What is the significance of the Acthar case?
Acthar contains every element critics cite — monopoly, buyout of potential competition, steep price increases, prescriber payments, copay subsidies masking true costs, and Medicaid rebate manipulation — making it the clearest example of how an old drug without competition can become extraordinarily expensive.
Acthar is arguably one of the clearest examples of how an old drug with little competition can become extraordinarily expensive without new evidence of benefit. Every element that critics worry about is present: a monopoly, a buyout of a potential competitor, steep price increases, heavy payments to prescribers, spending concentrated among a small group of specialists, subsidised copays that blunt price signals, and alleged manipulation of Medicaid rebate rules. Regulators did respond, through the FTC's divestiture-style remedy and the Medicaid rebate reset, but only after Medicare and Medicaid had spent billions. The case has influenced policy thinking on inflation rebates, copay charities and the FTC's approach to acquisitions of pipeline or foreign products that could compete with a US monopoly drug.