Defining US Pharmaceutical Market Access in 2024

Over the past few decades, the roles and responsibilities within market access have significantly evolved, driven by the increasing sophistication of "payers" and other population-based decision-makers (PBDMs). Not long ago, professionals in the US market access sector used terms like managed markets, organized customers, and themes centered around value to define their roles. We felt it was essential to document this shift and provide a clearer set of definitions for this rapidly changing field.

We have chosen the term "market access" due to its applicability across various industries, while recognizing the need for specific contextual clarification within the healthcare manufacturer sector.

Market access (across industries) is the ability of a company or country to sell goods and services across borders. While in this use it is particular focused on international trade and the government processes and negotiations which may be present from both the exporting and importing government.

Market access (for healthcare manufacturers) refers to ensuring that the right patients can obtain healthcare products at the right place and time. In the United States, this necessitates adherence to complex federal and state regulations while maneuvering through a fragmented and intricate reimbursement landscape. On a global scale, market access encompasses international trade, health technology assessment (HTA) processes, and interactions with governments in markets where they serve as the primary payer.

Population-based decision-makers (PBDMs) are stakeholders responsible for devising care plans, policies, formularies, and more for large patient groups. Typically, PBDMs consider both clinical and economic factors to guide their decisions. We use this broader term rather than "payers" to encompass IDN, hospital, and practice leadership. However, we refer to decision-makers in health insurance and pharmaceutical benefit management as "payers." It's important to recognize that "payers" might not be the most accurate term due to the complexity of this space, as some stakeholders act as "transaction intermediaries" rather than direct healthcare payers. This topic will be further explored in upcoming blog posts.

In the realm of healthcare market access, we have identified seven key areas of focus that serve as essential knowledge bases for experts. While some market access professionals have deeper expertise in certain areas, these domains collectively provide a comprehensive foundation.

The 7 domains of US market access:

• Population-management theory: The foundation of the PBDM mindset includes concepts like cost-effectiveness analysis and budget impact analysis. Though not explicitly mandated in the US, these frameworks are often utilized as tools for assessing value.

• Coverage: The various types of insurance options available to patients in the US include employer-sponsored plans, exchange plans, Medicare, and Medicaid, among others.

• Policy: Typically centered on utilization management (UM) within the pharmaceutical sector, coverage decisions also influence the way healthcare items are covered.

• Reimbursement: The processes through which products are financed by payers, such as insurance companies including coding systems which document the product use and determine reimbursement

• Pricing: Establishing the price for a pharmaceutical product, usually referred to as the Wholesale Acquisition Cost (WAC), is a strategic decision

• Contracting: Developing a tailored contract strategy to meet the distinct needs of various customer segments

• PBDM engagement (marketing & sales): Creating a messaging strategy along with the "sales" execution of communicating to the unique needs of PBDMs

These seven domains encompass a wide range of topics and concepts crucial for understanding the current healthcare market.