Coverage Counts: Improving Access to High Quality Diagnostics in Cancer Care is Critical
In cancer care today, there are an ever-growing number of targeted therapies and immunotherapies that may be the right match for an individual patient. While this is tremendous progress, the rapid pace of discovery can only truly impact patient care if there is access to high-quality tests used to guide diagnosis and treatment.
Foundation Medicine’s U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx and FoundationOne®Liquid CDx tests are high-quality comprehensive genomic profiling (CGP) tests that help physicians accurately identify the genomic mutations driving a patient’s cancer and match a patient to the most effective treatment options, including targeted therapies, immunotherapies, or clinical trials. Our tests facilitate an evidence-based approach to treatment decision-making – they can enable better outcomes for patients and help reduce waste in cancer treatment.[1,2,3,4]
High-quality tests are a critical component of precision medicine, and we need to prioritize increasing accessibility to these tests so patients and physicians can receive accurate and reliable information to confidently inform a diagnosis and treatment options.
Over the past several years, there has been progress in expanding this access. Genomic profiling is recommended by cancer treatment guidelines, including the National Comprehensive Cancer Network (NCCN). For Medicare patients, both of our FDA-approved tests are covered for individuals meeting coverage criteria, enabling access to testing regardless of tissue availability. Additionally, our tests have been gaining Medicaid coverage.
Many commercial insurance companies are also increasing their coverage of high-quality tests. National and regional commercial payers such as Aetna, Anthem Blue Cross Blue Shield, Blue Shield of California (BSC), Humana, UnitedHealthcare, as well as Medicare and Medicare Advantage plans have made the decision to cover our portfolio of tests. With such broad coverage, nearly 9 out of 10 patients pay zero dollars for Foundation Medicine testing.
For example, Anthem Blue Cross Blue Shield commercial plans recently expanded coverage to include FoundationOne CDx and FoundationOne Liquid CDx. FoundationOne®Heme is also now covered for patients with acute myeloid leukemia and myelodysplastic syndromes.
Also, we are an In Network (INN) provider with BSC and recently received expanded coverage for FoundationOne CDx and FoundationOne Liquid CDx. We also secured new coverage for FoundationOne Heme. What’s particularly exciting about this expanded coverage, in addition to greater access to high-quality CGP for patients, is that FoundationOne Liquid CDx is the only blood-based CGP test covered by BSC for prostate cancer, because it is the only liquid biopsy test that detects all guideline-recommended genes for prostate cancer and is called out as being the only test to currently meet certain prostate cancer criteria for detecting HRR genes. It also states that patients can be tested at diagnosis, progression, or recurrence which doesn't expressly limit coverage to once per patient.
Additionally, BSC’s policy expands coverage of CGP testing for lung cancer to earlier stages of disease. CGP for patients with early-stage cancer can now inform adjuvant treatment decisions, reduce expenditures on ineffective immunotherapy among biomarker-positive patients, and expedite time to targeted therapy initiation upon recurrence. High-quality CGP access and coverage for early-stage patients is increasingly critical for quality care.
While we have made impressive progress in expanding access to our tests, many commercial payers still lag in their coverage. As we continue to make advancements in precision cancer care, there is the risk of inadvertently increasing the gaps in access to targeted treatments. Improving access to high-quality tests will not only positively impact patient outcomes, but it will create more equitable access to personalized treatment options.
1 Milbury CA, Creeden J, Yip WK, et al. Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors. PLoS One. 2022;17(3):e0264138. Published 2022 Mar 16. doi:10.1371/journal.pone.0264138 https://pubmed.ncbi.nlm.nih.gov/35294956/ [pubmed.ncbi.nlm.nih.gov]
2 Keeling, Peter. “Transforming the Pharma Business Model to Prevent Lost Treatment Opportunities and Optimize Return on Investment.” Transforming the Pharma Business Model to Prevent Lost Treatment Opportunities and Optimize Return on Investment, Diaceutics, May 2017, www.diaceutics.com/docs/ft-2017-white-paper.pdf [diaceutics.com]. Accessed April 1, 2019
3 Schwaederle M, Parker BA, Schwab RB, et al. Precision Oncology: The UC San Diego Moores Cancer Center PREDICT Experience. Mol Cancer Ther. 2016;15(4):743-752. doi:10.1158/1535-7163.MCT-15-0795
4 Muthusamy, B, et al. Quantifying the Value of Multigene Testing in Resected Early Stage Lung Adenocarcinoma, Journal of Thoracic Oncology, Volume 18, Issue 4, 2023, Pages 476-486, ISSN 1556-0864,https://doi.org/10.1016/j.jtho.2022.11.027.
5 Data on file.