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National Coverage Determination on Aduhelm -

The Drug That Threatened to Break Medicare

By: Chalen Jackson, Compliance Officer

On April 7th, 2022, Medicare published the finalized National Coverage Determination for Aduhelm, Biogen’s novel Alzheimer’s treatment approved last summer by the FDA. Medicare changed little from the initial proposal, opting to cover this treatment only in for those enrolled in approved clinical trials. This critical and much-anticipated decision sets the stage for a number of unprecedented changes in Medicare. Let’s go back to the FDA approval of Aduhelm and track the chain of events up to now to discuss the ramifications of this decision.

In July 2021, Aduhelm (Aducanumab), a monoclonal antibody treatment for Alzheimer’s, was pushed through the FDA’s Accelerated Approval Pathway amid much skepticism. Many in the medical profession noted the early ending of Biogen’s two clinical trials, both of which showed minimal, if any, benefit to slowing cognitive decline in those who received the treatment. But, as noted in the approval request and decision, the drug was approved due to the ability to reduce amyloid plaques, which some research suggest may provide benefit to those suffering from Alzheimer’s.

Those working in the Medicare space felt a strong sense of concern almost immediately. At the original $56,000 annual cost of Aduhelm and an estimated 1 million potential patients relying on Medicare, if approved for coverage, this drug was expected to potentially double Medicare Part B spending. Not all therapies approved by the FDA are also approved by Medicare. In many cases, a drug goes through the coverage determination process to gain approval for Medicare payments. If Medicare determined it should provide coverage for this drug, many called into question the solvency of the Medicare Trust Fund, which provides the funding for Medicare claims payments and administration.

In November 2021, CMS announced the 2022 Medicare Costs, which included a startling increase of nearly $22 in the monthly part B premium. Though no determination had been made at that time, the anticipation that Medicare might need to cover Aduhelm was enough to drastically increase part B premiums. In January, amid slow adoption among payors, Biogen cut the shelf price of Aduhelm in half, lowering it to $28,000. This prompted early discussions among policymakers to propose lowering the Medicare part B premium, an unprecedented step, particularly mid-year.

In January 2022, CMS announced its proposed Coverage Determination for Aduhelm, which offered to cover the therapy only for those in approved clinical trials, which we saw carry through to the final decision. The final coverage determination also provided a pathway for coverage to other monoclonal antibody treatments that went through the longer, traditional FDA approval process.

So now we find ourselves caught up to the current day, where calls have renewed for lowering the part B premium. Whether or not that will happen is yet to be seen, but there is increasing support for such measures. Individuals on Medicare wishing to receive Aduhelm to treat Alzheimer’s will need to self-pay or find other funding sources. You can read the full coverage determination and related documents below under sources.

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