— Analysis has been commissioned by the U.S. Department of Veterans Affairs to help evaluate data from a completed clinical trial comparing patient outcomes with specially trained service dogs to outcomes with emotional support dogs without specialized training —

— The final ICER report will be submitted to the National Academy of Medicine for deliberation —

— Open Input now being accepted through October 2, 2020 —

BOSTON, August 28, 2020 – The Institute for Clinical and Economic Review (ICER) today announced it has been commissioned by the U.S. Department of Veterans Affairs (VA) to conduct an assessment of the cost-effectiveness of service dogs trained in tasks related to post-traumatic stress disorder (PTSD), based on findings from the largest related examination to date conducted by the VA. This randomized clinical trial compared outcomes for veterans with PTSD who were randomized to receive a specially trained service dog or an emotional support dog. The VA plans to present the key findings of the ICER report to the National Academy of Medicine in 2021 as part of a broader set of monographs evaluating the trial results.

“PTSD causes tremendous suffering and presents a significant challenge to veterans and the VA health system,” said Steven D. Pearson, MD, MSc, ICER’s President. “Like all health systems, understanding the evidence on comparative clinical effectiveness and cost-effectiveness can help the VA assure that the most effective treatments are selected and that prices are negotiated to maximize benefits while remaining financially responsible. We are proud to contribute to the evidenced-based approach that the VA is taking and look forward to gathering input from affected patients and other stakeholders to ensure that our analysis is rooted in the context of the patient experience.”

ICER’s website provides a complete timeline for this initiative. Beginning today, an Open Input period will enable stakeholders to share key information relevant to the assessment. We are particularly interested in learning about the clinical perspectives on the VA trial, titled “Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?” ICER seeks input on how well the selected outcomes and utility instruments in this trial captured the clinical benefits of service dogs, as well as veteran perspectives around what potential other benefits and contextual considerations may be important in understanding the overall value service dogs offer. There are no page limits or formatting requirements for Open Input, but it should be emailed to publiccomments@icer.org by 5 p.m. ET on October 2, 2020 to be considered. During this time, ICER will also conduct phone interviews with veterans’ organizations and clinical experts to gain further insights into these same questions.

This ICER report will differ in important ways from those developed as part of ICER’s drug assessment program. First and foremost, this report will not seek to review all available evidence on the outcomes associated with service dogs for patients with PTSD; instead, the scope of the review is limited to evaluating the evidence from the VA clinical trial. As with other ICER reports, however, we will seek to include perspectives gained from discussions with patients and other stakeholders on the broader potential other benefits and contextual considerations associated with the condition and the treatment options. ICER’s cost-effectiveness analyses will seek to evaluate whether service dogs achieve improved patient-important outcomes at an added cost, and we will also explore threshold analyses that might suggest how effective service dogs would need to be in order to justify their current cost, or analyses that would suggest at what price service dogs would meet traditional cost-effectiveness thresholds.

A final important distinction between this report and other ICER assessments is that this report will not be presented for public deliberation to one of ICER’s independent appraisal committees. Instead, this report will be submitted along with other monographs being developed by VA researchers for consideration by the National Academy of Medicine. Given this alternative process for deliberation, the Open Input process will be the primary mechanism for the public to provide comment to ICER during the development of the report. In addition to helping inform the assessment process, all input provided during this period will be included as part of the final report submitted to the National Academy.

This report will mark another important engagement between ICER and the VA health system. ICER’s ongoing drug value assessment collaboration with the VA continues to demonstrate that a health care system in the US can utilize independent cost-effectiveness analyses as an additional information resource to help make judgments about reasonable pricing for new health care services.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for interventions that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system. For more information about ICER, please visit ICER’s website.