News from Wednesday, March 19, 2025
Articles
Newer CLL Therapies Show Superior Long-Term Disease Control
(3/19, Hayden E. Klein, The American Journal of Managed Care) reports “Second-generation covalent Bruton tyrosine kinase inhibitors (cBTKis) and venetoclax-based regimens offer better long-term disease control and durability compared with older treatments for chronic lymphocytic leukemia (CLL), according to a study published in Cancers.” Full
UnitedHealth Group PBM to Cut Some Drug Reauthorization Requirements
(3/19, Lauren Berryman, Modern Healthcare) reports “...OptumRx will trim reauthorization requirements for about 80 drugs beginning May 1 and will consult with physicians and pharmacists to expand the list of medications over time, the company said in a news release Wednesday...The cuts will account for more than 10% of OptumRx's total pharmacy prior authorizations, the release said.” Subscription Required
German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies
(3/19, Eliza Slawther, Pink Sheet) reports “...Real-world data (RWD) and real-world evidence (RWE) have the potential to help support companies in demonstrating the value of novel therapies to payers in Europe, particularly in the gene therapy space where trial evidence might be more limited than usual. But according to company executives speaking at the Advanced Therapies Congress held in London, UK, this week, many health technology assessment (HTA) bodies are either unable or unwilling to use this type of data.” Subscription Required
Press Releases
New NEJM Catalyst Article Outlines Strategy to Accelerate Adoption of Value-Based Care
(3/19, Aledade Press Release) “...With growing recognition that the fee-for-service payment model does not align incentives that encourage preventive care, CMS could accelerate expansion of value-based care models to the majority of the nation’s primary care doctors as well as their patients. ‘The federal government has a proven track record of guiding health care transformation, as seen with the widespread adoption of EHRs,’ said [Aledade CEO Farzad Mostashari, M.D.] ‘Primary care physicians play a central role in patient health. As more of them shift to value-based care, patients will benefit from fewer hospitalizations, fewer emergency department visits, lower costs and better overall health.’” Full
Changes Approved to the Routing Criteria for Highly Specialised Technologies
(3/19, NICE Press Release) “At its meeting on 19 March our Board approved changes to the criteria we use to decide which treatments should be evaluated, to ensure more consistent, predictable and transparent decisions...We do not put any limit on the number of treatments that are routed via the HST programme. However, the routing criteria are crucial in helping to ensure that the focus remains on improving access to treatments for ultra-rare conditions, encouraging research and managing the wider impact to the NHS.” Full
Journals
Real-World Effectiveness of Frontline Treatments Among Patients with Chronic Lymphocytic Leukemia: Results from ConcertAI
Lindsey E. Roeker, et al.
February 26, 2025, cancers
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-Based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation
Nicolle M. Gatto, et al.
March 18, 2025, Therapeutic Innovation & Regulatory Science
Therapeutic Innovation & Regulatory Science
Waiver of Informed Consent in Clinical Research: A Summary of Contemporary Guidelines and a Resource for Researchers
Amanda Siriwardana, et al.
March 18, 2025, BMJ Open
Neoadjuvant Chemoradiotherapy vs Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma
Xufeng Guo, et al.
March 19, 2025, JAMA Surgery
Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone on Treatment Interruption: Comparing Findings from a Reanalysis of the X:BOT RCT and Harmonized Target Trial Emulation Using Population-Based Observational Data
Sara Lodi, et al.
March 19, 2025, Addiction
Crossing the Chasm: How to Expand Adoption of Value-Based Care
Farzad Mostashari, MD, ScM, and Geoffrey Moore, PhD
March 19, 2025, NEJM Catalyst