More Aduhelm Drama: Packaging Could Waste Medicare Millions; Trial Tossed

By Simon Spichak, MSc | June 27th, 2022

New findings reveal that the way Aduhelm is packaged leads to wasted medication — and as much as $605 million per year of Medicare funding wasted, too.  Meanwhile Biogen shuts down an Aduhelm trial.

UPDATE: 3 March 2024, 8:35 P.M. ET. In February 2024, Biogen took Aduhelm off the market, citing financial concerns. Although the drug did receive accelerated, conditional FDA approval for the treatment of early Alzheimer’s disease in 2021, it is no longer available to new patients. The company announced it would sunset trials in May 2024 and cease supplying the drug to current patients in November 2024.

Drugmaker Biogen had high hopes for its landmark Alzheimer’s medication Aduhelm. But ever since its controversial July 2021 approval by the Food and Drug Administration, Aduhelm has been bogged down by ambiguous efficacy data, leading to much lower sales numbers than projected

On June 21st, Biogen shut down a clinical trial aimed at collecting real-world data from 6,000 patients using Aduhelm, having only recruited 29 patients to date. Now, Biogen and other anti-amyloid drug manufacturers are once again in the hot seat, as a team of researchers at University of California Los Angeles scrutinize the wasted costs arising from inefficient packaging of the drug. 

A study published in the Journal of the American Geriatrics Society calculated the Medicare costs associated with administering Aduhelm to 10 percent of eligible people with Alzheimer’s. The drug is provided in fixed-dose vial sizes — 170 mg/1.7 mL and 300 mg/3.0 mL — administered based on a patient’s weight and other factors related to disease progression. 

However, at a 10 mg/kg monthly dose, a significant volume of the drug would be discarded each month amounting to a total cost between $115 million and $605 million per year. An example: A 85 kg patient would need 850 mg of the drug or three vials dosed at 300 mg/3.0 mL, leaving 50 mg being discarded from the third vial each month.

“With several other Alzheimer’s drugs in the pipeline, aducanumab [Aduhelm] will not be the last infusion drug to threaten Medicare’s budget,” said Dr. Carlos Irwin Oronce, a scientist at UCLA who led this study. “Given Medicare’s premium increase in 2022 partly due to aducanumab, greater focus on efficient vial packaging could improve the value of future Medicare spending, slow premium growth, and reduce beneficiaries’ out-of-pocket costs.”

Will Aduhelm cost taxpayers $605 million per year?

Currently priced at $28,200 per year if not covered by insurance, the drug’s high price tag has been blamed for an increase in Medicare premiums. Subsequently, the Centers for Medicare & Medicaid Services opted to eliminate Medicare coverage for anyone outside of clinical trials. This led to Biogen downscaling production of the drug.

According to the new study, reducing the size of the vials would reduce wasteful spending by 60 percent. But this is unlikely to worry Biogen, as they have recently shifted focus to the next anti-amyloid drug in its pipeline — lecanemab. Biogen has also downscaled Aduhelm manufacturing in response to the lack of insurance coverage for patients. 

Other anti-amyloid drugs in Phase 3 trials — lecanemab, gantenerumab, donanemab — may face scrutiny similar to Aduhelm if they are approved and also use fixed-volume vials for treatment. But even if Aduhelm proves effective in treating Alzheimer’s disease, the $605 million per year generated by the volume of drug wasted in the vials is a small fraction of the estimated $300 billion economic burden of the disease as well as the $770 billion that the federal government spends yearly on Medicare. 

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