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Lilly announces plan for generic rapid-acting insulin
Eli Lilly announced on Monday it will introduce an authorized generic version of insulin lispro injection in the United States, promising a list price that is 50% lower than the current Humalog list price, according to a press release from the company.
The lower-priced version, which will be available in vials and pens, will be called “insulin lispro” and is the same molecule as Humalog, according to the company. The list price of a single vial will be $137.35, according to Lilly. The list price of a five-pack of KwikPens will be $265.20.
The insulin will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems. Humalog will also remain available for people who want to continue accessing it through their current insurance plans, according to the company.
"We've engaged in discussions about the price of insulin with many different stakeholders in America's health care system: people living with diabetes, caregivers, advocacy groups, health care professionals, payers, wholesalers, lawmakers and leading health care scholars," David A. Ricks, chairman and chief executive officer of Lilly, said in the release. "Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help. We're eager to bring forward a low-priced, rapid-acting insulin.”
Introducing an alternative insulin option allows Lilly to provide a lower-priced insulin more quickly while providing payers time to renegotiate downstream contracts and adjust to new system economics, Ricks said in the release.
"While this change is a step in the right direction, all of us in the health care community must do more to fix the problem of high out-of-pocket costs for Americans living with chronic conditions," Ricks said. "We hope our announcement is a catalyst for positive change across the U.S. health care system."
The company stated that it began preparing manufacturing, labeling and shipping plans last year for the possibility of Lilly's insulin lispro, after exploring the logistics and feasibility of an authorized generic. Vials and pens of the lower-priced insulin have been manufactured, and Lilly will now work with supply chain partners to make them available in pharmacies as quickly as possible, it said in the release.
The news follows a December partnership announcement by Chinese insulin supplier Sandoz and Gan & Lee Pharmaceuticals to commercialize biosimilar versions of insulins used to treat patients with type 1 and type 2 diabetes. According to an industry press release, the agreement covers biosimilar insulins in early and clinical development for the European Union and the U.S. States for the top three selling branded insulins by sales: glargine (Lantus, Sanofi), lispro (Humalog, Eli Lilly) and aspart (NovoLog, Novo Nordisk). Sandoz, which currently has eight marketed biosimilars, is a division of Novartis Group.
Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, U.S., Switzerland, Japan, South Korea, Canada, Australia and New Zealand. Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential. – by Regina Schaffer
Disclosure: Ricks reports he is chairman and chief executive officer of Lilly.
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Eli Lilly, responding to public pressure regrading insulin pricing, has begun a process of elaborating a series of biosimilar insulins that market for half of the list price for their index molecule. As the launch of Basaglar has shown a market for these reduced-price therapeutic agents, they have developed as biosimilar version of insulin lispro for the marketplace to complement their basal biosimilar. Clearly, this is a step in the right direction with regard to the inexorable increases for branded insulins, but this does not solve the huge problem created by rebates and insurance and pharmacy benefit manager restrictions and prior authorizations. The latter have multiplied like weeds after a rain, choking off physician time and effort without any patient care benefit whatsoever. They do facilitate profitability and make these and insurance companies major growth players in the marketplace. All of this has yet to be addressed by the governmental forces that created them. This is an issue clearly calling for Congressional action.
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This is a curious development, and I do not understand Lilly’s motivation — unless they are committed to entering a price war over so-called generic insulins. We did not see this happen with insulin glargine. Lilly came out with Basaglar, a biosimilar to Sanofi’s Lantus, and then Sanofi came out with Admelog, their follow-on to Lilly’s Humalog. By precedent, I’m not sure that this new announcement is going to really effect the consumer price of insulin.
When Lilly came out with Basaglar, they now had in their portfolio a good basal insulin. Now they are announcing a plan for a generic version of insulin lispro, yet they already have Humalog, which is an equivalent. I am left scratching my head as to what the business decision was for Lilly to do this. Is it a response to outcry from the federal government over high insulin prices? I spent 6 years as a medical director at Lilly, and I would say the vast majority of people there have a big heart and would probably enter the unemployment line if they could cure diabetes. They used to tell us at Lilly that they were slaves to two masters: one was the shareholder and the other was the patient. Somewhere in between was where Lilly wanted to be.
Insulin pricing is a complicated area, and it tends to be oversimplified by blaming the pharmaceutical company. Insulin is a very expensive drug to make in terms of the investment and the quality control. What goes on between the time insulin leaves the factory, passes through a “middle man” and enters a consumer’s hands remains, to most people, a black box that adds to the price.
Physicians must educate themselves on how to use NPH and regular insulin. Some health systems like Kaiser Permanente are already doing this. The differences between the old insulins and the newer analogues are trivial. One answer to high insulin prices is to move back to the old insulins and start using them properly, at the cost of some inconvenience and a little more hypoglycemia in the patient. That’s one form of judicious protest that physicians and consumers can make.
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I find this decision very interesting. My question whether this is a true generic: Is Lilly taking the same molecule, saying, ‘This is a generic’ and then reducing the price? I haven’t seen any data to support that this is equivalent to lispro. Where is the pharmacokinetic/dynamicinformation?
Offering the same molecule at a reduced price could be an attempt at a workaround for dealing with the pharmacy benefit managers in the supply chain. As we know, the PBMs are really the devil in the room. They are milking the distribution process, and the patient is suffering.
Right now, our only options for over-the-counter insulins are NPH and regular. We must learn how to use the old insulins effectively to help our patients. I would rather see a more affordable insulin lispro out there vs. regular insulin, and if this is what we have to do to get it out there, then great, but this is still a bandage on a hemorrhage.