Building Market Access With Four “E”s

By Kevin D. Pawley

“Market Access is a dynamic process for building an ever-growing, ever-changing value story that validates a product’s price/position in healthcare practice”—at least, that’s what I claimed in my last article. Trying to see into the future, I’ve been reading, searching, studying, and talking with people to define the term and predict where this area of the healthcare industry, Market Access, is heading. The irony is that Market Access is evolving so rapidly that I settled on a definition that was equally changeable…my definition is more vague than I wanted it to be: it includes three terms—dynamic, ever-growing, ever-changing—that guarantee constant change.
But I believe in the foundation of my definition: “Market Access is a process for building a value story.” Logically, the next question is, “What are the building blocks of that value story…how do we construct the story?”
I have found answers as simple as “In the US, just build your value story with the Academy of Managed Care Pharmacy’s (AMCP) dossier template.” Or as complex as “Building a Market Access value story is finding the nexus of disease, product, economics, models and markets.” The answer must lie somewhere in between those two: using a “template” and “finding a nexus.”
I’ve arrived at an answer to the question—but because of the ever-changing nature of Market Access, I am open to everyone’s input to correct my answer or expand on it, but please don’t just dismiss it! Clearly, Market Access positioning and the value story to support a product in the US begins with the AMCP Format for Formulary Submissions (now in version 4.0)…but I offer the following “high altitude” view in answer to the question,  “What are the building blocks of that value story?”
The Four “E”s of Market Access
Epidemiology:  The value of any product begins with a comprehensive understanding of the disease: pathophysiology and presentation; risk factors; diagnostic pathways; scope and impact in the target population; practical impact on healthcare systems; and current clinical options. Epidemiology considerations should include real-world questions of “concomitant conditions” that may come into play…who are the subpopulations commonly found in this group—additional diseases or conditions (renal, hepatic, cardiovascular, etc.) that impact the patient, treatment decisions, or healthcare system capabilities. Ultimately, the epidemiology information needed for inclusion in the value story may be modest compared with the clinical and economic data, but it creates a framework for all the other evidence: who has the disease? How does it affect their lives, their jobs, the people around them? How does it affect the healthcare system they belong to?
Efficacy: We can presume that any product for which a value story is being built must have demonstrated its efficacy. But efficacy is a broad topic of consideration: clinical efficacy and effectiveness, safety and tolerability, comparative effectiveness versus standard treatment (where appropriate), and new levels/aspects of efficacy compared to currently available treatments. Importantly, the value of efficacy may be relative—does the product offer a unique aspect to its efficacy? Best-in-class efficacy in a high-risk specific subpopulation? Can its efficacy (ie, responders) be predicted based on genetic or clinical markers? The AMCP Format for Formulary Submissions discusses heterogeneity of treatment effect—"Individual patient variability, variability within populations studied, and variability between clinical studies”—that may be a special consideration in determining the value of a product…perhaps filling a specific unmet need in seemingly refractory patients.
Economics: The economic impact of any product is also an ever-changing issue. When a product first enters the market, its economic status is based on modeling, which itself is based on subjective assumptions and modifiable variables. In an economic model, change a price or an incidence of disease or predicted clinical events and the economic picture will change greatly. The solution has been to create several coordinated models—clinical events, life expectancy, and quality-adjusted life-years (QALYs)—to create reliably interpretable scenarios. Over time, the assumptions included in the models give way to or are refined by real-world evidence, moving the data away from subjectivity and closer to reality. Ultimately, the economic value of a product will depend on patient, provider, healthcare-system, disease-state, and treatment variables.  
Everything Else: For want of a better term, this last category encompasses all of the other potential factors that feed into a “value” proposition. Everything and anything may impact the value story depending on the real-world experience of having, diagnosing, treating, and covering a disease.

• Is the disease rare or common?
• How is the disease diagnosed: clinically, a blood test, specialized imaging, genetically?
• What is the time horizon associated with the disease: diagnosing? treating? surviving?
• What are the demands on the healthcare system to provide treatment: drug supply? storage? infusion facilities? personnel?
• What are the social implications of the disease and its treatments?

The development of HEOR (health economics and outcomes research) data over the past few decades has made clear the scope of possible value-related perspectives: burden of illness, utilization and policy, patient-centered care, patient-reported outcomes, adherence and compliance, real-world outcomes, health technology assessment, productivity, quality-of-life, and many more. “Everything else” matters as long as there is evidence to support it.
Which brings me to my summation: the Four “E”s of Market Access can be summed up with a single E: Evidence. In days gone by, Sales & Marketing of a pharmaceutical product was a matter of “features and benefits.” Today, creating a space for a pharmaceutical product—Market Access—is a matter of “features and evidence.” To tell the ever-changing value story that creates a product’s Market Access, the new world requires that Epidemiology, Efficacy, Economics, and Everything Else be supported by Evidence that proves the case.

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