CER Daily Newsfeed

Real-World Data Support Luspatercept vs ESAs for Anemia in Lower-Risk MDS

(6/5, Rose McNulty, The American Journal of Managed Care) reports “Luspatercept shows higher efficacy than ESAs in increasing hemoglobin levels and sustaining improvement in LR-MDS patients. Patients treated with luspatercept achieve faster and more sustained red blood cell transfusion independence compared with those receiving ESAs.” Full

P2Y12 Inhibitor Monotherapy Beneficial for Patients Who Undergo PCI

(6/6, HealthDay News) reports “For patients who undergo percutaneous coronary intervention (PCI) and discontinue dual antiplatelet therapy (DAPT), P2Y12 inhibitor monotherapy is associated with a lower risk for major adverse cardiac and cerebrovascular events (MACCE) compared with aspirin, according to a meta-analysis published online June 4 in The BMJ.” Full

When Placebo Plus Standard of Care Clouds the Signal: Unmasking the “Placebo Problem” in Lupus Clinical Trials

(6/6, Juan Ovalles, MD, PhD, Pharmacy Times) comments “...Health-plan actuaries run the numbers: If we treat 100 members, how many will gain beyond SOC? With a 40% placebo curve, perhaps half the spend buys no incremental outcome. That uncertainty drives: 1. Risk-sharing contracts (eg, rebates linked to steroid taper or flare reduction). 2. Step-therapy protocols (optimize SOC first and biologic only if flares persist). 3. Ongoing real-world evidence requirements, such as the FDA/European Medicines Agency post-marketing EMBRACE trial of belimumab in Black patients, requested because pivotal studies were under-powered in that group.” Full

Explore PCORI’s Engagement in Health Research Literature Explorer for Topics That Interest You

(6/6, The PCORI Blog) comments “...As part of PCORI’s effort to advance meaningful engagement in research, PCORI developed the Engagement in Health Research Literature Explorer, a searchable database of citations from peer-reviewed articles about engagement in health research. Updated regularly, this one-of-a-kind resource provides the public with free access to nearly 2,000 published articles on lessons learned and other topics related to the practice and study of engagement. The peer-reviewed articles listed, published from 2012 to present, are primarily sourced from MEDLINE — the National Library of Medicine database searchable via PubMed.” Full

Commentary: Strict Oversight of 340B is Crucial

(6/6, Jack Kalavritinos, Grand Forks Herald) comments “...One of the hospitals in the study, Bon Secours Mercy Health, used 340B to generate $276 million between 2018 and 2023. Another hospital system, Cleveland Clinic, received $993.7 million from the program. Both institutions maintain the increased revenue has gone toward ‘capital improvement projects’ and ‘community benefit programs’ but have declined to provide specifics about how the money is allocated. In addition, both hospital systems incorrectly argue that the 340B program was not intended by Congress to provide direct savings for patients.” Full

House Gives US FDA More Non-User Fee Funds Than Requested

(6/5, Sue Sutter, Derrick Gingery, Pink Sheet) reports “...A US House appropriations bill would give the US Food and Drug Administration $33.1m more in budget authority funding than requested by the Trump Administration for fiscal year 2026. The measure proposes $3.2bn in budget authority for the agency, a 1% increase over the administration's request for $3.17bn.” Subscription Required