Morning Briefing
Summaries of health policy coverage from major news organizations
Few Patients Receiving Alzheimer's Drug; Some Hospitals Are Refusing It
Axios: Outpatient Infusion Centers Offering Alzheimer's Drug Aduhelm
Some hospitals are refusing to administer Biogen's new Alzheimer's drug, Aduhelm, but many freestanding infusion centers are offering it despite concerns about the drug's safety and lack of effectiveness. Hardly any patients are receiving the drug, even with infusion centers eagerly advertising it. Just over 100 patients have actually gotten Aduhelm so far, way below Biogen's already-tempered forecasts, STAT reported. (Herman, 9/23)
In other pharmaceutical industry news —
Stat: Compound Pharmacies Win Battle Over FDA Plan For Monitoring Shipments
A U.S. federal court judge has ruled that an effort by the Food and Drug Administration to boost oversight of compound pharmacies violated the law and ordered the agency to rethink its approach to ensure that small compounders will not be jeopardized. At issue is an attempt to clarify state and federal responsibilities for monitoring inordinate amounts of medicines that are shipped by two different types of compounders — those making large quantities and smaller pharmacies dispensing medicines for individual patients. The distinction was created in 2013 as part of a federal law passed in response to a fatal outbreak of meningitis traced to a large compounder. (Silverman, 9/22)
Stat: Federal Officials Move Closer To Penalizing Drug Makers Over Discounts
Following a year of controversy, the Health Resources and Services Administration is taking steps to penalize six large drug makers for ending discounts to a federal program that provides medicines to hospitals and clinics serving mostly low-income populations. In a series of letters, the agency notified Eli Lilly (LLY), Sanofi (SNY), AstraZeneca (AZN), Novo Nordisk (NVO), Novartis (NVS), and United Therapeutics that their failure to comply with the 340B drug discount program was referred to the Office of Inspector General at the U.S. Department of Health and Human Services, which oversees HRSA. If assessed, penalties can total more than $5,000 per violation. (Silverman, 9/22)
KHN: Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough To Switch?
It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade. So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug. (Andrews, 9/23)
In updates from the Theranos trial —
The Wall Street Journal: Elizabeth Holmes Trial: Jim Mattis Tells Jury He Came To Doubt Theranos Technology
Former Defense Secretary Jim Mattis testified Wednesday in the criminal trial of Theranos Inc. founder Elizabeth Holmes that he and other board members were blindsided to learn in 2015 that the company hadn’t been conducting all of its blood tests using its proprietary technology. “There just came a point where I didn’t know what to believe about Theranos anymore,” the retired four-star general said. (Randazzo and Somerville, 9/22)
CNBC: Elizabeth Holmes Private Text Messages Leak During Theranos Fraud Trial
Former Theranos CEO Elizabeth Holmes believed in herself so much that she wrote in a text message to Ramesh “Sunny” Balwani proclaiming that she had “total confidence in myself best business person of the year.” The message to her then-boyfriend and Theranos President Balwani are among thousands of private texts and Skype messages obtained by CNBC that show Holmes had no lack of confidence in herself and Theranos, the blood-testing company she founded. They also reveal that Holmes told Balwani about courting high-profile investors who ended up giving Theranos hundreds of millions of dollars. (Khorram, 9/22)
