See updates to this post below:
Biogen’s new Alzheimer's drug Aduhelm (aducanumab), recently approved by the FDA, is as controversial for its benefits as it is for the process of regulatory approval this past year! Aduhelm is prescribed for patients with mild cognitive impairment (MCI) or mild dementia to reduce amyloid beta plaques, long thought to be hallmarks of Alzheimer's Disease (AD).
The controversy stems from the FDA approving the drug under accelerated approval policies, yet Aduhelm's clinical trial results do not definitively show benefit for patients.
Critics say that the clinical trial data submitted to the FDA for approval was substandard and Biogen even stopped trials acknowledging that moving forward would show no improvements. Later, Biogen reframed the data and resubmitted the results looking for approval after all.
Aduhelm is administered by intravenous infusion every 21-30 days. Each infusion session lasts about an hour. Prior to the first dose, patients will need to have an MRI of their brain to establish a baseline and then subsequent MRIs before the 7th and 12th visits and possibly additional scans to check for amyloid abnormalities. I am not sure how long treatments will last but for most participants in the clinical trials, treatments lasted 6 months, for a few it lasted 12 months, and some for 18 months, and others more than 4 years.
Although the total cost of all treatments and scans is expected to cost around $100,000 per person, Biogen Inc. is pricing the drug treatment Aduhelm at $56,000 per person, per year. Annual revenue for Biogen is estimated at $5 billion. Now typically, Medicare pays for FDA-approved drug therapies. Since most people with dementia are over 65 Medicare, which usually covers Approved drugs, the cost of the drug seems very high and unsustainable for Medicare. In fact, Medicare officials are currently discussing how they will cover the drug and possibly developing criteria on who would be eligible for coverage. As of now, there are 12 regional Medicare administrators across the US who each determine coverage for their areas. In the end, there may be a national policy that would apply the same criteria for all regions. The question is who will cover treatments for people younger than 65, not covered by Medicare!?
Looking at the cost of coverage another way...
If Medicare covers Aduhelm for 1 million people, it would spend approximately $57 billion per year for the treatment. In 2019, Medicare spent a total of $37 billion on part B medications. It does not sound like it will be blanket coverage for everyone who requests it from their healthcare provider...nor should it be. There are potentially very significant side effects which include brain swelling, brain bleed, as well as headaches, confusion, dizziness, and fall risks.
Many healthcare providers and researchers are not confident that removing or reducing amyloid plaques slows the progression of AD (The amyloid hypothesis is considered controversial by many in the field). In one clinical trial, some of the participants showed a modestly slower cognitive decline. But in another trial, there was no benefit. Additionally, there were no reversal of symptoms and no cognitive improvements. In the end, it seems like some patients may get some benefit in the early stages of MCI/dementia.
If the Aduhelm treatments are eventually deemed successful (and safe), this can pave the way for other AD/dementia treatments to get fast-tracked. There is a tremendous amount of pent-up demand for a cure or treatments that will significantly slow the progression or even cure many different forms of dementia
For patients and families, Aduhelm provides hope, perhaps a bit more than a glimmer.
Update: 7/16/2021
Three hospitals announced that they would not prescribe or administer Adulelm to patients.
The Cleveland Clinic
Mount Sinai, New York
Providence in Renton, Wash.,
The controversy regarding the effectiveness of the drug was one of the issues. The other was concern that the FDA compromised its standards/values in the approval process. Additionally, Blue Cross/Blue Shield of North Carolina refuses to cover treatments because of the risks of brain swelling and bleeding. There is also concern that the FDA has lost trust or credibility with organizations and agencies that rely on the FDA for guidance.
More to come I'm sure...
Update: 7/25/2021
Below is a link to an article by Dr. Whitehouse & Dr. George regarding Aduhelm. It came out two weeks ago and has a very good breakdown of the issues. This is a complex and controversial disease and the rush to find treatments or cures is certainly understandable. But it has to be done right. Too many questions, side effects, uncertainty, etc...
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