CER Daily Newsfeed

Sacubitril/Valsartan, Enalapril Show Comparable Efficacy in Pediatric Heart Failure

(9/25, Christina Mattina, The American Journal of Managed Care) reports “Both sacubitril/valsartan (Entresto) and enalapril (Vasotec) were associated with improvement in clinical measures among children aged 1 month to younger than 18 years who had heart failure attributable to systemic left ventricular systolic dysfunction, according to findings published in Circulation. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor, did not show superiority over enalapril, an angiotensin-converting enzyme (ACE) inhibitor.” Full

Video: The Importance of RWD in Rare Disease Research

(9/24, Andy Studna, Applied Clinical Trials) “In this video interview with ACT editor Andy Studna, Rich Gliklich, MD, founder of OM1 discusses how real-world data can be useful throughout the different stages of a trial.” View Video

Incorporating the Patient Experience in Real-World Evidence Studies: An Interview with Emily Hardie, Kyowa Kirin International and Susan Thornton, Cutaneous Lymphoma Foundation

(9/25, The Evidence Base) reports “...In this interview, we speak with Susan Thornton (Cutaneous Lymphoma Foundation) and Emily Hardie (Kyowa Kirin International, UK) to learn more about their collaboration in the design of the PROSPER study. This real-world study aims to understand the experiences of patients with cutaneous T-cell lymphomas and of their caregivers in real-world clinical practice through the collection of patient-reported outcomes data, enriched with qualitative data on disease and treatment experience and burden.” Full

UAB Awarded More than $11 Million to Lead Study on Telehealth Options for Chronic Disease Management

(9/25, Emily Harley, UAB News) reports “The University of Alabama at Birmingham Department of Family and Community Medicine was awarded over $11.4 million from the Patient-Centered Outcomes Research Institute to lead a study into how primary care can help patients with physical disabilities, who also deal with Type 2 diabetes and other chronic disease, best manage their health.” Full

CMS Holds Accountable Care Organizations Harmless for ‘Highly Suspect’ Medicare Billing

(9/25, Rebecca Pifer, Healthcare Dive) reports “...The anomalous billing had the potential to hurt accountable care organizations, or ACOs, in the Medicare Shared Savings Program by impairing their ability to capture shared savings. ACOs are groups of providers that assume responsibility — and occasionally, financial risk — to care for a group of patients. However, the CMS’ rule finalized Tuesday shields ACOs by excluding payments for suspect catheter billing codes from the 2023 performance year.” Full

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

(9/25, Francesca Bruce, Pink Sheet) reports “...Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.” Subscription Required