Thought Leadership

When a pharma company secures expedited approval for a drug in development, everyone involved is usually thrilled. After all, a faster approval process means that patients in need will be able to access this critical treatment more quickly. Manufacturers also assume that expedited approval will lead to faster revenue recognition, but this isn’t always true.

Due to the end of the public health emergency for COVID-19 and subsequent redeterminations for Medicaid, health plan enrollment data has become increasingly volatile. As of this spring, states were able to resume Medicaid eligibility redeterminations, which were stopped during the pandemic. For three years, states couldn’t check members’ income to determine whether they were still under the income limits for Medicaid in their states, which caused Medicaid membership to increase steadily throughout the pandemic, particularly in the first year, when so many people lost their jobs. Now that states can disenroll beneficiaries who don’t meet income requirements, the opposite is happening, and Medicaid enrollment is decreasing for the first time in years. In addition, we expect to see a corresponding increase in health exchange enrollment and eventually in commercial group membership.

The explosion of real-world data (RWD) now available to pharma companies can be overwhelming. While many larger manufacturers with their own teams of data analysts have been using RWD for years, smaller manufacturers are just beginning to incorporate RWD into their clinical development and market access strategies. Which data sets do they need, and how can they use them most effectively?

Many oncology manufacturers assume that a therapy’s inclusion on clinical pathways is more important than its coverage profile, but this isn’t always true. Across every oncology class, manufacturers need to know which organizations—IDNs, provider organizations, payers or PBMs—have the biggest positive and/or negative influence on their products’ utilization.

Recently, payers have started to use the phrase “member disruption” to refer to the potential impact of an impending formulary change on their members. This qualitative term is mentioned with increasing frequency during contracting discussions and P&T sessions, although the weight of these considerations varies between organizations.

In the wake of the COVID-19 pandemic, drug shortages, caused by increased demand, supply chain difficulties, and supplier issues have plagued payers and patients alike, making it harder for patients to access the therapies they need and causing delays in treatment. Drug shortages hit a record five-year high in 2022, according to a U.S. Senate report.

Over the past two decades, skyrocketing list prices for insulin have threatened medication adherence for the estimated 7.4 million American diabetics who rely on insulin to manage their disease.

For manufacturers, building a static commercialization strategy will only take you so far. But infusing that strategy with real-world data (RWD)—consisting of medical claims, lab testing and pharmacy data, and electronic health records—provides a more holistic view of the patient journey.

Respiratory syncytial virus (RSV) can impact anyone, but infants and older adults are most at risk of illness. With multiple new immunizing agents gaining FDA approval in 2023—and more in the pipeline—manufacturers and payers have a role to play in educating patients and providers about the importance of immunizations to combat RSV.

For manufacturers, the success of a new brand hinges on its uptake in the first few months after launch. Many pharma companies are surprised to realize that payer coverage is more limited than anticipated, especially in highly competitive markets. A poor launch can quickly lead to a disappointing performance trajectory.