By Kevin D. Pawley I’ve enjoyed a long career in medical communications, a business that has changed as constantly and quickly as the pharma market that it supports. Among all the constant change has been the rise, expansion, and confusion of a thing called “Market Access.” A long time ago, Market Access was only a matter of “negotiating a price with payers.” As payers began to manage their costs more aggressively—based on utilization data that piled into their databases—the challenges of offering the “right price” grew more complex. Outcomes became an important addition to clinical efficacy; economic impact became an important addition as healthcare costs climbed; now, real-world evidence has provided a powerful perspective as the volume of utilization data has grown to astronomical size and modeling of these data gives it refined meaning. Today, definitions of the term Market Access are as numerous as the people you ask…but everyone will use the word “value” in the definition, maybe not even mentioning the word “price.” You’ll notice, however, that those same people will show frustration with their definitions, because in the end, they’ll have to justify and validate a price…based on an ever-changing value story. Even the Academy of Managed Care Pharmacy (AMCP)—which established the industry standards for evaluating products for formulary placement, coverage, and reimbursement decisions in the US—says that “communications between manufacturers and healthcare decision makers should evolve over the product lifecycle as new evidence becomes available.” While launch-timed dossiers may rely to a greater extent on modeled projections based on clinical trial evidence and reasonable assumptions related to market dynamics and product uptake, new evidence describing the actual use and effect of the product in a real-world setting should be developed to inform formulary management across the product lifecycle. Ongoing generation of real-world evidence serves the important purpose of further defining and validating claims related to product value. (The AMCP Format for Formulary Submissions, Version 4.0; “Foreword”) The resulting definition of Market Access, then, is a dynamic process for building an ever-growing, ever-changing value story that validates a product’s price/position in healthcare practice. “An ever-growing and ever-changing value story” creates a continual challenge to keep the story up-to-date, to educate internal personnel continually, and to communicate with the market about complex real-world evidence…the scope and meaning of Market Access continues to evolve.
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