CER Daily Newsfeed

340B Rebate Pilot Tees up Healthcare Industry Firestorm

(8/11, Bridget Early, Modern Healthcare) reports “...Although the 340B rebates pilot is voluntary for drugmakers, it isn’t for providers, which at a minimum will prompt administrative challenges, said Sarah Bowman, a principal at the accounting and healthcare consulting company Pershing, Yoakley & Associates...‘It puts quite a bit of pressure — administrative pressure, financial pressure, operational pressure — on covered entities,’ Bowman said. ‘I don’t know of any covered entity that’s got a whole lot of [full-time employees] that are looking for something to do.’” Subscription Required

The Dysfunctional Drug Discount System's Serious Implications On Patient Health

(8/10, Kenny Cole, MedCity News) comments “...Drug discount programs, including the 340B Program, which nearly half the hospitals in the U.S. participate in, are designed to allow hospitals that serve a large demographic of poor, uninsured, or underinsured patients to purchase medications at discounted prices. Despite their intent to help patients afford medications, the current system is inefficient and vulnerable to abuse, providing little benefit to patients. With the direct negative effects on patient health, the system needs to be reformed to make medication accessible and affordable for everyone.” Full

Podcast: Is Trump's MFN Pricing Order More Bark Than Bite?

(8/11, Ayla Ellison, Fraiser Kansteiner, Eric Sagonowsky, Fierce Pharma) reports “...In this week's episode of ‘The Top Line,’ we break down the latest Most Favored Nation pricing pressures in the U.S., how companies are responding and which facets of the proposal might fall short of Trump's goals. Fierce Pharma's Eric Sagonowsky and Fraiser Kansteiner discuss the current state of those reform efforts and past attempts to rein in U.S. drug costs, followed by a brief discussion on tariffs.” Full

Saudi Arabia’s SFDA Issues Draft Framework on Real-World Data and Evidence for Regulatory Use

(8/11, Katie McCool, The Evidence Base) reports “The Saudi Food and Drug Authority (SFDA) has published a draft guideline on the use of real-world data (RWD) and real-world evidence (RWE) in medicines marketing authorizations. The document, now open for stakeholder feedback, aims to improve regulatory decision-making in line with Saudi Vision 2030 by defining key concepts, outlining quality standards, and expanding potential applications.” Full