Finally, Karina gives us a view into the changes for Medicare Advantage into 2024. As this segment of health insurance continues to grow, it may have growing influence on access to therapeutics. She provides several strategies to ensure manufacturers stay abreast of changes and position themselves favorably.

An overarching theme throughout the health care ecosystem—including behavioral health—is that within a landscape fraught with post-pandemic and economic transitional uncertainty, patients and their care partners expect health care stakeholders to simplify complexity, help manage risks, and solve their problems. A 2023 Bain survey, and an NEJM article, “Health Care 2030: The Coming Transformation,” are calling for the abandonment of traditional perspectives, and adoption of transformative mindsets and systems focused on providing solutions and offering personalized, preventive care for populations.

The Public Health Service Act 340B Drug Pricing Program enables providers that serve vulnerable patient populations to access outpatient drugs at significantly lower costs, which helps improve overall patient care. Since the Medicaid Drug Rebate Program and the 340B Drug Pricing Program were established in the early 1990s, stakeholders have struggled to resolve questions surrounding duplicate discounts. Expanding these programs under the Affordable Care Act in 2010 exacerbated the issue and further complexity will be added through the Inflation Reduction Act.

American author H.P. Lovecraft wrote that “the oldest and strongest emotion of mankind is fear, and the oldest and strongest kind of fear is fear of the unknown.” And unknown territory is where we are heading when it comes to forecasting payer actions in response to the impending liabilities and costs stemming from the Inflation Reduction Act. What we know for sure, however, is that payer liability is increasing.

On September 15, 2023, the Food and Drug Administration released draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency is accepting comments through November 17, 2023, and the finalized guidance will revise and replace the 2018 guidance for the industry entitled “Labeling for Biosimilar Products.”