A new report from the National Academies of Sciences, Engineering, and Medicine aims to reduce key barriers to the development and clinical adoption of biomarker tests for molecularly targeted therapies. Included in the report are recommendations designed to facilitate rapid learning from patient experience through enhanced data-collection and data-sharing in one or more large public repositories that should be created.

BALTIMORE, Maryland (March 4, 2016) – A new report from the National Academies of Sciences, Engineering, and Medicine aims to reduce key barriers to the development and clinical adoption of biomarker tests for molecularly targeted therapies.  Included in the report are recommendations designed to facilitate rapid learning from patient experience through enhanced data-collection and data-sharing in one or more large public repositories that should be created.  This would include the capture of biomarker test results linked with molecularly targeted therapies and clinical patient outcomes data in electronic health records.  

“We came to similar conclusions,” said Donna Messner, Vice President and Senior Research Director at the Center for Medical Technology Policy, referring to a 2015 Green Park Collaborative (GPC) report cited in the National Academies report.  “Our multi-stakeholder collaborative also concluded that rapid learning from large cancer genomic repositories was essential to facilitate health plan coverage of beneficial genomic testing in oncology.  So promotion of high-quality data collection and aggregation became an immediate priority for this year.”  

GPC is now working with the Medical Evidence Development Consortium (MED-C) and major groups working on repositories such as the National Cancer Institute, the American Association for Cancer Research, and the American Society for Clinical Oncology, among others, to agree on a core set of clinical data elements that all such repositories should collect, and standards for collecting these data elements.   Stakeholders interested in these issues will be meeting in Baltimore on April 27 to discuss a draft framework.  These efforts will make it possible to aggregate key data across repositories for more powerful analyses, and for more rapid generation of evidence for decision making.   

Consistent with recommendations in the GPC report, the National Academies study group also recommended that the Centers for Medicare & Medicaid Services, as well as private health plans, continue to explore payment policies that promote high quality post-market data collection on biomarkers for which adequate initial evidence of clinical utility exists.  The report specifically noted the work that GPC’s parent organization, the Center for Medical Technology Policy (CMTP), has done in this area.  

“The Committee’s recommendations highlight the importance of enabling a broad range of public and private sector experts and stakeholders to work together to accelerate progress in precision medicine”, said Sean Tunis, the President and CEO of CMTP, and a member of the committee.  “We look forward to continuing our efforts to support collaborative work in this area.”     

GPC is currently recruiting participants for this initiative.  Visit our website for additional information on participation and sponsorship opportunities.    Copies of Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine are available at www.nap.edu. 

About GPC
GPC is a multi-stakeholder forum focused on improving clinical evidence and policies for health plan reimbursement. GPC, a major initiative of the Center for Medical Technology Policy (CMTP), convenes working groups to develop condition and technology-specific study design recommendations that focus on real-world effectiveness and value, meet the evidence expectations of payers, and are informed by the views of patients and clinicians.  

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