Bringing the patient voice to health economics: Lessons learned from an ICER lupus nephritis review

By Emily Lemiska

Topping out at more than $3 trillion a year, health care costs in the United States are some of the highest in the world. From 1960 to 2018, total health care expenditures increased from 5% to 18% of the nation’s gross domestic product.

Patients, providers, and policymakers alike have long sought solutions to the financial burden of health care in America. But one organization, known as the Institute for Clinical and Economic Review (ICER), has made the biggest splash since its establishment in 2006.

Thus far, the Boston-based nonprofit has analyzed the cost-effectiveness of roughly 100 therapies, primarily medications, releasing reports about its findings. While ICER has no official regulatory or policy-making power, insurance companies are increasingly using the organization’s decisions to inform what treatments to cover and at what cost.

Because medications for auto-

immune conditions are often costly, many of these conditions have been under the ICER microscope—including, most recently, two treatments for lupus nephritis, a complication of lupus that involves the kidneys. 

Friend or foe?

ICER’s criticism of high-cost drugs relative to their benefit has put pressure on pharmaceutical companies to lower prices, making those therapies more affordable. However, many patients and patient groups feel ICER’s findings decrease access by undervaluing a treatment’s effect on quality of life, which may lead insurers to limit or eliminate coverage.

Patients and patient groups have been particularly critical of ICER’s use of a metric called quality-adjusted life years (QALYs). QALYs are defined as the cost of one year of good health for one patient; the higher the cost of a drug relative to QALY, the less cost-effective the drug is.

 The problem, say patient advocates, is that it’s difficult—and perhaps cruel—to assign a numerical value to someone’s quality of life, especially in people with serious disabilities or illness. What may seem like negligible improvements to an able-bodied person can mean the world to someone with a severe chronic condition.

 “Unfortunately, because of the QALY, there’s historically been a view of ICER as not being very patient-friendly,” says Kathleen Arntsen, president and CEO of Lupus and Allied Diseases Association (LADA), which was closely involved in the lupus nephritis review. Arntsen—who has lived for decades with multiple autoimmune conditions, including lupus—has fought for the patient viewpoint to be included in initiatives such as value assessments.

Defining value

Arntsen says her group’s recent experience with ICER was overwhelmingly positive.

“We felt that a recent review was very positive for the lupus community, as it showed value in two lupus nephritis treatments,” says Arntsen. “LADA actively engaged in the review process from the very beginning and fought very hard to ensure that the ICER team listened to us regarding lifetime impacts to patient and caregiver lives.”

The review process typically takes eight months and is broken into multiple stages, culminating in a public meeting and final report. At each stage, community and patient input are sought. 

Arntsen was closely involved as the patient reviewer for two of the reports and served as one of the patient panelists for the public meeting. 

“Although this project took a tremendous amount of effort and time on our parts, the outcome made it worthwhile,” says Arntsen.

Fighting to be heard

But as Arntsen alludes to, participating is not easy. ICER moves rapidly and sometimes gives short notice for public comment, despite the reality that people with chronic and disabling conditions—who already face constraints on their bandwidth—need ample time to participate and prepare, and that patient organizations, as nonprofits, have limited resources.

That said, Arntsen feels ICER recognizes the importance of working collaboratively with patients and patient groups. She offers four suggestions for those hoping to bring the patient perspective to future reviews.

Be engaged. “You have to be all in. They require certain things at certain times, so make sure you’re familiar with how the process works, their terminology, and the documentation required at each step of the way.”

Have a strategy from day one. “Know what key topics you’re trying to cover by sharing the patient or caregiver experience and who in your community and network could help underscore those points the strongest. For us, what resonated were the potential impacts of the lupus nephritis treatments on a person’s ability to experience motherhood, achieve career and education goals, and reduce steroids, and to reduce overall health inequities.” 

Bring the evidence to support whatever point you’re trying to make. “Even evidence that is unpublished is acceptable as long as it’s publicly available. We were able to draw heavily from the LADA, Lupus Foundation of America, and Lupus Research Alliance’s externally-led Lupus Patient-Focused Drug Development Meeting and Report and other available public resources.”

Remain positive throughout, and share the evidence once the review is completed. “Be hopeful and motivated that the outcome will be the best it can be because you gave it your all.”

Continuing to amplify the patient voice

Arntsen reminds patients and patient groups that they don’t have to be health economists to have an impact in the review process.

“Our job is to bring the patient voice to the table and make them understand the true patient experience,” she says.    •

To learn more about ICER, including review results and more information on patient engagement, visit

To learn more about LADA, visit