News from Friday, October 6, 2023
Articles
Cancer Patient Advocates To CMS: Factor Unmet Medical Needs In Price Negotiations
(10/5, Gabrielle Wanneh, InsideHealthPolicy) reports “...To ensure consideration of patient perspectives related to the selected oncology drugs, including Imbruvica, the groups recommend CMS investigate comparative effectiveness research from the National Comprehensive Cancer Network’s Drug and Biologics Compendium and treatment guidelines to learn of the comparative effectiveness of the oncology drugs selected for price negotiation and their therapeutic alternatives. The groups also say CMS should consider various patient health outcomes, including those reported by patients themselves, and any experience data.” Subscription Required
Intravascular Imaging Improves PCI Outcomes in Meta Analysis
(10/5, Dave Fornell, Cardiovascular Business) reports “...Gregg Stone, MD, FACC, FSCAI, professor of medicine at the Icahn School of Medicine, Mt. Sinai, New York, explained the comparative effectiveness of intravascular imaging-guided PCI versus angiography-guided PCI. He spoke to Cardiovascular Business about this study at ESC. ‘The results of this network meta-analysis emphasize the importance of physicians using intravascular imaging with either OCT or IVUS to optimize stent outcomes and improve the long-term prognosis of their patients,’ Stone explained. ‘Four new, big randomized trials have been presented at ESC comparing either OCT or IVUS compared to angiography and guiding stent implantation.’” Full
Video: Dr Rajini Katipamula-Malisetti: Minnesota Oncology Takes Value Very Seriously
(10/6, Brooke McCormick, The American Journal of Managed Care) “Rajini Katipamula-Malisetti, MD, executive vice president of Minnesota Oncology, defined value-based cancer care and its importance.” View Video
Press Releases
Clinical Trials: Two Arms Are Better than One
(10/6, IQWiG Press Release) “The German Institute for Quality and Efficiency in Health Care (IQWiG) has responded critically to a reflection paper by the European Medicines Agency (EMA) on the approval of new drugs based on single-arm studies. The EMA correctly points out that studies without a control arm are subject to bias and that, in general, it is hardly possible to estimate causal effects from them. However, it does not provide clear criteria for limiting drug approval based on such studies to extremely rare exceptional cases.” Full
Journals
A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer's Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial
Julia F Shaw, et al.
October 6, 2023, JMIR Research Protocols