Posted on May 3, 2022 by Larry Johnson
Posted on May 3, 2022 by Larry Johnson
After Biogen introduced its new Alzheimer’s medication, aducanumab, better known as Aduhelm, to the general public in June of 2021, speculation arose as to whether or not Medicare would cover costs of purchasing the Alzheimer’s medication. Medicare has been somewhat resistant to accept the medication, which led Biogen to begin offering it to select patients for free last fall.
While the Centers for Medicare and Medicaid Services (CMS) haven’t completely changed course on covering Aduhelm, they’ve slightly relaxed their position. On April 7, 2022, CMS finalized a decision to cover Aduhelm for patients involved in randomized clinical trials conducted through the FDA or the National Institutes of Health. The trials do not have to be approved by CMS.
This is great news for patients involved in trials for Aduhelm. However, some may wonder why CMS doesn’t just choose to cover the Alzheimer’s medication without conditions. The organization continues to have some concerns about the medication, which they feel still has a way to go before it’s proven to treat Alzheimer’s.
Aduhelm was given conditional approval after an accelerated process in the summer of 2021 to treat all Alzheimer’s patients. Though Aduhelm has been approved, clinical trials continue to show mixed results when it comes to the effectiveness of the drug in slowing the progression of Alzheimer’s Disease.
Biogen’s aducanumab is a monoclonal antibody that’s designed to reduce the amount of amyloid plaques that build up in the brain. This is key, as scientists believe that high buildup of these plaques can lead to Alzheimer’s and related cognitive illnesses. Aduhelm has been proven to reduce amyloid plaques, but many medical researchers still believe that it hasn’t shown a concrete result in regards to halting cognitive decline.
Because of that belief, two Phase III clinical trials were stopped in the early phases. While the stoppage of trials isn’t an unusual step, it is a sign that a medication may not work as it should. However, positive new data did arise as a result of these trials, specifically in those who received the high dose of Aduhelm. Studies showed that cognitive function of high dose recipients declined 23% more slowly than those in the low dose group, which inspires optimism in the results that Biogen’s aducanumab can yield in the future.
While mixed trial results may sound concerning, it is important to remember that Aduhelm is still a fairly “young” Alzheimer’s medication. The drug is still developing, and is currently still undergoing clinical trials to gauge how it works with Alzheimer’s patients. With information gathered from further trials, Biogen can find new ways to improve the overall effectiveness of the medication.
Another reason CMS may be holding back on allowing Aduhelm to be covered by Medicare as an Alzheimer’s medication is the fact that the Alzheimer’s medicine appears to pose some safety risks. This led the FDA to require Biogen to place a warning on Aduhelm’s label. This warning advises physicians to monitor patients and obtain two MRI brain scans during a patient’s first year of treatment with aducanumab.
The main issue researchers have found with Aduhelm is that it can lead to cerebral swelling or hemorrhage. While 41 percent of patients who received the high dose of Aduhelm in the Phase III trials mentioned above were said to have experienced these issues, the cases were relatively minor and asymptomatic.
Another issue that may have been of concern to CMS was that patients who were selected for the Phase III studies were excluded if they had certain medical conditions common for seniors. Conditions that led participants to be excluded included:
This limited the scope of the clinical trials to patients who were otherwise healthier, and may or may not have had better access to Aduhelm, than the general population of American seniors. In turn, this limited results that could have been yielded from conducting trials with a broader demographic.
CMS has updated its stance on future Alzheimer’s medications that target amyloid proteins thought to cause the disease. These types of Alzheimer’s drugs must now go through the traditional approved process, which would allow Alzheimer’s patients in a patient registry to have their medications covered by Medicare.
The changes to CMS’ policy on Alzheimer’s medicines that target amyloid proteins may be great news in the long run for patients who are looking to use Aduhelm, but cannot afford the medication. Biogen plans to begin screening patients for a post-marketing trial in May of 2022. This trial could meet CMS’ standards of coverage, which means the drug would be covered by Medicare for these patients.