USA – U.S. Health Secretary Xavier Becerra has directed the Centers for Medicare & Medicaid Services (CMS) to reconsider a hefty 2022 Medicare Part B premium hike proposal based in part on the estimated cost of Alzheimer’s drug Aduhelm.
On Monday, the secretary asked CMS to reconsider a recommendation that would raise the monthly Part B premium by approximately US$22 to US$170.10.
According to CMS, more than half of this unusually large premium increase was intended to create reserves to cover Aduhelm’s potential use.
Neurologists, on the other hand, have not flocked to the monoclonal antibody drug, which targets amyloid beta plaques in the brain and was approved in 2021 amid controversy.
Biogen has since cut Aduhelm’s US$56,000 price tag in half, owing to uncertainty about the drug’s cost-benefit profile, which has slowed uptake.
As a result, Becerra has questioned the need for the full Medicare premium hike. “With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” he wrote in a directive to the agency.
Medicare announced the program’s largest-ever premium increase for 2021 in November, citing uncertainty about the cost of Aduhelm, a new Alzheimer’s therapy that has sparked controversy due to its questionable clinical benefit, high price, and potentially serious side effects.
Aduhelm is administered in physicians’ offices, which means it is part of the Medicare program, which is funded in part by senior premium payments and in part by taxpayer revenue.
Medicare pays for more expensive drugs than Aduhelm, but it has a much larger potential patient population than, say, a specialty cancer drug.
Regulators are racing against the clock to release a draft of their national coverage determination by Wednesday.
The final coverage decision, which is expected by April 12, could have a significant impact on how much Aduhelm costs the Medicare program, depending on how much patient access is restricted by diagnostic test results, which physicians can prescribe the drug, and other factors.
The decision could set clinical guidelines for who can receive the drug and other future therapies that work similarly to Aduhelm, and it is dependent on whether such drugs are deemed “reasonable and necessary” for treating Alzheimer’s disease, which affects more than 6 million people in the United States.
Traditionally, regulators are not supposed to consider cost when making their decision. According to Fierce Pharma, CMS is expected to announce whether the drug will likely be covered for seniors on Wednesday, January 12.
Democrats in Congress have pressed Becerra to persuade Medicare to reconsider its premium decision as the midterm elections approach later this year, and President Biden’s massive domestic spending package, which would reduce some health-care costs, has stalled.