On January 11, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated National Coverage Determination (“NCD”) decision for anti-amyloid monoclonal antibodies for the treatment of Alzheimer’s disease.
Although this decision is still awaiting public comment and further agency evaluation before final decisions are made on April 11, it has sparked numerous discussions— good and bad.
This coverage decision, if accepted would mean that Medicare will only cover the bills of patients with anti-amyloid monoclonal antibodies (specifically, Biogen’s drug Aduhelm) who have participated in clinical trials to determine whether the drug showed a significant difference in effectiveness in terms of decline in cognition and function, and safety.
Biogen has argued that Medicare’s decisions were not in favor of patients with Alzheimer’s as the clinical trials can take months or years to complete. According to Biogen, “hundreds of Alzheimer’s patients…are progressing each day from mild to moderate disease stages where treatment may no longer be an option.”
Many believe Medicare’s decision was made because of the exorbitant cost of Aduhelm, which was a problem for Medicare premiums and out-of-pocket costs. However, Medicare officials have stressed that clinical trials are being conducted to determine the effectiveness and necessity of using these drugs to treat Alzheimer’s patients enrolled in the program, and not because of the cost of Aduhelm.
Biogen originally marketed Aduhelm at a price of $56,000 per year, which resulted in a nearly $22 increase in Medicare’s monthly “Part B” premium for outpatient care. Medicare attributed their plan’s price increase to the exorbitant cost of Aduhelm. After careful consideration, Biogen lowered the price of the drug to $28,200, which has prompted Medicare to reconsider its premium increase.