Patients with Alzheimer’s disease are faced with unimaginable challenges. Now, they are finding it necessary to fight for access to innovative therapies, too.
There are several new medications that have the potential to change the course of the disease’s progression, but getting them depends on effectively countering the outsized influence wielded by economists and academics who are outside the formal health care system.
An organization called the Institute for Clinical and Economic Review, for instance, conducts economic reviews of breakthrough medicines, usually declaring them not worth their price tag. The Food and Drug Administration still holds the official power to review and approve new therapies. But insurance companies and government agencies increasingly follow ICER’s guidance about which drugs to cover or how much to pay for them.
However unofficial, ICER economists sometimes have more say over patients’ treatment options than their doctors or themselves.
In January, the FDA granted accelerated approval to lecanemab, a potentially game-changing Alzheimer’s treatment that reduces the amyloid beta plaques that attack Alzheimer’s patients’ brains. But ICER had begun its own analysis of lecanemab a year earlier, before the FDA ever weighed in.
Their final determination is still pending. But if history is any guide, ICER’s eventual pricing recommendation will lead insurers and payers to restrict patient access to it.
That is what happened in 2021, when the FDA approved a different amyloid beta-directed antibody, aducanumab. Within months of the drug being approved by federal regulators, ICER questioned its cost-effectiveness. By the time the dust settled on the controversy, Medicare had restricted reimbursement for aducanumab (and all other yet-to-be approved drugs in the class) to patients who could get into clinical trials – trials that are yet to be set up.
The result: the first medications approved by the FDA to treat a deadly, incurable disease afflicting millions of American seniors have been shunned by America’s national health care program for seniors. As of now, patients’ only option to get either drug is by paying out of pocket. For most, that’s just not feasible.
Standing Up for Patients and Care
The Alzheimer’s community has waited decades for the promising therapies now coming through the pipeline. If they want that wait to end, though, waiting won’t be enough. They’re going to have to advocate for themselves and their loved ones. This toolkit for Alzheimer’s advocacy is a great place to start.