Seven leading diagnostics companies and laboratory service providers have formed the Access to Comprehensive Genomic Profiling Coalition (ACGP). The goal of the organization is to collectively advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer. The current members of ACGP are Exact Sciences, Foundation Medicine, Illumina, LabCorp, QIAGEN, Roche Diagnostics, and Thermo Fisher Scientific.
CGP testing performed soon after a diagnosis of advanced cancer better informs medical management, including treatment decisions and patient care, which can improve clinical outcomes. In advocating for coverage of CGP, ACGP will educate health insurers and other healthcare stakeholders about the clinical utility and economic value of CGP.
CGP tests assess the genomic alterations within a patient’s cancer to help physicians make more informed decisions about personalized treatment approaches. Using next-generation sequencing (NGS) with a tissue biopsy or a blood sample, this testing method can detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. These tests can reveal clinically relevant alterations and biomarkers in the tumor’s DNA and RNA. This helps identify patients who could respond to specific targeted therapies and immunotherapy that can be more effective and may have fewer side effects. Healthcare professionals can use CGP to help predict patient benefit across multiple targeted therapies and cancer indications, with benefits in progression-free survival for patients with non-small cell lung cancer (NSCLC) as one example.
“Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade,” said Jim Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and the chairman of ACGP. “The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments.”
Despite evidence of the benefits of this approach, some health insurers still use an outdated framework to evaluate coverage for CGP, creating a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do. Limited insurance coverage options may prevent some treating physicians from ordering CGP for their patients.
“There is no question that obstacles to coverage have inhibited physicians from ordering comprehensive genomic profiling,” said Almas. “Additionally, we believe some clinicians are not aware of the advantages of a comprehensive testing approach and the benefits of one CGP test to provide genomic profiling, detect microsatellite instability and tumor mutational burden, and help physicians identify clinical trials for which patients may be candidates.”