When the Biden administration eventually makes its decision over whether Medicare will cover the controversial and costly Alzheimer’s drug Aduhelm, Biogen shouldn’t be the only drugmaker paying attention.
That’s because whatever consensus the Centers for Medicare & Medicaid Services (CMS) reaches over Aduhelm will apply to all future monoclonal antibodies, including Eli Lilly’s beta amyloid-targeting therapy donanemab, Cowen analysts wrote to clients following a call with CMS late last week.
On an earnings call Thursday, Biogen execs pointed to the pending CMS National Coverage Decision (NCD) as part of the reason why Aduhelm’s initial rollout has been slower than expected. Hospitals and insurers are sitting in a holding pattern until CMS decides which Alzheimer’s patients on federal insurance programs will be covered, if any.
CMS’ Tamara Syrek Jensen, whose office makes the final determination over NCDs, said in a separate call last week that the process could take until April 2022, Cowen analysts wrote. Whatever decision CMS reaches will cover “all future monoclonal antibodies” for Alzheimer’s, Syrek Jensen said, as quoted by the analysts.
In the pipeline include Lilly’s donanemab, which the FDA recently granted a breakthrough designation that will aim to expedite its development and review. The company said it plans to file for an accelerated approval by the end of this year. Roche also has its own portfolio of AD treatments, including amyloid-targeting gantenerumab.
To the Cowen analysts, it’s likely CMS will offer conditional coverage for Aduhelm in line with the FDA’s revised label, which narrows the treatment pool to patients with milder forms of the disease. Those patients would likely be added to a registry for follow-up clinical evaluations.
Whatever ruling CMS eventually reaches will have larger implications not only for amyloid-targeted therapies but for Medicare’s budget given Biogen’s decision to set Aduhelm’s list price at $56,000 annually.
Critics have argued that CMS should limit Aduhelm’s coverage, or not reimburse it all, given its murky clinical benefits and the considerable cost.
In the meantime, reimbursement decisions for Medicare patients, who are thought to be a majority of American Alzheimer’s patients, are in the hands of local Medicare Administrative Contractors, or MACs. The contractors are private health care insurers who process Part A and Part B claims.
Based on recent precedent set under CAR-T treatments, Biogen told investors last week that they believe local contractors will cover the treatment while CMS holds its months-long NCD process.
Not everyone agrees, however. Prior to Biogen’s earnings, the former head of CMS and the FDA, Mark McClellan, told the drug cost watchdog ICER that access would probably be “pretty limited” while payers wait for CMS’ move.