Study: Medicare could waste up to $605M on Alzheimer's drug vials

WASHINGTON, June 27 (UPI) -- The vials containing an expensive, controversial drug for Alzheimer's disease are fixed in size, yet the amount required by patients varies widely, since it is administered via intravenous infusion partly based on body weight.

This issue alone could waste $605 million in Medicare spending annually, assuming the use of Aduhelm (known generically as aducanumab) becomes widespread, new research suggests.

The National Institutes of Health-funded study, led by researchers at the University of California, Los Angeles, said the issue of fixed-amount vials might cause large volumes of aducanumab to be discarded unused.

According to the researchers, the infusion drug comes in two fixed-dose vial sizes of 170 mg/1.7 ml and 300 mg/3.0 ml, which are administered based on a patient's weight and factors such as amyloid plaque rates.

Biogen, the drug's manufacturer, could go a step further and the medication could be supplied in more efficient vial sizes to contain costs, should the drug be approved for general use, the researchers said.

Their letter was published Monday in the peer-reviewed Journal of the American Geriatrics Society.

The UCLA-led team of researchers said aducanumab -- which got its first green light a year ago from Food and Drug Administration via an accelerated approval process -- has been found to have little, if any, benefit for Alzheimer's patients. Although Medicare has restricted its use in clinical trials, this decision could be overturned by appeal or legal challenges.

The FDA, in approving Aduhelm, noted it was the first novel therapy approved for Alzheimer's disease since 2003 and the first treatment directed at the disease's underlying physiological processes and the presence of amyloid beta plaques in the brain.

Effective Jan. 1, Biogen said it was reducing aducanumab's wholesale acquisition cost in the United States for a 100 mg/ml injection for intravenous use by about 50%. For a patient of average weight, listed at 163 pounds, Biogen said the yearly cost at the maintenance dose would be $28,200.

On April 7, the Centers for Medicare and Medicaid Services issued a final national coverage determination that limits access to Aduhelm to only those Medicare beneficiaries in early stages of the disease who are enrolled in FDA or NIH-approved clinical trials.

Three weeks later, Biogen announced plans to help patients in the United States who are currently on Aduhelm avoid treatment interruptions after the decision.

Biogen spokeswoman Ashleigh Koss cited the drug maker's statements on the Medicare coverage determination and plans to offer continuity of care to patients taking aducanumab. Asked about the drug's sales, she told UPI, "Given the [CMS] decision effectively denies all Medicare beneficiaries access to Aduhelm, we are not anticipating sales continuing to increase."

"We are not providing updates on Aduhelm sales, and we don't have any comment on the UCLA study," Koss said.

Biogen cited inventory write-offs related to Aduhelm in its earnings report for the quarter ended March 31. The company reported U.S. sales of $2.8 million for the drug over the three-month period.

Previous UCLA research suggested that ancillary care services associated with aducanumab -- such as a brain MRI and its administration in a physician's office -- could account for nearly 20% of Medicare costs for patients treated with the drug.

Several other Alzheimer's drugs are in the pipeline, so aducanumab won't be the last infusion drug to threaten Medicare's budget, said Dr. Carlos Irwin Oronce, the study's lead author and an assistant project scientist in the UCLA Division of General Internal Medicine and Health Services Research.

He told UPI the bottom line is that "with these types of medications, with biologics, they're often administered in an inefficient way," and higher than necessary dosing in the vials "means you're always going to discard" some amount.

"So, if manufacturers used vials with smaller doses, you'd get closer to what the patients need," he said.

"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," he concluded in a news release.

For their analysis, the UCLA-led researchers used nationally representative data from the 2016 Health and Retirement Study, co-sponsored by the National Institute on Aging and the Social Security Administration.

They assumed a 10 mg/kg monthly dosage of the drug and, based on the study cohort's weight distribution, they defined 27 patient weight categories ranging from 104 pounds or less to greater than 330 pounds.

These categories reflected 27 possible aducanumab vial combinations needed to properly dose the drug for the patients potentially eligible for it, the scientists said. They subtracted the total amount of drug in the vials from the total amount needed for each patient in the survey based on the patient's weight.

For example, a 187-pound patient requires 850 mg of drug provided by three 300-mg/3.0 ml vials (900 mg total), which would result in 50 mg of discarded drug per month.

Based on the wasted drug calculated from each patient in the nationally representative survey sample, the authors then estimated the potential amount of drug wasted for the entire U.S. Medicare population of patients who could be expected to receive aducanumab annually.

They identified lower and upper estimates of 737 to 2,035 participants, representing about 2.9 million to 8.4 million Medicare Part B beneficiaries age 65 or older with mild cognitive impairment or mild dementia

If aducanumab is approved for widespread use, the study said, and assuming a conservative 10% drug uptake, between 132,398 and 694,258 vials would be discarded, and this would add up to anywhere from $115 million to $605 million wasted by Medicare for its enrollees annually. But reducing the drug's vial size could lessen wasteful spending by 60%, according to the study.

The researchers acknowledged the study's limitations, explaining that the measures used to classify cognitive impairment may have misclassified some cases. They also assumed that the drug's price would not change.

The head of a pharmacy benefit manager, the middleman in the pharmaceutical industry, said the issue of vial size isn't confined to a single medication.

"This is a larger, widespread problem across the healthcare industry specifically for single-dose vials such as Aduhelm and cancer drugs," Mesfin Tegenu, chairman and chief executive officer of RxParadigm, a Delaware-based PBM, told UPI.

"This topic has raised much debate over the years as many have conducted studies into the impact, as well as raised awareness prior to the release of Aduhelm," he said. "But the scrutiny surrounding Aduhelm has brought more light around this more global issue."

As the issue became more widespread, Tegenu noted that CMS introduced "the JW modifier" in 2017 to help track the amount the program spent on discarded drugs.

"With the kind of price [that] drug manufacturers charge, I think it is reasonable to suggest that adding alternative unit doses instead of just manufacturing one or two doses of vials sizes can potentially lead to lessen the wastage," he said.

Since CMS gathers the JW report showing the discarded amount of prescription drugs, Tegenu said, "what I am suggesting is if they are not already doing it, CMS should incorporate the report result in its reimbursement structure and only pay for the used amount."