Why is Levemir being discontinued? Senators demand solutions
Three U.S. Senators say they’re “alarmed” Novo Nordisk discontinued U.S. gross sales of a well-liked insulin model and are demanding solutions from the pharmaceutical big they are saying left sufferers with out an reasonably priced substitute.
In a letter Tuesday to Novo Nordisk’s high executives, Sens. Jeanne Shaheen, D-N.H., Raphael Warnock, D-Ga., and Elizabeth Warren, D-Mass., mentioned the corporate’s resolution to discontinue Levemir, a long-acting insulin, “didn’t think about affected person entry to reasonably priced, long-acting insulin substitutes.”
Final November, Novo Nordisk introduced it could cease promoting the injectable FlexPen model of Levemir this month and halt gross sales of Levemir vials by December 2024. The choice to discontinue Levemir was introduced simply earlier than Novo Nordisk’s 65% listing worth minimize of Levemir took impact on January 1.
Within the letter addressed to president and CEO Lars Fruergaard Jørgensen, on the firm’s headquarters in Denmark, and U.S.-based president Douglas J. Langa, the senators mentioned they had been “alarmed by Novo Nordisk’s resolution to discontinue Levemir earlier than permitting the value discount to enter impact.”
Greater than 7 million U.S. sufferers use insulin merchandise. All sufferers with Kind 1 diabetes and a few with Kind 2 diabetes depend on insulin to outlive.
Novo Nordisk representatives didn’t instantly reply to request for remark concerning the senators’ letter.
Novo Nordisk beforehand informed USA TODAY it could discontinue U.S. gross sales of Levemir as a result of international manufacturing constraints and the provision of different types of insulin. The corporate additionally blamed pharmacy managers and insurers who restricted entry to Levemir on drug formularies, the listing of medicine insurers cowl for sufferers.
The senators demanded the corporate executives describe “points associated to formulary placement” and international provide chain constraints which may have challenged manufacturing of the drug. In addition they requested Novo Nordisk to elucidate how sufferers now on Levemir will get entry to “related long-acting insulin merchandise with out gaps in protection and at related cost-sharing.”
Two different, long-acting “basal” insulins in the marketplace embrace Sanofi’s Lantus and Novo Nordisk’s Tresiba. When Levemir is not obtainable to U.S. shoppers, the senators requested whether or not the corporate plans to scale back the value of Tresiba.
“Now we have vigorously advocated for common entry to reasonably priced insulin merchandise,” the senators wrote. “Sadly, that aim stays out of attain for too many People, specifically for in-demand, long-actinginsulins with confirmed outcomes.”
The senators additionally wished to know whether or not different drug producers had contacted Novo Nordisk about making a biosimilar model of the drug. Biosimilar medication, which should be authorized by the Meals and Drug Administration, usually are used the identical means and have the identical power, dosage and unintended effects.
The senators requested whether or not Novo Nordisk would assist “facilitate” a biosimilar Levemir if one other drug firm already has expressed curiosity. If not, the senators requested that Novo Nordisk “commit to creating the related patents, applied sciences and manufacturing capabilities obtainable” to a drug firm that expresses curiosity sooner or later.
The senators wish to guarantee sufferers have entry to Levemir, whether or not it is offered by Novo Nordisk or an authorized biosimilar from one other drugmaker, in line with an aide for Sen. Shaheen.
Lengthy-acting insulins lengthen the time between injections and permit sufferers to take care of baseline blood glucose ranges. Of all of the long-acting insulins, Levemir is the one one that’s FDA-approved for being pregnant, the senators mentioned.
Dad and mom of a number of teenagers informed USA TODAY they like Levemir to different long-acting insulins as a result of it metabolizes extra shortly and permits energetic teenagers to regulate their dosages extra shortly.
