text: Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.
  The FDA has approved a novel formulation of insulin lispro (Lyumjev) for the control of blood sugar in adults with type 1 and type 2 diabetes. The product is injectable and designed for rapid absorption of insulin following meals. It was developed by Eli Lilly and Company.
  The drug company said the insulin product will be made available to patients with commercial insurance or without insurance of any kind to purchase monthly supplies of Lyumjev for a maximum out-of-pocket of $35, based on an insulin-affordability program Eli Lilly implemented in April.
  "Lilly is committed to ensuring all of our insulins, including Lyumjev, are accessible to people living with diabetes through our wide range of affordability options, such as the Lilly Insulin Value Program," said Adrienne Brown, vice president of US Connected Care and Insulins for Lilly, in a statement.
  The move to cap insulin prices at $35 comes amid widespread policy changes by private and public payers in response to growing public concerns about the gap between those who can afford insulin and those who cannot.
  In March, CMS announced a savings model designed to encourage Medicare Part D sponsors to lower insulin co-pays to $35 for beneficiaries in the coverage gap. The agency predicted a potential savings of $250 million, based on extended manufacturer discounts, over 5 years. In May, CMS reported that health payers representing over 1750 individual Medicare Part D and Medicare Advantage plans had signed aboard the plan, set to start in 2021.
  Lilly has previously said a reason for its cap on insulin costs is the financial hardship now faced by many US residents as a result of coronavirus disease 2019.
  The insulin lispro product was previously approved in Japan and the European Union. Lilly said that in the United States, the list price will be the same as for Humalog, also a Lilly insulin lispro drug.
  The FDA approval was based on data from 2 randomized, phase 3 studies: PRONTO-T1D and PRONTO-T2D. These compared Lyumjev and Humalog in patients with type 1 and type 2 diabetes. Each study met the end point of noninferiority for reduction of glycated hemoglobin.
  “Lyumjev demonstrated superior reduction in blood glucose spikes at both 1 hour and 2 hours after a test meal compared with Humalog,” Lilly said. Safety and tolerability profiles were similar.