Smaller vial size for Alzheimer’s drug could save Medicare hundreds of millions per year

(Press-News.org) Medicare could save up to 74% of the money lost from discarded Alzheimer’s drug lecanemab by the simple introduction of a new vial size that would reduce the amount of unused medication that is thrown away, new research suggests.

The researchers on the study, to be published October 14 in the peer-reviewed JAMA Internal Medicine, estimate that Medicare could waste up to $336 million annually due to discarded medication. Administered dosages are based on each patient’s body weight. But because the drug is currently available only in single-use 500 mg and 200 mg vials, substantial amounts of the expensive medication are discarded when the dose a patient is prescribed is lower than the amount contained in the vials.

Clinical trials have found that the drug, intended for people with mild cognitive impairment or mild dementia, has marginal net clinical benefit. Previous UCLA-led research has suggested that the cost of the drug, plus ancillary costs such as treatment for brain swelling linked to the medication, could cost Medicare $2 billion to $5 billion per year.

Healthcare costs continue to increase each year, placing significant strain on the Medicare budget, said lead author Frank Zhou, a fourth-year medical student at the David Geffen School of Medicine at UCLA.

“It is imperative to reduce spending on services that do not improve the health of patients, and this is a prime example of such, given that Medicare is paying for a drug only to literally throw part of it away,” he said. “There are significant opportunities for savings even with this single drug, implying that even greater savings could be achieved if our proposed solutions were applied to other infused therapies.”

Medicare spent $33 billion on Part B infusion drugs in 2021, said Dr. John Mafi, associate professor-in-residence of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA.

“So there is substantial opportunity for cost savings by reducing waste from all infusion drugs said Mafi, the study’s senior author.

Under the Infrastructure Investment and Jobs Act of 2021, manufacturers are required to reimburse Medicare for waste exceeding 10%, Zhou said. “However, we estimate lecanemab waste to be only 5.8%, rendering current policy ineffective, and sounding the bell that further policy changes are likely needed,” he said.

Using the nationally representative 2020 Health and Retirement Study, the researchers analyzed data from participants aged 65 years and older, had Medicare Part B coverage, and were eligible for lecanemab. They calculated each person’s required weight-based dose, subtracted that amount from each patient’s dispensed dose to determine how much would be discarded, and then multiplied that amount by the number of doses per year to estimate the annual wasted amount.

For instance, a 65 kg patient would be prescribed a 650 mg dose. Given that this patient would be dispensed one 500 mg vial and a 200 mg vial, 50 mg would ultimately be tossed out.

Assuming conservative lecanemab uptake rates of 1.1-2.9% for an estimated 82,000 to 208,000 of eligible people, current vial sizes would lead to an estimated $133 million to $336 million worth of medication thrown away every year. This means that the discarded lecanemab from 16 patients could provide enough medication for an additional person.  The researchers suggest that this waste could be reduced by 74% by adding a third, 75 mg vial without significantly harming quality of care or risking a drug price increase that exceeds inflation.

The cohort the researchers studied may not have identical weights to actual lecanemab users, expected uptake rates are not precise, manufacturing and regulatory costs of changing vial sizes were not incorporated into the findings, and the amount of waste may have been underestimated due to the algorithm used, all of which limit the findings, the researchers note.

Study co-authors are Chi-Hong Tseng, Mei Leng, Dr. Benjo Delarmente, Dr. Catherine Sarkisian, and Dr. John Mafi of UCLA, and Cheryl Damberg of RAND Corporation.

The study was funded by the National Institute on Aging (R01AG070017-01).

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