On April 7, 2017, the Institute for Clinical and Economic Review (ICER) published its final report, titled, Targeted Immune Modulators for Rheumatoid Arthritis: Effectiveness & Value.1 The stated objective of the report was to assess the comparative clinical effectiveness of the targeted immune modulators (TIMs) used to treat patients with moderate to severe active rheumatoid arthritis (RA), as well as the comparative value of these therapies in terms of cost effectiveness.1
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Explore This IssueJune 2017
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A Flawed Report?
The good news from the report: TIMs are highly effective in treating moderate to severe RA. Their life-changing effects for RA patients were emphasized by ICER President Seven D. Pearson, MD, in a press release accompanying the report’s publication.2
However, the report also found that none of the TIMs was considered cost effective based on the methodology used in the report.
This latter finding is generating considerable concern among rheumatologists and patient advocacy groups who fear that any documented analysis showing the use of these expensive drugs is not cost effective may interfere with patient access to these drugs and may, ultimately, be used to set policy and formulary decisions.
“The ICER report is basically flawed in that the methodology and analysis do not cohere with the ACR and EULAR guidelines on RA treatment with TIMs,” says Elizabeth A. Tindall, MD, a rheumatologist from Rheumatology Consultants of Oregon LLC, who reviewed and commented on drafts of the report before its final publication. “This would limit patient access to many RA therapies.”
Guy Eakin, PhD, senior vice president of scientific strategy for the Arthritis Foundation (AF), acknowledged the flaws in the methodology used in the report, specifically questioning the patient population used in the study to generate the cost-effectiveness analysis, which he thinks is not representative of the true patient population with RA. However, Dr. Eakin, who worked closely with ICER in developing the report, commended the ICER report for its transparency in tackling the difficult issue of cost of these expensive medications.
Report Basis, Findings, Recommendations
The ICER report was based on an analysis of data from 67 randomized clinical studies and 17 observational studies on the use of 11 TIMs (or biologics) either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs) to treat patients with moderate to severe RA. Included in the analysis were nine TIMs approved by the Food and Drug Administration (FDA) for RA, as well as two investigational TIMs still awaiting FDA approval (Table 1).1