The state’s second-biggest health insurer is threatening to limit or not cover Biogen’s new Alzheimer’s drug, accusing the Cambridge biotech of putting “excessive corporate profits” ahead of patients by charging $56,000 a year for the controversial treatment. Michael Sherman, chief medical officer for Point32Health, the insurance company formed by the recent merger of Tufts Health Plan and Harvard Pilgrim Health Care, said Biogen should cut the cost of the drug called Aduhelm by a factor of roughly 10, to $5,400, given the medicine’s questionable benefits and potential risks.
Sens. Elizabeth Warren (D‑Mass.) and Bill Cassidy (R‑La.) want Congress to take a deeper look at how Biogen’s controversial and pricey new Alzheimer’s drug, Aduhelm, will affect the Medicare program, they wrote in a letter Wednesday. The bipartisan duo is pressing the Senate Finance Committee to take on “the vexing new questions and challenges that approval raises for the Medicare program and other health programs” the panel oversees, they wrote.
The Letter from Sens. Elizabeth Warren (D‑Mass.) and Bill Cassidy (R‑La.):
… Under the broad label that FDA approved, the drug is available to all Alzheimer’s patients, and the agency did not place limits on treatment duration suggesting that patients could remain on the drug indefinitely. We are troubled by reports that those factors could lead the drug to command “somewhere between” the $37 billion we currently spend on Medicare Part B and the $90 billion we currently spend on Medicare Part D. This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency.
… Medicare coverage is limited to items and services that are considered “reasonable and necessary” for the diagnosis or treatment of an illness or injury, fit within the scope of a benefit category, and are not otherwise specifically excluded from coverage. The Centers for Medicare and Medicaid Services (CMS) … may also need to make decisions about coverage for potential ancillary services like amyloid PET scans. CMS might address these issues under its current authorities through the issuance of a national coverage determination, which could authorize coverage without restriction, limit coverage, or delay full coverage pending collection of more evidence. It might also be prudent for Congress to make policy changes to enable Medicare to move towards value-based payment arrangements, which directly connect prescription drug pricing to clinical effectiveness.
News in Context:
- Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)
- US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab
- First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
- Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen