Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.
In a letter (PDF) addressed to Novo’s CEO Lars Fruergaard Jørgensen and North American chief Doug Langa, three senators wrote that they were “alarmed” by the Danish drugmaker’s decision to call it quits on Levemir, which is one of just a handful of long-acting insulins available on the U.S. market.
A Novo Nordisk spokesperson confirmed over email that both Levemir FlexPen and Levemir vials will be discontinued on Dec. 31, 2024. The company did not address the senators' letter directly.
The move could leave diabetes patients—and especially those who are pregnant—in the lurch, the senators warned. Levemir is the only insulin FDA-approved for use during pregnancy, according to the senators’ letter.
The letter was penned by Sens. Jeanne Shaheen, D-New Hampshire, Raphael Warnock, D-Georgia, and Elizabeth Warren, D-Massachusetts.
Last March, Novo announced it would slash the list price of several insulin products in the U.S. following a similar move by Eli Lilly. Along with discounts for its products NovoLog and Novolin, the company said it would cut the cost of Levemir by 65% starting Jan. 1, 2024.
However, before the discounts went into effect, Novo in early November revealed plans to withdraw Levemir in the U.S. completely. The company predicted supply disruptions would kick off in mid-January before a formal discontinuation of its Levemir FlexPen vial by the end of 2024, the senators explained in their letter.
In telegraphing the discontinuation, Novo at the time blamed supply chain constraints, formulary concerns and the wide availability of alternative insulins for patients.
Novo's spokesperson did not go into further detail about the manufacturing and reimbursement hurdles behind the drug's pull.
More than 7 million U.S. patients rely on insulin, with the drug’s long-acting formulation the most prescribed version.
Aside from Levemir, Novo Nordisk sells another long-acting insulin known as Tresiba, which was not included in the company’s price-cutting plan.
In an effort to get to the bottom of the issue, the senators have demanded Novo answer a number of questions by May 1. Their inquiries cover potential formulary placement challenges and supply chain constraints that led to the discontinuation of Levemir, plus any steps Congress could take to alleviate such issues in the future.
Further, they’re asking Novo whether it plans to reduce the cost on any other long-acting insulins, such as Tresiba, as well as whether Novo would commit to producing a Levemir biosimilar until another copycat version of the med becomes available.
On that note, the senators have also asked whether Novo has been contacted by any manufacturers looking to produce a Levemir biosim.
Novo, for its part, is recommending patients and healthcare providers discuss switching over to alternative treatments offered by both Novo and other drugmakers, according to the company's spokesperson. There are several other basal insulin options available besides Levemir, she added, including Eli Lilly's Basaglar and Rezvoglar, as well as Sanofi's long-acting insulin Lantus or its Viatris-made biosimilar Semglee.
As for the pregnancy piece, Novo's spokesperson explained that the label for Levemir's sister product, Tresiba, includes an open-label study showing that a once-daily dose of the drug in pregnant women with type 1 diabetes showed no notable differences in pregnancy outcomes or newborn and fetal health versus a regimen of insulin detemir and insulin aspart.
The brouhaha over Novo Nordisk’s Levemir pull in many ways resembles the situation with GSK’s recent decision to drop its brand-name asthma inhaler Flovent HFA in favor of an authorized generic.
Last month, Warren wrote a letter to GSK’s CEO Emma Walmsley accusing her company of marketing its own authorized generic at an “artificially inflated price” to “avoid accountability for years of outrageous price hikes.” Similar to the Novo situation, Warren claimed GSK had pulled its brand-name product in order to dodge a Medicaid rebate on Flovent HFA that would have been applied on Jan. 1.
GSK, for its part, told Fierce Pharma it had been planning to discontinue its branded Flovent products for “some time,” adding that it was introducing generics for Flovent HFA and its sister product Flovent Diskus to help maintain access to the drug, potentially at a lower cost.
Editor's note: This story has been updated with comments from Novo Nordisk.