Specifically, she took aim at the model framework used to calculate cost, emphasizing that it is inconsistent with the recommendations of the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis, which recommends a treat-to-target strategy.
“In the clinic, we measure disease activity, not an ACR20 response, to determine appropriate treatment,” she says, adding that she is also concerned about the limited treatment options allowed in the report and, especially, the final palliative care sequence.
“The ACR 2015 RA [guideline does] not limit treatment to three TIMs, nor are patients placed on palliative care/conventional DMARD treatment after three switches,” she wrote in a letter to ICER prior to the final publication of the report. “The ideal target should be low disease activity or remission, as determined by the clinician and the patient,” she said.
ACR President Sharad Lakhanpal, MD, MBBS, also expressed concern over the potential for limited access to appropriate care based on the report’s findings. While acknowledging the importance of comparative effectiveness research (CER), he stresses the importance of not limiting treatment options for patients. “Ideally, CER would highlight the need for multiple treatment options to address heterogeneous groups of patients with individual and unique co-morbidities,” he said in a press release.4 “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.”
Dr. Tindall also expressed concerns over the calculations used to assess the cost of TIMs, highlighting the failure in the report to include rebates/vouchers, infusion facility costs, direct out-of-pocket costs, time off work for infusion, monitoring costs and office vs. hospital charges.
“If you’re talking about cost, why don’t you really talk about cost?” she asks, adding that the report fails as a true cost-effective research analysis due to its failure to include all relevant costs.
Looking at this in a different way, Louis Tharp, executive director and co-founder of CreakyJoints, emphasizes the need to look at cost in terms of the benefit of controlling disease. “We believe it is imperative that such a report incorporate the economic benefits to society derived from sustained worker productivity and quality of life that results from the use of biologics,” he says. “The report is inexcusably flawed with this value omitted. The report relies on short-term clinical trial data, ignoring the nearly two-decades-old benefits of substituting legs for wheelchairs.”