Medtech & Diagnostics

Global Diagnostics Commercial and P&MA Strategy

Charting a Global Commercialization Path

What Our Client Needed

A leading diagnostics firm with historic focus in R&D services and technology sought a partnership with a pharmaceutical company to develop proprietary next-generation sequencing (NGS) diagnostics for a variety of oncology biomarkers, requiring a better understanding of the current and evolving reimbursement landscape in the U.S., EU, and Asia.

ClearView has extensive experience developing global commercialization and reimbursement strategies for diagnostics. In addition, ClearView was well-positioned to convey the perspectives of the partner pharma company to ensure our client was considering all relevant angles.

Our Solution

ClearView developed a multi-faceted approach to elucidate current and evolving NGS pricing and market access trends in oncology and understand potential value drivers for a proprietary CDx in an emerging, but increasingly competitive, landscape.

In addition, we assessed stakeholder perception of the client’s assay and evaluated potential pricing and reimbursement or funding pathways. Ultimately, we synthesized global and market-specific strategic considerations for the client, highlighting the funding pathways with greatest viability and potential strategies enhance reimbursement potential.

Our Impact

ClearView’s analysis provided the client with a strategic roadmap to ensure full realization of the diagnostic’s value.

This roadmap included development of a compelling value narrative tailored to each market and an outline of key advantages related to clinical and economic value. In addition, we worked with the client to align on the most likely paths to funding and reimbursement for each market, accounting for tradeoffs between price, access and volume.

Lastly, broader recommendations around market building activities helped our client thoughtfully consider potential investment needs for laboratory infrastructure, stakeholder education, and policy initiatives, among other considerations.