Thought Leadership

In the complex healthcare analytics landscape, understanding the nuances of open and closed claims is critical for researchers and analysts. Open and closed claims each offer unique insights into the patient journey.

Open claims, sourced from various clearinghouses and warehouses across the U.S., present a vast collection of data, while closed claims, adjudicated by insurers, provide a detailed, individualized perspective. Open claims are rather like a wide-angle view of the forest, whereas closed claims are more like a view of the individual trees.

Our first post in this series discussed how early market access research, conducted in the 12-18 months before launch, helps pharma companies identify differentiators and establish accurate expectations.

As your organization moves closer to launch, your market access team will need to establish a commercially focused definition for your patient population. You’ll need to identify treating physicians, define the current standard of care, and establish how your brand will fit into the existing landscape. Critically, your team will also need to develop a pricing and contracting strategy to encourage early coverage determinations.

Before physicians prescribe a new therapy, they need to trust that it is the most effective and appropriate treatment for an individual patient. They need education on the drug’s efficacy and safety, dosing and administration, and the clinical criteria that define eligibility. They also need to know if the drug is affordable and accessible for their patients.

According to our 2024 State of Patient Access survey, 81% of pharma companies are launching their market access planning much earlier than they did five years ago. By Phase I, one-third of pharma companies are already engaged in market access research, with most pharma companies (54%) engaged by Phase II – III.

For the past year, Medicaid has been the predominant topic of conversation for those who monitor insurance market share shifts. Medicaid enrollment peaked at 94.5 million in April 2023, when states resumed eligibility redeterminations after a multi-year pause. In the year that followed, Medicaid enrollment declined 10.4%, and has continued to plummet in recent quarters, with this channel losing nearly 4.9 million beneficiaries from Q3 to Q4 2023.

The vertical integration between payers, PBMs, specialty pharmacies, and providers has grown stronger in the last decade, with more negotiating power concentrated among a handful of major players. Now insurers are adding production into the mix, following the lead of CVS Health, whose strategy to cash in on the scramble for Humira biosimilar market share has proven successful.

For manufacturers of medical benefit drugs, ensuring accurate provider reimbursement is essential. If providers are unaware of how to appropriately bill for a particular drug, their errors will result in claims denials, which in turn may lead them to stop prescribing that drug in favor of another. Inadvertent underbilling for services rendered is also a top provider concern, especially given the popularity of buy-and-bill procurement.

For years, many manufacturers have assumed that pre-market physician education was not strictly necessary unless their brand was the first to market or had a novel mechanism of action. With the advent of precision medicine, however, ongoing disease state education has become increasingly critical. Today’s molecular-targeted therapies have very different treatment paradigms, not to mention cost structures.

Since its passage in 2022, many have speculated on the impact of the Inflation Reduction Act (IRA) on providers, manufacturers and payers—especially those with Medicare Advantage plans. Just over half of all Medicare beneficiaries are currently enrolled in a Medicare Advantage plan, and enrollment is projected to reach 60% of the eligible population by 2029.

Although the biosimilar market is expected to continue growing over the next few years, adoption thus far has been somewhat slow and uneven. Recent research published in Health Affairs takes a look at how upcoming provisions of the Inflation Reduction Act (IRA) are likely to impact biosimilar coverage, concluding that both Medicare beneficiaries and the government could realize substantial savings if Part D formularies resembled those of employer-sponsored plans.