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Biogen's Alzheimer's drug aducanumab (Aduhelm) may have been cleared by the FDA, but its uptake will be influenced by insurance coverage, particularly by Medicare.

The $56,000 annual price tag on the therapy is far higher than the $8,300 estimated by the Institute for Clinical Economic Review (ICER) to be cost-effective, setting the stage for potential insurance challenges.

"Only a hypothetical drug that halts dementia entirely would merit this pricing level," ICER said in a statement. "The evidence on aducanumab suggests that, at best, the drug is not nearly this effective."

ICER noted that the FDA label for the drug extends beyond the study population of patients with mild cognitive impairment and mild dementia to all patients with Alzheimer's, making nearly 6 million people in the U.S. eligible for the therapy. Biogen that 1 to 2 million people in the U.S. who have mild cognitive impairment or mild dementia would likely have amyloid beta pathology if tested.

ICER noted that "even at the lower range of the estimated number of eligible patients, at this price the drug maker would stand to receive well in excess of $50 billion per year even while waiting for evidence to confirm that patients receive actual benefits from treatment."

It could take a while before that confirmation is available: Biogen's CEO Michael Vounatsos the company has up to to complete the trial.

In the meantime, insurers will weigh the value of the drug, as well as the accompanying scans, infusions, and other procedures, in any coverage decisions. The , for instance, recommends obtaining an MRI prior to initiating treatment, and obtaining MRIs "prior to the 7th and 12th infusions" to assess risk of ARIA-H, or cerebral microhemorrhages.

All eyes are on given that a significant proportion of Alzheimer's patients are covered under Medicare. The agency could launch a National Coverage Determination (NCD) process for aducanumab, according to a by Sean Dickson, JD, MPH, of West Health Policy Center, a think tank focused on lowering healthcare costs, and colleagues.

NCDs are "the most powerful coverage tool Medicare has," Dickson and colleagues wrote, and they're generally reserved for costly treatments, services that have variable local coverage decisions, or when there's scientific dispute about efficacy in beneficiaries. Aducanumab meets all three of those criteria, the paper argued.

Medicare also has the option of issuing a "Coverage with Evidence Development" decision that would cover those enrolled in a clinical trial aimed at collecting more data, as was .

A CMS spokesperson said in an email to 番茄社区 that the agency is "reviewing the FDA's decision regarding aducanumab and will have more information soon."

As for commercial insurers, Biogen and partner Eisai they "intend to enter into a value-based contract" with Cigna "to ensure that there is a streamlined path to access treatment for patients consistent with the population in which Aduhelm was studied."

Cigna's chief clinical officer Steve Miller, MD, that the company will likely cover the drug for those who match the profile of clinical trial participants, but noted that additional out-of-pocket testing costs "could be a real barrier for those patients who lack the financial means."

Biogen already has patient support available, which helps eligible patients access financial assistance options. In its press release, the company stated that "co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0" for commercially insured patients.

番茄社区 reached out to several commercial insurers -- including UnitedHealthcare, Cigna, Aetna, and Anthem -- but only Humana responded: "As we develop our coverage policy at Humana, we will look to the Centers for Medicare and Medicaid Services for guidance to ensure that there is consistent access to this therapy in the Medicare program for patients and their families," referring to the insurer's Medicare Advantage plans.

As for its commercial plans, the spokesperson said the company's "Pharmacy and Therapeutics Committee will evaluate coverage of Aduhelm."

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