Biogen’s Aduhelm may have stirred up controversy after its landmark FDA approval, but some Alzheimer’s disease doctors are tabling the many unanswered questions as they appear ready to prescribe the drug.
Doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment, Jefferies analysts found after surveying 50 U.S. neurologists or psychiatrists who currently treat about 12,000 Alzheimer’s patients.
The rate suggests “good planned uptake” of the med compared with Wall Street’s expectations, the Jefferies team noted. If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.
The FDA has blessed Aduhelm with a broad label that allows doctors to use it in a wide range of patients. Investigators only studied the drug in mild Alzheimer’s patients who tested positive for beta amyloid plaques, which the drug was designed to target, but the label doesn’t restrict Aduhelm’s use based on either a patient’s clinical stage or biomarkers.
In the survey, doctors told Jefferies analysts they’d only require beta amyloid screening in about 60% of their patients. The number is lower than expected and “points to docs wanting to get [patients] on,” the analysts noted. Plus, docs also expressed interest in treating about 10% to 20% of patients that have late stages of the disease.
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Still, given the launch hasn’t even started, many uncertainties remain. While the FDA didn't impose any restrictions, a “leading neurologist” who oversees over 1,000 Alzheimer’s patients at his center expects commercial and federal payers will set some limits, the analysts wrote. The expert figured some payers will restrict use around the beta amyloid biomarker and disease severity, the Jefferies team said in a note Saturday.
To the leading expert, demand may vary among physicians based on how they see the drug’s benefits and risks. The doctor has participated in many Alzheimer’s drug trials, including one of the two Aduhelm phase 3 trials Biogen used for its FDA filing.
During the survey, a third of physicians said they’re concerned about payer coverage. Still, the Jefferies team figures reimbursement likely won’t be an issue, at least for Medicare. The Alzheimer’s expert believes Medicare will likely also pay for the beta amyloid test to screen patients.
Another potential hurdle? A quarter of surveyed doctors believe patient access to physicians, screening and infusion centers will pose challenges. The response at least suggests strong demand for Aduhelm, Jefferies pointed out.
Meanwhile, one of the major side effects of Aduhelm is amyloid-related imaging abnormalities, or ARIA, which involves swelling of the brain. To monitor for ARIA, the FDA label currently requires MRI scans prior to infusions at Month 7 and Month 12 of treatment with Aduhelm. The Alzheimer’s expert plans to do more frequent tests despite already constrained MRI machine capacity. Nevertheless, he thinks he can treat 100 patients within the next 12 months and 200 over a couple of years, the analysts wrote.
Biogen has said it can start delivering Aduhelm to about 1,000 infusion centers within weeks. For these centers, the expert pointed out that Medicare’s 6% reimbursement surplus on top of the drug’s average sales price could benefit doctors economically.