Understanding Patient Access Programs

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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

Daria has 11 years of experience relating to health economics, reimbursement, and public policy.

Ms. Schuman is responsible for overseeing the development and negotiation of clinical trial agreements and related budgets on behalf of study sponsors running clinical research managed by MCRA's Clinical Research Organization.


Aleshia Polk, Senior Director, Patient Access Program Operations, MCRA

Aleshia has more than 17 years of experience in the healthcare arena. Some of her areas of expertise include performance management, policies and procedures, reporting and process improvement.
Ms. Polk leads the Patient Access Program (PAP) service line within MCRA’s Reimbursement, Health Economics, and Market Access Division.

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MCRA is the leading industry-specialized CRO and integrated advisory firm that assists clients through the entire technology life cycle, from strategic planning through commercialization.

MCRA's regulatory team, which includes many former FDA Branch Chiefs and reviewers with combined agency and industry experience in the areas of cardiovascular, orthopedics, neurology and digital health, provides best in class regulatory strategy support.

MCRA's reimbursement team works with many early stage companies to define and execute successful US reimbursement and market access strategies across all medical devices.

MCRA's full service CRO can fully manage clinical studies, beginning with study design and protocol development, or provide support to companies as they take lead in study execution.

The MCRA team provides services to a wide range of organizations in the healthcare industry, including start-ups to the world's leading healthcare organizations.

The full suite of integrated advisory services helps augment internal capabilities and processes, as well as ensure the ability to overcome regulatory and reimbursement hurdles while collecting the necessary clinical evidence.

www.mcra.com

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