In the run-up to the Biden administration’s final Medicare coverage decision for Aduhelm, Biogen hired an unusual lobbyist to jockey for patient access.
Biogen tapped William Clyburn Jr. of Clyburn Consulting, a relative of House Majority Whip Jim Clyburn, D-SC., to lobby for “Alzheimer’s disease treatment availability,” a federal disclosure of lobbying activities in the first quarter shows.
Clyburn’s expertise isn’t exactly in the healthcare field. He was once the commissioner of the U.S. Surface Transportation Board, and he previously counseled former U.S. Senator Zell Miller mainly on airport planning and other infrastructure development projects, according to his biography. His lobbying firm currently lists transportation and telecommunications as its main areas of focus.
During the same quarter, Biogen also retained several other lobbying groups to tackle Alzheimer’s projects. Among them, lobbyists from Federal Street Strategies worked on topics including Alzheimer’s disease and treatment, and those from Capitol Counsel on issues including “Medicare beneficiary access to treatments for Alzheimer’s disease.”
Before the Centers for Medicare & Medicaid Services finalized its restrictive policy for Biogen’s Aduhelm and other future anti-amyloid beta antibodies against Alzheimer’s earlier this month, many lawmakers had pushed back against the agency’s initial proposal released in January.
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But the political pressure didn’t work out in Biogen’s favor as the CMS recently finalized guidance limiting Aduhelm’s coverage to patients enrolled in clinical trials. Biogen and some patient advocacy groups have argued that the ruling denies patients access and is biased against Aduhelm versus other FDA-approved therapies.
In an earlier statement sent to Fierce Pharma, Biogen CEO Michel Vounatsos said the policy “undermines the FDA’s accelerated approval pathway and will severely limit patient access to new innovations.”
Given that the CMS policy has been implemented, the next question is whether the decision can be legally challenged. Biogen and other affected Alzheimer’s drug developers aren’t necessarily the proper entities to bring such a lawsuit against CMS, Allison Hoffman, a law professor at the University of Pennsylvania, told Bloomberg Law. Instead, only individual beneficiaries are in a position to challenge the policy.
Per U.S. Social Security laws, an action seeking review “may be initiated only by individuals entitled to [Medicare benefits] who are in need of the items or services that are the subject of the coverage determination.”
As Hoffman noted, drugmakers like Biogen may still support administrative appeals and potential lawsuits financially.
In a statement right after CMS published its verdict, Biogen said it was “carefully considering its options” and will provide updates later.
If Biogen eventually decides to fund a legal challenge against CMS, it likely won’t have any difficulty finding a patient agent. Several patients groups, most notably USAgainstAlzheimer’s, have been siding with the company throughout the FDA approval and CMS battle.