While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when it comes to the treatment’s safety.
In a note to clients on Wednesday, RBC Capital Markets analysts highlighted a recent study that applied Biogen’s publicly disclosed clinical trial inclusion criteria for Aduhelm to 911 patients in a geriatric outpatient unit at a hospital in Milan, Italy.
Researchers determined that only six patients, or less than 1% of those evaluated, would have qualified for the treatment’s clinical trials—known as Emerge and Engage—ahead of the FDA’s historic approval in June, according to a letter published in the Journal of the American Geriatrics Society in late July.
To the RBC analysts, this suggests that there’s room for previously undetected side effects for the infusion once it’s administered to thousands of patients beyond those who were represented in the clinical trials, according to the note … This could affect Aduhelm’s “narrative and ultimate launch curve, not to mention potential reimbursement breadth,” the analysts said.
“Real world” eligibility for aducanumab (Journal of the American Geriatrics Society):
To identify the proportion of patients who would be potentially eligible to receive aducanumab in the “real world”, we systematically applied the criteria adopted in the pre-approval research protocols to a representative clinical population referring to a geriatric outpatient unit of a tertiary university hospital in Milan (Italy). A total of 911 patients consecutively attending the unit for cognitive complaints were considered … only six patients (i.e., 0.66%) of the study population would potentially be candidates to aducanumab … It is thus clear how the resulting gap between the research and “real world” fields is massive, exemplifying once again the “evidence-based medicine issue” challenging decisions in geriatric care.
News in Context:
- Veterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence
- Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker
- Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)