Skysis | CASE STUDY
Optimizing the Payer Value Story
01 | BACKGROUND
A compound that demonstrates robust efficacy and a good safety profile in clinical development is likely to receive marketing approval by regulators. A compound’s efficacy and safety are measured against the primary and secondary endpoints included in registration trials. However, a compound’s regulatory approval does not guarantee payer reimbursement, especially in therapeutic categories that are tightly managed.
02 | CHALLENGE
Optimally, the framework for the payer value story is established when a compound reaches proof of concept in clinical development. The payer value story then impacts the design of the late-stage clinical development program, including registration trials and post-marketing studies. Sometimes the payer value story is overlooked or is started late, requiring a quick assembly from available data sets just months before a product is approved or launched.
03 | METHODOLOGY
For clients that engage Skysis early in clinical development, Skysis assists in building the payer value story framework, identifying clinical endpoints, formulation, and dosing included in a product’s label that support a premium value. Skysis also identifies the clinical and commercial data necessary to support the unmet need within the disease and the beneficial economic impact of the product for successful negotiation with payers. For clients that start later, Skysis’ market access experts will triage the situation, expertly leveraging Skysis’ panel of payer executives for relevant and actionable insights on the treatment options, appropriate analogs for payer management strategies, and how the product’s target product profile (label expectations) might be managed, or utilization otherwise restricted. A plan is then established to address the highest priority areas of the payer value story.
04 | OUTCOME
Skysis delivers an experienced and independent view of the payer value story. Our knowledge and insights enable clients to identify risks in the payer value story, opportunities for enhancement, and actionable plans to effectively address both.
