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What We're Reading: FDA Addressing Baby Formula Imports; Nivolumab, Ipilimumab in Urothelial Carcinoma; Antibiotics Linked With IBD
FDA to make an announcement regarding importation of baby formula; first-line use of nivolumab and ipilimumab vs standard of care chemotherapy fails to meet primary end point of overall survival in phase 3 CheckMate 901 trial; study finds link between antibiotic prescriptions and inflammatory bowel disease diagnosis in older adults.
FDA to Address Baby Formula Imports
Reuters is reporting that the FDA will make an announcement as soon as later today regarding potential policy changes on the importation of baby formula. FDA Commissioner Robert Califf, MD, noted in an interview that he does not expect the shortage of baby formula to last until the end of the year, as manufacturer Abbott Laboratories, whose facility in Sturgis, Michigan, was closed amid investigations that concluded it failed to maintain sanitary conditions, is likely to reopen that facility in about 2 weeks. The United States currently does not import baby formula from abroad.
Nivolumab, Ipilimumab Combo Fails First-line Study in Urothelial Carcinoma
Bristol Myers Squibb announced today that its phase 3 CheckMate 901 trial investigating the use of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma did not meet the primary end point of overall survival in patients whose tumor cells express programmed death-ligand 1 (PD-L1) greater than or equal to 1 at final analysis. An independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary end points, with current studies underway investigating the combination therapy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy.
Antibiotics Linked With IBD in Older Adults, Study Finds
A study selected for presentation at Digestive Disease Week 2022 found that antibiotic use in people 60 years and older was associated with a 64% increase in their risk of developing ulcerative colitis and Crohn disease—the main subtypes of inflammatory bowel disease (IBD). CIDRAP is reporting that risk rose with each additional dose of antibiotics among participants, and risk of IBD was highest among those who had been prescribed antibiotics 1 to 2 years prior to diagnosis vs patients who had received antibiotics 2 to 5 years before diagnosis.
CMS' 340B Repayment Proposal May Harm Vulnerable Hospitals, Reward Those With Higher Revenues
April 26th 2024The 340B hospitals not receiving an offsetting lump-sum payment from CMS following 2018-2022 cuts later ruled unlawful are disproportionately rural, publicly owned, and nonacademic, according to a new study.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Navigating Health Literacy, Social Determinants, and Discrimination in National Health Plans
February 13th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the February 2024 issue of The American Journal of Managed Care® about their findings on how health plans can screen for health literacy, social determinants of health, and perceived health care discrimination.
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Mental Health Diagnoses, Care Challenges Rise Among US Youth, Report Finds
April 26th 2024While behavioral health care utilization has been rising, the treatment landscape has been worsening. New findings show that 20% of youths did not receive any form of treatment within 3 months of their initial behavioral health diagnosis.
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