The U.S. Supreme Court on Wednesday extended a stay on lower court rulings that implemented restrictions on the abortion medication mifepristone, in today's bite-sized hospital and health industry news from the District of Columbia/Maryland, Massachusetts, and Ohio.
- District of Columbia/Maryland: The U.S. Supreme Court on Wednesday issued an order that extended a stay on lower court rulings that implemented restrictions on the abortion medication mifepristone until Friday, April 21 at 11:59 p.m. The temporary stay will allow the justices more time to consider the case, which could broadly impact FDA's authority to approve and regulate drugs. Currently, access to mifepristone remains unchanged, and federal restrictions previously instated by lower courts will be delayed until at least Friday. Meanwhile, GenBioPro, a manufacturer of generic mifepristone, on Wednesday sued FDA to prevent the medication from being removed from the market. In the lawsuit, the company said it hopes to prevent the Biden administration "from upending nearly a quarter-century of public reliance on a safe and effective drug by bringing criminal and civil enforcement actions against GenBioPro, its agents, manufacturers, distributors, partners, and customers" and that "the result will be chaos" if FDA's authorization of mifepristone is revoked. (González, Axios, 4/19 [1]; AP/Modern Healthcare, 4/19; Owermohle, STAT, 4/19; González, Axios, 4/19 [2]; McCammon, NPR, 4/19)
- Massachusetts: The Institute for Clinical and Economic Review (ICER) on Monday released a report indicating that lecanemab — a drug approved by FDA in January for the treatment of early Alzheimer's disease — was found to lack a "net health benefit" when compared to supportive care. In a global study of 1,795 people with mild cognitive impairment or mild Alzheimer's disease, the drug slowed cognitive decline by 27%. But ICER's recommended health benefit price benchmark falls between $8,900 and $21,500 per year and the Alzheimer's drug in question, developed by Eisai and Biogen, has a current list price of $26,500 per year. All 15 panelists who made the decision agreed that the current price of lecanemab demonstrates a "low" long-term value. The report concluded that the drug costs 19% to 66% higher than its benefit. (Twenter, Becker's Hospital Review, 4/18; Bettelheim, Axios, 4/18)
- Ohio: Cleveland Clinic and Verizon have announced a partnership to deploy a 5G network at a new "smart" hospital set to open this July in Mentor, Ohio. The network will enable digital health innovations such as patient check-in kiosks, digital displays, hospital resource tracking, and virtual reality adoption for clinician and patient education. The 5G network will allow for more engaged patients, improved connectivity, and a larger smart ecosystem. Verizon intends to offer the network as a service model to make the technology more accessible to providers. If successful, the hospital's infrastructure could become the new norm for healthcare. "Our goal is to prove that this is the future," said Matt Kull, CIO at Cleveland Clinic. "If we're successful here, all facilities will be built with this type of infrastructure. We think that this is going to become not the exception but the norm for healthcare." (Devereaux, Modern Healthcare, 4/19)