As Biogen and Eisai’s second Alzheimer’s drug Leqembi nears a potential full FDA approval, the Centers for Medicare and Medicaid Services (CMS) this week detailed plans to cover new Alzheimer’s meds with the use of a registry to collect real-world data. But industry trade group PhRMA has problems with the approach.
PhRMA believes the plan will “severely restrict” patient access and that the registry requirement will enact barriers to “potentially life-changing” treatments, a spokesperson said in an emailed statement.
CMS maintains there is a “strong precedent” for using registries for newly approved treatments. In its own statement, the agency celebrated the approach as a way to "ensure availability" of the drugs.
Under CMS guidelines, new Alzheimer's drugs are only covered in clinical trial settings while they carry accelerated approvals from the FDA. The new CMS registry approach is intended to make the drugs more widely available once they gain full FDA approvals.
But PhRMA argues that not all patients are able or willing to participate in a registry. Plus, the plan could force patients to travel to providers who are participating in the registry program, the trade group says.
Further, PhRMA flagged concerns that the registry might not be available when the FDA approval lands.
“We’re extremely disappointed CMS continues to refuse to reconsider the discriminatory national coverage determination for these Alzheimer’s treatments,” the spokesperson said.
While the industry has advanced treatments for tough-to-treat diseases such as Alzheimer’s, these “efforts are in vain if patients are prevented from accessing these life-altering treatments," PhRMA's spokesperson added.
But there are some silver linings to the plan, analysts from Mizuho Securities say. CMS specifically notes that the registry will collect information in an “easy-to-use” format, which the analysts said is encouraging.
In addition, William Blair analysts don’t see registries at specialist centers to be a “substantial hurdle." The team believes that Leqembi can hit peak sales of $8 billion regardless of registry requirements.
However, those sales hinge on the success of the subcutaneous injection formulation, which is due to post data next year, the William Blair analysts said in a note to clients.
Up next, Leqembi will face a panel of independent experts at an advisory committee meeting next week. The drug is due for an FDA decision on its full approval in July.
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