The ACR recently contributed comments to the Institute for Clinical & Economic Review (ICER) to inform the initial drafting of an assessment of the efficacy and cost effectiveness of medical therapies for lupus nephritis. In a Sept. 21 letter, the ACR encouraged ICER to consider a number of issues essential for the appropriate treatment of lupus nephritis, highlighted limitations in analyses to date and provided current references about lupus nephritis treatment and outcomes.
Founded in 2006, ICER is an independent research organization that evaluates the clinical and economic value of medical treatments. It has published numerous assessments of the cost effectiveness of prescription drugs in various clinical areas using a systematic methodology that estimates the amount of money per year available for spending on new drugs in the U.S. and dividing that amount by the number of expected approvals by the U.S Food & Drug Administration.
Two previous ICER projects also focused on therapies for rheumatic conditions: In 2017, ICER reviewed the cost effectiveness of biologic drugs and in 2019 conducted a more targeted 2019 review of the cost effectiveness of Janus kinase inhibitors (JAKs).
In 2017, The Rheumatologist reported that then ACR President Sharad Lakhanpal, MD, MBBS, had expressed concern over the potential for access limitations to appropriate care based on the report’s findings. While acknowledging the importance of comparative effectiveness research, Dr. Lakhanpal stressed the importance of not limiting treatment options for patients. He said, “Ideally, [comparative effectiveness research] would highlight the need for multiple treatment options to address heterogeneous groups of patients with individual and unique co-morbidities. The ACR is concerned that the ICER report, while based on a commonly used method to assess cost effectiveness, provides insufficient information on model structure and validation.”
According to Chris Phillips, MD, a rheumatologist on the ACR’s Committee on Rheumatologic Care (CORC) and the ACR’s representative to ICER, ACR involvement has grown with each project, reflecting the importance the ACR places on working closely with ICER to ensure its assessments accurately address the essential issues of treating patients with rheumatic conditions.
“We recognize that ICER’s footprint in the economic discussions regarding drug pricing is growing, and we are glad to be able to have a good working relationship with them,” says Dr. Phillips.
Meaningful Discussions
To develop an assessment, Dr. Phillips explains, ICER first chooses a scope for its review then performs an extensive literature review to gather relevant data. For rheumatoid arthritis, for example, that data would focus on drug efficacy. Then ICER uses validated cross-walks between outcome measures (such as ACR 20/50/70 responses) and quality-adjusted life years (QALY) gained as inputs for drug pricing and economic models to try to measure cost per QALY.
