CER Daily Newsfeed

Understanding The Explanations For The 2027 Medicare Drug Price Negotiation Cycle

(3/26, Kristi Martin, Rachel Sachs, Health Affairs Forefront) comments “...CMS indicated that as part of its holistic comparative evidentiary review, the agency prioritized direct comparative evidence (e.g., head-to-head randomized controlled trials) but also considered mixed and/or indirect treatment comparisons (e.g., network meta-analyses) and real-world evidence (e.g., observational studies). In this second cycle, it appears that more real-world data and evidence was included in the public explanations, compared to the first cycle. An emerging theme is CMS's consideration of each of the selected drugs' use in real life—for example, tolerability and how it improves daily living, with CMS citing real world data in the explanations along with the clinical data when assessing clinical benefit.” Full

Who Really Owns Pharmacy Data?

(3/25, Noah A. Chapman, Pharmacy Times) comments “...[Payers and manufacturers] cannot call real-world evidence ‘transformative’ and ‘indispensable,’ build strategies on top of it, and then pretend that the entities generating much of that evidence are just interchangeable end points. If the industry genuinely believes community pharmacy is essential, then it should be prepared to share more than talking points. That means including independent pharmacies as named stakeholders in data collaborations, designing contracts that recognize their contributions, and returning actionable insights—not just aggregate benchmarks—that help them improve care and make a sustainable business case for clinical services.” Full

Regulatory Setback or Scientific Signal? The Case for Human-Relevant Evidence

(3/26, Jenna DiRito, Janeta Nikolovski, PharmaPhorum) comments “...[M]uch of our translational infrastructure is built on precisely that assumption. The result is predictable: therapies that appear robust in preclinical settings enter the clinic with incomplete insight into how they will behave in real patients. When the data falls short, whether on efficacy, safety, or durability, it is often interpreted as a regulatory hurdle. But, in many cases, it reflects uncertainty embedded much earlier in the development process. And the consequences are significant. Development timelines lengthen. Costs escalate. Regulatory scrutiny intensifies. Investor expectations rise. Most importantly, patients wait.” Full

NAACOS Signals Support For ACO Path After Klomp Floats Auto-Enrollment Into ACOs, MA

(3/25, Jalen Brown, Inside Health Policy) reports “...‘So, we know that accountable care works. It gives beneficiaries access to coordinated care, to team-based care, and still leverages their primary care relationships. There’s a whole team supporting them with their ongoing care needs,’ [NAACOS svp of government affairs Aisha Pittman] said...‘It saves Medicare money and so conceptually, since we know ACOs provide better outcomes and create stronger financial performance for traditional Medicare, if you bring more beneficiaries into ACOs, you will generate more savings to the program over time.’ ‘And so, from a concept perspective, we’re really supportive of that approach,’ Pittman added.” Subscription Required