Richard L. Schilsky, MD
The growing use of genetic biomarker tests to screen, monitor, diagnose, and treat patients with cancer has the potential to improve outcomes and reduce costs (Table)
, but payment systems for covering and reimbursing for these tests have fallen behind the times.
Insurers tend to require evidence of value before approving payment, which often involves doing the test first in the hope that it will be covered; and testing for multiple gene mutations at once, rather than doing costly individual tests, is a practice not yet fully accepted by payers.
“These biomarker tests are increasingly useful and valuable to help refine the prognosis of patients,” Richard L. Schilsky, MD, chief medical officer of ASCO, said in an interview. “They are becoming critically important for selecting the right therapy for patients.”
Traditional biomarkers measure individual protein molecules, such as prostate-specific antigen (PSA). But new and emerging technologies used in cancer detection and treatment encompass single nucleotide polymorphism (SNP) analysis, genomic and proteomic profiling, epigenetic profiling, and gene expression profiling. These new technologies carry the promise of a greater level of individualized disease management.
Biomarkers can inform from predictive and prognostic standpoints. As a predictive tool, biomarkers can help determine whether a person’s cancer will respond to a specific treatment, in addition to providing in-depth biological data that lead to better patient outcomes through more accurate diagnoses and optimal treatment routing. From a prognostic perspective, biomarkers can provide estimates of the chance of recovery or recurrence of a cancer.
If payment for the tests is difficult or impossible to obtain, doctors may be forced to substitute less than ideal means of diagnosing patient conditions. Biomarker tests can identify therapies most likely to work for patients, and also therapies that are unlikely to work so that patients can seek better alternatives.
“We need to be able to use the tests in a responsible way,” said Schilsky, “and we need to demonstrate that the tests produce clinically meaningful information for patients.”
But in the current reform environment “The reimbursement on these tests has dramatically decreased over the last 2 years,” says Alvin Martin, MD, medical director for pathology and laboratory services of Norton Healthcare, a network of 5 large hospitals, 12 immediate care centers, and more than 90 physician practice locations in Kentucky. “If it drops any more it will become much more difficult for us to adequately perform these tests.”
Tissue Limitations Make Comprehensive Testing More Practical
Alvin Martin, MD
Physicians are less likely to encounter payment problems for companion diagnostic tests, which are usually laboratory tests that are co-developed with the drug and approved by the FDA at the same time as the drug. Drug reviews are conducted in the FDA’s Center for Drug Evaluation and Research and the companion test is reviewed by the Center for Devices and Radiological Health, under its separate procedures for medical devices.
Reimbursement and insurance coverage problems are more likely to plague next generation sequencing (NGS) that uses multiple assays. Complicating the issue is the fact that more tissue is needed to conduct a large number of different assays than for a single NGS test that examines for multiple biomarkers.
“Human tissue is precious and not easy to come by,” says Schilsky; “that’s a practical issue.” A limited amount of tissue is available for testing, and each individual test consumes some.
“For a lung cancer patient, it would now be considered standard to test for EGFR mutations or ALK translocations. I could order a test that would require me to send a separate tissue specimen for each of those genetic abnormalities individually, which would require a lot of tissue.”
Table. Use and Potential Economic Value of Cancer Biomarkers
Source: Schneider JE, Sidhu MK, Doucet C, et al. Economics of cancer biomarkers. Per Med. 2012;8:829-837.