Amid a torrent of negative press for Biogen’s troubled Alzheimer's disease treatment Aduhelm, there remains a significant community of patients and doctors who are hoping to use and prescribe the drug, a team of analysts found.
Meanwhile, with the Centers for Medicare and Medicaid Services considering restricting Aduhelm’s use and an April 11 decision date looming, there is renewed support for the antibodies which target amyloid plaque.
Senators Shelley Moore Capito (R-West Virginia) and Susan Collins (R-Maine) have sent a letter (PDF) to the CMS urging it not to follow through with its plan to restrict the use of Aduhelm to clinical trials.
Many doctors hope to be able to employ the drug, as well. A recent survey conducted by RBC Capital Markets, polling 88 physicians who service more than 10,000 patients, showed a strong market exists for Aduhelm or similar beta-amyloid antibodies.
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“Despite all the recent negative publicity, Alzheimer's physicians would have sufficient appetite to prescribe beta-amyloid antibodies to support multi-billion sales,” RBC analyst Brian Abrahams, wrote in a note to clients.
The survey found that approximately 10% of the doctors’ treated Alzheimer’s patients would receive Aduhelm near-term if reimbursement barriers are removed.
If Aduhelm restrictions are loosened, or an ongoing phase 3 trial of another drug, lecanemab, reads out positively—which the analysts see as a “50/50” proposition—doctors would be much more open to using the antibodies, the analysts wrote. The market opportunity remains large, as the analysts see up to $8 billion in potential sales from Biogen's Alzheimer's franchise.
“We acknowledge that uncertainties remain about future beta-amyloid competitive dynamics,” RBC analysts wrote, referring to Lilly’s Alzheimer’s candidate donanemab and Roche's gantenerumab. Lilly's drug is in a head-to-head trial against Aduhelm, with data expected to emerge by the middle of this year.
As for the push in Congress, Sens. Capito and Collins have joined a group of 78 House Republicans who pushed back last month after the CMS proposed national coverage determination (NCD) on the drug.
“CMS proposed a particularly burdensome and restrictive approach that could sharply curtail access not just to one approved product, but to an entire class of potential future products still in the development pipeline,” Collins and Capito wrote. “It is highly unusual, if not precedent-setting, for CMS to attempt to evaluate a drug’s clinical benefit. Congress has reserved this task for the FDA, which said that Aduhelm’s effect on cognition was enough to merit accelerated approval pending confirmation of the clinical benefit.”
CMS proposed restricting coverage of the drug to patients in approved clinical trials, arguing that Biogen has yet to demonstrate a clear picture on Aduhelm's benefits and risks. Critics say the agency is effectively duplicating the FDA's review process and could set a bad precedent for patient access moving forward.
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The Alzheimer’s Association and UsAgainstAlzheimer’s have joined Capito and Collins' push.
“Every day, 1,000 people slip from mild Alzheimer’s to moderate Alzheimer’s,” George Vradenburg, co-founder of UsAgainstAlzheimer’s, said in a release. “Since these treatments are most effective in the early stages of Alzheimer’s, every day it takes CMS to do the right thing is another day lost for patients and their families who don’t have time to spare.”