Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
Although Pfizer Inc. has the only drugs approved in the U.S. to treat a rare, progressive heart disease, the U.S. Court of Appeals for the Second Circuit agreed this week with the Department of Health and Human Services, and a lower court, that Pfizer’s proposed copay assistance program for middle-income Americans covered by Medicare would violate the federal Anti-Kickback Statute – even if the company has no “corrupt” intent.
Responding to concerns about last-minute changes the Trump administration made to the Part D Payment Modernization Model for calendar year 2022, the Centers for Medicare & Medicaid Services (CMS) said March 16 that it is not moving forward with the formulary flexibilities that could have restricted Medicare patients’ access to necessary drugs.
Ignoring industry’s threat of a lawsuit, U.S. President Donald Trump is moving forward with his plan for “most-favored nation” pricing of certain prescription drugs. The president, on Sept. 13, signed the executive order he threatened in July if industry didn’t come up with a better offer by Aug. 24. Industry did make a counter offer last month, but apparently it wasn’t enough.
Citing the First Amendment, the Fifth Amendment and the logic of fair play, Pfizer Inc. is taking on a Health and Human Services’ (HHS) antitrust policy that prohibits drug companies from helping Medicare beneficiaries with hefty copays.
How U.S. health care emerges from the COVID-19 pandemic is a million-dollar question, as patients, providers, payers and drug manufacturers are adapting to a new reality that’s advancing telehealth and changing how providers interact with patients.