- Biogen makes a new Alzheimer's drug costs $56,000 each year.
- People who are eligible for the drug also will need expensive tests like PET scans or spinal taps.
The eye-popping $56,000 price tag on Biogen’s newly approved Alzheimer’s medication has generated significant debate on the value of a drug not yet proven to slow the mind-robbing disease.
But Aduhelm's price is only the start of what consumers and insurers might pay to get the first new Food and Drug Administration-approved drug to treat Alzheimer's since 2003.
Many experts say patients will need expensive tests to verify they have the underlying sticky clumps of protein the drug targets in the brains of Alzheimer's patients. Patients could see other bills from doctors, as well as from facilities that administer the drug via IV and imaging centers for MRIs to monitor common side effects such as brain swelling and bleeding.
The unknowns about how much people will pay for the drug and related testing are among a growing list of questions as the drug hits the market in the coming weeks.
The price of the drug, diagnostic tests and monitoring could lead to tension between the drug's maker, Biogen, and providers who bill patients and the Centers for Medicare and Medicaid Services, private insurers and patients who pay. The agency that oversees Medicare usually pays for FDA-approved drugs, but it must evaluate which treatments and diagnostic tests are reasonable and necessary.
There are "more questions than answers at the moment," said R. Scott Turner, a neurologist and director of Georgetown University’s Memory Disorders Program. "CMS has a lot of decisions to make because the FDA just sort of passed along the decision-making."
'Need to prioritize both access and affordability'
Clinical trials show Aduhelm is effective at removing amyloid beta, a sticky protein that forms plaques in the brains of Alzheimer’s patients. Two large trials reported mixed results on whether the drug effectively slowed clinical decline from Alzheimer’s, a disease that afflicts 6.2 million Americans.
The FDA approved Aduhelm for all patients with Alzheimer's disease. In doing so, the agency didn't limit the monoclonal antibody to those with early signs of dementia, known as mild cognitive impairment, who were studied in the company's clinical trials. That means doctors must decide who gets the drug. CMS and private health insurers could limit eligibility for testing to those most likely to benefit.
In 2013, CMS chose not to pay for the Alzheimer's diagnostic scans called positron emission tomography, or PET. The test involves injecting a tracer chemical into the bloodstream so a scan can reveal amyloid plaques in the brains of Alzheimer’s patients, a hallmark of the disease.
It's unclear whether the agency will reverse course and pay for these tests, which cost several thousand dollars, now that an amyloid-clearing drug is available. A cheaper though less frequently used test involves a spinal tap to measure cerebrospinal fluid for amyloid beta or tau, another protein that forms tangles in the brains of Alzheimer's patients.
'A new day':FDA approves new Alzheimer's drug, Aduhelm, the first in nearly two decades
FDA will decide fate of contentious Alzheimer's drug:The stakes 'could not be higher.'
'You reach for anything':Doctors must decide whether patients should get the new $56,000 Alzheimer's drug, Aduhelm
When asked whether the agency will cover Aduhelm and related testing, a CMS spokesman said the agency is reviewing the FDA’s decision regarding aducanumab,the drug's scientific name, and will have more information soon.
Private health insurers often rely on CMS' coverage decisions before extending coverage to new drugs, tests and procedures. Health insurance industry representatives said payers are closely monitoring the federal agency's cues.
"When the launch and list prices of medicines are outrageously high, families and individuals pay more for their coverage," said David Allen, spokesman for America's Health Insurance Plans. "We need to prioritize both access and affordability, guided by input from experts, based on clear clinical efficacy and scientific evidence."
The FDA's approval didn't say whether patients who want the drug need to be tested for amyloid beta, so that decision might rest with Medicare, private insurers and doctors who prescribe the drug.
Cigna will draw guidelines to narrow eligibility by first requiring patients to pass a cognitive test. Based on conversations with Biogen, the insurer estimated about 1.2 million to 1.5 million people have mild forms of the disease and could be eligible for amyloid testing via a PET scan or spinal tap.
It is critical to narrow eligibility because the U.S. does not have enough neurologists or geriatricians to screen patients and imaging centers with the expertise to conduct PET scans for all suspected Alzheimer's patients, said Dr. Steve Miller, Cigna's chief clinical officer.
Miller said the narrow criteria will allow doctors and insurers to more quickly identify those who are likely to benefit from Aduhelm. Administering PET scans to everyone – including those with advanced forms of the disease who are less likely to benefit from the drug – could delay treatment for those who might improve with timely treatment.
"You are working against a clock," Miller said. "This was one of the crises created by the FDA. If you gum up the system with lots of ineligible patients, they still need to be evaluated. Then you compound this problem."
That lack of clarity from the FDA comes as doctors who care for Alzheimer's patients are getting calls and queries from families of loved ones afflicted with the disease. Last Wednesday, a 70-year-old realtor from Rhode Island, became the nation's first person to get the drug outside a clinical trial, Reuters reported.
"They are starting to ask when is it going to become available? When is it going to covered by Medicare? What sort of restrictions are they going to be?" Turner said.
'Some potential safety concerns'
Companies that make the chemicals used in PET scans also are waiting to hear more about whether their tests will be covered by Medicare and private insurers. So far, the chemical tracers mainly have been used in clinical trials for drug companies studying anti-amyloid drugs.
Now that the technology will be available to Alzheimer's patients outside of carefully monitored studies, it becomes especially important to ensure the right patients are getting the drug, said Andrew Stephens, Chief Medical Officer of Life Molecular Imaging, which makes a chemical tracer used in PET scans.
Stephens cited a 2019 study that evaluated whether PET scans of people with uncertain forms of cognitive impairment could lead to better, more accurate diagnoses. In the study of more than 11,000 patients, researchers found 35.6% of patients were misdiagnosed and 60% of those with early stage memory and thinking problems had changes in their care plans, such as starting or discontinuing medications.
In the two clinical trials evaluating Aduhelm, 41% of participants on the drug experienced side effects such as painful brain swelling, headaches and dizziness, compared with 10% who took a placebo. A smaller percentage of patients who received the drug in clinical trials had small bleeds in their brains.
"Aduhelm is both expensive and not necessarily benign – it has some potential safety concerns," Stephens said. "If you have an antibody that’s taking amyloid out of the brain you’d like to make sure the brain has amyloid in it before you apply this antibody."
Stephens said PET testing for Alzheimer's disease can be expensive. His company markets one of three FDA-approved tracers used to display amyloid beta in a PET scan. Once the company prepares the drug, it must be used in a patient within 10 hours.
In addition to charging for the tracer, hospitals and other memory care centers charge for administering the PET scan. And an imaging specialist interprets the results to verify whether a patient has amyloid beta.
Aduhelm's approval 'electrified 20 million people'
Families who care for loved ones with Alzheimer's also await decisions on whether the tests and drug will be covered.
Sherman, Connecticut, resident Jim Taylor said his wife, Geri, carefully tracked her symptoms for years. As a former health care executive and long-term care nurse with a family history of suspected Alzheimer's disease, she knew she could be susceptible.
When she noticed memory and thinking problems in 2012, she sought care and was diagnosed with mild cognitive impairment. But she did not know whether she had Alzheimer's disease.
"It was that gnawing feeling of not knowing for certain that you have the right diagnosis, the right treatment plan," Jim Taylor said.
It was only after she volunteered for a clinical trial in 2015 at Yale University that she received a PET scan revealing the hallmark amyloid plaque and an Alzheimer's diagnosis. She became eligible for the clinical trial and received aducanumab, the drug now marketed as Aduhelm.
Taylor said his wife's cognitive decline appeared to slow while on the drug. She maintained a busy travel schedule during which she talked with Biogen employees, among others, about her experience on the experimental drug and coping with the disease.
He believes his wife's resilience shows what's possible when someone is diagnosed early and gets a drug to slow cognitive decline. He has advocated for Medicare to reverse its decision and begin paying for PET scans.
News of the drug's approval has been a "tremendous shot in the arm," Taylor said.
"We’ve been waiting a long time for this. It is going to encourage early diagnosis. (Including patients and caregivers) it has electrified 20 million people."
Ken Alltucker is on Twitter as @kalltucker or can be emailed at [email protected]
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