For example, in the lupus nephritis assessment currently underway, ICER is evaluating the clinical and economic value of two medical therapies not yet approved by the FDA: voclosporin and belimumab. In its September letter to ICER, the ACR raised concerns about the lack of head-to-head or real-world data comparisons to these new therapies. To better assess the efficacy of these new therapies, the ACR urged ICER to consider trends seen in the standard-of-care arms of clinical trials of the new therapies and incorporate data on flares, end-stage renal disease, need for steroid rescue, dropouts or treatment failures and deaths.
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The ACR has a good relationship with ICER despite questions about the methodology used, Dr. Phillips stresses. However, he expresses ongoing concerns about the ramifications of ICER’s conclusions, such as whether patients may lose access to treatment if insurance decides not to cover a drug that doesn’t meet the formal cost/QALY threshold used in an ICER assessment.
“We have found ICER to be fairly even-handed in [its] assessment of the data, and [it has] a genuine interest in helping to drive drug pricing to more rational levels,” Dr. Phillips says. “While we continue to be wary of whether the conclusions may be used by payers to be more restrictive to drug access, we have found [ICER] receptive to our input.”
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.