CER Daily Newsfeed

Cefiderocol Equally Effective as Monotherapy and Combination Therapy for Gram-Negative Bacterial Infections

(12/16, Medscape) reports “...Cefiderocol was effective in multiple gram-negative bacterial infections, particularly in patients with complex clinical profiles and prior antibiotic exposure, with no significant difference in 30-day survival between monotherapy and combination therapy regimens.” Full

Addressing Low-Value Care In Traditional Medicare

(12/16, Michael E. Chernew, A. Mark Fendrick, Health Affairs Forefront) comments “...Reducing the rate of Medicare spending growth, which is now projected to exceed both inflation and gross domestic product growth, will require attenuation of the increase in use of services. The focus should be on the reduction in use of low- or no-value services and the preservation of evidence-based care. There are several broad approaches to achieve this goal in traditional Medicare, including UM and APMs to counteract incentives of fee-for-service payment. UM programs such as the WISeR model, if well designed and implemented, can be important steps toward this goal.” Full

FDA Wants to Use More Real-World Data and Calls Again for Early-Phase Trials Reform

(12/15, Max Bayer, Endpoints News) reports “The FDA will consider more real-world data in drug and device applications, including from large datasets that don’t have identifiable patient data, Commissioner Marty Makary told a Wall Street audience on Monday in New York...[FDA] will allow the use of data that don’t include ‘private, confidential information at the individual patient level,’ a broadening of its current standard that could include large, real-world datasets from insurers, hospitals or patient registries, for example.” Subscription Required

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

(12/15, Brooke McCormick, The American Journal of Managed Care) reports “...‘We're removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster,’ FDA Commissioner Marty Makary, MD, MPH, said in a news release. ‘This common-sense reform will unlock access to vast databases like cancer and cystic fibrosis registries that contain critical insights about how treatments work in the real world.’ Building on this change, the FDA also claimed it intends to consider updating its guidance for drugs and biologics.” Full

Hospitals, Health Systems Expect to Ramp up Value-Based Care in 2026, 2027

(12/16, Dave Muoio, Fierce Healthcare) reports “...Sage’s survey was fielded in the second quarter of this year and reached 101 respondents with job titles ranging from chief medical officer and chief quality officer to CEO...Sixty-nine percent said their organization is participating in an accountable care organization, which was up from 53% in 2023. Sixty-one percent leverage bundled payment models, also up from 46% in 2023. Reported rates of participation in a pay-for-performance program were roughly the same from 2023 to 2025, falling between 50% and 60%, as was participation in a value-based purchasing program.” Full