Summary: The June 2021 FDA approval of Aducanumab for Alzheimerâs, despite absent evidence of clinical benefit, and now a sharp increase in Medicare Part B premiums, reflects much of whatâs 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.
âRecklessâ 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 Administrationâs scandalous approval of a costlyâand, according to many experts, dubiousâAlzheimerâs drug.
âMedicareâs inability to negotiate lower drug prices means that Big Pharma companies can charge whatever they want.â 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 yearâs level of $148.50.
While CMS officials cited several factors in their explanation of the premium boostâincluding costs imposed by the coronavirus pandemicâthey attributed roughly half of the increase to âadditional contingency reserves due to the uncertainty regarding the potential use of the Alzheimerâs drug, Aduhelm™ (aducanumab), by people with Medicare.â
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 billionââan amount that far exceeds spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending.â âŠ
The FDAâs 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 Alzheimerâs-induced cognitive decline.
On top of concerns about the treatmentâs 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 âthreatens to bankrupt the Medicare program.â
Dr. Michael Carome, director of Public Citizenâs Health Research Group [said] âTo 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 Alzheimerâs disease patients.â
F.D.A. Approves Alzheimerâs 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 Alzheimerâs treatment in 18 years and the first to attack the disease process. But some experts say thereâs not enough evidence it can address cognitive symptoms.
Nothing is right about the approval of aducanumabâand nothingâs 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, M.D., M.P.H.
Hereâs 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.
Hereâs what happened with aducanumab: the intervention doesnât work (according to clinical trials), it wasnât 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 â 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 didnât 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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