Vials containing an expensive and controversial drug for Alzheimer’s disease have a fixed size, but the amount required by patients varies widely, as it is administered by intravenous infusion in part based on body weight.
That problem alone could waste $605 million a year on Medicare spending, assuming the use of Aduhelm (generically known as adducanumab) is expanded, according to new research.
The study, funded by the National Institutes of Health, led by researchers at the University of California, Los Angeles, said the problem of fixed-amount vials could 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 the patient’s weight and factors such as now amyloid plaque rates.
Biogen, the drug’s maker, could go a step further and the drug could be supplied in more efficient vial sizes to contain costs, if the drug is approved for general use, the researchers said.
His letter was published Monday in the Journal of the American Geriatrics Society, peer-reviewed.
The UCLA-led team of researchers said aducanumab, which received its first green light a year ago from the Food and Drug Administration through an accelerated approval process, has been found to have few benefits. , if any, for Alzheimer’s patients. Although Medicare has restricted its use in clinical trials, this decision could be overturned by appeals or legal challenges.
The FDA, in approving Aduhelm, noted that it was the first new therapy approved for Alzheimer’s disease since 2003 and the first treatment aimed at the physiological processes underlying the disease and the presence of amyloid beta plaques in the brain.
As of Jan. 1, Biogen said it was reducing the wholesale acquisition cost of aducanumab in the United States for an injection of 100 mg / ml for intravenous use by 50%. For an average-weight patient, listed at 163 pounds, Biogen said the annual cost at the maintenance dose would be $ 28,200.
On April 7, the Medicare and Medicaid Service Centers issued a final determination of national coverage that limits access to Aduhelm only to Medicare beneficiaries in the early stages of the disease who are enrolled in clinical trials approved by the FDA or the NIH.
Three weeks later, Biogen announced plans to help U.S. patients currently under Aduhelm avoid treatment interruptions after the decision.
Biogen spokeswoman Ashleigh Koss cited the drug maker’s statements about determining Medicare coverage and plans to provide continuity of care to patients taking adducum. Asked about the drug’s sales, she told UPI: “Given the [CMS] The decision effectively denies access to Aduhelm to all Medicare beneficiaries, we do not expect sales to continue to rise. ”
“We don’t offer updates on Aduhelm’s sales and we don’t have any comments on the UCLA study,” Koss said.
Biogen cited Aduhelm-related inventory cancellations in its quarterly earnings report that 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 auxiliary care services associated with adducanumab, such as a brain MRI and its administration to a doctor’s office, could account for nearly 20% of Medicare costs for patients treated with the medicine.
Several other drugs for Alzheimer’s are in the process, so adducanumab won’t be the last infusion drug that will threaten the Medicare budget, said Dr. Carlos Irwin Oronce, lead author of the study and assistant scientist at the project in the General Division of Internal Medicine and Health at UCLA. Research Services.
He told UPI that the conclusion is that “with this type of medication, with biological products, they are often administered inefficiently,” and a higher dose than necessary in the vials “means that you will always discard” some amount.
“So if manufacturers used vials with smaller doses, you would get closer to what patients need,” he said.
“Given the increase in the Medicare premium in 2022, in part due to aducanumab, a greater focus on efficient vial packaging could improve the value of future Medicare spending, curbing the growth of premiums and reduce the out-of-pocket costs of beneficiaries, ”it concluded in a press release.
For their analysis, UCLA-led researchers used nationally representative data from the 2016 Health and Retirement Study, co-sponsored by the National Institute on Aging and Social Security Administration.
They took a monthly dose of 10 mg / kg of the drug and, based on the weight distribution of the study cohort, defined 27 patient weight categories ranging from 104 pounds or less to more than 330 pounds. .
These categories reflected 27 possible combinations of aducanumab vials needed to properly dose the drug to 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 needs 850 mg of drug provided by three vials of 300 mg / 3.0 ml (900 mg in total), which would result in 50 mg of discarded drug per month.
From the calculated wasted drug of each patient in the representative sample of the national survey, the authors estimated the potential amount of wasted drug for the entire U.S. Medicare patient population that could be expected to receive aduncanumab annually.
They identified lower and upper estimates of 737 to 2,035 participants, representing between 2.9 and 8.4 million Medicare Part B recipients 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 drug intake of 10%, between 132,398 and 694,258 vials would be ruled out, and that would be between $ 115 million and $ 605 million than Medicare. it wastes annually for its registrants. . But reducing the size of the drug vial could reduce unnecessary spending by 60 percent, according to the study.
The researchers acknowledged the limitations of the study and explained that the measures used to classify cognitive impairment may have misclassified some cases. They also assumed that the price of the drug would not change.
The head of a pharmacy benefits manager, the pharmaceutical industry intermediary, said the vial size problem is not limited to a single drug.
“This is a bigger and widespread problem in the healthcare industry specifically for single-dose vials such as Aduhelm and cancer drugs,” Mesfin Tegenu, president and CEO of RxParadigm, a PBM based in Delaware.
“This issue has sparked much debate over the years, as many have conducted impact studies as well as raised awareness prior to Aduhelm’s release,” he said. “But the scrutiny surrounding Aduhelm has shed more light on this more global issue.”
As the problem spread, Tegenu noted that CMS introduced “the JW modifier” in 2017 to help keep track of how much the program spent on discarded drugs.
“With the price type [that] Drug manufacturers charge, I think it’s reasonable to suggest that adding alternative unit doses instead of just making one or two doses of vial sizes can lead to reduced waste, ”he said.
Because CMS collects the JW report that shows the discarded amount of prescription drugs, Tegenu said, “what I suggest is that if they are not already doing so, CMS should incorporate the report’s result into their refund structure and pay only the amount used “.
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