A new consortium of payers, clinicians, patients, and pharmaceutical companies are developing recommendations to help generate evidence-based guidelines to define coverage and develop payment decisions for treating cancer. The Green Park Collaborative—USA (GPC-USA) was launched in Baltimore last week by the Center for Medical Technology Policy (CMTP). Its members are tasked with developing methodological standards for studies intended to demonstrate real world effectiveness and value. Two disease-specific consortia have been launched: oncology and metabolic and endocrine diseases.
During the past decade, there has been increasing emphasis on generating evidence of effectiveness and value that payers need to make decisions, while also providing useful information for patients, consumers, clinicians, and other healthcare decision makers.
The consortia will be charged with creating Effectiveness Guidance Documents
publications that set out reasonable methodological standards for clinical development and market access. Each consortium gathers a range of expertise and perspectives from key players who influence research, clinical and patient decision making, and 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 set of guidance documents.
Both the oncology and endocrine consortia expect to publish their guidance documents during 2014.
The center notes that for pharmaceutical companies, the FDA develops guidance on study design that is required for regulatory approval. However, there is no corresponding organization that can provide clear guidance to researchers and life sciences companies reflecting reimbursement requirements.
Health plans have limited technical capacity and resources to devote to this work. And while the Patient-Centered Outcomes Research Institute (PCORI) is developing general methods standards for comparative effectiveness research (CER), it does not intend to develop standards for specific clinical conditions or categories of technology.
In developing the Effectiveness Guidance Documents, the consortium will also incorporate patient reported outcomes (eg, health-related quality of life, health status, medication use, and satisfaction) and other reliable, validated measures that meaningfully assess outcomes, such as cost-utility and cost-effectiveness, in a way that minimizes patient burden and utilizes electronic data capture technologies so that data can be collected as quickly as possible.