CER Daily Newsfeed

Advancing Patient-Centered CER: Highlights From the 2025 PCORI Annual Meeting

(11/20, The PCORI Blog) comments “...Technology and data advancements were also featured prominently. Attendees learned about opportunities for CER to address evidence gaps in remote blood pressure monitoring to manage hypertension, one of the leading causes of disability and death. Another breakout session showcased the use of PCORnet® data resources to inform CER studies on how to prevent, diagnose and treat conditions like postpartum hemorrhage. These discussions underscored how data and technology can help advance research and also help shape care strategies that reflect everyday needs in peoples’ lives.” Full

Stakeholders Weigh in on FDA’s Draft Clinical Outcome Assessment Template

(11/20, Joanne S. Eglovitch, Regulatory Focus) reports “Pharmaceutical industry stakeholders suggested some modifications to the US Food and Drug Administration’s recently released draft clinical outcome assessments template for ensuring that treatments are patient-centric and support effective regulatory decision-making...Companies also supported FDA's proposal to include a new COA that focuses on the meaningful aspects of health when evaluating the benefits of medical products. This proposal was discussed during the workshop and subsequently incorporated into the FDA’s finalized guidance on Patient-Focused Drug Development.” Full

How One Insurer Is Improving Adherence To Evidence-Based Clinical Guidelines

(11/21, Geoffrey Crawford, Winnie Chi, Catherine Gaffigan, Robert Mandel, Shantanu Agrawal, Health Affairs Forefront) comments “...Despite their foundational role in promoting evidence-based care, utilization review strategies, particularly utilization management and prior authorization, have become a focal point of controversy within the health care system. They are often perceived by providers as an administrative hurdle and as tools driven primarily by cost containment, rather than clinical value. These perceptions can create friction among payers, providers, and patients—particularly when utilization management is seen as impeding timely access to personalized care.” Full

Building The Future Of Tech-Enabled Health Care: Let Accountable Care Lead The Way

(11/21, Anna Taylor, Megan Reyna, Ashish Parikh, Health Affairs Forefront) comments “...It’s time to build the infrastructure for a truly patient-centered, tech-enabled future in health care. That means moving beyond outdated reporting mechanisms and empowering ACOs to lead the way with scalable, interoperable solutions. CMS can build national reporting approaches that support this kind of flexibility through mechanisms available to them. At a minimum, CMS should continue to support current reporting options, including Medicare Clinical Quality Measures (CQMs) and Merit-based Incentive Payment System CQMs, until ACOs can successfully report dQMs.” Full

UK's Drug-Cost Watchdog Recommends Alnylam's Heart Disease Drug

(11/20, Reuters) reports “...The country's drug regulator had approved the injectable drug, Amvuttra, in July to treat ATTR-CM, a condition where faulty transthyretin proteins accumulate in the heart, potentially causing the organ to fail. It is also approved to treat nerve damage related to the disease.” Full