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New policy recommendations aim to increase the uptake of biomarker testing

Precision Medicine

The American Cancer Society Cancer Action Network (ACS CAN) released new policy recommendations meant to increase the uptake of biomarker testing and advance health insurance coverage for precision medicine in cancer care.1

Precision medicine, which uses information about an individual’s own genes or proteins to prevent, diagnose, or treat diseases, has led to more targeted cancer therapies, ASC CAN said in a news release.2

“These therapies can lead to better outcomes and improved quality of life across cancer types,” ASC CAN said. “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.”

Health insurance coverage for biomarker testing is still failing to keep up with innovation and large coverage gaps remain, according to new report by ACS CAN and the LUNGevity Foundation.3

The review, which focused on breast, colorectal, lung, and prostate cancers, determined that coverage is more prominent for single-gene tests, and health insurance companies are still slow to cover multi-gene panels, ASC CAN said.

In addition, results of an ACS CAN survey of patients with cancer and survivors showed that only 1-third of patients had 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,” ASC CAN said.4

“We are saving more lives from cancer today than ever before. 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,” said Lisa Lacasse, president of ACS CAN. “But with this opportunity comes the responsibility to ensure patients have access to the diagnostic testing necessary to utilize this promising treatment strategy.”

ASC CAN’s new policy recommendations include:

Payers should provide coverage for FDA-cleared or FDA-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.

Payers should provide coverage and access to genetic counseling prior to and after the interpretation of biomarker tests.

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,” ASC CAN said.

Providers and institutions should be equipped with tools (eg clinical decision support), resources (eg 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.

Prashant Tambe
Prashant Tambe
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