Who will pay for Aduhelm?

Now that Aduhelm (aducanumab) has been approved by the FDA for people with early-stage Alzheimer’s, those with mild cognitive impairment or mild dementia, who will be responsible for the $56,000 annual price tag? A recent opinion paper in JAMA points out just how complicated this question can be. Just because the FDA has approved a drug doesn’t mean that the Centers for Medicare & Medicaid Services (CMS) will necessarily pay for it. The standards for approval by the FDA and CMS are different. “In contrast to the FDA’s ‘safe and effective’ standard, the statutory requirement for Medicare payment is that the product must be ‘reasonable and necessary’ for the treatment of beneficiaries.” There are some medications and imaging methods that have been approved by the FDA but not by CMS. For example, currently amyloid PET scans are FDA approved but covered by CMS only if they are done as part of an approved clinical trial. That coverage will probably need to be broadened as most experts feel that Aduhelm should not be administered without evidence of brain amyloid. Spinal fluid tests for amyloid may be sufficient to qualify, but they may not be as accurate as the PET scan. Blood tests for amyloid and tau should be commercially available within a few years, but for now, the amyloid PET scan is the gold standard. A decision by CMS whether to cover Aduhelm will likely take months.  Another government agency has weighed in on the controversy.  The Department of Veterans Affairs announced a few days ago that it will not provide Aduhelm to veterans.

Regardless of how you feel about whether FDA approval of Aduhelm was justified, you should be very concerned about the potential for a funding crisis.  If, like the VA, CMS decides not to cover Aduhelm and the additional necessary costs of an initial PET scan and multiple MRI scans monitoring for adverse side effects, only the wealthy will be able to afford this new medication.  To me, that is unacceptable.  On the other hand, do we want to potentially bankrupt Medicare for a medication that most experts feel has not yet been proven effective?

I want to thank Dr. Ron Louie for bringing the news about the VA decision on Aduhelm to my attention today. Ron is a pediatric oncologist who now is the fulltime caregiver for his wife who has early-onset Alzheimer’s.  I recommend his blog to other caregivers.