The Centers for Medicare and Medicaid Services announced that it will finalize its proposal for Medicare to cover Aduhelm and related drugs, but only for beneficiaries in qualifying clinical trials. Biogen says it’s exploring its options and questions the legality of the CMS’s authority to condition coverage on additional studies. But analysts say the company would only be able to challenge the decision indirectly by supporting an administrative appeal or lawsuit filed by individual beneficiaries. This comes as payer groups are supporting the CMS decision to finalize the narrow coverage decision.
Lawsuit
A potential lawsuit from Biogen will hinge largely on whether it can find patients who say they have been unreasonably denied access to the treatment. As has been reported by Bloomberg, this may be difficult for Biogen to do.
“Once CMS has made its decision, it’s up to the beneficiaries in the program to say, ‘You’ve harmed me,’ rather than a drug company to say, ‘You’ve harmed my pocketbook,’” said Allison Hoffman, a professor of law at the University of Pennsylvania specializing in health insurance regulation and policy.
“If beneficiaries don’t think they’ve been harmed, then it doesn’t make any sense for a drug company to be able to make those kinds of claims,” she said.
The Medicare Act mandates that beneficiaries who allege they’ve been unjustly denied coverage first must go through the Health and Human Services Departmental Appeals Board before challenging a national coverage determination in court. Biogen could support these administrative appeals financially, including by paying legal fees. If unsuccessful, beneficiaries could file a lawsuit that could put the entire coverage determination at stake.
The success of an appeal might be complicated by past coverage decisions and the uncertainty surrounding the relationship between amyloid plaques—sheets of abnormal protein in Alzheimer’s patients’ brains—and the progression of the disease. Biogen, along with other drugmakers and beneficiaries, also already had an opportunity to voice concerns during a public comment period after CMS issued its draft coverage decision in January.
Payer Groups
“We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP, as reported by Fierce Healthcare. AHIP applauded CMS for covering the drug and “related services such as PET scans if required by the trial protocol.”
A survey of major insurers conducted by Bloomberg found that a majority of insurers questioned whether the drug was medically necessary and followed criticism by the FDA’s own advisers that Aduhelm wasn’t effective.
New York-based Excellus BlueCross Blue Shield said back in August it won’t cover Aduhelm, and insurer Highmark will only cover it with prior authorization. Larger providers such as Cleveland Clinic and Mount Sinai also said they will decline to cover the drug. The Department of Veterans Affairs has decided not to include Biogen’s drug aducanumab on its national formulary over “the risk of significant adverse drug events” plus a “lack of evidence of a positive impact on cognition,” Fierce Pharma reported.