Washington, D.C.– The American Cancer Society Cancer Action Network (ACS CAN) released new policy recommendations today to increase uptake of biomarker testing and advance the use of precision medicine in cancer care. The recommendations follow the release of new data that shows access is not keeping up with innovation when it comes to biomarker testing.
Progress in improving cancer outcomes increasingly involves the use of precision medicine, which uses information about a person’s own genes or proteins to prevent, diagnose or treat diseases like cancer. The use of precision medicine is evolving rapidly and has led to more targeted cancer therapies, which interfere with specific cellular processes involved in the growth, spread and progression of cancer. These therapies can lead to better outcomes and improved quality of life across cancer types. But in order to determine if a patient will benefit from this type of treatment, doctors must test for specific biomarkers found in blood, tissues or other bodily fluids that provide insight into physiological processes, medical conditions or disease. Without access to biomarker testing, the advances in cancer care that precision medicine provides cannot be realized on a large scale.
“We are saving more lives from cancer today than ever before,” said Lisa Lacasse, ACS CAN president. “The rapid increase in the development of new targeted treatments and diagnostics within precision medicine is providing doctors and patients with better, more effective ways of treating this disease. But with this opportunity comes the responsibility to ensure patients have access to the diagnostic testing necessary to utilize this promising treatment strategy.”
A new report by ACS CAN and the LUNGevity Foundation found while health insurance coverage for biomarker testing has improved since the organizations’ last report in 2018, coverage is still failing to keep up with innovation and large coverage gaps remain. The review, which focused on breast, colorectal, lung and prostate cancers, found coverage is more prominent for single-gene tests, and health insurance companies are still slow to cover multi-gene panels.
Additionally, in an ACS CAN survey of cancer patients and survivors conducted in Spring of 2020, just over one-third of respondents reported having biomarker testing. Of those who reported not receiving biomarker testing, more than a quarter said it was because insurance would not cover it or their out-of-pocket costs would be too high.
While coverage is foundational to accessing biomarkers for determining the best treatment for a specific cancer diagnosis, it is just one of several factors necessary, as highlighted in a new white paper from ACS CAN released today. According to the white paper, additional factors include availability of reliable, valid and relevant tests on the market; health care provider knowledge and awareness of which tests to utilize and when, as well as how to utilize the results in care for their patients; health care facilities equipped with the appropriate testing infrastructure for the efficient and sufficient collection and handling of tissue for testing and the technology to manage results and assist in clinical decision-making.
“Precision medicine is shifting how health care providers and patients think about cancer treatment,” said Lacasse. “We must work to ensure we’re doing all we can to dismantle every barrier that prevents patients from benefiting from this type of care and we must do so in a way that benefits all patients equally, regardless of race, ethnicity, gender, age, sexual orientation, socioeconomic status or zip code. ACS CAN’s policy recommendations work toward that goal.”
To address these barriers, ACS CAN recommends:
1. Payers should provide coverage for FDA-cleared or -approved companion and complementary diagnostics as necessary to evaluate patient eligibility for a given targeted therapy, and all National Comprehensive Cancer Network (NCCN) guideline-indicated biomarker tests.
2. Payers should provide coverage and access to genetic counseling prior to and after the interpretation of biomarker tests.
3. Comprehensive biomarker testing provides value beyond therapy selection and results from testing should be utilized to inform patients of relevant clinical trial opportunities.
4. Biomarker tests should be reliable, valid, and relevant to a patient’s cancer diagnosis. This should be realized with a harmonized system of regulatory oversight for all biomarker tests that features tiered requirements based on the risk posed by a given biomarker test.
5. Providers and institutions should be equipped with tools (e.g. clinical decision support), resources (e.g. access to a tumor board), and training for the efficient and sufficient collection and handling of tissue for testing, and for proper test selection, administration, and interpretation.
While treatments for cancer continue to become more advanced, ACS CAN’s focus remains on ensuring patients have access to these promising innovations. For more information on precision medicine, cancer biomarkers, access barriers that exist and ACS CAN’s policy recommendations, visit: www.fightcancer.org/biomarkers.