Understanding Patient Access Programs

Understanding Patient Access Programs & Their Strategic Utility During Pre- or Post-Market Clinical Trials

Early reimbursement planning can be critical to a company’s successful launch of an emerging or innovative healthcare technology. This includes what occurs during the pivotal trial evaluating a particular product.

Technologies involved in upcoming or ongoing research should understand the role of a Patient Access program during their trial, including the essentials for establishing a compliant and efficient Patient Access program, in addition to the strategic reasons behind pursuing the program during a clinical trial.

Though not a “one-size-fits-all” approach, utilizing Patient Access solutions during the clinical trial phase serves as the foundation for executing on a longer-term reimbursement strategy.

• Understand what a Patient Access program is in its basic form. This will include an overview of processes, strategic intent, and the value of the program for commercialized technologies, with an introduction to Patient Access program utilization during a clinical trial.

• Determine if a Patient Access program would have utility during your clinical trial.

• Determine the value proposition for all stakeholders (i.e., Patient, Provider and Manufacturers)

• Understand that Real World Evidence (RWE) will be required beyond what is needed for regulatory approval/clearance

• Establish Patient Access solutions to overcome evidence hurdles and build market demand with the payors for the technology

Hear from:

Daria Schuman, Senior Director, Reimbursement, Health Economics & Market Access, MCRA
Aleshia Polk, Senior Director, Patient Access Program Operations, MCRA

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