questions to reflect the expertise of different interviewee groups, in order to maximise the value of responses. The value proposition was updated based on the feedback, with insights also informing evidence generation plans
• Early global value dossier: We developed an early value dossier, to expand on the evidence supporting the value proposition in a concise and compelling manner, and to facilitate early engagement between local affiliates and payers.

Impact

Despite only two individuals at the small company overseeing the commercialisation of the product, we enabled delivery of this multi-faceted project within the space of 12 months. We also provided strategic guidance to the client on how to approach key challenges in their early strategic planning