By Barbara Pierce
Despite FDA approval, drug not reaching people who need it
In June of 2021, FDA approved the first medication to slow the progression of Alzheimer’s disease.
Aducanumab, sold under the brand name Aduhelm, was announced as a milestone in the treatment of the disease; the beginning of a new future for the treatment of Alzheimer’s.
While it’s not a cure, it’s a very significant step forward. Though it doesn’t restore cognitive functioning that has been lost, Aduhelm does reduce amyloid plaques, which is believed to lead to a reduction in further decline of cognitive functioning.
“Aduhelm received accelerated approval from the FDA. This is the first FDA-approved therapy to treat the underlying biology of Alzheimer’s,” said Cathy James, CEO of the Alzheimer’s Association of Central New York.
“It’s the first therapy to demonstrate that removing beta-amyloid plaques, one of the hallmarks of Alzheimer’s disease, from the brain, is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s,” she added.
But then, since last summer when it was approved, we didn’t hear any more about this new wonder drug. It isn’t reaching many patients.
According to npr.org, reasons for this include its extravagantly high cost, ($55,000 per year), the reluctance of Medicare and other insurers to cover it, and lingering questions about whether it actually slows memory loss.
Many concerns come from the fact it received accelerated approval from the FDA. The accelerated approval program allows for earlier approval of drugs that treat serious diseases and fill an unmet medical need. The manufacturers of Aduhelm have until 2030 to conduct and report evidence from clinical trials demonstrating its effectiveness.
Clinical trials are now beginning. James said the Alzheimer’s Association announced in August it has launched the first network developed to collect the data that will determine the effectiveness of the medication and its side effects. The network, ALZ-NET, will gather “real-world” data and outcomes.
The data will be shared with doctors, patients, family members, researchers, the FDA and insurers, such as Medicare. ALZ-NET will include people from a variety of backgrounds and communities to achieve a representative sample.
Medicare will cover the cost of Aduhelm and other medicines in its class only for persons with Alzheimer’s who are enrolled in the qualifying clinical trials.
Notably, Medicare said in its decision that the only way for patients to access the first approved FDA treatment that targets amyloid in those living with Alzheimer’s is to enroll in a clinical trial.
“In reality, this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment,” said James.
The medication is given intravenously by infusion over a one-hour period once a month for an indefinite period of time.
The FDA has so far imposed strikingly few limitations on Aduhelm. It does require patients to have regular MRI scans because the drug can cause swelling or hemorrhaging in the brain.
Aduhelm is not a cure, but is a very important advance for treatment. The therapy has not yet been tested on people with more advanced cases of dementia.
To receive Aduhelm, individuals must undergo an FDA-required diagnostic test. The Alzheimer’s Association will do everything in its power to ensure access to the medication and any diagnostic test needed during the treatment process for all who will benefit.
The historic approval of Aduhelm ushers in an exciting era in Alzheimer’s and dementia treatment and research. Approvals of the first drug in a new category benefit people living with the disease by invigorating the field, increasing investments in treatments and generating innovation.
If you or a loved one has been diagnosed with Alzheimer’s disease, talk to your healthcare provider about whether Aduhelm may be suitable. They may know about ongoing clinical trials for Aduhelm or other medication that is being investigated.
To locate a clinical trial near you, see alz.org/trialmatch or call 1-800-272-3900. For more information on Aduhelm see: alz.org.