A UCLA-led cost analysis of the controversial new Alzheimer's disease drug aducanumab shows that ancillary care services, such as additional MRIs and neurologist visits to monitor the potential brain swelling and bleeding associated with the medication, account for nearly 20% of total Medicare costs related to the drug, or $6,564 per patient per year.
With 1.1 to 5.7 million Medicare beneficiaries who have mild dementia or cognitive impairment identified as potentially eligible for the drug, these ancillary services could substantially increase annual Medicare spending, the analysis shows.
In June 2021, the U.S. Food and Drug Administration approved aducanumab to treat Alzheimer's disease despite questions about evidence related to the drug's efficacy and concerns about its high price. The drug's manufacturer recently reduced the annual price of aducanumab from $56,000 to $28,200 per patient. (Previous spending estimates did not explicitly quantify aducanumab's ancillary costs and did not incorporate this price reduction.)
Approximately 4 in 10 patients on aducanumab display what are known as amyloid-related abnormalities during brain imaging -; a warning sign of bleeding or swelling -; requiring multiple follow-up MRI scans and visits to the neurologist. In part due to these safety concerns, Medicare has preliminarily announced that it plans to restrict access to aducanumab to only those patients enrolled in clinical trials.
The researchers examined data on approximately 8,400 Medicare Part B beneficiaries age 65 and older and identified those with mild cognitive impairment or mild dementia who were potentially eligible to receive aducanumab. The study used validated cognitive measures and data from the nationally representative 2016 Health and Retirement Study, a longitudinal panel survey supported by the National Institute on Aging.
The ancillary costs associated with aducanumab could add further pressure on Medicare, raising questions of how to maximize the value of public dollars, particularly for a drug with uncertain benefit and a known risk of patient harm, the researchers said. They noted that the recent Centers for Medicare and Medicaid Services announcement of a large annual increase in Medicare premiums can be seen as just one example of aducanumab's budgetary impact.
Mafi, J.N., et al. (2022) Estimated Annual Spending on Aducanumab in the US Medicare Program. JAMA Health Forum. doi.org/10.1001/jamahealthforum.2021.4495.