Two major US health systems will not administer controversial new Alzheimer’s drug to patients.
Adulhelm, received the US. Food and Drug Administration (FDA) approval on June 7 despite mixed clinical trial results.
The Cleveland Clinic, one of the most respected systems in the country, and Mount Sinai, a system in New York City, both said they will not prescribe the drug to patients due to a possible 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 it will cover the drug’s costs, and the FDA has asked for an investigation into its agency’s communications ahead of the approval of the drug.
Cleveland Clinic (pictured) and Mount Sinai will not administer newly approved Alzheimer’s drug Aduhelm after controversial FDA approval
Aduhelm gained 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 data on this drug”
“Based on current data on safety and efficacy, we have decided not to carry aducanumab at this time,” the statement said.
Doctors at the hospital can prescribe Aduhelm to patients, but they will have to go elsewhere to get the drug.
Mount Sinai said the decision not to administer the drug came after news of the FDA investigation.
‘Aduhelm is not eligible to infuse patients on any of its campuses until and unless [an investigation by the inspector general of the Department of Health and Human Services,] affirms and reaffirms the integrity of the relationship between FDA and Biogen [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 insurance company that covers 62 million people across the country, has also announced that they have no plans to reimburse the drug.
Biogen responded to the hospitals’ decision by staying behind its drug.
“Biogen continues to stand 100 percent behind Aduhelm and the clinical data supporting approval,” Biogen, based in Cambridge, Massachusetts, wrote in an email to the Times.
“If a patient is denied access to care, we encourage them to contact us for assistance as we remain committed to supporting access to Aduhelm for all eligible patients.”
Some medical experts have doubts about the effectiveness of the drug.
HOW TO DETECT ALZHEIMER’S DISEASE?
Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking, and the ability to perform simple tasks.
IIt is the cause of 60% to 70% of dementia cases.
The majority of people with Alzheimer’s disease are 65 years and older
More than six million Americans have Alzheimer’s disease.
It is not known what causes Alzheimer’s disease. 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 healthcare professionals
- More severe memory loss
- Difficulty speaking, swallowing and walking
Stages Of Alzheimer’s Disease:
- Mild Alzheimer’s (Early Stage) – A person may be able to function independently but have amnesia
- Moderate Alzheimer’s (Middle Stage) – Typically the longest stage, the person may confuse words, become frustrated or angry, or have sudden changes in behavior
- Severe Alzheimer’s disease (late stage) – In the final stage, individuals lose the ability to react to their environment, carry on a conversation and eventually control movement
Biogen launched two clinical trials for Aduhelm in 2016.
Both were halted halfway through because researchers concluded that neither trial would ultimately achieve their goal.
The company later revealed updated data from the second study that showed patients had a 22 percent decrease in the rate of their cognitive decline.
It also showed that Aduhelm could remove amyloid beta plaques in the brain.
Some believe that removing these plaques could halt cognitive decline, making the drug the only available treatment for Alzheimer’s disease.
Others criticize Biogen for extracting data from a failed trial, not interpreting the company’s data in the same way.
dr. David Knopman, a neurologist at the Mayo Clinic, published an analysis of Biogen’s data in November, in which he disagrees with the company’s conclusions about the drug’s effectiveness.
Knopman sat on the FDA’s advisory committee that voted 10-0 against the drug’s approval, and he later resigned in protest at the drug’s approval.
A study of neurologists by Spherix Global Insights found that neurologists only believe the drug is appropriate for use in one in seven Alzheimer’s patients.
“Regardless of pent-up patient demand, the expansion of the Aduhelm prescriber base is likely to be slower than usually seen with other launches in the neurology market — as fewer than half of neurologists believe they will become adopters within the first six months of availability. become,” wrote in a release.
The FDA is also beginning to have doubts about 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 mild Alzheimer’s.
It was previously recommended to all Alzheimer’s patients.
dr. FDA Commissioner Janet Woodcock even asked the Inspector General’s office to investigate communications between her staff and Biogen employees leading up to the drug’s approval.
The Cleveland Clinic cites this research as a reason for not wanting to use the drug.
Aduhelm has also been criticized for its high price tag.
Biogen sticks to his medicine. The company charges $56,000 for a year of treatment with Aduhelm
Biogen has set a price tag of $56,000 for a year of treatment.
A nonprofit think tank focused on drug pricing estimated the drug’s true value at between $3,000 and $8,400 per year.
Two congressional committees have launched investigations into the drug’s price and the high price tag that Medicare could cost.
An analysis published by the Kaiser Family Foundation estimates that if just 500,000 Medicare recipients were prescribed Aduhelm, it would cost Medicare nearly $29 billion a year, far more than any other drug.
The Centers for Medicare and Medicaid Services launched their formal process earlier this week to decide whether or not the agency will cover the drug.
A final decision is unlikely to be made until spring 2021.