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too late, the pharmaceutical equivalent of putting a Band-Aid on a person who has nearly bled to death. So researchers have moved their trials into patients who don’t yet have full-blown symptoms.
Eli Lilly (NYSE: LLY) of Indianapolis took solanezumab, which failed to improve people with mild to moderate disease, and tried again in a trial focused only on mild disease, which should produce results later this year. If all goes well Lilly could ask the FDA for approval of the drug in 2017. Cambridge, MA-based Biogen, jumped its aducanumab last year into twin 1,350-person Phase 3 trials in early Alzheimer’s, after a 166-person Phase 1 trial produced promising results.
And despite a failed Phase 2 trial with its anti-amyloid antibody gantenerumab, Roche saw hopeful signals in a sliver of patients with mild disease and is pressing ahead with a Phase 3 trial. (Both solanezumab and gantenerumab are also being evaluated as a preventative measure in a trial for people at risk for or starting to show symptoms of an inherited form of Alzheimer’s.)
People running these trials have taken great care selecting the patients for the experiments. If one of these drugs is approved for patients with mild Alzheimer’s, doctors will have to be just as careful. Assessing who’s in that window is no easy feat. Patients with mild Alzheimer’s have symptoms that have begun to affect their daily lives—like getting lost in their own neighborhood—but those can be due to other causes. Specialists wrongly diagnose Alzheimer’s in those who don’t have it about 30 percent of the time, and the false positive rate is even higher in non-specialists, says Peter Snyder, chief research officer of Rhode Island’s Lifespan Hospital System and a neurology professor at Brown University.
“Insurance companies will insist on scans,” says Snyder, to show that a patient really has a buildup of amyloid in his brain before agreeing to pay for an anti-amyloid drug. Such scans cost about $5,000 a pop, he says, raising the question whether everyone who needs one will be able to get one, either due to their location, their insurance coverage, or both.
One scan used to detect amyloid employs a tracer agent called florbetapir F 18 (Amyvid) that’s made by Avid Radiopharmaceuticals, which Lilly bought for $300 million upfront in 2010. The agent is approved by the FDA but not covered by Medicare.
And such scans aren’t foolproof. A percentage of people—one study says 20 percent—who have discernible amyloid in their brains never lapse into dementia.
Several clinicians told me they hope a less expensive test or set of tests will eventually make the scans irrelevant. (In this story, I delved into some of the technologies, like retinal scans, that one day could help diagnose Alzheimer’s.)
There’s a separate question about brain scans. Some drugs, such as Biogen’s aducanumab and Roche’s gantenerumab, can cause edema, or swelling, in the brain. Regulators might insist that patients who take those drugs be monitored with MRI scans for side effects, further straining the health system’s infrastructure. (Side note: Lilly’s solanezumab to date hasn’t produced edema problems, probably because it prevents amyloid plaques from forming instead of busting them up. Its approval might not require follow-up scans.)
Doctors’ role in sorting out who will benefit from a drug will remain important. But if an approved drug suddenly offers hope, specialists will be stretched thin. Primary care doctors will have to shoulder much of the load, which leads to a second point that several in the field raised with me: Training.
Thanks to the Affordable Care Act, the annual checkup for Medicare patients now includes a memory evaluation. But David Morgan, CEO and director of the University of South Florida’s Byrd Alzheimer Institute in Tampa, says because it takes extra time without separate reimbursement, doctors often do a perfunctory exam. “Most physicians check the box by asking if you’ve had memory problems lately,” Morgan says. “We need greater training.”
There are programs underway, such as this one run by the U.S. Department of Health and Human Services. Morgan’s group has received one of its grants. The Byrd Institute is recruiting retired healthcare workers to set up free memory testing sites in retirement communities, which could add a layer of screening to find people in the early stages of Alzheimer’s. (Morgan and George Vradenburg of USAgainstAlzheimer’s penned an op-ed for The Hill recently to make a plea for more preparation to Washington insiders.)
Out west, the Banner Institute’s parent group, Banner Health, is rolling out training to its healthcare workers to help with the influx of patients with dementia (whether new Alzheimer’s drugs are available or not). “The rest of the system has to become ‘dementia capable,'” says Tariot.
That includes specialty centers that do nothing but imaging or infusions. There are plenty of infusion centers for chemotherapy or multiple sclerosis drugs. If new antibody drugs become available for a huge population of patients with cognition problems, those patients could require monthly infusions for the rest of their lives. That could put a strain on capacity, not to mention the skills of the people running the front desk and putting in IV lines.
While Biogen’s Scangos has publicly worried about infusion capacity, others say a big Alzheimer’s market will provide … Next Page »