Crucial Drugs Added To Formulary Exclusion List By CVS
Modern Healthcare covers the controversial moves, with pharmacy benefit managers said to be increasingly dropping key medications from coverage lists. Separately, a small company lost regulatory approval for drugs to treat the rare Lambert-Eaton myasthenic syndrome.
Modern Healthcare:
CVS Adds Eliquis, Other Vital Drugs To Formulary Exclusions
The formulary exclusion comes as PBMs increasingly drop medications from their coverage lists, attracting attention from federal and state lawmakers aiming to reign in non-medical switching, said Ryan Gough, executive director of the Partnership to Advance Cardiovascular Health, a patient advocacy group. "I've never seen an issue galvanize the cardiovascular community like this," Gough said. The decision sparked outcry from 14 patient advocacy groups, which wrote to CVS Health's chief medical officer in December calling for him to reverse the "dangerously disruptive" decision. Experts from the American College of Cardiology and American Society of Hematology also continue to meet with CVS Caremark about the move. (Tepper, 2/7)
In other pharmaceutical and biotech news —
Stat:
Some Patients Say They've Lost Out In Unusual Battle Over Rare Disease Drug
An unusual, decade-long fight over an orphan drug market appears to be at an end after a small, family-run company was defeated in a bruising battle with a rival and has now lost regulatory approval of its medicine. Late last month, a federal appeals court refused to revisit a ruling that the U.S. Food and Drug Administration improperly approved a drug used to treat a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS, which is sold by Jacobus Pharmaceuticals. As a result, the FDA last week withdrew final approval of the medicine. Shipments to patients are already winding down. (Silverman, 2/7)
Stat:
Biosplice’s Massive Valuation Turned Heads. Now, Layoffs Raise Questions
Biosplice, once the world’s most valuable biotech startup, is laying off nearly a quarter of its workforce and has stopped internal development of one of its late-stage medicines, a treatment for hair loss in men, with hopes of licensing that program to another drug company. The layoffs, which took effect Tuesday, could be seen as yet another reality check for the outsized bets made by some investors on privately held biotechnology firms. In 2016, Biosplice, then known as Samumed, made headlines by raising $220 million at a $6 billion valuation; two years later, it raised another $438 million at a $12.8 billion valuation. (Wosen and Herper, 2/8)
Stat:
In A Victory For Medical Journals, Pacira Loses A Libel Lawsuit
A federal judge has dismissed an unusual libel lawsuit brought by Pacira BioSciences (PCRX) that claimed a medical journal, its editor, and the authors of several papers published articles that were based on “faulty scientific research” that portrayed its only medicine as ineffective. Pacira alleged the papers, which were published early last year in the journal Anesthesiology, reflected a “bias” against its Exparel painkiller and “disparaged” the drug, as we noted at the time. Exparel is used after surgeries, although is not an opioid. As a result, the company contended customers canceled contracts or declined to purchase the drug, or considered removing it from hospital formularies. (Silverman, 2/7)
In case you missed it —
Miami Herald:
Wound Gel Recalled For Contamination That Can Cause ‘Life-Threatening Infections’
A gel applied to wounds to prevent microbial infections has been recalled after a bacterial contamination was found in the gel itself. And that contamination, according to the FDA-posted recall notice by Blaine Labs Company, can make RevitaDerm Wound Care Gel deadly. (Neal, 1/31)
