For the first time in nearly 20 years, the Food and Drug Administration granted limited approval for a new Alzheimer’s treatment. This comes despite the FDA’s independent advisory committee’s recommendation not to approve the drug due to limited evidence of effectiveness. Despite the FDA’s requirement that Biogen verify the effectiveness of the treatment through an additional clinical trial, that did not deter Biogen from setting Aduhelm’s yearly cost at a staggering $56,000. The Institute for Clinical and Economic Review has estimated the treatment would be cost-effective only below $8,300. Biogen stands to make billions even as millions of older adults, many of whom are desperate for treatment options, are already struggling to pay for essential medications. More than 90% of those living with Alzheimer’s are over 65, creating a hazardous financial strain for Medicare.This hefty price tag for a drug with uncertain benefits underscores the urgent need for congress to pass the Lower Drug Costs Now bill to give Medicare the power to negotiate for lower drug prices.

Axios: Biogen Is Banking On Aducanumab. “Market analysts estimate Biogen could price aducanumab as high as $50,000 per year of treatment, if it’s approved. Independent experts have said that price is too high considering the clinical trial data doesn’t prove the drug is effective in combating the brain disorder. Even if only a small portion of the 6 million Alzheimer’s patients are able to obtain the drug, Biogen would net billions of dollars in new sales annually.” [Axios, 6/7/21]

Axios: Aduhelm’s Price To Squeeze Medicare And Patients. “Aduhelm could create massive strains on Medicare spending and could create financially ruinous prospects for patients and their families. If Medicare decides to cover the drug with no restrictions, it would pay almost $59,000 annually for a course of treatment. Biogen could easily fetch tens of billions of dollars every year if fewer than 10% of the 6 million Alzheimer’s patients get it.” [Axios, 6/8/21]

New York Times: Alzheimer’s Drug Is Bonanza For Biogen, Most Likely At Taxpayer Expense. “The drug is all but certain to unleash a gusher of profits for Biogen — the drug is expected to become one of the best-selling pharmaceutical products in the world within a few years. Those billions of dollars in anticipated costs are likely to be shouldered largely by Medicare. The drug’s approval could drive up insurance premiums, according to health care policy experts. And it could add new out-of-pocket costs for some families that are already facing years of staggering costs for caring for loved ones with Alzheimer’s. There is not strong evidence that the drug helps patients, and it comes with potentially serious side effects. Prominent experts, including the F.D.A.’s independent advisory committee and a professional society representing geriatricians and other health care providers for older adults, urged the agency not to approve the drug.” [New York Times, 6/8/21]

STAT News: ‘The Price Is Bewildering’: The Cost of Biogen’s Alzheimer’s Drug May Lead Payers To Erect Roadblocks. “At a wholesale price of $56,000 per year, the company exceeded some Wall Street expectations, and greatly surpassed the $8,300 threshold that a nonprofit determined was the price at which the medication could be considered cost-effective. The Centers for Medicare and Medicaid Services could [initially] let providers and patients make decisions about who gets the drug. But this has the potential to severely affect the Medicare budget, which affects taxpayers.” [STAT News, 6/7/21]

Bloomberg: Biogen’s Costly, Unproven Drug Feared As Health Budget Buster. “The approval of Biogen’s $56,000-a-year Alzheimer’s therapy creates an unprecedented challenge for the U.S. health system: a drug that many patients may get at a high price even though it may not slow their cognitive decline. With Monday’s FDA clearance of Aduhelm, the health system is taking on a treatment that as many as 1 million people might qualify at a total annual cost of as much $50 billion. Despite the large burden that represents, there is little certainty about whether patients will be better off.” [Bloomberg, 6/8/21]

Bloomberg (Opinion): Approving Biogen’s Alzheimer’s Drug Is A Big Mistake. “The price of the drug is just the beginning of the financial damage. Getting it will require doctor’s visits and scans to establish eligibility and monitor side effects, creating significant additional costs for Medicare, patients and their caregivers. Multiply those costs by even a fraction of the millions of Americans with Alzheimer’s, and you have a budget crisis.” [Bloomberg Opinion, 6/7/21]