CER Daily Newsfeed

Incorporating HEOR Into Clinical Operations and Business Management: Using Real-World Data To Drive Better Outcomes

(2/12, Victoria Barnosky, CRA, FAHRA, The Association for Medical Imaging Management: LINK) comments “...Purchasing decisions for imaging equipment and software are increasingly evaluated based on comparative effectiveness and cost-utility data rather than solely technical specifications. Monitoring patient outcomes through the integration of operational and clinical data helps ensure that imaging protocols align with both diagnostic accuracy and value-based reimbursement requirements...The shift toward value-based care has made RWE essential for demonstrating quality and outcomes to external stakeholders, including CMS programs and ACR registry benchmarks.” Full

Why Modest Trial Gains Aren’t Enough: The Case for Value-Driven Drug Approval

(2/13, Rita Numerof, PhD, Pharmacy Times) comments “...The American pharmaceutical industry remains a global leader in science and innovation, but its reputation has suffered from the perception that high prices are divorced from value and health outcomes. Rebuilding trust means showing that cost and benefit are proportionate. Manufacturers that embrace transparency by publishing outcomes data, engaging patients as research partners, and pricing based on demonstrated impact will be best positioned to lead.” Full

Senate Questions Health Care Firm for Profiting Off Program Meant for Poor

(2/12, Ellen Gabler, The New York Times) reports “...Senator Bill Cassidy, the Republican committee chairman and a doctor from Louisiana, sent a letter last week to Apexus, the Texas-based company, asking about its profits, business practices and role in the 340B Drug Price Program...Apexus manages 340B and collects a fee for almost every drug sold under the program...Dr. Cassidy wrote that as a for-profit company, Apexus had benefited from 340B's ‘precipitous growth.’ That has led to questions about where revenue generated from the federal program is going, he said, and whether that revenue is being used ‘pursuant to the original intent of 340B.’” Subscription Required

HHS Seeks Details as It Weighs Second Attempt at Drug Rebates

(2/13, Nyah Phengsitthy, Bloomberg Law) reports “...The request for information issued Friday weighs whether the US government should implement a rebate system under the 340B Drug Pricing Program-a federal plan that historically has required drugmakers to offer up-front discounts to health providers that treat low-income and uninsured patients. The HHS seeks to understand the administrative, operational, financial, and drug access concerns with rebates, according to the notice. Comments are due to the government by March 19.” Subscription Required

Patient Identification Hurdles Sink English HTA For Roche’s Tumor-Agnostic Rozlytrek

(2/13, Eliza Slawther, Pink Sheet) reports “...Challenges with identifying eligible patients within the England’s National Health Service care pathway meant there was insufficient evidence to support a full reimbursement application for Rozlytrek to treat NTRK fusion-positive solid tumors, Roche has said.” Subscription Required