Federal regulators have approved the first new drug for Alzheimer's disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment.
Health care experts expect broad coverage of the drug, which was approved Monday. But what that means for patients will vary widely depending on their insurance plan.
Here's what you need to know:
What was approved?: The Food and Drug Administration said it granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer's patients.
It's the only drug U.S. regulators have said can likely treat the underlying disease, rather than just manage symptoms. The new drug, which Biogen developed with Japan's Eisai Co., did not reverse mental decline. It slowed it in one study.
The FDA's decision came despite the conclusion of its advisory committee that there wasn't enough evidence the drug slowed the brain-destroying disease.
What does it do?: It aims to help clear harmful clumps of a protein called beta-amyloid from the brain.
What will it cost?: Biogen said the drug would cost approximately $56,000 for a typical year's worth of treatment.
Is coverage guaranteed?: Medicare is widely expected to cover the treatment. Insurers that offer private or commercial coverage also will pay for care that doctors deem medically necessary.
That may not mean every case, though. If the treatment is proposed for a patient with advanced Alzheimer's, and research shows the drug isn't effective in that population, the insurer may not pay for it.
What will patients pay? That's impossible to say broadly. It can depend on the person's coverage and their out-of-pocket maximum, which is a plan's limit for how much a patient pays in a year for in-network care before insurance picks up the rest of the bill.
Some patients who are already receiving a lot of care may not wind up with a huge added expense from the drug before they hit that limit. Patients who have a supplemental plan for their Medicare coverage also may wind up with few out-of-pocket costs for the drug.
Patients with Medicare Advantage coverage, which is run by private insurers, or individual health insurance could pay several thousand dollars before they hit their plan's annual limit, depending on the plan.