The BioMedical Innovation That is Here: Precision Oncology
How to Close the Gap in Diagnosis and Care
by Jeff Elton PhD, Louis Culot, Mike Rossi, PhD
Periodically, we cover different aspects of what is required to implement precision oncology as a routine and fully realized part of clinical practice in all settings of care. We do this for a few reasons. First, targeted therapies have a high likelihood of delivering therapeutic benefit if they are used and used as early as possible. We practice medicine and engage in biomedical research to save patients’ lives, yet an exceptionally high number of patients are still not beneficiaries. Second, a growing proportion of clinical trials target specific mutations that are driving a patient’s cancer. Providers want to offer patients the opportunity to participate in these trials, but we can’t match these patients to appropriate trials without the timely diagnostic data that elucidates the relevant mutations.
Earlier this year, ASCO published a summary on the state of personalized medicine.[1] They presented that patients who do receive biomarker testing, have a specific mutation, and were administered a targeted therapeutic matched to that mutation have the most favorable outcomes. However, they also noted that many patients don’t receive biomarker testing because: (a) a biospecimen was never obtained (author comment: with blood biopsies, this should never be a reason); (b) insufficient specimen material existed for testing or to assure that the driver mutation cells could be detected; (c) experienced a false positive because of overestimation or other limitations on accuracy; (d) wrong tests were ordered; (e) treatment was initiated before the test results were delivered; (f) test delivered a false-negative; (g) test results reporting was delayed; or (h) targeted treatment was not selected despite clear results indicating a targeted therapeutic. Overall, 64.4% of potentially eligible patients did not receive precision oncology treatment – with 49.7% being associated with the testing process and 29.2% resulting from decisions that were counter to the test results.
Compounding this situation is the fact that most physicians won’t order tests if they are not going to be reimbursed, since they do not want their patients to pay out-of-pocket for expensive genomic sequencing. For several years, the American Cancer Society and the Cancer Action Network (ACS CAN)[2] have advanced an effort to get state-level mandates in place to assure that biomarkers with appropriate evidence and utility are reimbursed. These are called the Biomarker Bills. To date, 30 states have advanced such legislation with 20 of them signing these bills into law. Biomarker testing coverage for all state-regulated plans is in place in AZ, CA, GA, IL, IN, IA, KY, MD, MN, NM, NY, OK, PA, RI, and TX, with partial testing in AR, CO, CT, FL, and LA, and legislation under formal consideration in HI, MA, ME, NV, NJ, OH, VT, WA, and WV. The ACS CAN initiative is focused on multiple test types: single analyte, multiplexed panels, genes and proteins, exomes, genomic, and approved companion diagnostic tests. The focus of these efforts is commercial, Medicare, and state-level Medicaid programs. Still, even when these programs are advanced through legislative processes and passed, implementation can be a multi-year process. Also, large employers and national plans from commercial payors fall outside of state jurisdiction. In states where this has been implemented, there has been ongoing push-back from insurers on covering the tests, requiring test labs, providers, and others to work with each to assure that each test type gets the mandated coverage.
As we laid out this perspective, we decided not to lay out the cost of all this in terms of patients’ lives and additional years they could have had with their families. But we hope the significance of this cost is obvious and motivating.
These are barriers under our control. For its part, ConcertAI is implementing notifications of testing eligibility across the CancerLinQ network through its SmartLinQ solution which is deployed within the clinical workflows of the sites. We are also looking to implement molecular pathways where testing data can be integrated with other clinical data sources to place a patient within a specific set of treatment pathways or guidelines. All of this is supported by our investments in our CARAai platform, which allows for the lowest possible latency in clinical data and assures that complex and evolving treatment guidelines can be defined in real time to best support clinical decisions at the right time. Here, too, our TriaLinQ solutions can provide clinical trial alternatives when the current standard of care is unlikely to provide a positive therapeutic response.
Implementation of precision medicine in cancer care is not easy. It is a matter of having therapeutics targeting a specific mutation; the therapeutic pathways and care-assignment approach of the care provider; testing efficacy; and reimbursement. But these are problems of execution, not of new biomedical innovation or evidence generation. As such, we should have a healthy intolerance of the current state, ensure that legislation is in place in all states assuring reimbursement, and provide clinicians with the tools they need to practice precision oncology without burden.
[1] Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care, https://ascopubs.org/doi/10.1200/OP.23.00601
[2] https://www.fightcancer.org/what-we-do/access-biomarker-testing