CER Daily Newsfeed

End the IRA’s Innovation-Killing “Big Payor” Bailout

(1/28, Peter Pitts, DrugWonks.com) comments “GLP-1 drugs (Ozempic, Wegovy, Zepbound, etc.) have important therapeutic potential beyond weight loss...With such exciting potential, why aren’t the expensive large-scale clinical trials that would move these new therapeutic opportunities moving forward at warp speed? One troubling answer is an unintended (but entirely predictable) codicil of the Inflation Reduction Act, specifically, the IRA’s blunt language that says that any ‘negotiated’ price covers all indications current or future. In blunt terms, the IRA is saying to drug developers, ‘You will not be rewarded for investing in any new important science.’ This predictable stifling of innovation cannot and must not stand.” Full

Aledade’s Chief Policy Officer on Advocacy for Alternative Payment Models

(1/28, Healthcare Innovation) reports “...Healthcare Innovation Editor-in-Chief Mark Hagland interviewed Sean Cavanaugh, Aledade’s chief policy officer, regarding the announcement, and about the policy landscape around accountable care organizations (ACOs) and alternative payment models (APMs).” Full

Drugmakers Show Restraint On Price Increases in New Trump Era

(1/28, Jared S. Hopkins, The Wall Street Journal) reports “Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year. The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration's support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year's median price increase was 4.5%. Prices rose on brand-name medicines sold by companies ranging from Pfizer to Novartis and Bristol-Myers Squibb, according to an analysis for The Wall Street Journal by 46brooklyn, a nonprofit drug-pricing research group.” Subscription Required

US FDA's Accelerated Approval Council: Bigger Role, More Transparency Coming?

(1/27, Sue Sutter, Pink Sheet) reports “...The HHS Office of Inspector General wants the FDA's accelerated approval council to be more involved in specific product decisions, but the agency said it would complicate a future product withdrawal under the expedited procedures. In 2024, the council discussed increasing transparency about its activities and issues related to withdrawal proceedings. Oncopeptides' Pepaxto was the first product withdrawn under the FDORA procedures, a process that agency officials said is more straightforward, but still consumes a lot of resources.” Subscription Required

What Does HEOR Really Mean in 2025?

(1/28, PMLiVE) comments “...[I]n European markets, HEOR insights might focus on cost-effectiveness thresholds and health system affordability, whereas in the US, robust real-world data and patient preference studies can differentiate products for commercial payers seeking value-based care solutions. In Asia–Pacific markets, evidence often needs to address healthcare access disparities and demonstrate cost efficiency for treatments within resource-limited settings. Meanwhile, in emerging markets, HEOR may be critical in supporting priority-setting frameworks to optimise scarce healthcare budgets.” Full