Biogen’s much-criticized pricing of its controversial Alzheimer’s drug Aduhelm took a nosedive from $56,000 to $28,200. The late December change in pricing strategy represents only the latest in multiple problems for the drug manufacturer.
Scientists and Doctors Ask FDA to Pull Aduhelm off the Market
The company slashed the annual price for Aduhelm (also known as Aducanumab) on the same day the Food and Drug Administration (FDA) received a request to pull the drug off the market with an “accelerated withdrawal.” Eighteen scientists, a majority of whom were doctors, issued a statement saying that “The FDA’s decision to approve Aduhelm is indefensible in both scientific and clinical terms,” and that “This drug should be withdrawn from the market immediately.”
The statement further reports that Aduhelm:
- Failed to show clinical benefits to patients—a requirement for regular approval
- Failed to satisfy FDA requirements for accelerated approval because the basis for this approval—the removal of the amyloid plaque’s being likely to predict a benefit—does not mirror known symptoms, progression, or severity of Alzheimer’s disease
- Presents unacceptable risks (especially given the lack of proven clinical benefits) in the form of brain swelling, bleeding, falling, and disorientation, with possible links to death
The statement’s signees protested the FDA’s use of amyloid plaque PET scans rather than evidence of actual patient improvement. The scientists expressed their concerns that the approval would lead to “widespread overtreatment” of Aduhelm, which would not only fail to help patients but could also increase their risk of serious health problems.
Biogen CEO Michel Vounatsos issued a statement about the company’s decision to slash prices of the Alzheimer’s drug, calling it a response to “too many patients…not being offered the choice of Aduhelm due to financial considerations.”
It’s true that a number of major health systems (Mount Sinai Health System, Cleveland Clinic, Department of Veterans Affairs, Mass General Brigham) are not offering Aduhelm, according to The New York Times. However, the entities attribute this decision to questions about the risks vs. benefits of the drug.
The price drop has met with commentary from the financial community. The Institute for Clinical and Economic Review (ICER), an independent source of evidence review, stated the following in the ICER Final Evidence Report and Policy Recommendations on Aducanumab for Alzheimer’s Disease:
“...if Medicare and private insurers choose to provide coverage, millions of patients and families will face the question of whether to use it — which means many patients and families will suffer financial toxicity without knowing whether they are taking a drug more likely to help them than hurt them. The company had another path open to them. They could have priced in line with our current best estimate of clinical value at a tenth of their current list price and still expected to make billions of dollars each year. It is unfortunate that they did not choose such a path.”
In short, the new Aduhelm price, though dramatically lower than Biogen’s initial price, is still significantly higher than a sizable number of analysts feel is justified.
CMS Limits Coverage of Aduhelm
It seems that the Centers for Medicare and Medicaid Services (CMS) agrees. In early January, CMS announced it would limit coverage of Aduhelm treatment to patients who are already enrolled in clinical trials.
Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, explained the agency’s decision in an agency-issued press release:
"This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients. This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds.
We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision.
Therefore, based on the public comments submitted previously and evidence CMS reviewed, the potential for harm, and important questions that remain, we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians, and caregivers, and we look forward to receiving feedback on the proposal."
Aduhelm drew interest from the legal community when the FDA’s adverse event reporting dashboard revealed a number of fatalities connected to the drug. One report detailed the demise of a 75-year-old Canadian woman who had been taking Aduhelm to treat her Alzheimer’s. The patient was admitted to the hospital with swelling in the brain, or amyloid-related imaging abnormality-edema (ARIA-E), a known side effect of Aduhelm. Another 79-year-old woman who was enrolled in the Aduhelm clinical study wound up in the emergency room unable to speak and suffering from dizziness. An investigation revealed that the patient’s condition was linked to her receiving five doses of aducanumab.