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Biogens’ Alzheimer’s drug Aduhelm could end up costing Medicare more than all other Part B drugs combined, by some estimates. Now influential senators are joining the growing chorus of congressional criticism asking Washington to weigh its options.
In a letter to the Senate Finance Committee on Wednesday, Senators Elizabeth Warren, D-Massachusetts and Bill Cassidy, R-Louisiana called for a hearing to consider the new issues and thorny challenges that the new Aduhelm approved by the FDA poses to Medicare. program.
The letter is just the latest example of Capitol Hills’ lingering apprehension towards Aduhelm, also known as aducanumab. Earlier this month, the drug became the first Alzheimer’s disease treatment in nearly two decades to receive a favorable opinion from the FDA, but its debut has sparked much concern and criticism.
Among these is Biogens’ decision to set Aduhelm’s list price at around $ 56,000 per year, well above what many analysts and advisory groups had predicted. The price tag could pose a particular threat to health insurance spending given that most of the estimated 6 million Americans with Alzheimer’s disease are enrolled in the federal insurance program.
RELATED: A $ 57 Billion Drug? Medicare faces massive bill for Biogens Aduhelm even though it limits coverage
Even if only a quarter of the 2 million Medicare registrants who currently use Alzheimer’s disease treatment end up being prescribed in Aduhelm, total spending would reach $ 29 billion in just one year, the Kaiser Family found. Foundation in a recent report.
This level of potential new spending, especially for a single product with limited evidence of clinical efficacy to date, tests the resilience of programs, Warren and Cassidy wrote in their letter.
All of that spending would be spent on a drug that has shown obscure clinical benefits at best, critics say. A key moderate Democrat Senator Joe Manchin of West Virginia even called on President Joe Biden to oust Acting FDA Commissioner Janet Woodcock, MD over the decision.
The Centers for Medicare & Medicaid Services (CMS) could thwart the problem, note Warren and Cassidy. Technically, CMS does not have to cover all patients with Alzheimer’s disease, as the FDA label allows, but could restrict reimbursement to those who benefit the most.
Yet, since Medicare is extending coverage to drugs deemed reasonable and necessary, “it is generally consistent with the FDA label.
Senators are probably preaching to the choir with their letter. Committee chair Senator Ron Wyden, D-Oregon, has been one of Aduhelm’s most vocal critics in Washington, calling his price “unreasonable.”
On Tuesday, Wyden presented his own proposal, which builds on a previous plan from last Congress that would target price hikes and allow Medicare to negotiate with the pharmaceutical industry, among other ideas, Politico reports.
I think it’s high time we gave Medicare the power to negotiate better prices for prescription drugs on behalf of more than 50 million seniors, Wyden said during a Department of Health budget hearing and of Social Services (HHS) in early June.
With criticism on the rise, Biogen released a lengthy response on Wednesday promising to work with public and private insurers to ensure Aduhelm doesn’t break their budgets. The Cambridge, Massachusetts-based drugmaker did not say whether it would lower the price of Aduhelm, but reiterated its promise to forgo price hikes for four years.
Biogen CEO Michel Vounatsos has vigorously defended the Aduhelm award, saying it is “justified by the value it should bring to patients, caregivers and society.
RELATED: High Cost of Biogen’s Aduhelm Sparks Even More Talks About A Drug Price Suppression. But will it happen?
Shortly after Aduhelm’s approval in early June, it was believed he could become the star child of drug pricing reform. Lawmakers, mostly Democrats, were quick to criticize its price and said it was further proof that our drug pricing system was broken.
But it is not known if these rumblings will be significant. There is no indication that Aduhelm’s price changed the Biden administration’s stance of waiting for Congress to find a bipartisan compromise in the Senate, Cowen researchers said in a memo earlier this month, citing Prevision Policy consultants.
It’s still an open question at this point, said Juliette Cubanski, KFF deputy director for health insurance policy. In the group’s latest report, KFF noted that a high-priced new drug like Aduhelm could spur Congress to act.
A bill reintroduced in the House, known as HR3, would give the HHS secretary the power to negotiate the prices of hundreds of drugs, including Aduhelm. Other proposals under consideration would limit annual price increases for Part B and D drugs, the KFF added.
I think policymakers are aware that drug prices are always a concern for their constituents, Cubanski said in an interview.
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