Policy Alignment For A New Cell Therapy


Reimbursement Case Brief

A small cell therapy company is developing a novel biologic for use in chronic wound care. Executives wanted to define the product’s most promising reimbursement strategy — especially given changes in Medicare’s payment policies for some wound care products. They also wanted to understand the potential to leverage the product’s regulatory position as a biologic agent, along with high-level clinical evidence they expect to generate through Biologics License Application clinical trials.

Our Role
We performed an in-depth analysis to identify how evidence generated from clinical trials could differentiate the product for coverage. We also looked at how the unique way this therapy is administered might influence payment.

The scope of our investigation included primary research among payers, as well as analysis of information from secondary sources. We confirmed that specific data must be captured and communicated in peer-reviewed publications to gain support for payer coverage. We also identified specific actions that would lead to more favorable payment and pricing conditions.

Our analysis served as the basis for a reimbursement strategy the client can pursue prior to approval and launch of its biologic product. This prompted the company to focus resources on reimbursement during the pre-launch phase, so a solid foundation will be in place for coverage and payment when the product is brought to market.

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