News from Thursday, December 18, 2025
Articles
New Research Highlight Shines Spotlight on PCORnet® Studies to Improve the Health and Healthcare of Children
(12/18, PCORnet Blog) comments “...The research highlight provides an overview of pediatric PCORnet® Studies that are generating real-world evidence to help patients and their caregivers make healthier choices and more informed healthcare decisions. The Pediatric PCORnet® Population Insights Report provides researchers with details about the capacity of the infrastructure of PCORnet to support national-scale pediatric research across a range of common and rare health conditions.” Full
CMS’ ACCESS Model: A New Push to Rewire Medicare Around Outcomes?
(12/18, Katie Adams, MedCity News) reports “...Experts think it is CMS’ clearest attempt yet to move traditional Medicare fee-for-service toward an outcomes model, as well as a key effort to help expand care beyond the four walls of a hospital or clinic. However, they provide a caveat: the success of ACCESS will depend on sustained participation, clear metrics and the ability to integrate data and digital tools across fragmented care settings.” Full
340B Transparency Requirements Will Begin Restraining Spending Growth in 2026
(12/17, Cathy Kelly, Pink Sheet) ...[Drug Channels Institute President Adam Fein] said the rate of 2026 spending at 340B prices will slow significantly relative to current trends and total $96bn, or 16.9% above 2024. ‘The Inflation Reduction Act is going to force transparency into the 340B program,’ he said. ‘In fact, I suspect the hospital associations and others [representing 340B covered entities] who were big advocates of the IRA are probably regretting their lobbying dollars right now.’” Subscription Required
Accelerating HTA Readiness with Generative AI
(12/17, Angeline Dhas, PharmTech) comments “...Once an industry player demonstrates a significant time- and efficiency-advantage in the regulatory path to patient access, the bar is raised for everyone else. Likewise, as GenAI becomes more accepted, HTAs will require faster evidence synthesis with ever more robust validation capabilities. More transparent justification of value will also be necessary as the technology is tested with projects of greater complexity.” Full
Press Releases
NICE issues Final Draft Guidance Recommending RYBREVANT®? (amivantamab) with LAZCLUZE™? (lazertinib) as a First-Line Treatment for Adult Patients with Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21 L858R Substitution Mutations
(12/18, Johnson & Johnson Press Release) “Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended RYBREVANT® (amivantamab) with LAZCLUZE™ (lazertinib), for use within its marketing authorisation, as an option for untreated advanced non-small cell lung cancer (NSCLC) in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, in its Final Draft Guidance.” Full
Journals
Comparative Effectiveness of Adjunctive Rifampicin Versus Gentamicin for Prosthetic Valve Endocarditis Due to Staphylococcus Aureus
Taito Kitano, Sayaka Yoshida
December 16, 2025, JAC Antimicrobial Resistance
Comparative Effectiveness of Atogepant and Rimegepant for Migraine Prevention in Japanese Patients: An Anchored Matching-Adjusted Indirect Comparison
Tsubasa Takizawa, et al.
December 18, 2025, Expert Review of Neurotherapeutics
A Practical Method for Estimating GRACE Utilities and Willingness to Pay Corrections
Anirban Basu, PhD, Darius Lakdawalla, PhD
December 18, 2025, Value in Health