By JOHN DWYER
Global Alzheimer’s Platform Foundation
The Biden administration has a big problem on its hands.
It’s sending mixed signals on new Food and Drug Administration approved Alzheimer’s drugs, and patients are suffering.
The Centers for Medicare and Medicaid Services is continuing an unprecedented, discriminatory policy that prevents 1.2 million Medicare beneficiaries from accessing a whole class of new Alzheimer’s treatments.
In one unthinkable move – first implemented in 2022 with Biogen’s Aduhelm and continued with a decision to deny access to another new treatment, Leqembi – CMS has made it all but impossible for seniors on fixed incomes to go to a doctor and get a prescription for an FDA-approved drug to treat Alzheimer’s disease.
This month, the Veterans Health Administration confirmed that FDA approval of a drug means something and that it would pay for Leqembi, providing treatment options for the nearly 168,000 veterans with Alzheimer’s disease.
What the hell?
CMS has waged this war against 1.2 million Americans – and counting – under the guise of suddenly requiring drug manufacturers to prove that any new Alzheimer’s anti-amyloid treatments that are approved by the FDA are also “reasonable and necessary.”
To be sure, this new hurdle isn’t the norm.
The policy is so beyond the pale that dozens and dozens of congressional lawmakers on both sides of the aisle have called for CMS and the Biden administration to fix this inequitable policy.
Most recently, a group of bipartisan senators questioned U.S. Health and Human Services Secretary Xavier Becerra about the government’s failure to provide Medicare beneficiaries access to approved Alzheimer’s treatments that could improve their lives and slow their memory loss.
Millions of Americans with Alzheimer’s could agree with Sen. Susan Collins, who reminded Becerra, “It is not CMS’s job to second-guess the drug approvals of the FDA.”
The fact that CMS has blocked access to an entire class of Alzheimer’s treatments leads some to speculate that rationing Medicare benefits for Alzheimer’s patients is just the beginning.
There’s no question: The VA’s coverage decision is a rebuke to CMS. The Veterans Health Administration is saying we care about our veterans. CMS is saying the sick and aging don’t matter.
Now the hard questions must be asked and answered.
Earlier this month, President Joe Biden requested $2.8 billion from Congress for his cancer moonshot. That’s the same moonshot mission the president announced last year. And in the same breath that he committed to making progress on cancer, he called out Alzheimer’s disease as necessitating swift and committed action.
As his administration announced, the goal of this moonshot is to “improve the U.S. government’s capabilities to speed research that can improve human health – to improve our ability to prevent, detect and treat a range of diseases including cancer, infectious diseases, Alzheimer’s disease and many others.”
If that’s so, the estimated 6.5 million Alzheimer’s patients deserve an answer to the question: How can the president improve on treating diseases like Alzheimer’s when his own administration puts forth policies that deny access to care?
In denying coverage of Leqembi, CMS said it needed more data to evaluate how the treatment works in the “real world.” The FDA doesn’t require that. The VHA didn’t either. And yet, the Alzheimer’s community has already marked its calendar for July 6, when the FDA is expected to give Leqembi traditional approval. Everyone’s guess is that even traditional approval may not change the mind of CMS.
Without doubt, the announcement from the VHA is great news for 168,000 veterans. But that still leaves more than one million Americans with Alzheimer’s without a therapy, or hope.
CMS still has a chance to do the right thing. And if Biden means what he says about prioritizing an Alzheimer’s moonshot, he can make a life-changing difference for millions of Americans.
Mr. President, tell CMS to do the right thing now.
John Dwyer is president and Founding Board Member of the Global Alzheimer’s Platform Foundation, a patient-centric, non-profit organization dedicated to speeding the delivery of innovative therapies to those living with Alzheimer’s by reducing the time and cost of Alzheimer’s disease clinical trials. Learn more at https://www.globalalzplatform.org.