ICER Pricing Report: Creating a Dialogue or Just Playing for Headlines?
(1/12, National Pharmaceutical Council: E.V.I.dently Today) comments “...In its new report, ICER again ignored relevant economic information – the kind used by payers in their decision-making – to paint an unflattering and inaccurate picture of industry. Health researchers have found that over time, some medicines reduced health system spending, such as through their route of administration or a reduced need for doctor visits. This type of economic information, viewed as important by most health care payers, was not considered...Going forward, we need to ask critical questions and have a broader dialogue before citing flawed reports like ICER's. Flawed information can lead to flawed policy decisions, and that won't benefit patients or society. This report may get headlines -- it won't, however, create a productive dialogue.” Full
The Prices of 7 Drugs Were Hiked Without Proof of New Benefits, Costing the U.S. $1.2 Billion in 2019
(1/12, Ed Silverman, STAT Plus) reports “...[T]he National Pharmaceutical Council criticized the [ICER] report and cited an analysis that found net prices overall declined by 2.2% over the past five years. ‘Given those declines in prices, the Institute for Clinical and Economic Review's second report on drug pricing – focusing on a hand-picked, narrow group of medicines rather than the overall landscape – is an unnecessary and misleading exercise. ICER used incomplete evidence and inadequate analyses, creating a flawed report that should not be relied on by any policy- or decision-maker interested in developing sound, evidence-based drug policy.’” Paid Subscription Required
FDA Lays out 2021 Regulatory Science Areas of Focus
(1/11, Kari Oakes, Regulatory Focus) reports “...The final data-centric area of focus is the increasing importance of real-world evidence in the conduct of clinical trials and postmarketing review. Following the establishment of the RWE program under the 21st Century Cures Act, ‘FDA is committed to exploring the use of RWE in regulatory decision-making, including its ability to provide fit-for-purpose clinically meaningful information about the safety and effectiveness of medical products,’ according to the [Focus Areas of Regulatory Science] report.” Full
ICER Identifies Most Significant 2019 US Drug-Price Hikes — Even After Rebates — That Were Not Supported by New Clinical Evidence
(1/12, ICER Press Release) “...Among the top drugs with price increases in 2019 that had substantial effects on US spending, ICER determined that seven of 10 lacked adequate new evidence to demonstrate a substantial clinical benefit that was not yet previously known. The 2019 unsupported price increases on these seven treatments, even after pharmaceutical rebates and other concessions, cost the US health system an additional $1.2 billion beyond what would have been spent if their net prices had remained flat.” Full
Scientists Receive $3.4 Million to Study Care Options for Patients with Chest Pain Due to Anxiety
(1/11, Regenstrief Institute Press Release) “Indiana University School of Medicine and Regenstrief Institute research scientists have received a $3.4 million award from the Patient-Centered Outcomes Research Institute to investigate the best care options for the 40 percent of people who go to the hospital emergency department with chest pain that is determined to be caused by anxiety rather than a cardiac event.” Full
STaRT-RWE: Structured Template for Planning and Reporting on the Implementation of Real World Evidence Studies
Shirley V Wang, et al.
January 12, 2021, BMJ
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research
Elizabeth Gargon, Sarah L. Gorst , Karen Matvienko-Sikar, Paula R. Williamson
January 12, 2021, PLOS One