As biomarker testing becomes more prevalent in cancer diagnosis, patient advocates have been pushing for better insurance coverage.

The most recent victory came in October, when California adopted a law barring insurers that cover biomarker testing from requiring prior authorization for patients with advanced-stage cancer.

While the legislation is welcome, advocates said, it falls short of the longer-term goal: to require coverage of biomarker testing, which helps doctors determine which therapies may be effective in treating a given cancer.

“This is a big priority for our organization,” said Hilary Gee Goeckner, senior state and local campaigns manager for the American Cancer Society Cancer Action Network, the advocacy affiliate of the American Cancer Society.

It is a priority being pursued on a state-by-state basis, though there has been some action at the federal level.

In 2018, the Centers for Medicaid and Medicare Services granted national coverage to so-called companion tests approved by the Food and Drug Administrations. The tests are paired with specific therapies designed to beat back specific cancers based on their genetic profiles.

At the state level, two bills became law this year. In Illinois, a new law generally requires state-regulated insurance plans to cover evidence-based biomarker testing for patients. Lawmakers in Louisiana, meanwhile, passed a bill requiring coverage for a specific menu of genetic tests, including somatic and germline analysis and next-generation sequencing.

The Cancer Action Network plans to continue lobbying next year, Goeckner said. “We are anticipating there will be continued interest and activity.”

The broader goal is to make coverage of biomarker testing more widely available, Goeckner said, noting that coverage often depends on a patient’s health plan.

“Not necessarily everyone who could benefit from biomarker testing is getting it,” Goeckner said.

Coverage tends to be better under Medicare and large employer-sponsored plans, Goeckner said. It is spottier for state Medicaid programs and smaller employer-sponsored plans.

In addition, plans may cover specific single-gene tests paired with individual therapies but not tests that offer a broader look, Goeckner said. “The whole-genome sequencing provides a lot more information,” she added. “Our position is that insurance should cover either and that it should be up to the treating doctor which should be ordered.”

The tests can be costly, which is one reason insurers may balk at covering them, experts said. The science also is new, so it may take time for insurers to catch up.

But, they argued, the treatments that result are less costly and more effective than traditional treatments involving chemotherapy.

“The cost of a biomarker testing may be high, but the payoff for the patient, which is the most important ingredient for them to consider, is enormous,” said AJ Patel, a cancer survivor and an insurance industry legal analyst from Orange, California.

The more common the tests become, the more costs will come down, he added.

Startups already have been developing biomarker tests they say will be more cost-effective. The startups include Biofidelity, a molecular diagnostics company based in Cambridge, England, with a US office in Research Triangle Park, North Carolina.

The company is gearing up to launch its first diagnostic product, ASPYRE-Lung, which is for lung cancer, according to Biofidelity CEO Barnaby Balmforth.

Existing multigene tests yield a lot of information, which can make them costly, Balmforth said. But much of the information is not useful for doctors treating cancer patients.

Biofidelity’s test homes in on what is clinically actionable, Balmforth said. “That’s our core belief, that all patients deserve to have access to the information that’s needed to ensure they get the best care they can.”

Health care is moving in that direction, Balmforth added. But progress has been slow and not always equitable.

“Some patients have access to that information and can get access to lifesaving treatments, while other patients do not have access to that information because it is not covered by their insurance plans or because they do not have insurance,” he said.

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