CER Daily Newsfeed

Similar CV, Kidney Benefits With Semaglutide, Older GLP-1s

(10/14, Miriam E. Tucker, Medscape) reports “The three GLP-1 receptor agonist (RA) drugs liraglutide (Victoza), semaglutide (Ozempic), and dulaglutide (Trulicity) provided similar cardiovascular and kidney benefits in people with type 2 diabetes (T2D) although liraglutide was associated with lower mortality than dulaglutide, a new comparative effectiveness study found. The three drugs also produced similar gastrointestinal outcomes.” Full

Study Finds Poor Evidence For Many FDA Breakthrough Devices

(10/10, Jessica Karins, Inside Health Policy) reports “...‘The FDA did not require postmarket studies for any of the 8 devices authorized without premarket clinical testing and only required postmarket studies for 4 of the 11 (36.4%) devices in which a pivotal study failed to meet a primary effectiveness end point,’ the JAMA study says. The researchers said approximately 10% of devices reviewed under the program became clinically available without clinical testing and there were limitations in the evidence supporting many breakthrough devices, with about one third of devices supported primarily by surrogate endpoints. One in eight devices lacked comparative effectiveness testing and one in seven failed to meet their primary effectiveness endpoint.” Subscription Required

Finerenone in HFpEF and HFmrEF: Emerging Evidence and Guideline Updates

(10/12, Naiha Muneer, Mehak Muneer, Catherine E. Cooke, PharmD, MS, BCPS, PAHM, Drug Topics) reports “...Current heart failure guidelines highlight differences in evidence across ejection fraction groups...While trial data exist for this population, the lack of robust head-to-head comparisons with legacy MRAs such as spironolactone or eplerenone complicates comparative-effectiveness estimates. Historically, these older agents were prescribed on the basis of weak or indirect evidence, making them less reliable benchmarks for modern cost-effectiveness analyses.” Full

Step Therapy In MA: Mixed Evidence And An Uncertain Path Forward

(10/14, G. Caleb Alexander, Health Affairs Forefront) comments “...While in some settings step therapy may reduce prescription drug use and spending, it also has potential unintended consequences. Disease symptoms may persist while patients go through the process of ‘failing first’ on first-step medications; this may lower a patient’s health-related quality of life...Other economic analyses suggest step therapy may delay treatment access and shift costs toward other health care services.” Full