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Policy Changes Needed to Address Biomarker Testing Disparities for Medicaid Patients, Experts Say


NEW YORK – While precision oncology advances have led to improvements in the standard of care in cancer, these biomarker-driven therapies often don't reach Medicaid beneficiaries because they face more social and economic barriers, including lacking covered access to tests that will determine their eligibility for these drugs.

Studies exploring access barriers for cancer patients on Medicaid tend to rely on older or insurance claims data, which may not accurately reflect current oncology practice, where biomarker testing and biomarker-driven therapies have become the standard of care. Researchers tried to provide a more up-to-date snapshot of the challenges by drawing on electronic health records of advanced non-small cell lung cancer patients and reported in the Journal of the National Comprehensive Cancer Network recently that Medicaid beneficiaries were less likely to receive biomarker testing than patients under commercial plans. Consequently, Medicaid beneficiaries had worse survival outcomes, highlighting a need for policy solutions that bring those coverage decisions into alignment with evidence-based best practices.

Will Wong, a coauthor of the study and a principal health economist at Genentech, said that he and his colleagues chose non-small cell lung cancer because it is a disease area where some of the biggest advances in precision oncology have been made, and disparities in access to biomarker testing were most likely to have a measurable impact on patient outcomes.

While a great many factors, such as geography, availability of specialized cancer care, and cost can result in patients receiving disparate quality of care, Wong and his collaborators wanted to zero in how much access to biomarker testing and biomarker-driven therapies contributes to those disparities. They carried out a retrospective analysis using longitudinal data derived from nationwide EHRs obtained from the Flatiron Health database.

Researchers collected data on commercially insured and Medicaid-insured patients diagnosed with advanced NSCLC between Jan. 1, 2011, and Sept. 30, 2019. The study tracked testing rates for ALK, EGFR, ROS1, BRAF, and PD-L1 — biomarkers that guidelines bodies recommend NSCLC patients be tested for to guide treatment decisions — as well as patients' treatment outcomes on various first-line therapies and mortality data.

The rate of biomarker testing among Medicaid recipients was 57 percent for any biomarker, and for commercially insured patients, it was 71 percent. For individual biomarkers, the testing rates were lower in every case for Medicaid recipients. The difference between testing rates for commercially insured patients and Medicaid recipients ranged from 15 percent for ALK and ROS1 to 9 percent for PD-L1 expression. Median overall survival for the Medicaid group was 7.8 months compared to 10.3 months for those with commercial insurance, and Medicaid patients had 23 percent higher mortality.

"The results suggest that there's really a need for equitable access to precision oncology care, and that improving access to testing and treatment may improve outcomes for these Medicaid beneficiaries," Wong said.

Although there are many possible reasons for the shortfall in testing, one of the most obvious is reimbursement. According to a 2020 report from cancer patient advocacy group Lungevity, only 40 percent of state Medicaid programs provide comprehensive biomarker testing. Wong speculated that the rapid pace of innovation in oncology may present a challenge for state Medicaid policies to remain up to date with the latest recommendations on biomarker testing and biomarker-driven therapies in cancer.

"Given the rapid expansion of actionable biomarkers, expanding access to comprehensive testing with technology such as next-generation sequencing is one way to ensure access to all of the latest relevant biomarkers," which would allow identification of the "full array of relevant mutations at the time of their diagnosis," Wong said. "I think policymakers have an important role to play here."

Hilary Gee Goeckner, senior state and local campaign manager on access to care with American Cancer Society Cancer Action Network (ACS-CAN), concurs that policy changes are needed to improve access to biomarker testing. She's been working with coalitions in a number of states to pass legislation that would align insurance coverage for biomarker testing with clinical practice guidelines and other sources of evidence. The group has drafted model legislation, and laws based on that model, which apply to all insurance plans including Medicaid, have been successfully passed in Arizona, Illinois, Louisiana, and Rhode Island. Similar legislation is under consideration in California and Ohio. 

While in recent years, payor coverage for genomic testing to guide cancer therapy has improved, there are still differences in what commercial plans and the government are willing to cover. For example, the Centers for Medicare & Medicaid Services since 2018 has had a national coverage determination for FDA-approved NGS panel tests when performed in late-stage cancer patients with Medicare coverage. Tests without FDA approval have variable coverage based on Medicare contractors' local coverage determinations. Medicaid coverage, meanwhile, is largely determined on a state level, and commercial payors also make their own coverage determinations after reviewing the available evidence on tests.

"The huge variation in coverage and access can contribute to widening health disparities," Gee Goeckner said. "We want to see all cancer patients able to benefit from the latest advances in treatment, and now that's increasingly reliant upon access to comprehensive cancer biomarker testing."

The new laws being advanced at the state level generally require that the plans cover biomarker testing when it is FDA approved or cleared, is labeled for use with an FDA-approved drug, has a Medicare coverage determination from the Centers for Medicare & Medicaid Services, or its use is backed by clinical practice guidelines from the National Comprehensive Cancer Network and the American Society of Clinical Oncology.

Gee Goeckner said the bills have had opposition from insurers in every state where they've been proposed. However, she believes this opposition is shortsighted because biomarker testing doesn't just give patients access to expensive targeted therapies; it also allows providers to avoid expensive, ineffective treatments and gives patients the option of avoiding aggressive therapies.

"It's not just about the targeted treatments, it's really about making better treatment decisions overall," she said, noting that studies focusing on NSCLC patients have shown that paying for comprehensive biomarker testing can yield savings in overall treatment costs for patients. "It's really important for payors, including Medicaid, to recognize the value of comprehensive testing that's in line with clinical treatment guidelines in not only improving patient outcomes and often quality of life, but also in potentially reducing treatment costs."

Ken Kehl, an oncologist with Dana-Farber Cancer Institute, said that in his practice, getting biomarker testing reimbursed is not a certainty, whether through private insurance or Medicaid, and much of the decision hinges on how well established that test is within the standard of care. For example, for a patient newly diagnosed with stage IV non-squamous NSCLC, the "universally recognized" standard of care would call for testing for several biomarkers with approved targeted therapies and would be reliably covered by insurance.

On the other hand, Kehl said that with the recent approval of immunotherapies in the adjuvant setting for patients with early-stage PD-L1-expressing NSCLC, reimbursement for broad panel testing that includes the biomarkers associated with targeted therapy as well as PD-L1 might not be a sure thing. 

"We're trying to think about immunotherapy [in the context of] testing for EGFR and PD-L1" and other biomarkers, said Kehl. "Some folks would, if they had access to broad biomarker data, fold that information into recommendations about immunotherapy. But this is not a context where broad biomarker testing is considered standard of care, and so it can be more difficult to get it done outside of a research study."

Gee Goeckner said that her group has observed that payors are more likely to cover single-gene testing than more comprehensive panels. "It's foolish to try to save a few hundred or a thousand dollars up front on the testing cost," she said. "If you're giving a treatment that's effective, rather than going through trial and error on many different chemotherapies or non-targeted treatments that aren't working, wouldn't you rather spend money on a treatment that's actually going to work for that patient?"

Kehl, who published a study in 2019 looking at the interaction of race and poverty with implementation of precision medicine in lung cancer, pointed out that while insurance coverage is a big contributor to disparities in access to biomarker testing and biomarker-driven therapies, factors such as the patient's resources or family support also play a role. "I suspect the association between Medicaid and lower rates of testing is not primarily causal," Kehl said. "It reflects some of the other challenges that patients who happen to have Medicaid coverage probably encountered" leading to a longer journey getting diagnosed and treated.

Wong acknowledged that social determinants of health were likely contributing to the differences observed in his study. "That being said, no matter what the exact combination of these factors are between social determinants of health and biomarker testing that's driving survival differences, equitable access to biomarker testing and biomarker-driven therapy is an important part of that equation," Wong said.