Atlanta, GA, August 7, 2017––The American College of Rheumatology (ACR) today issued the following statement in response to a Final Evidence Report from the Institute for Clinical and Economic Review (ICER) titled, “Anabolic Therapies for Osteoporosis in Postmenopausal Women: Effectiveness and Value.”

While we appreciate the ICER’s effort to identify clinically appropriate strategies to help osteoporosis (OP) patients manage their condition, as well as the report’s policy findings in favor of lower drug prices and more transparent step edit criteria, we have several concerns surrounding the methodology used to generate this report which could lead to serious unintended negative consequences for OP patients. Specifically, we believe that the applicability of the findings in the final report is likely diminished due to its heavy reliance on clinical trial data without sufficient information reflective of ‘real–world’ patient experiences, that the report did not adequately consider the long–term effects of anabolic treatments on a patient’s bone architecture, and that it also failed to account for possible reasons why a clinician might recommend an anabolic agent as a first–line therapy in certain clinical scenarios.

Osteoporosis patients in the care of rheumatologists often suffer additional comorbid conditions – such as rheumatic diseases – that complicate the treatment of OP. Furthermore, these comorbidities may not be captured in a typical clinical trial due to strict inclusion criteria. We recognize that real–world data may not have been readily available for several of these therapies and thus it is difficult to reach definitive conclusions with validity and broad applicability to rheumatology patients. Therefore, conclusions based on analyses that do not include such patients must be tempered.

Additionally, we believe that any attempt to define the clinical benefit of OP therapies for such patients must include data from real–world patient populations. In this context, we think the preference for clinical trial data predisposes the ICER report to underestimate the value of anabolic therapies.

Clinical trial data also frequently fail to capture long–term outcomes, in this case the effects of anabolic treatments on OP patients’ bone architecture. The potential long–term impacts of these therapies may not be realized for years following initiation of therapy and therefore short–term studies will systematically underestimate their value. We understand that long–term data may not have been readily available, and urge ICER to publically acknowledge such shortcomings.

The final report also fails to consider scenarios in which clinicians might choose an anabolic agent as first–line therapy. Anabolic therapies are faster acting and can stabilize a patient more quickly than bisphosphonates, and published data suggest a patient’s response to anabolic agents may be blunted by prior therapy with an antiresorptive. For these reasons, a clinician and patient may appropriately choose an anabolic agent as first–line therapy in high–risk scenarios.

Finally, we are concerned that the two clinical experts involved in the supervision of this report were too few for an analysis of this complexity. Moving forward, we suggest a more comprehensive expert panel should be utilized for this type of review.

The ACR appreciates the opportunity to respond to this report and remains committed to advancing clinically appropriate and cost–effective strategies for treating patients with osteoporosis. We hope this dialogue continues into the future so that patients living with chronic conditions – OP and rheumatic disease among them – will have better access to effective treatments.