News from Monday, October 2, 2023
Articles
FDA Official Discusses Use of RWE in Cancer Research and Approvals
(9/29, Joanne S. Eglovitch, Regulatory Focus) reports “...Donna Rivera, associate director for pharmacoepidemiology in the Oncology Center for Excellence, noted that RWE was used in the successful application for accelerated approval of Piqray (alpelisib) on 5 April 2022...FDA approved Orencia (abatacept) in December 2021 for prophylaxis of acute graft-versus-host disease...To get these treatments approved, Rivera stressed that the sponsors had to predefine the essential elements of their studies, use two real-world data sources to describe how each element was identified, address issues that are essential for determining the reliability and relevance of the data in the protocols, and confer with FDA before starting to ensure the acceptability of the evidence sources used.” Full
Court Denies Bid to Halt Medicare Drug Price Talks
(9/29, Lauren Gardner, Politico) reports “...‘The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,’ [Judge Michael J. Newman] wrote in his opinion. ‘Any economic harm - which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis - will not occur for years in the future.’ A spokesperson for the U.S. Chamber of Commerce, which sought the injunction alongside local and state chambers, said the group is reviewing the decision.” Full
Press Releases
ICER Publishes Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations
(10/2, ICER Press Release) “...‘The US is beginning a new era in which the federal government will engage in negotiating drug pricing,’ said ICER’s President Steven Pearson, MD...‘ICER has submitted a Special Report to CMS on two of the drugs whose prices will be negotiated as part of the public comment process defined in CMS guidance. This ICER report includes sections on multiple elements related to value, providing different options for translating evidence into initial offer prices and for assessing counter-offers from drug makers.” Full
16 New Sites Will Expand the Diversity of PCORnet
(9/29, PCORnet Press Release) “...‘PCORnet is a go-to resource for researchers who want to study the full fabric of the U.S. population —people from all walks of life, identifying across all racial and ethnic groups, living in all places and circumstances,’ said Betsy Shenkman, PCORnet Steering Committee Chair. ‘This expansion makes the Network’s breadth and depth even more robust, empowering PCORnet users to close more gaps in evidence than was previously possible.’” Full
Journals
Comparative Effectiveness Analysis of Lumpectomy and Mastectomy for Elderly Female Breast Cancer Patients: A Deep Learning-Based Big Data Analysis
Jiping Wang, et al.
September 29, 2023, The Yale Journal of Biology and Medicine
Reports
Events
Proposed New Methodology Standards for Usual Care as a Comparator (2023): Open for Comments
October 2 - November 30, 2023