Early Market Access Planning for Successful Commercialization of Healthcare Innovations in the USA

There are many considerations to account for, both prior to and during the development of any new healthcare solution or innovation. Proactive steps such as performing market research, assessing competitors, and developing a strategy to comply with country-specific regulatory requirements are very important and well-established. If the strategic plans for your offering include making your innovation available in the United States market, it is critical to assess and define a cohesive and complementary market access strategy to maximize your chances of successful market entry and adoption.

Market Access in the US

The US healthcare system continues to undergo rapid transformation. The number of impactful innovations coming to market continues to grow at an accelerated pace. Competition is fierce, raising capital is challenging, and those who don’t account for market access considerations early in the development process are more likely to struggle. US market access can be defined as the intersection three score, interdependent categories:

1. Reimbursement-pricing, coding, coverage & payment
2. Value proposition–evidence showing the clinical, economic, quality of life(QoL) impact on patients, clinicians, payers, and society versus competitors and standard care
3. Payer access–medical policy and payment from government & private insurance companies, health systems, self-insured employers

Important Questions to Consider

Is there (what is) a viable reimbursement pathway to payment for your solutions from Medicare and private health insurance plans? Is there a code I will need for payment from insurers? Will I need a new code, or can I use an existing code? What are the requirements to obtain a new code? What is the value (clinical, economic, quality of life improvements) your solution can bring to patients, physicians, and insurance companies in the US versus competitors and/or standard care? How does your innovation improve patient outcomes, change physician treatment protocol? Is your solution cost-effective? What is the budget impact on payers? (How) does it improve patient experience? Which payers should you target? What do payer Medical Directors think are the most important areas for which to define and illustrate value for your specific innovation? What is your evidence and publication strategy to illustrate this value to various stake holders in the US healthcare ecosystem? Can you (how can you) incorporate various endpoints into your clinical trial design? What other studies will you need? What other tools will be necessary to show value? How will you price and justify the pricing for your solution in the US?

Whether your innovation is a diagnostic test, medical device, digital platform, SaaS or a therapeutic, assessing and establishing market access pathways early in the development process, combined with thorough market research and a well-defined regulatory approach (when applicable) will maximize the opportunity to drive successful market entry and adoption for your innovation. The author is a visionary market access leader with extensive experience in health technology reimbursement, value creation, and payer access.

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