Radar on Drug Benefits

In October, the FDA granted a fast-track designation for tirzepatide, a medication to treat obese adults or overweight adults with weight-related comorbidities. As such, the agency will likely fully approve the drug in the next few months, according to drug pricing and market access professionals who spoke with AIS Health. They say the decision will have a major impact on PBMs, payers and employers.  

Taken together with the FDA’s June 2021 approval of Wegovy (semaglutide) for weight management, tirzepatide’s arrival on the market means “this is really the beginning of the windfall of weight loss drug utilization and costs for employers,” Chantell Sell Reagan, Pharm.D., director and national pharmacy clinical leader at WTW, tells AIS Health, a division of MMIT. 

Via the FDA’s accelerated approval pathway, Biogen and Eisai got the green light from federal regulators on Jan. 6 to take their Alzheimer’s drug Leqembi (lecanemab) to market. But sources tell AIS Health, a division of MMIT, that uptake and coverage of the medication will likely be underwhelming until it receives full FDA approval — a designation the manufacturers have already filed to acquire. 

Leqembi represents the drugmakers’ second crack at offering a breakthrough Alzheimer’s drug, as they launched Aduhelm (aducanumab) in 2021 after it received its own accelerated approval nod despite considerable controversy over the medication’s safety and efficacy. Both drugs are monoclonal antibodies that aim to slow cognitive decline in Alzheimer’s patients by reducing amyloid plaque buildup on the brain of patients in early stages of the disease.  

HHS set important deadlines for Medicare drug price negotiation on Jan. 11: Biden administration officials said that the first 10 drugs selected for negotiation will be announced on Sept. 1 of this year, and the maximum fair price for those drugs will be revealed on the same day in 2024. Those prices will go into effect at the start of 2026. HHS also released more information about the process it designed to select drugs and negotiate prices, which will include public comment periods and official consultations with stakeholders including manufacturers, insurers and providers. 

HHS has a “plan to voluntarily solicit public comments on key elements of the program,” said CMS Administrator Chiquita Brooks-LaSure during a press conference call. “Input from our partners is essential to effectively and expeditiously implementing the Medicare drug pricing negotiation authority. We are committed to engaging with our partners through our timeline to maximize transparency, predictability and collaboration.” 

For the past few years, PBMs and plan sponsors have waited for the arrival of Humira (adalimumab) biosimilars. The first such product, Amgen’s Amjevita, is expected to hit the market on Jan. 31, more than six years after the FDA approved the drug. The agency has approved seven other Humira biosimilars, some of which are expected to become available next year, as well.  

The competition means AbbVie, Humira’s manufacturer, will no longer have a monopoly on the drug category, which generated $13.6 billion in revenue in the U.S. during the first nine months of 2022, up 6.5% from the same time period in 2021.