Two major U.S. health systems will not be administering a controversial new Alzheimer’s drug to patients.
Adulhelm, received US. Food and Drug Administration (FDA) approval on June 7 despite mixed clinical trial results.
The Cleveland Clinic, one of the most well-respected systems in the country, and Mount Sinai, a New York City-based system, both said they will not prescribe patients the drug due to a potential investigation into the drug’s FDA approval.
In the time since the drug’s approval, three members of an advisory board have stepped down, Medicare is reviewing whether or not it will cover the drug’s cost and the FDA has asked for an investigation into its own agency communications leading up to the drug’s approval.
The Cleveland Clinic (pictured) and Mount Sinai will not administer the newly approved Alzheimer’s drug, Aduhelm, after its controversial FDA approval
Aduhelm received FDA approval despite two failed clinical trials, and limited results that the drug worked
In a statement, the Cleveland Clinic said it ‘had reviewed all available scientific evidence on this medication
‘Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time,’ the statement read.
Doctors at the hospital will be able to prescribe Aduhelm to patients, but they will have to go elsewhere to receive the drug.
Mount Sinai said it decision to not administer the drug came after the news of the FDA investigation.
‘Aduhelm will not be considered for infusion into patients on any of its campuses until and unless [an investigation by the inspector general of the Department of Health and Human Services,] affirms the integrity of the FDA-Biogen relationship and goes on to reaffirm [the basis for the FDA’s approval],’ Dr Sam Gandy, director of the Mount Sinai Center for Cognitive Health, wrote in an email to the New York Times.
Blue Cross Blue Shield, a health insurer that covers 62 million people across the country, also announced that they do not plan to cover the drug.
Biogen responded to the hospitals’ decision by standing by its drug.
‘Biogen continues to stand 100 percent behind Aduhelm and the clinical data that supported approval,’ Biogen, which is based in Cambridge, Massachusetts, wrote in an email to the Times.
‘If any patient is denied access to care, we encourage them to contact us for help as we remain committed to supporting access to Aduhelm for all appropriate patients.’
Some medical experts have doubts about the drug’s effectiveness.
HOW TO DETECT ALZHEIMER’S DISEASE
Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills and the ability to perform simple tasks.
It is the cause of 60% to 70% of cases of dementia.
The majority of people with Alzheimer’s are age 65 and older
More than six million Americans have Alzheimer’s.
It is unknown what causes Alzheimer’s. Those who have the APOE gene are more likely to develop late-onset Alzheimer’s.
Signs and symptoms:
- Difficulty remembering newly learned information
- Mood and behavioral changes
- Suspicion about family, friends and professional caregivers
- More serious memory loss
- Difficulty with speaking, swallowing and walking
Stages of Alzheimer’s:
- Mild Alzheimer’s (early-stage) – A person may be able to function independently but is having memory lapses
- Moderate Alzheimer’s (middle-stage) – Typically the longest stage, the person may confuse words, get frustrated or angry, or have sudden behavioral changes
- Severe Alzheimer’s disease (late-stage) – In the final stage, individuals lose the ability to respond to their environment, carry on a conversation and, eventually, control movement
Biogen launched two clinical trials for Aduhelm in 2016.
Both were stopped midway because researchers concluded that neither trial would end up reaching its goal.
Later, the company revealed updated data from the second study showed patients had 22 percent decrease in speed of their cognitive decline.
It also showed that Aduhelm could remove amyloid beta plaques on the brain.
Some believe the removal of these plaques can stop cognitive decline, which would make the drug the only available Alzheimer’s treatment to do so.
Others criticize Biogen for pulling data from a failed trial, and do not interpret the company’s data in the same way.
Dr David Knopman, a neurologist with the Mayo Clinic, published an analysis of Biogen’s data in November, where he disagrees with the companies conclusions on the drug’s effectiveness.
Knopman was on the FDA advisory committee that voted 10-0 against approving the drug, and he later resigned in protest of the drug’s approval.
A survey of neurologists by Spherix Global Insights found that neurologists only believe the drug is adequate for use in one-in-seven Alzheimer’s patients.
‘Regardless of pent up patient demand, expansion of the Aduhelm prescriber base will likely be slower than typically seen with other launches in the neurology market – as less than half of neurologists believe they will become adopters within the first six months of availability,’ Spherix wrote in a release.
The FDA is also beginning to show doubts in their own approval of the drug.
Earlier this month, the agency revised their label of the drug, now only recommending it to people in the early stages of the condition or with a mild case of Alzheimer’s.
It was previously recommended to all Alzheimer’s patients.
Dr Janet Woodcock, commissioner of the FDA, even asked for the Office of the Inspector General to investigate communications between her staff and Biogen employees in the lead up to the drug’s approval.
The Cleveland Clinic cites this investigation as reason for not wanting to deploy the drug.
Aduhelm has also received criticism for its large price tag.
Biogen stand by its drug. The company will charge $56,000 for a year of treatment using Aduhelm
Biogen has set a $56,000 price tag for a year of treatment.
A nonprofit think tank focused on drug pricing pegged the drug’s actual value at between $3,000 and $8,400 per year.
Two congressional committees have launched investigations into the price of the drug and the large price tag it could cost Medicare.
An analysis published by the Kaiser Family Foundation estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost Medicare nearly $29 billion a year, far more than any other medication.
The Centers for Medicare and Medicaid Services launched their formal process to decide whether or not the agency will cover the drug earlier this week.
A final decision will likely not be made until Spring 2021.