Biogen’s Alzheimer’s disease drug Aduhelm could end up costing Medicare more than all other Part B drugs combined, some estimates figure. Now, influential senators are joining the growing chorus of congressional critics asking Washington to evaluate its options.
In a letter to the Senate Finance Committee on Wednesday, Sens. Elizabeth Warren, D-Massachusetts, and Bill Cassidy, R-Louisiana, called for a hearing to “examine the vexing new questions and challenges” the newly FDA-approved Aduhelm poses to the Medicare program.
The letter is just the latest example of Capitol Hill’s lingering apprehension toward Aduhelm, also known as aducanumab. Earlier this month, the medicine became the first treatment for Alzheimer’s in nearly two decades to score an FDA nod, but its debut has come with a heap of concerns and criticisms.
Chief among those has been Biogen’s decision to set Aduhelm's list price at about $56,000 per year, well above what many analysts and advisory groups had predicted. The price tag could especially pose a threat to Medicare spending given that most of the roughly 6 million Americans with Alzheimer’s are enrolled in the federal insurance program.
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Even if just a quarter of the 2 million Medicare enrollees who currently use an Alzheimer’s treatment end up prescribed to Aduhelm, total spending would reach $29 billion for just one year alone, the Kaiser Family Foundation found in a recent report.
“This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” Warren and Cassidy wrote in their letter.
All of that spending would be for a drug that has shown murky clinical benefits, at best, critics argue. One key moderate Democrat, Sen. Joe Manchin, D-West Virginia, even called for President Joe Biden to oust the FDA’s interim commissioner Janet Woodcock, M.D., over the decision.
The Centers for Medicare & Medicaid Services (CMS) could thwart the problem, Warren and Cassidy note. Technically, CMS doesn’t have to cover all Alzheimer’s patients, as the FDA’s label allows, but could narrow reimbursement to just those who stand to benefit most.
Still, since Medicare extends coverage to medications considered “reasonable and necessary," it usually hews closely to the FDA’s label.
The senators are likely preaching to the choir with their letter. The committee’s chairman, Sen. Ron Wyden, D-Oregon, has been among Washington’s sharpest critics of Aduhelm, calling its price "unconscionable.”
Tuesday, Wyden outlined his own proposal, which builds on a previous plan from last Congress that would target price hikes and allow Medicare to negotiate with pharma, among other ideas, Politico reports.
“I believe it’s long past time to give Medicare the authority to negotiate better prices for prescription drugs on behalf of more than 50 million seniors,” Wyden said during a Department of Health and Human Services( HHS) budget hearing in early June.
With criticism mounting, Biogen issued a lengthy response Wednesday promising to work with public and private insurers to ensure Aduhelm doesn't break their budgets. The Cambridge, Massachusetts-based drugmaker didn't say whether it would discount Aduhelm's price but did reiterate its promise to forgo price hikes for four years.
Biogen CEO Michel Vounatsos has vigorously defended Aduhelm's price, arguing it's "substantiated by the value it is expected to bring to patients, caregivers and society.”
RELATED: Biogen's hefty Aduhelm cost sparks even more talk of a drug pricing crackdown. But will it happen?
Soon after Aduhelm was approved in early June, it was thought that it could become the poster child for drug pricing reform. Lawmakers, mostly Democrats, were quick to criticize its price tag and said it was “further evidence that our drug-pricing system is broken.”
But it’s unclear whether those rumblings will amount to much. There’s no indication that Aduhelm’s price “has changed the Biden Administration’s posture of waiting for Congress to find a bipartisan compromise in the Senate,” Cowen researchers said in a note earlier this month, citing consultants at Prevision Policy.
“It’s still an open question at this point,” said Juliette Cubanski, a KFF deputy director on Medicare policy. In the group’s latest report, KFF noted that a new high-priced drug like Aduhelm could energize Congress to act.
One reintroduced bill in the House, known as H.R.3, would give the HHS secretary the authority to negotiate prices for hundreds of drugs, which could include Aduhelm. Other proposals under consideration would limit annual price increases for Part B and Part D drugs, KFF added.
“I do think policymakers are aware that drug prices are still a concern for their constituents,” Cubanski said in an interview.