NCCN Holds Molecular Testing Summit

On Thursday, July 14, 2011, the National Comprehensive Cancer Network® (NCCN®) convened the NCCN Oncology Policy Summit: Molecular Testing – Effectiveness, Efficiency, and Reimbursement in Washington, DC at the National Press Club. This invitation-only Policy Summit was attended by patient advocates, providers (e.g., oncologists, pathologists, other laboratory professionals, etc.), payors, laboratory accreditation organizations, government, and industry representatives within the oncology community. These key stakeholders gathered for a day-long session to discuss current policy issues surrounding molecular testing in oncology. Personalized medicine in oncology is maturing and evolving rapidly, and the utilization of molecular biomarkers in clinical decision-making is growing. The Food and Drug Administration (FDA) has recently announced plans for oversight of Laboratory Developed Tests (LDT). As recognized by the FDA, these types of diagnostic tests are used increasingly to directly inform treatment decisions, and this especially impacts patients with cancer and their oncologists.

The Summit featured two expert roundtable discussions, moderated by William T. McGivney, PhD, Chief Executive Officer of NCCN, and several presentations by members of the NCCN Molecular Testing Work Group. The Work Group is comprised of thought leaders from NCCN Member Institutions and external organizations, representing providers (oncologists and pathologists), patients, administrators, industry, payors, and government, who worked over the past several months to identify challenges and reach consensus on molecular testing issues in oncology. The Work Group's efforts will culminate in the publication of a white paper on molecular testing in oncology later this year.

To frame the sessions, Marc Ladanyi, MD, Director of the Diagnostic Molecular Pathology Laboratory at Memorial Sloan-Kettering Cancer Center and Work Group member, provided an overview of the role of molecular testing in oncology, including a description of the various uses of molecular tests (risk assessment, diagnosis and disease classification, prognosis, response prediction, toxicity prediction, and dose determination) and how clinical and analytic validity of these tests are assessed. Dr. Ladanyi highlighted some important areas of stakeholder interest regarding molecular testing, including but not limited to safety, efficacy, efficiency, access to testing, and affordability, which also served to provide a platform for further presentations.

During the second presentation, Paul Engstrom, MD, Senior Vice President, Extramural Research Programs at Fox Chase Cancer Center and Work Group Chair, discussed the challenges and recommendations compiled by the Work Group, which will be explored further in the aforementioned white paper. It was noted that the Work Group agreed on a definition of molecular testing in oncology, which refers to the detection of somatic or germline mutations, as well as changes in gene or protein expression that could impact the diagnosis, prognosis, prediction, and evaluation of therapy for patients with cancer. Dr. Engstrom reviewed challenges for molecular testing identified by the Work Group from the regulatory policy, clinical, and reimbursement/coverage policy perspectives. Recommendations addressed education for patients, clinicians, and policy-makers, and the need to ensure patient access to safe, effective, and efficient molecular tests.

Two roundtables sessions were also held, the first of which addressed clinician, patient, and scientific issues related to molecular testing. The second of which was introduced by presentations providing FDA and Centers for Medicare and Medicaid Services (CMS) perspectives regarding molecular testing in oncology. The panel, moderator, and audience members discussed expectations for FDA's LDT policy, FDA's recently released In Vitro Companion Diagnostic Device guidance as well as how CMS and private payors are addressing molecular testing as it relates to coverage policy.

Through stakeholder engagement and dialogue, the consensus of the Summit was apparent. It is crucial that the oncology community continues to work collaboratively to ensure molecular testing is safe, effective, and efficient for patients with cancer.