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Value Communications for Market Access: Case Study 2

Situation:

A US device manufacturer was facing an uphill battle securing Medicare beneficiary access to a new, important, treatment alternative to prevent thrombolytic events in patients with a particular heart condition.  Local Medicare medical directors were declining to approve patient access.  In addition, the broad scope of the labeled indication was potentially threatening national coverage.

Solution:

The policy experts on the 3D Market Access team applied their knowledge of the Medicare coverage environment to assist the company in developing a focus on key policy issues, the data and messages to address those key issues. We also conducted analysis of other relevant coverage positive and negative coverage decisions to identify consistent or inconsistent application of clinical data or policy issues.   Because 3D supported this manufacturer at their FDA panel meeting, 3D was uniquely positioned to work with the company to select and summarize years of data from multiple clinical trials and then develop a succinct set of messages and communications related to coverage.  This core communications work aligned everyone in the company to the same core issues, data, and messages for all coverage-related communications.

Results:

Medicare coverage was granted. 3D’s prior involvement guiding the company through the FDA Advisory Committee process for this device enabled 3D to create a highly efficient process to assist the company with its Medicare coverage request.