Thought Leadership

According to the American Society of Health-System Pharmacists (ASHP), U.S. drug shortages are the highest they’ve been in more than two decades. As of the end of 2024’s first quarter, 323 drugs were in short supply, including many chemotherapy, ADHD, and pain and sedation medications. These drugs run the gamut from basic drugs to life-saving therapies, and are predominantly generics, with 46% of the quarter’s new shortages being injectables.

In the shift toward value-based care, more payers are outsourcing the management of specific therapeutic areas to third-party specialty benefit managers (SBMs). These companies help payers manage high-cost, high-complexity disease states by leveraging provider networks and making coverage recommendations intended to improve outcomes and lower cost.

Manufacturers engage with managed care organizations (MCOs) in a number of ways, from deep conversations regarding clinical indications and brand coverage to general sessions focused on product portfolios and overall business. Although pharma companies have historically engaged with payers in phase III of the drug development lifecycle, pharma/payer meetings are now shifting to earlier in the timeline, during phase I and phase II. 

At the beginning of May, almost 8,000 attendees descended on Las Vegas for Asembia’s AXS24 Summit. While all of the session speakers discussed the future of healthcare in one way or another, MMIT noticed a few common trends about the state of the industry today.

At the beginning of May, almost 8,000 attendees descended on Las Vegas for Asembia’s AXS24 Summit. While all of the session speakers discussed the future of healthcare in one way or another, MMIT noticed a few common trends about the state of the industry today.

Navigating the landscape of patient access in the pharma industry has become increasingly complex, extending far beyond traditional channels. The challenges are multifaceted, influenced by evolving policies, innovative payer strategies, and shifts in provider dynamics.

Recent market research conducted by MMIT and The Dedham Group, encompassing insights from more than 300 industry stakeholders, sheds light on the critical barriers to patient access that are top of mind for pharma executives.

Despite the rapid evolution of personalized medicine, access to genetic testing and next-generation sequencing (NGS) is a challenge—due in no small part to coverage confusion. Physicians struggle to navigate poorly defined testing coverage policies and a fragmentated payer and vendor ecosystem, resulting in delayed care for patients requiring precision therapies.

The hypertension market is no stranger to new entrants, with therapies ranging from calcium channel blockers and angiotensin II receptor blockers (ARBs) to angiotensin-converting enzyme (ACE) inhibitors and beta blockers. As a mature market, generics are widely available, and many of the more recently approved therapies are combinations of existing agents or different formulations of FDA-approved treatments.

Consideration of patients’ social determinants of health (SDoH) has been a facet of healthcare delivery in the United States for decades. The CDC defines SDoH as the nonmedical factors that influence a patient’s health outcomes, such as access to care services and medication, housing and food stability, education levels, and employment.

When it comes to the degree of payer management within a therapeutic area, pharma companies are becoming the victim of their own successes. One prime example is the rapid growth of competitive therapies across tumor types, pharmacological classes, and mechanisms of action in oncology. Payers have responded to the launch of more innovative and highly effective therapies with increased utilization management restrictions to balance the cost and quality of care.