Thought Leadership

The past few years saw the launch of several direct-to-consumer (DTC) programs, including Amazon One Medical and Mark Cuban’s Cost Plus Drugs. In 2024, several manufacturer-designed DTC programs, such as LillyDirect and PfizerForAll, have been added to the mix, demonstrating pharma’s continuing shift toward an integrated model of patient care.

While these programs can benefit multiple stakeholders, pharma companies should be aware of the existing and potential challenges before rolling out such a program.

The weeks preceding a pharma product’s launch date are a critical window for market access teams. The ability to pivot and adjust to last-minute shifts can make all the difference between a successful first year and a disappointing launch trajectory. While much of your market access research may have already been completed by the time you go to market, there are several ways your team can continue impacting coverage and utilization.

Our first post in this series discussed the benefits of early market access planning in Phase II-III, while the second post shared six essential steps to complete in the year before approval. In this post, we’ll discuss how post-launch market research on payer and HCP behavior can enable optimal performance for your brand.

As the pharma industry continues to adjust to the provisions of the Inflation Reduction Act (IRA), the country will soon be ushering in a new presidential administration—leaving the future of the IRA in question. Despite ongoing regulatory uncertainty, manufacturers will still be focused on the same concerns: drug development, pipeline performance and ensuring patient access to their therapies.

To better understand what 2025 might bring, I asked three of my colleagues to share their perspectives on upcoming market shifts. Their answers provide key insights into the year ahead.

Initially developed to manage type 2 diabetes, glucagon-like peptide-1 (GLP-1) agonist medications have become exceptionally popular for weight loss. High-profile celebrity endorsements and widespread media coverage has led to an overwhelming spike in demand.

By any estimation, the American market for weight-loss GLP-1s is enormous. According to a Kaiser Family Foundation analysis, more than 40% of privately insured adults under 65 are clinically eligible for a GLP-1 drug to treat obesity. Although there are several GLP-1 agonists on the market, only three are currently approved for weight management: Novo Nordisk’s Saxenda (liraglutide), Novo Nordisk’s Wegovy (semaglutide), and Eli Lilly’s Zepbound (tirzepatide).

In recent years, pharma companies have begun to embrace lab data as a richly rewarding dataset for a whole host of purposes, including trial enrollment and site identification, patient monitoring and disease progression, and commercial targeting and market access insights. Along with test orders, values, and results, deidentified lab data includes a wealth of information, such as a patient’s demographic information, diagnosis codes, and ordering provider and facility details.

During the pandemic, the number of individuals in the U.S. enrolled in both fee-for-service and managed Medicaid programs increased dramatically. This increase was tied to a provision in the Families First Coronavirus Response Act, which boosted federal dollars to the states in exchange for keeping individuals covered through Medicaid, even if their eligibility changed since they enrolled.

In a competitive market, pharma companies are increasingly relying on various datasets to drive their decision-making. With so many disparate sources, however, data standardization presents a challenge, especially for companies eager to use predictive analytics tools. In a recent survey of 125 pharma executives, nearly half cited data integration and cleanliness as the primary roadblocks to adopting technologies like AI. 

As payers grapple with their ever-increasing spend on healthcare services, many are entering into various arrangements with pharma manufacturers to help mitigate their risk when paying for cell, gene and specialty therapies—which often have price tags ranging from several hundred thousand to millions of dollars. A warranty-based agreement is one approach that can benefit both stakeholders. These agreements can potentially boost the uptake of high-cost treatments by increasing the likelihood that payers will cover products, particularly those with unclear efficacy or durability.

To fully understand how payers impact patient access, pharma companies should be evaluating payers using multiple datasets, including both coverage/restriction data and claims data. While payer policies indicate how payers plan to manage a product or service, medical and pharmacy claims reveal how payers actually manage that product in reality.

For the past decade, biosimilar adoption in the U.S. has proceeded at a relatively slow pace, due in large part to limited financial rebates for payers and provider preferences for biologics. Recent research suggests that utilization is finally picking up steam as more health plans place both biosimilars and their reference biologics on preferred formulary tiers.

A Health Affairs study found that preferred coverage of a single biologic declined by 47% between 2017 and 2022, while preferred coverage of multiple drugs rose 46% in the same period. In September 2024, an analysis of coverage data from MMIT Analytics confirmed the progression of this trend, finding that most patients covered by the same health plans tracked in the Health Affairs study are covered for both biosimilars and their reference biologics.