Eli Lilly and Co. is paying $13.5 million to bow out of a class action lawsuit that claimed the list price of several insulin analogue products was fraudulent. Lilly also committed to capping the monthly patient out-of-pocket cost at $35 for its insulin products for at least four years, bringing the total value of the settlement, announced May 26, to more than $500 million, according to the attorneys who filed the class action on behalf of patients in 2017.
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
As expected, pharmacy benefit managers are challenging a final rule that would end Medicare’s antitrust safe harbor for the rebates drug companies pay to the PBMs for formulary placement.
If the FDA’s opening meeting Nov. 19 on the reauthorization of BsUFA is anything to go by, interchangeability could be a key part of the next round of U.S. biosimilar user fee negotiations.