Ancillary costs associated with administering the controversial Alzheimer’s drug aducanumab (Aduhelm) — such as additional imaging to monitor the amyloid-associated imaging abnormalities (ARIAs) — will raise Medicare spending on the drug by an additional $6564 per patient per year, a new analysis suggests.
“Clinical trials have shown that 41% of patients receiving aducanumab developed potentially serious brain swelling or bleeding, and 2% of patients experienced severe adverse events (eg, irreversible brain damage),” lead author John Mafi, MD, MPH, with the Division of General Internal Medicine and Health Services Research at the David Geffen School of Medicine at UCLA, Los Angeles, California, told Medscape Medical News.
“While there has been a lot of talk about the drug’s high price tag, no prior peer-reviewed study has explicitly measured the ancillary costs of the adverse side effects of aducanumab,” he noted.
“Our study shows that the ancillary costs of dealing with the serious side effects of aducanumab — brain swelling or bleeding — would comprise nearly 20% of the total spending estimates,” Mafi said.
The study was published online January 14 in JAMA Health Forum.
An “Unwise” Approval
As previously reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved aducanumab to treat Alzheimer’s disease in June, against the advice of its own advisory panel and despite questions regarding the strength of the evidence supporting its efficacy and concerns about its high cost.
Last month, in response to the outcry over its pricing, Biogen cut the annual cost of the drug in half — from $56,000 to $28,200 per patient.
Last week, Medicare announced plans to restrict access to aducanumab only to individuals with Alzheimer’s enrolled in clinical trials, significantly limiting the number of eligible patients.
The UCLA team estimated lower and upper bound annualized Medicare costs for administering aducanumab to beneficiaries, focusing on the degree to which associated ancillary health services affect spending.
The lower bound estimates cover patients eligible for aducanumab and assume prescribers would apply clinical trial inclusion criteria to adults with MCI or mild dementia with amyloid plaque on positron emission tomography (PET) imaging results.
The upper bound estimate includes an expanded population of patients with MCI or mild dementia and plaque without age or comorbidity restrictions to reflect potential off-label prescribing.
The analysis was based on 8396 adults aged 65 years and older (representing 41.2 million adults) with Medicare Part B coverage in 2016.
On an annual basis, total weight-based drug costs per patient were $27,759 and ancillary costs per patient were $6564.
For the lower bound estimate, if 25% of the 1,066,670 eligible patients with MCI or mild dementia and plaque with clinical trial age and comorbidity restrictions received aducanumab, Medicare would pay $7 billion (95% CI, $6.2 to $7.8 billion) each year, the researchers calculate.
For the upper bound estimate, if 25% of an expanded population of 5,715,983 eligible patients with MCI or mild dementia and plaque received treatment with aducanumab, Medicare would pay $37.4 billion (95% CI, $34.4 to $40.3 billion).
Ancillary health services comprised 19.4% of total population spending estimates.
“Our findings on the ancillary costs of aducanumab support CMS’ proposed decision to restrict its use to clinical trials. The drug has uncertain benefits and known risk of patient harm,” Mafi told Medscape Medical News.
“CMS made the best of a challenging situation to mitigate the FDA’s unwise, accelerated approval,” Mafi said.
Major Strain on Medicare
Going forward, Mafi said he has two major concerns.
First, that special interest groups and lobbyists could pressure CMS hard enough to force it to revert to fully covering a drug that has “real harms, unproven benefits, and very high financial costs,” he said.
Second, “even if CMS succeeds in finalizing its decision in spring 2022 to restrict aducanumab’s use to randomized controlled trials only, it remains unclear what will happen to state Medicaid programs, who are technically still on the hook to cover this FDA-approved drug,” Mafi said.
Even a small amount of use of the drug could “seriously threaten the solvency of state and managed Medicaid budgets, thereby impairing their ability to cover care that does have proven effectiveness, such as cardiac catheterizations for heart attacks,” Mafi warned.
“Straining Medicaid budgets has the potential to harm health equity because patients with Medicaid coverage are typically underresourced and from disproportionately racial and ethnic minority groups,” Mafi said.
Support for the study was provided by grants from the National Institute on Aging (NIA) of the National Institutes of Health. Mafi has received grants from the NIA during the conduct of the study, as well as nonfinancial support from Milliman MedInsight and grants from Arnold Ventures. Co-author Catherine Sarkisian, MD, reported grants from the National Institutes of Health during the conduct of the study.
JAMA Health Forum. Published online January 14, 2022. Full text
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