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Aducanumab As a Lens on US Healthcare

Summary: The June 2021 FDA approval of Aducanumab for Alzheimer’s, despite absent evidence of clinical benefit, and now a sharp increase in Medicare Part B premiums, reflects much of what’s wrong with our healthcare system: huge profits enabled by flawed medical care policies and extortionate prices, racism in clinical trial design, and financing burdens transferred to those who can least afford them.

‘Reckless’ FDA and Big Pharma Greed Blamed for Medicare Premium Hike
Common Dreams; November 16, 2021; By Jake Johnson

Medicare Part B recipients will soon be hit with one of the biggest premium increases in the history of the government program, a hike driven in large part by the Food and Drug Administration’s scandalous approval of a costly—and, according to many experts, dubious—Alzheimer’s drug.

“Medicare’s inability to negotiate lower drug prices means that Big Pharma companies can charge whatever they want.” Last week, the Centers for Medicare and Medicaid Services (CMS) announced that monthly Medicare Part B premiums will be raised to $170.10 in 2022, up from this year’s level of $148.50.

While CMS officials cited several factors in their explanation of the premium boost—including costs imposed by the coronavirus pandemic—they attributed roughly half of the increase to “additional contingency reserves due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm™ (aducanumab), by people with Medicare.”

Medicare is currently in the process of deciding whether to cover the drug, which is priced at a staggering $56,000 per year.

A June analysis by the Kaiser Family Foundation estimated that if 500,000 Medicare recipients are prescribed Aduhelm, total spending on the drug in a single year would be close to $29 billion—”an amount that far exceeds spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending.”

The FDA’s accelerated approval of aducanumab sparked outrage among public health experts and prompted the resignations of several agency advisers, who said there was not enough evidence showing the drug actually works to slow Alzheimer’s-induced cognitive decline.

On top of concerns about the treatment’s lack of effectiveness as well as potentially unlawful coordination between the FDA and manufacturer Biogen throughout the approval process, advocacy groups warned the decision to greenlight the exorbitantly priced drug “threatens to bankrupt the Medicare program.”

Dr. Michael Carome, director of Public Citizen’s Health Research Group [said] “To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients.”

F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
New York Times; June 7, 2021; By Pam Belluck and Rebecca Robbins

Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s not enough evidence it can address cognitive symptoms.

Nothing is right about the approval of aducanumab—and nothing’s new
The BMJ Opinion; November 4, 2021; By Nancy Olivieri

[More on the science and on flawed FDA regulatory history]

What the Aducanumab Approval Reveals About Alzheimer Disease Research
JAMA Neurol; October 4, 2021: By Jennifer Manly and Maria Glymour

FDA approval was based on trials that were not inclusive of the people who bear a disproportionate burden of disease. Only 0.6% of participants (ie, 19 individuals) identified as Black … Older Black adults are estimated to have AD incidence up to double the rates in older White people. Despite this, Biogen reported that only 6 Black people were randomized to the treatment dose approved by the FDA.

Instead of wasting money on aducanumab, pay for programs proven to help people living with dementia; J American Geriatrics Society; August 2021; By Lauren Hunt et al.

[W]e are heartbroken at the opportunity cost that may result from spending of limited resources on aducanumab versus the many ways we could help PLWD [persons living with dementia] … we expand on several specific approaches that we believe could have the highest yield in improving care for PLWD and their caregivers. Home-based Personal Care … Comprehensive Dementia Care … Community-Based Palliative Care.

Comment by: Jim Kahn

Here’s how health policy is supposed to function, IMHO: new interventions are demonstrated effective in relevant populations, and then added to the healthcare toolkit, with all efforts made to assure affordability for patients and the system.

Here’s what happened with aducanumab: the intervention doesn’t work (according to clinical trials), it wasn’t tested in high risk black populations, and it was approved by the FDA anyway, with undue manufacturer influence. The Medicare program is not permitted to negotiate prices, so the drug is sold at a massive price per patient per year (enriching the manufacturer Biogen), and the cost is passed along to Medicare enrollees, coming out of their social security income. Programs for PLWD that are known to work remain unfunded.

Note – these big price boosts are for traditional Medicare, thus enhancing the marketing position of private Medicare Advantage plans. The CMS officials in the thrall of private insurers didn’t mind that a bit, no doubt.

Under single payer, aducanumab would be reimbursed only once shown effective, and only once the price was negotiated down to an affordable level. Meantime, proven community programs would be funded.

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