CER Daily Newsfeed

The Patient-Centered Trial Paradigm For Knee Osteoarthritis

(4/22, Katie Mowry, Ph.D., Clinical Leader) comments “Patient-centered trials that prioritize validated patient-reported outcomes (PROs) are essential for evaluating the real-world impact of new therapies. That’s especially true for those with knee osteoarthritis...However, PROs introduce analytic and operational complexities that differ from those of more straightforward structural or radiographic metrics. And while that might be challenging, it’s essential that a trial’s design reflects patients’ true knee OA challenges to produce meaningful evidence for patients, clinicians, and policymakers.” Full

External Control Arms in Oncology Drug Development: Methodological Insights, Real-World Data Challenges, and Regulatory Priorities

(4/22, Katie McCool, The Evidence Base) reports “...Turning to the meeting’s objectives, Jeff Allen (Friends of Cancer Research) highlighted the growing role of real-world evidence (RWE) pilot initiatives in strengthening methodological approaches. He explained that ‘the goal of each of these projects is to advance the methodologies and pressure test the feasibility of using RWD as a research tool,’ underscoring the importance of coordinated efforts to build confidence in emerging evidence approaches.” Full

Top Drug Lobbyist Calls Trump's Efforts to Codify His Drug Pricing Deals 'The Wrong Policy Prescription'

(4/21, David Lim, Politico) reports “...‘There’s a big difference between individual, voluntary, bespoke agreements that have been reached between the administration and individual companies and codifying the concept of MFN,’ [PhRMA CEO Stephen Ubl] added. He instead stressed the importance of reforms tothe operations of pharmacy benefit managers — which serve as a middleman between drug companies and insurers and employers — and to the 340B hospital program as ways to meaningfully reduce costs for consumers.” Full

States Should Avoid Repeating The IRA's Price-Setting Mistakes

(4/21, Reid Porter, PhRMA Blog) comments “...Many states are beginning to employ more effective tools, such as requiring health insurance companies and PBMs to share at least part of their negotiated savings with patients at the pharmacy counter, as well as protecting patient assistance and insurance design fixes, to reduce patient costs today without jeopardizing access, competition or innovation. If states want to improve affordability and access, the lesson from the IRA is simple: don't repeat a policy that's already failing patients.” Full