Katherine Ellen Foley, David Lim, and Rachel Roubein, Politico: June 15, 2021
The controversial approval of the first drug to target Alzheimer’s disease in nearly 20 years has opened the door for patient advocacy groups to pressure Medicare and private insurers to cover expensive tests needed to concretely diagnose Alzheimer’s disease.
Advocates hope that the new therapy will be the first to slow the disease afflicting over 6 million older adults. But patients will likely have to jump through hoops, or pay exorbitant prices, because the tests needed to diagnose Alzheimer’s and monitor the drug’s safety aren’t generally covered by Medicare, potentially putting patients on the hook for out-of-pocket costs.
The cascading challenges and looming questions around the new drug, Biogen’s Aduhelm, could also influence whether private insurers decide to pay for other costly drugs and services. Several health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results. The FDA’s decision to grant accelerated approval to Aduhelm has led to the resignations of three members of the agency’s neurological drug advisory committee.
“You don’t have to be a rocket scientist to know that the impact on Medicare is likely to be devastating,” said Diana Zuckerman, the president of the National Center for Health Research, who is not on the advisory committee that evaluated Biogen’s drug.
The $56,000 annual price tag of Biogen’s new drug, Aduhelm, already threatens to balloon health care costs — potentially swelling premiums for millions of older adults across the U.S. Patients could be on the hook for 20 percent of its cost. Or they could have supplemental insurance to cover the drug, but still might be responsible for thousands of dollars in fees for PET scans, which can confirm the presence of the amyloid plaque in the brain.
“Ideally, we want to use [Aduhelm] only on patients that we know have a reasonable chance of benefiting from that therapy,” Eric Rohren, chair of radiology at Baylor College of Medicine, said of the drug, which targets toxic protein buildup in the brains of people with the disease. “And so that’s where that role of PET scanning comes in: really identifying the patients with amyloid deposition who we predict will respond to the therapy.”
Patients receive the drug intravenously in a health care setting, meaning it falls under the purview of Medicare Part B. But in 2013, the Centers for Medicare and Medicaid Services decided that it generally won’t cover the specific PET scans used in Biogen’s clinical trials to help determine whether a patient has the amyloid buildups consistent with Alzheimer’s disease — and that’s putting pressure on the federal Medicare agency to cover the cost of making the diagnosis. States also have serious skin in the game because their Medicaid programs will feel pressured to cover the drug.
It’s also not clear how Medicare would cover the newly approved Alzheimer’s therapy. CMS Administrator Chiquita Brooks-LaSure declined to say whether the agency would launch a process for determining how Medicare will cover the drug, which could install clinical guidelines that effectively narrow who’s eligible for the treatment.
“We are really focused on making sure that people have access to innovative drugs and can afford it,” Brooks-LaSure said at a press briefing Monday. “We’re considering our options, and we’ll be looking very closely at the science moving forward.”
Coverage from Medicare would undoubtedly mean higher premiums for 56 million older adults, and some experts say the federal government shouldn’t cover the drug given the scant evidence it works.
“As a private citizen, I think the drugs should not be covered by Medicare,” said Peter Bach, the director of the Center for Policy and Health Outcomes at Memorial Sloan Kettering. Bach chairs the Medicare coverage advisory committee, which could weigh in on the decision.
Meanwhile, private insurers haven’t said how they will cover the therapy. According to several insurance lobbyists, health plans are in the beginning stages of strategizing how they will approach coverage of Aduhelm and associated care.
“We need to prioritize both access and affordability, guided by input from experts based on clear clinical efficacy and scientific evidence,” David Allen, spokesperson for major insurer lobby AHIP, said in a statement.
Another concern is safety monitoring. In Biogen’s last clinical trials, some participants — particularly those with two copies of a gene known to increase the risk for developing Alzheimer’s disease — experienced a swelling or bleeding of the brain as the drug removed amyloid. This swelling and bleeding can be dangerous.
These individuals were in the earliest stages of Alzheimer’s, with relatively little amyloid. Because the FDA’s label for Aduhelm didn’t specify what stage of disease it was for, some physicians have concerns that this side effect may be worse for more advanced patients.
Practically, health care providers will need to monitor brain health with an MRI, which could be another logistical hurdle for patients and their caregivers. And demand could increase as more patients are eligible for the drug.
“The package insert specifically talks about MRI that patients need to have … within a year of starting the treatment, and then at various time points after initiation of therapy,” Rohren said. “And certainly if they have symptoms or side effects.”
The availability of a novel treatment for Alzheimer’s will inevitably garner significant demand — even though the drug’s benefits for all people living with the disease are unclear. But the sheer cost of the drug has huge implications for the American health care system’s financial viability — and could sock taxpayers with the cost.
The FDA is no stranger to public debate about its regulatory decisions, but its approval of Biogen’s drug has the potential to spark an even larger controversy than when it gave the greenlight to Sarepta Therapeutics’ duchenne muscular dystrophy drug Exondys 51 in 2016.
“Sarepta’s drug was for a rare disease; this is for a huge number of people,” Zuckerman said. “Don’t we all know someone who is going to use this drug?”
Sarah Owermohle and Susannah Luthi contributed to this report.
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