Insulin lispro

Dive Brief:The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.The agencys administrative complaint alleges CVSCaremark, Cignas Express Scripts and UnitedHealths Optum Rx steered patients toward higher priced insulin to bring in larger rebates from pharmaceutical manufacturers.As a result, patients who werent eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.Dive Insight:The FTCs long-awaited lawsuit comes as tensions rise between PBMs, middlemen in the drug supply chain, and the lawmakers and regulators looking to crack down on U.S. drug prices.The companies have abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication, the FTC said.The agencys complaint hinges on how PBMs have negotiated discounts for insulin medications with drugmakers.Pharmaceutical companies pay PBMs to have their medications placed on a favorable tier of the formulary, or list of covered drugs. According to PBM critics, that structure incentivizes the middlemen to prefer drugs with higher list prices, resulting in higher consumer costs.In 1999, the average list price of Eli Lillys brand-name insulin, Humalog, was $21, according to the FTC. But due in part to PBMs rebating practices, Humalogs list price increased to more than $274 by 2017, the complaint alleges. Meanwhile, PBMs collected billions of dollars in rebates.In a statement, Rahul Rao, the deputy director of the FTCs Bureau of Competition, called Caremark, Express Scripts and Optum Rx medication gatekeepers that extracted millions of dollars off the backs of patients who need life-saving medications.The FTCs administrative action seeks to put an end to the Big Three PBMs exploitative conduct, Rao continued.The FTC also names group purchasing organizations owned or affiliated with the three PBMs Zinc Health Services, Ascent Health Services and Emisar Pharma Services as defendants.Express Scripts, Caremark and Optum Rx decried the FTCs lawsuit on Friday.The action is based on a profound misunderstanding of how drug pricing works, according to an Optum Rx spokesperson, and is simply wrong, a Caremark spokesperson said.Andrea Nelson, Cignas chief legal officer, slammed the FTCs lawsuit as an unsubstantiated and ideologically-driven attack.The fact is that in the unlikely event the FTC succeeds in its suit and forces PBMs to include drugs on formulary even if they have higher net costs for plan sponsors and regardless of whether they are clinically necessary the FTC will drive drug prices higher in this country, Nelson said in a statement.PBMs maintain that they pass through the majority of rebate savings to their clients, and save customers money overall by negotiating down the price of drugs. Instead, the industry has attempted to refocus blame on drugmakers, arguing the core problem behind unaffordable U.S. drugs are the list prices set by manufacturers.The FTC noted PBMs arent the only problematic companies. The Bureau also remains deeply troubled by the role drug manufacturers like Eli Lilly, Novo Nordisk, and Sanofi play in driving up list prices of life-saving medications like insulin. Indeed, all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns, the agency said in a statement.Speculation the FTC would sue the companies started in mid-July,after the FTC released an interim reporton the status of its yearslong investigationinto the PBM industry.Express Scripts sued the FTC over the report on Tuesday, arguing it was defamatory and damaging to the PBMs business.Regulators and lawmakers in Washington have been more aggressive in cracking down on profiteering in the healthcare industry.Congress appeared poisedto curb some PBM practices last year, including forcing the companies to disclose more information about their negotiation practices to their employer and health plan clients. The push failed to materialize in any passed legislation. Still, lawmakers have held a number of hearings this year, including one over the summer in the House Oversight Committee where representatives on both sides of the aisle were highly critical of the drug middlemen.PBMs have also faced a number of recent lawsuits over their alleged contribution to rising costs, including from state attorneys generaland independent pharmacies. '

Eli Lilly is conducting five registrational QWINT studies to establish that once-weekly insulin efsitora is not inferior to daily insulin injection in managing type 1 and 2 diabetes. Image Credit: Tada Images / Shutterstock. Eli Lilly has released detailed results from the Phase III QWINT-2 and QWINT-5 trial showing that its once weekly insulin efsitora (efsitora alfa) demonstrated a similar reduction in HbA1C levels compared to daily insulin injections in adults with type 2 and type 1 diabetes, respectively. The company is conducting five registrational QWINT studies to establish that once-weekly efsitora is not inferior to daily insulin injection in managing type 1 and 2 diabetes. The results from the two QWINT studies were presented at the European Association for the Study of Diabetes (EASD) 2024 meeting taking place from 9-13 September in Spain. The QWINT-2 and QWINT-5 data were also concurrently published in the New England Journal of Medicine and the Lancet . The data presentation comes on the heels of the positive topline data from the QWINT-1 and QWINT-3 trials . Both studies met their primary endpoint by demonstrating that efsitora’s HbA1C reduction was non-inferior to that of insulin glargine and insulin degludec, respectively. Diabetes is a high-grossing indication for Lilly. Apart from the GLP-1 receptor agonists, which have generated billions for Lilly in both diabetes and obesity indications, the company’s insulin products have been extremely successful too. Humalog (insulin lispro), a fast-acting insulin, raked in $1.67bn in sales last year, as per the company’s financials. The randomised open label QWINT-2 trial (NCT05362058) enrolled 928 participants with type 2 diabetes. The study compared insulin efsitora to insulin degludec. At 52 weeks, participants on efsitora reduced their mean HbA1C levels by −1.26 percentage points comparable to the −1.17 percentage point reduction seen in the insulin degludec group. The non-inferiority in Hb1C reduction was maintained whether the participants used GLP-1 receptor agonists or not. See Also: FDA grants breakthrough therapy designation to Neuraptive’s NTX-001 FDA grants breakthrough therapy status to Arrowhead’s plozasiran No episodes of severe hypoglycaemia were observed in the efsitora group, whilst six participants in the degludec group suffered from severe hypoglycaemic episodes. The number of nocturnal hypoglycaemic episodes was similar for both groups, 32 in the efsitora group and 35 in degludec group. The randomised open-label QWINT-5 trial (NCT05463744) enrolled 893 participants with type 1 diabetes. The participants received either insulin efsitora to insulin degludec in combination with insulin lispro. At 26 weeks, participants on efsitora reduced their mean HbA1C levels by -0.51%, comparable to the -0.56% reduction seen in the insulin degludec group. Rates of hypoglycaemia were higher with efsitora compared with degludec, with 10% of patients in efsitora group observing severe hypoglycaemia compared to 3% in the degludec group.