Novo Nordisk has joined Eli Lilly and Sanofi in cutting the price of insulin in the United States. The company will offer an authorized generic or follow-on brand version of insulin aspart and insulin aspart mix beginning in January 2020 at 50% off the current list price for its NovoLog and NovoLog Mix, the company announced in early September.
The generics will be marketed by the newly created Novo Nordisk Pharma Inc. The list prices range from $144.68 for insulin aspart 10-mL vial/1,000 units to $279.41 for insulin aspart mix box of 5 pens/1,500 units. The company will continue to offer the branded products.
At the same time, the company announced a $99 cash-card program that permits patients—with or without insurance—to purchase a month’s supply of Novo Nordisk analog insulin. The card covers three vials or two packs of FlexPen or FlexTouch pens of any combination of analog insulins, or about 3,000 to 3,600 units, depending on the brand.
The announcement follows the introduction of Eli Lilly’s authorized generic version of insulin lispro injection, also at a 50% price reduction compared with its name-brand version, Humalog. Both rapid-acting insulin products contain the same molecule, and pharmacists can substitute insulin lispro for Humalog, the company said.
Marketed through ImClone Systems, an Eli Lilly subsidiary, insulin lispro costs $137.35 per vial and $265.20 for a pack of five KwikPens.
Sanofi has not introduced a generic for its insulin products, but it substantially expanded its Insulin Valyou Savings Program in June, resulting in a significant price cut for many patients. The revised program effectively dropped the price of insulin for many consumers to $99 per month. Patients can get up to 10 boxes of pens and/or 10-mL vials each month with a valid prescription for the set price, regardless of income level.
The new discount program represented a more than 90% drop compared with prices set in April 2018 of $99 per 10-mL vial or $149 for a single box of insulin pens for patients who pay cash for their medications. Sanofi noted that government regulations prohibit offering the program to patients with Medicare, Medicaid, or similar federal or state coverage.
Recent congressional hearings and the specter of increased competition may be driving the new spate of price-cutting announcements.
In May, the FDA issued final guidance on requirements for biosimilars to gain an interchangeable label. The guidance called for a switching study to show that patients can move from the name brand to the biosimilar without a significant change in safety or efficacy. As of March 23, 2020, insulin will be regulated under the Public Health Service Act, which the FDA expects will streamline approval of biosimilar insulins as interchangeable.
“For chronically used biologic medications patients get at the pharmacy, such as insulin, the ability to have a licensed interchangeable that can be substituted at the pharmacy without the intervention of the prescribing health care professional—much like how generic drugs are routinely substituted for brand name drugs—could be integral to the success of reducing drug prices for patients,” said Acting FDA Commissioner Norman E. Sharpless, MD.
International competitors are lining up to submit applications under the new pathway in March. Mylan has an insulin glargine biosimilar on the market in Europe and is expected to bring it to the U.S. next year. Sandoz is expected to have biosimilar versions of insulin glargine, insulin lispro, and insulin aspart ready to submit under the new rules through a partnership with Chinese manufacturer Gan & Lee. Gan & Lee already has insulin glargine and insulin aspart in its portfolio.
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Published November 14, 2019