New Consortia in Oncology and Metabolic Diseases Launch Efforts to Develop Methodological Standards to Guide Reimbursement Decisions

Green Park Collaborative-USA 's Inaugural Annual Meeting Gathers Nearly 100 Healthcare Leaders from Industry, Patient Groups,

November 21, 2013

Green Park Collaborative-USA 's inaugural annual meeting gathers nearly 100 health care leaders from industry, patient groups, payers, regulators and academia.

Baltimore, MD—November 21, 2013—The Center for Medical Technology Policy (CMTP) announced the leadership of two new disease-specific consortia and associated working groups of the Green Park Collaborative-USA (GPC-USA) at the Collaborative’s first Annual Meeting in Baltimore last week.

GPC-USA is a multi-stakeholder forum that is developing condition-specific study design recommendations to guide the generation of evidence needed to inform coverage and payment decisions in the United States. The GPC-USA serves as a trusted forum where payers, life sciences companies, patient groups, clinicians, researchers, regulators and other stakeholders can engage in dialogue regarding methodological standards for studies intended to demonstrate real world effectiveness and value.

“Though it has been just six months since its initial launch, GPC-USA has already made tremendous progress, launching its first two consortia on oncology and endocrine/metabolic diseases” said Sean Tunis, MD, MSc, President and CEO of CMTP, the group’s sponsor. “The level of engagement from key organizations and leaders throughout the clinical research enterprise has been extremely encouraging. We believe that these sustained multi-stakeholder discussions are critical to generating the evidence needed to inform reimbursement and clinical decision-making while sustaining innovation.”

At its first Annual Meeting, GPC-USA described its progress establishing two new Consortia that will create Effectiveness Guidance Documents (EGDs), publications that set out reasonable methodological standards for clinical development and market access. Each Consortium gathers a range of expertise and perspectives from key actors who influence research, clinical and patient decision-making, reimbursement and regulation.

Led by Donna Messner, PhD, Research Director at CMTP, the Oncology Consortium will focus on developing methodologic recommendations and data strategies to help shape research on the best ways to sequence cancer care treatments. Anne Schott, MD, who specializes in medical oncology at the University of Michigan, will chair the Technical Working Group responsible for developing initial recommendations for the Consortium’s first EGD.

The Metabolic and Endocrine Consortium is led by C. Daniel Mullins, PhD, Professor, Pharmaceutical Health Services Research Department (PHSR) at the University of Maryland School of Pharmacy. Its initial EGD will focus on Guidance for designing trials that are more informative about real world, effectiveness and report outcomes that are most meaningful to patients. Its Technical Working Group, chaired by Nisa Maruthur, MD, MHS, Assistant Professor of Medicine and Epidemiology, Johns Hopkins University School of Medicine, will particularly examine research issues related to evaluating Type 2 diabetes medications.

“The guidance that CMTP has produced and that these Consortia are working on can be invaluable tools,” said Elaine Jeter, MD, Medical Director of Palmetto, GBA, a Medicare Administrative Contractor and the developer of the MolDx program. “They can help us evaluate the quality of the evidence supporting new interventions and guide drug, device and diagnostic test makers in their efforts to demonstrate the clinical utility of their products.”

Both Consortia expect to publish their guidance documents during 2014.

For more information about GPC-USA, please click here.

About CMTP

The Center for Medical Technology Policy (CMTP) is an independent, non-profit 501(c)(3) organization that aims to make health care more effective and affordable by improving the quality, relevance, and efficiency of health care research. We focus on the design and implementation of comparative effectiveness research to produce information that helps patients, clinicians, and payers make informed treatment and policy decisions. CMTP provides a trusted forum in which a broad range of stakeholders can collaborate to identify important research questions, design appropriate studies, and develop innovative partnerships to implement these studies.


Julie Simmons