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Amgen Statement and Response to ICER Rheumatoid Arthritis Draft Evidence Report

Amgen strongly believes in the clinical and economic value of Enbrel® (etanercept) in moderate to severe rheumatoid arthritis (RA), reinforced by nearly 20 years of patient experience. Numerous disease state registries backed by dozens of publications have documented the relentlessly progressive and severely debilitating nature of RA prior to the availability of biologic DMARDs. By contrast, the ICER model presents an oversimplified representation of RA that relies too heavily on short-term controlled clinical trial data and therefore overestimates the treatment effect of continued conventional DMARD (cDMARD) therapy. The failure to utilize real-world evidence of progressively worsening disease activity on cDMARDS denies the known natural history of RA in the face of ineffective treatment and is a major methodologic flaw that must be addressed.

ICER should correct the flawed assumptions and methodologic issues to produce a meaningful and clinically relevant patient-centric model. In particular, we continue to recommend that ICER pay attention to and model the obvious and well-known consequences of uncontrolled moderate to severe RA. For example, recognizing the dramatic change that has occurred in the RA population regarding the use of disability aids like wheelchairs in those who have failed cDMARDs and would have previously had no further treatment options.

Amgen Response to ICER Rheumatoid Arthritis Draft Evidence Report