The Powerful Private Organization Putting a Price on Life –Again and Again
Every year on Groundhog Day, those of us who grew up in snowy states will wait to see whether Punxsutawney Phil will spot his shadow.
But for millions of families living with Alzheimer’s disease, this Groundhog Day may feel more like the time loop trap from the 1993 Bill Murray movie.
That's because this year, an influential non-governmental organization – which markets itself as the arbiter of which medical treatments are worth insurance coverage – has made February 2nd the final day for patients to voice their opinions on the value of a new Alzheimer's drug.
The organization, the Boston-based Institute for Clinical and Economic Review (ICER), issues value assessments on new, FDA-approved therapies, usually for conditions where patients either have no treatment options or have run out of them. Patient advocacy organizations feel obligated to drop what they’re doing and respond to "requests for public comment" in order to weigh in on behalf of the families they represent. Patients and advocacy groups like mine can't simply ignore these requests, since ICER's reports influence whether health insurance providers – including the Department of Veterans Affairs and state Medicaid agencies – make medicines available to patients.
If we don’t respond, the patients we represent run a real risk of losing access to medicines, especially since ICER's methodology – and its recommendations – undervalue treatments for populations that have fewer expected years of life left or shorter average life spans than the overall population.
Consider how ICER's reports rely on a metric known as a Quality-Adjusted Life Year (QALY).
In a QALY analysis, a year of so-called "perfect" health is more valuable than a year in which a person experiences health problems. By the same reasoning, a drug that returns a patient to that supposedly perfect state is considered more cost-effective than an identically priced one that merely prolongs life or alleviates symptoms.
The fundamental problem with this rating tool is that it discriminates against any group of people who are sicker or older than the general population. That includes people with disabilities, as well as groups who experience poorer health because they face inequities in access to care.
ICER's current request for comment concerns lecanemab, a new treatment for Alzheimer's disease that was approved under accelerated approval by the FDA in early January. Alzheimer's is an irreversible, degenerative brain condition affecting more than 6.5 million older adults that starts by destroying memory and thinking skills, progresses to an inability to wash oneself or go to the bathroom, and ends as people living with the disease can no longer walk, eat, talk, or swallow.
The older age demographic and large number of people impacted provides plenty of fodder for ICER’s QALY-based assessment to assign Alzheimer's treatments a lower cost-effectiveness. Add in the fact that older adults often have comorbidities such as heart disease, and the cost-effectiveness erodes further.
This kind of cold valuation of whose life is worth living can play out terribly for people who face long-term health challenges as they age. As a November report by the National Council on Disability observed, QALY-based analysis "puts lesser value on drugs and treatments that extend the lives of people with disabilities as compared to the lives of people without disabilities or chronic illnesses." The report also noted that in countries that apply QALY-type measures across their healthcare systems, the result has been restricted access to drugs for people with disabilities.
Recognizing the potential for harm, several members of Congress banded together yesterday to introduce H.R. 485, the Protecting Health Care for All Patients Act, which would prohibit the use of QALYs in all federal programs – an expansion from the current prohibition that only applies in a limited fashion to the Medicare program. Yet now, the private health insurance companies that cover tens of millions of Americans are relying on ICER, which uses QALY-based methodology, to help them decide whether to cover new FDA-approved treatments for cancer, rare diseases, Alzheimer’s and other life-threatening conditions.
No one elected ICER or appointed it to a government role – at least not yet. Payers have simply handed them the power to make life-or-death decisions. The Inflation Reduction Act allows Medicare to set prices for prescription drugs starting in 2026, and left the door wide open to how it will be operationalized. ICER is at the front of the line, standing by – and that should concern all of us. For patient advocates, it's déjà vu with each ICER report, as we jump through hoops to demonstrate the worthiness of the human beings we represent. We all deserve better.
Sue Peschin is the president and CEO of the Alliance for Aging Research.
