Case Studies – Market Access
A growing biotechnology company in the US, specializing in gene-screening diagnostics in oncology approached to develop their regulatory documentation for the FDA (NDA) and a single technology appraisal for NICE in the UK. We prepared and successfully submitted both appraisals leading to approval and recommendation for use.
We also trained the field based market access team to effectively communicate the value proposition and budget-impact model of the novel diagnostic devices to regional commissioners and payers. This involved the development of a focused value dossier and a negotiation-handler document that predicted the likely questions (sampling in schematic below) from commissioners and supplied top line and in-depth responses to issues concerning fulfillment of unmet need and the economic impact of the device on overall healthcare services according to endpoints demonstrated in the budget impact model.
In addition, the value dossier and negotiation documents we also armed the Market Access team with a smart phone app to calculate cost-benefit based on regional/local need and patient numbers for utilization with the payers. This tool was particularly effective in helping to communicate the problem to payers before offering up a solution.