GPC to Discuss Comparative Effectiveness and Value of Weight Loss Treatments
October 17, 2014
The GPC Endocrine-Metabolic Consortium will host a workshop this January to discuss comparative effectiveness and value of weight loss treatments.
FOR IMMEDIATE RELEASE
Green Park Collaborative to Discuss Comparative Effectiveness and Value of Weight Loss Treatments
Baltimore, MD (October 17, 2014) – The Green Park Collaborative (GPC) will bring together representatives from the FDA, public and private payers, medical device and pharmaceutical companies, as well as patient representatives, clinicians, and other experts January 12, 2015 at its first ever workshop on the comparative effectiveness and value of weight loss treatments. Participants will discuss study designs to evaluate weight loss devices, as well as their comparisons to other treatment options, including drug therapies.
The workshop will build on the benefit-risk framework for weight loss devices developed by the FDA, and will expand the dialogue to address evidence expectations of payers, as well as the information needs of patients and clinicians. A critical objective is to obtain greater clarity and consistency regarding the evidence needed by public and private payers, and to align those requirements with FDA regulatory standards to the greatest extent possible.
The discussion will also consider the feasibility and cost of various approaches to clinical studies, how best to accommodate individual patient preferences with respect to benefits and risks, and how different evidence thresholds impact innovation for these devices. Additionally, the session participants will explore pathways to more efficient generation of evidence that is relevant to decision makers. The results of the discussions will be reflected in a proceedings summary, and will also determine whether GPC will also develop a detailed effectiveness guidance document (EGD) with specific recommendations for the design of studies intended to support reimbursement decisions.
About CMTP and GPC
The Center for Medical Technology Policy (CMTP) has extensive experience convening stakeholder groups to discuss value, evidence, and methodological standards. CMTP’s work on such standards is conducted under the umbrella of the Green Park Collaborative-USA (GPC-USA), a neutral forum to support dialogue and consensus among diverse stakeholders on methodological standards for clinical research and clinical utility, focusing on real-world effectiveness and value. GPC standards emphasize the evidence expectations of payers, informed by the views of patients, clinicians and product innovators.
Julie Simmons, CMP
410-547-2687 ext 116