Political headwinds grow against CMMI accelerated approval drug price model

The Center for Medicare and Medicaid Innovation (CMMI) is taking more heat for its proposed drug price model, with more Republicans charging the agency is undermining the Food and Drug Administration (FDA). 

A group of 18 Senate Republicans blasted CMMI in a letter earlier this week (PDF) over a proposed CMMI model they say cuts off benefits from the FDA’s accelerated approval pathway, which quickly clears groundbreaking treatments. The political opposition raises questions over the long-term viability of the model, especially if the federal government changes hands after the 2024 election. 

The Republicans are at odds with CMMI over the impact of the Accelerating Clinical Evidence Model, which was recently announced by the center. The model would cut payments to drugs approved under the pathway until the manufacturer completes confirmatory trails.

“If proposed and finalized as described, this profound policy shift would inevitably chill incentives for leveraging the FDA’s game-changing expected regulatory avenue, which has served patients with life-threatening diseases for decades,” according to the letter led by Sens. Mike Crapo, R-Idaho, and Susan Collins, R-Maine.

Republicans say the model directly contradicts FDA’s affirmations that drugs approved via the accelerated pathway have to meet similar safety and effectiveness as traditionally approved drugs. 

But the model “appears to call this paradigm into question, treating drugs approved through the [pathway] as substandard and penalizing frontline providers who choose to administer products that advance through this pathway, regardless of clinical value,” the lawmakers wrote. 

This model could have a detrimental effect on research and development and runs counter to President joe Biden’s Cancer Moonshot that seeks to advance new cancer therapies. 

Republicans charge that CMMI is “doubling down” on a prior decision by the Centers for Medicare & Medicaid Services (CMS) to narrow Medicare coverage of a class of new Alzheimer’s disease treatments.

Last year, CMS decided to cover Alzheimer’s drug Aduhelm only for beneficiaries in qualifying clinical trials and decided to adopt the decision to drugs in similar such classes. 

Senators said that such trials can take years to complete for Alzheimer’s and cancer. 

“Punitive treatment of products that opt for accelerated approval sends a precarious signal to patients, providers, payers and the public that CMS lacks confidence in this life-saving pathway,” the letter said.

CMS did not comment but noted it would review the letter. 

But the missive shows the political headwinds CMMI could experience as it seeks to launch the drug price models, which were directed by an executive order from Biden.

Republicans in the House and the Senate have also raised concerns about the use of quality-adjusted life years (QALYs) within federal healthcare programs. Lawmakers have sought to ban use of the metric, which aims to measure how well a treatment can lengthen and improve a patient’s life. 

“While recent decades have seen countless life-saving and life-enhancing advances in treatments and cures … the rise in QALYs risk reversing these trends,” the group of senators said. 

Senators were worried in a letter to the Department of Health and Human Services leadership earlier this month (PDF) that QALY would be used in the upcoming Medicare negotiations for lower drug prices, which are set to take effect in 2026. 

“The U.S. must take proactive steps to prevent bureaucratic price controls from constraining patient access to new treatments or leveraging metrics that devalue the lives of those living with rare diseases,” the letter said.