Description: The coming wave of biosimilars could dramatically affect prescription drug costs and benefit strategies over the next several years. The launch of many Humira biosimilars in 2023 is the Big Event that will largely determine the impact of the biosimilar wave. Payers have many decisions to make about coverage and formulary tiers. What factors will drive payer decision-making?

Description: PBMs are positioned in the healthcare delivery system as the only entity that is not regulated for profitability. The Commercial Fully Insured Health Insurance Plans are heavily regulated by the State Insurance Commissioner who allows only 2%-3% profit margin. The self-funded Health Plans are regulated by ERISA fiduciary responsibility that prohibits excessive compensation. PBMs are classed as a service provider and are not regulated by either. This allows PBMs to implement large, unreasonable mark ups for profit. PBMs are massive commercial entities, states are trying to sue under antitrust law. PBMs found a sweet spot in the regulation. Large Insurance Carries understood that and either acquired large PBMs or merged with them. It is likely that a combination of measures will be needed to regulate PBMs. The most direct approach would be for Congress to pass a law establishing PBM as a fiduciary under ERISA just like an “investment advisor” providing advice for a fee. Establishing PBM as a fiduciary will help Courts and other Federal Agencies ensure that PBMs do not unfairly retain rebates and inflate the prices of Rx drugs sold to employer health plans, and the US population in general.