Too high a cost for too iffy a drug
More than 6 million people in the U.S. live with Alzheimer's. Credit: Getty Images/Branimir76
The question of how much it’s worth to us to prevent or treat Alzheimer’s isn’t terribly difficult: For a workable solution, our commitment ought to be nearly infinite.
About 6 million Americans suffer from this leading cause of dementia, a number expected to double over the next few decades as the population ages. Sufferers live an average of four to eight years, but can linger for 20. For patients it is agony. For families it is worse. It kills more people than breast and prostate cancer combined. Dementia costs the United States $355 billion a year, a number expected to climb to $1 trillion.
There is no better use of resources than Alzheimer’s prevention and treatment.
But how much should we spend on a medicine that experts say very likely won’t help? Should we even allow doctors to prescribe it, and compel insurers and Medicare and Medicaid to pay for it?
In November an independent panel of experts advising the FDA evaluated the data on aducanumab, developed to treat Alzheimer’s, and not one voted to recommend the drug's approval.
When the Food and Drug Administration approved aducanumab this week over the objections of that panel of experts, it did so even though clinical trials failed to show it helps patients much, if at all. One defining trait of the Alzheimer’s patient’s brain is the buildup of amyloid plaque. Aducanumab reduces that buildup. Scientists, though, don’t agree that excess amyloid plaque causes the cognition loss, or that reducing the buildup slows that loss. Many researchers are seeking treatments along other paths, including drugs designed to reduce another protein excessively present in Alzheimer’s victims, called tau.
Aducanumab developer Biogen seemed to accept the failure of the drug when two trials showed so little benefit they were shut down early. But the company then refocused on a subset of patients in one study who took the highest doses, and found a slowing of declines. That study showed no help at lower levels. The other study showed no improvement at any dosage. And 40% of subjects suffered brain swelling.
The drug is priced at $56,000 a year, a bargain if it works and a rip-off if it doesn’t, and even Biogen only claims it slows decline a bit, at best. The Institute for Clinical and Economic Review estimates the cost-effective price of the drug would be between $2,560 and $8,300 annually.
If 10% of American Alzheimer’s sufferers began using aducanumab, the tab would be $33.6 billion annually, billed to Medicare for the still-solvent sufferers and Medicaid for those bankrupted by the disease.
And patients who take the drug, and their loved ones, will still be in agony.
Resources are finite. If we spend $33 billion on a drug that doesn’t help much, we won’t have that money to deploy toward better tools or other causes. If we pursue the wrong path incautiously, we risk missing the right one.
The federal government asked 11 experts to evaluate this drug. That’s our system, and it makes sense. Not one could support its approval. The FDA shouldn’t have, either.
And the reason is not that helping these patients via aducanumab would cost too much money. It’s because failing to help them in such an expensive manner, and in a way that potentially stymies the search for potentially better cures and treatments, could cost too many lives.
Lane Filler is a member of Newsday's editorial board.
Lane Filler is a member of the Newsday editorial board.
