As adoption of comprehensive genomic profiling (CGP) becomes more widespread in cancer treatment, new research is redefining the clinical utility of diagnostic tests in this age of precision medicine. The value of CGP lies in helping to inform decisions on available treatment options, including clinical trial participation, based on the unique genomic profile of a patient’s tumor. However, when it comes to coverage, decisions are often based on outcomes associated with drug efficacy, such as overall survival (OS), and diagnostic tests are often held to higher outcomes thresholds than the associated therapies that have a direct impact on clinical outcomes.
While the clinical utility of CGP is well-supported by extensive research, many payers still express concerns over covering the tests. As a result, many patients and their doctors encounter barriers to accessing important information about a tumor’s genomic profile that is needed for a complete picture of possible treatment and clinical trial options. As payers evaluate the value of oncology care when making coverage decisions, the use of real-world evidence is important to consider, particularly in community-based settings where the majority of cancer patients are treated.
A new study recently published in the Journal of Managed Care & Specialty Pharmacy1 adds to this body of real-world evidence supporting the value of CGP and has identified an additional area of significance: a potential cost-benefit to payers.
Researchers conducted a retrospective, observational analysis of medical records and payer data for 96 cancer patients from a large community oncology practice who received CGP testing following a regional health plan’s implementation of CGP coverage. A majority of these patients had non-small cell lung cancer (NSCLC) or colorectal carcinoma, and nearly all had stage IV disease at the time of CGP testing.
Notably, the payer’s coverage policy is reflective of the recent Center for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for next-generation sequencing (NGS) testing for patients with advanced cancer.2
The analysis found that the majority of patients who received CGP (89%) had clinically-relevant genomic alterations. Importantly, among the subset of patients with clinically-relevant genomic alterations detected by CGP who also previously received conventional testing, 84% had alterations found by CGP that were not identified by the previous testing methods. Of all patients with successful test results, 79% of patient reports listed at least one CGP-matched FDA-approved therapy, and 44% of patients had matched therapy approved for treatment of the same tumor type.
Ultimately, 22% of patients with genomic alterations detected by CGP were treated with a matched therapy or enrolled into a clinical trial based on test results.
Perhaps most interestingly, through a cost diversion analysis of 20 patients who enrolled in phase I clinical trials, the analysis showed that clinical trial enrollment may have resulted in an estimated $25,000 per-patient potential cost-benefit accrued to the payer. To our knowledge, this is the first study known to report the potential cost off-set for patients enrolling in clinical trials.
Impact of Collaboration
These encouraging findings help support the value of CGP. In addition to further establishing meaningful clinical utility, this analysis illuminates how CGP can facilitate clinical trial enrollment and contribute to potential cost diversion from payers to study sponsors in the pursuit of investigational therapies for patients for whom clinical trials are an appropriate option.
It is clear that collaboration between the health plan and the physicians was a critical success factor in this approach. In working together, physicians and payers were able to demonstrate how CGP has the potential to better informs treatment decisions – enabling patients to access evidence-based treatments, including clinical trial options – with a medical policy for coverage and integration into clinical practice.
The insights gleaned from this study contribute to the growing body of evidence in support of CGP for patients with advanced cancers. This includes the recently discussed findings from studies that help:
- Quantify the costs and benefits of genomically matching patients with metastatic cancer to therapy;
- Highlight the potential value of, and need for genomic testing; and
- Demonstrate a favorable cost-benefit relationship for cancer therapies guided by genomic profiling.3,4,5,6
Other studies have shown that strategies such as virtual molecular tumor boards (MTB) to guide CGP in integrated community oncology programs have improved understanding of the impact of precision oncology in the community setting.7
Both real-world evidence and clinical trial data are helping further reinforce the value of CGP to both health care providers and payers. This includes fostering a better understanding of CGP’s clinical utility, its role as an important component to improving the practice of evidence-based medicine in oncology, its ability to deeply impact the quality of care patients receive, and its potential as a source of cost off-set for the healthcare system. With this value having been already recognized by CMS resulting in the NCD, it is critical that private payers work together with the oncology community to ensure all eligible cancer patients have equal access to targeted therapies, and by default equal access to comprehensive genomic profiling tests. The evidence of the value of CGP will only continue to build, and it is difficult to imagine achieving optimal care of advanced cancer patients without access to broad molecular testing.