Palmetto GBA on Comprehensive Genomic Profiles

Today marks a meaningful milestone for molecular oncology and an important step forward towards delivering precision medicine, a theme of President Obama’s State of the Union Address this week, to many more patients with cancer. Palmetto GBA, a Medicare administrative contractor (MAC) and emerging thought leader in molecular diagnostics through its innovative MolDx Program, published a draft local coverage determination (LCD) which outlines MolDx guidelines for coverage of well-validated comprehensive genomic profiles (CGPs) for cancer, such as FoundationOne®. These guidelines address the reimbursement of CGPs in an initial subset of patients diagnosed with non-small cell lung cancer (NSCLC), and we believe this first step is an important one towards broader coverage of expanded indications as evidence continues to evolve.

It is our understanding that FoundationOne®, a CGP developed and offered commercially by Foundation Medicine since 2012, meets the standards necessary to be covered under this LCD if adopted by National Government Services (NGS), our designated Medicare Administrative Contractor (MAC). Although the insurance coverage process in the United States for new molecular diagnostic approaches is not straightforward or easy, we are very excited about this important development in setting the stage for increased access to CGPs and supporting our efforts to obtain broad reimbursement for FoundationOne.

Palmetto’s LCD was published on the heels of a recent article published in Clinical Cancer Research, which highlights the success of FoundationOne in identifying clinically relevant genomic alterations previously missed by conventional genomic tests, thereby enabling successful targeted treatment in patients with NSCLC. The LCD reflects the importance of evidence-based coverage and sets a very high standard for the analytic validation of CGPs in cancer. Importantly, it references the extremely high benchmarks for the industry that we set in our analytic validation study published in Nature Biotechnology in the Fall of 2013. In addition, FoundationOne has received certification from the New York State Department of Health, establishing a new standard for quality in large scale, multi-gene sequencing-based testing in cancer. The LCD also highlights the critical distinctions between hotspot-based testing and CGPs given the inherent limitations of hotspot testing in failing to comprehensively analyze the entire coding regions of cancer genes and to detect all four classes of genomic alterations, thereby missing targeted therapy options that are clinically relevant for treatment of advanced cancer. We believe this LCD is an important first step that lays the groundwork for coverage of FoundationOne in NSCLC initially, followed by additional clinical indications as evidence continues to evolve.

The existing model of cancer care is increasingly viewed as clinically challenging and financially unsustainable. Physicians and insurers alike understand that innovative technologies and access to molecular information will positively address elements of this model. We applaud Palmetto and other stakeholders who are working to advance cancer care in a responsible and data driven manner and who want to assure broad patient access to important advanced assays.

While Palmetto GBA is not Foundation Medicine’s MAC, it is viewed as a leader in assessing coverage and reimbursement for complex molecular diagnostic services due to efforts such as the MolDx Program and the recently announced Molecular Evidence Development Consortium (MED-C). As such, MolDx and MED-C are influential platforms in the ongoing paradigm shift in cancer treatment. Palmetto’s announcement today and its continued focus in this area both on its own and in conjunction with MED-C can have a significant impact in shaping the future reimbursement landscape for molecular diagnostics. We are excited to continue our collaborative work with Palmetto and NGS to implement this new guidance and work towards coverage in our jurisdiction, and to work with MED-C to expand the initial scope of covered indications over time. This news is further validation of Foundation Medicine’s approach of comprehensively profiling the genomics of patients with cancer, coming on the heels of Priority Health’s broad coverage of FoundationOne and FoundationOne Heme.