Eli Lilly on Monday announced it will sell a generic version of its Humalog insulin injection at a list price 50% lower than Humalog's current price].
Background: Lawmakers investigate rising insulin prices
U.S. insulin prices have increased drastically in recent years, sparking concerns about patients' access to the life-saving drug. For instance, a Health Care Cost Institute report released earlier this year found per-person spending on insulin for patients with Type 1 diabetes nearly doubled from 2012 to 2016, driven in large part by increases in insulin prices.
A separate report released by Reps. Diana DeGette (D-Colo.) and Tom Reed (R-N.Y.), co-chairs of the Congressional Diabetes Caucus, in November 2018 found payment incentives, outdated patent regulations, and other factors have allowed drugmakers to increase the price of insulin by nearly 300% from 2002 to 2013.
Further, Side Effects Public Media/NPR in September 2018 reported that about one in four diabetics has resorted to rationing their insulin doses to combat rising prices, even though the practice can have lethal consequences.
Last month, Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Sen. Ron Wyden (D-Ore.), the ranking member on the committee, launched a bipartisan investigation into rising insulin prices in the United States, and asked executives at Eli Lilly, Novo Nordisk A/S, and Sanofi SA—the three leading manufacturers of insulin in the United States—for information on insulin price hikes.
Separately, Sens. Bill Cassidy (R-La.), Kevin Cramer (R-N.D.), Dick Durbin (D-Ill.), and Tina Smith (D-Minn.) in a letter sent Friday urged FDA Commissioner Scott Gottlieb to ease the agency's regulatory framework for approving generic versions of insulin. According to The Hill, the senators called on Gottlieb to amend 2018 FDA guidance, which the senators claimed poses "unreasonable approval delays for insulin products that could help patients with diabetes."
Eli Lilly to launch generic, lower-priced version of Humalog
Amid the growing scrutiny over rising insulin prices, Eli Lilly on Monday said it will launch an authorized generic version of its Humalog insulin injection. The generic, called Insulin Lispro, will be identical to Humalog but will be sold through Eli Lilly's subsidiary ImClone Systems with a different label. Eli Lilly said the subsidiary would make Insulin Lispro available as soon as possible at a list price of $137.35 per vial, which is about half the price of Humalog.
Eli Lilly CEO David Ricks on Friday told the New York Times, "There are clearly patients who, despite many best efforts, are struggling to afford their insulin. This is a step we can take to close part of that remaining gap."
Ricks separately said he hopes the company's announcement will serve as a "catalyst for positive change across the U.S. health care system." He said Eli Lilly's move aims to address the fact that not all patients directly benefit from drug rebates pharmaceutical companies offer in an attempt to make prescription drugs more affordable. Ricks said, "[T]he significant rebates [Eli Lilly] pay[s] on insulins do not directly benefit all patients. This needs to change" (Thomas, New York Times, 3/4; Weixel, The Hill, 3/1; Mulier, Bloomberg, 2/4; Mishra, Reuters, 3/4).
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