CER Daily Newsfeed

Peek Behind the Paper: Availability of Comparative RWE in Medicare Patients – Implications for CMS Drug Price Negotiations

(10/12, Ashley Jaksa and Pat Arena, The Evidence Base) reports “...[Ashley Jaksa, Market Access Scientific Strategy Lead, Aetion:] Our findings highlight the need for more comparative RWE studies for the drugs set to undergo CMS price negotiations in order to ensure that the evidence base for these drugs is as complete as possible. Additionally, though our primary analysis considered only the first ten drugs set to undergo price negotiations in 2026, we believe it is reasonable to assume our findings can be generalized to the additional drugs that will undergo price negotiations in subsequent years. Therefore, manufacturers, CMS, and/or other researchers should consider proactively generating comparative RWE studies in Medicare patients to address relevant evidence gaps.” Full

Evidence Review of Upadacitinib for the Treatment of Axial Spondyloarthritis

(10/12, Hibah Khaja, PharmD, Rheumatology Advisor) reports “Janus kinase (JAK) inhibitors may be preferable among patients with axial spondyloarthritis (axSpA) who favor oral medications and for those who do not respond to tumor necrosis factor (TNF) or Interleukin 17 (IL-17) inhibitors, though additional data is necessary to thoroughly evaluate their efficacy and safety, according to study results published in Immunotherapy.” Full

Video: AMCP’s Jennifer Mathieu Previews AMCP Nexus 2023

(10/12, Brooke McCormick, The American Journal of Managed Care) “Jennifer Mathieu, MA, senior vice president of professional and government affairs of the Academy of Managed Care Pharmacy (AMCP), described what is in store for attendees during next week's AMCP Nexus meeting.” View Video

Convergence: Expert Calls for Data Governance Structure for Collection of Real-World Data

(10/12, Joanne S. Eglovitch, Regulatory Focus) reports “While regulatory acceptance of of real-world data and evidence (RWD/RWE) is increasing, there is a need for a global data governance structure outlining how patient data should be collected to ensure that data is being used in a compliant fashion, Johnson & Johnson’s Heather Colvin told attendees at RAPS Convergence 2023. The science around using RWD may be picking up, but the policy is lagging behind, said Colvin, director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson.” Full

Scotland Fast Tracks HTA For AbbVie’s Aquipta While England Switches To Lengthier Process

(10/12, Francesca Bruce, Pink Sheet) reports “...Scotland’s health technology assessment body has beaten its counterpart in England to approving AbbVie’s migraine treatment Aquipta for reimbursement on the National Health System.” Subscription Required