On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step toward Florida facilitating importation of certain prescription drugs from Canada. The authorization holds for 2 years, beginning when Florida notifies the FDA of the first imported drug shipment. This is the first authorization of a section 804 importation program (SIP) in the United States. Although several other states have passed bills that establish drug importation programs, none are certified yet by the FDA. While drug importation on a large scale has the potential to lower prices for cash-paying patients, it is likely not a viable means to an overall lowering of drug prices in the United States, given concerns regarding safety, cold chain logistics, and uncertainty around cost savings.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program
Novo Nordisk has decided to permanently discontinue the manufacturing and distributing of all formulations of Levemir® (insulin detemir) and GlucaGen® HypoKit® in the U.S. market. Contributed factors to the Levemir®discontinuation decision includes global manufacturing constraints, significant formulary losses impacting…
On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved Zepbound™ (tirzepatide) injection for chronic weight management in adults. Tirzepatide, the active ingredient in Zepbound™, is already approved under the trade name Mounjaro™ to be used in the treatment of type 2 diabetes mellitus. In clinical trials, patients that received the highest dose of Zepbound™ experienced an average weight loss of 20.9%. Novo Nordisk’s Wegovy® (semaglutide) was studied in a similar population and patients experienced an average weight loss of 14.9% at the recommended maintenance dose. Lilly has announced that Zepbound™ will be available in the United States by the end of 2023 with an estimated annual cost of $13,778, which is approximately 20% less than the annual WAC of Wegovy®. People who are commercially insured without coverage for Zepbound™ may be eligible to pay as low as $550 for a 1-month prescription of Zepbound™, approximately 50% lower than the list price, a similar savings program for Wegovy® lowers out-of-pocket cost for patients without coverage to approximately $1,119.
On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved Wezlana™ (ustekinumab-auub) injection manufactured by Amgen. This is the first approved biosimilar to Stelara® (ustekinumab) injection manufactured by Janssen Biotech – Wezlana™ is also interchangeable. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara® without contacting the prescriber. Ustekinumab is used to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC), psoriatic arthritis (PsA) or plaque psoriasis. Under a settlement agreement, Wezlana™ can be launched in the U.S. at any time before January 1, 2025. Additional biosimilars to Stelara® are expected to launch in 2025. U.S. sales for Stelara® amounted to approximately $6.4 billion in 2022.
On March 14, 2023, Novo Nordisk announced price cuts to several prefilled insulin pens and vials, which will be effective starting on January 1, 2024. Outlined below…
