The anti-dementia medication lecanemab, and its ancillary costs, could add $2 to $5 billion in annual Medicare spending if the Centers for Medicare and Medicaid Services revises its coverage decision, according to a research letter in JAMA Internal Medicine.
Currently, the medication is covered only for patients who are enrolled in clinical trials.
Medicare fee-for-service spending was $37 billion in 2019 for drugs such as lecanemab that are administered in outpatient settings. In addition to higher Medicare spending, lecanemab’s medication and ancillary out-of-pocket costs for patients lacking supplemental coverage could reach $6,600 per year, which is approximately one fifth of the median income of a U.S. Medicare beneficiary, data showed.
Medicare annual spending on lecanemab’s medication costs alone would place it among the most expensive Part B medications delivered in outpatient facilities, authors said.
WHAT’S THE IMPACT
Lecanemab is currently available as a treatment for mild cognitive impairment and mild dementia under the Food and Drug Administration’s accelerated approval program.
The FDA is expected to grant lecanemab traditional approval later this year, prompting Medicare to reconsider its coverage restrictions and potentially enabling widespread use. Clinical trials have shown that the drug has modest clinical benefit.
Moreover, because of its risk of brain swelling and brain bleeding, also known as amyloid-related imaging abnormalities, or ARIA, the treatment requires frequent monitoring via neurology visits and MRI scans.
The researchers performed a cost analysis using data from the nationally representative 2018 Health and Retirement study (HRS), incorporating both the direct drug costs as well as the indirect ancillary costs for associated health services such as MRIs, neurology visits and other related care.
Limitations to the study include use of plaque rates derived from population studies rather than from HRS participants’ scans, possible misclassification of some cases of dementia prevalence and stage, and responses from participants with cognitive impairment which may not be reliable, although proxies can respond on their behalf.
THE LARGER TREND
According to Optum, there’s a high unmet need for treatments for Alzheimer’s disease, since it’s a leading cause of illness and death among the elderly. Existing treatment options have been ineffective.
In June 2021, the FDA approved Aduhelm (aducanumab), the first amyloid beta-directed antibody, via the accelerated approval pathway based on reductions in amyloid beta plaques. Subsequently, a CMS National Coverage Determination limited Medicare coverage for Aduhelm and other beta-amyloid targeted therapies to patients enrolled in clinical trials because of unknown clinical benefit.
Lecanemab would be the second drug in the class with FDA approval through the accelerated approval pathway that was followed to approve Aduhelm, based on the surrogate of reductions in beta-amyloid plaques.
In January, CMS released a proposed National Coverage Determination decision memorandum that said the NCD would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development, meaning for Medicare recipients enrolled in qualifying clinical trials.