Institute for Clinical and Economic Review - Peterson Health Technology Institute value assessment framework for digital health technologies.

Digital health technologies (DHTs) are a broad and rapidly innovating class of interventions with distinctive pathways for development, regulatory approval, uptake and reimbursement. Given the unique nature of DHTs, existing value assessment frameworks and evidence standards for health technologies such as drugs and devices are not directly applicable. The value assessment framework presented here describes a conceptual model and associated methods to guide assessments of DHTs. The framework seeks to accomplish two goals: to set evidence standards that guide technology developers to generate robust evidence on their products; and to provide reviews that help organizations adopt high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings. This assessment framework will serve as the roadmap for future evaluations of DHTs by the Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI). We believe that all stakeholders will benefit from comprehensive and explicit standards of evidence on the different dimensions necessary to understand the value of DHTs.

Evaluating the evidence on comparative effectiveness and value of management options for treatment-resistant depression.

Treatment-resistant depression (TRD) is a debilitating patient condition with significant clinical and economic impact. The introduction of a new treatment approach, repetitive transcranial magnetic stimulation (rTMS), created the opportunity for a multi-stakeholder initiative to examine the comparative clinical effectiveness and comparative value of the different approaches to managing patients with TRD. The New England Comparative Effectiveness Public Advisory Council (CEPAC) convened in December 2011 to discuss the evidence on management options for patients with TRD. The Council voted that rTMS was as good or better than usual care and represented a reasonable value compared with usual care. The votes and deliberation of CEPAC led to first-in-the-nation payer coverage policies allowing patients access to this new treatment option. Regional groups that examine and deliberate on the comparative effectiveness evidence for existing and emerging treatments can have a direct influence on medical policy that accelerates access to innovative treatments.

Management strategies for attention-deficit/hyperactivity disorder: a regional deliberation on the evidence.

Parents, clinicians, and policymakers require the latest evidence to help inform treatment decisions. The New England Comparative Effectiveness Public Advisory Council (CEPAC) leverages existing federally produced comparative effectiveness research supplemented with additional clinical and economic analyses to deliberate on the latest evidence. At its June 2012 meeting, the CEPAC voted on the evidence for the treatment of attention-deficit/hyperactivity disorder (ADHD) in preschoolers and school-aged children. The CEPAC voted unanimously that parent behavior training was better than usual care (eg, wait-list control) for the preschool population. They also judged it to be of "reasonable value" compared with usual care. The CEPAC also stipulated unanimously that medications are better than usual care (eg, services provided at individual practitioner discretion) for school-aged children in regards to long-term effectiveness and safety. The CEPAC members and clinical experts recommended the increased use of parent behavior training as first-line therapy for preschoolers and emphasized the importance of proper monitoring of and dosing for all children who receive medication for their ADHD symptoms. The ADHD CEPAC meeting demonstrated the important role that a public, transparent deliberation on the latest medical evidence can have in supporting informed decision making and efficient use of health care resources.