Wesley Mizutani, MD: SB 496 Expands Insurance Coverage for Biomarkers

In October 2023, Governor Gavin Newsom signed the Senate Bill 496 (SB 496) into law to expand insurance coverage for biomarkers in the state of California, requiring Medi-Cal and private insurers to cover medically necessary biomarker testing, which in turn will enable more patients to access effective and individualized treatment.¹

This legislation is also significant as it allows current and future biomarkers from various medical specialties to be covered by insurance.

In an interview with HCPLive, Wesley Mizutani, MD, rheumatologist at Optum and a member of the Alliance for Patient Access, explainshow the accessibility of biomarkers through insurance is crucial, especially when considering they often play a pivotal role in determining the most effective drug for a specific patient. Without insurance coverage, patients might face barriers to accessing the biomarker-guided treatments essential for their particular diseases. Mizutani foresees an increasing role of biomarkers in rheumatology, guiding the selection of optimal medications for individual patients.

In rheumatology, biomarkers can indicate the likelihood of success with certain medications. For example, a biomarker could reveal whether a group of medications, such as biologic tumor necrosis factor (TNF) inhibitors like etanercept and adalimumab, would be ineffective for a patient with rheumatoid arthritis. Without insurance coverage, patients might be unable to afford the cost of biomarker testing, leading to potentially prescribing medications that may not be effective. This delay in identifying the right treatment could result in worsening disease activity and increased disability for the patient. The legislation, by extending insurance coverage to biomarkers, ensures that patients can access the most suitable medications promptly, thereby improving their overall healthcare outcomes.

“As with any legislation, once it's passed that's only half the job,” Mizutani cautioned. “A lot of it has to do with how it gets implemented and who determines who's going to be the kind of dog watcher to look at whether this is really happening… That is something we have to be careful and cognizant of with any bill that is passed, in particular these biomarker bills, to make sure that it does what it says is supposed to do.”

Wesley Mizutani, MD, has no relevant disclosures to report.

References

1. ^{One step closer to equitable cancer care with new Biomarker Testing Law. University of California Health. October 25, 2023. Accessed January 23, 2024. https://health.universityofcalifornia.edu/news/one-step-closer-equitable-cancer-care-new-biomarker-testing-law#:~:text=Authored%20by%20California%20State%20Senator,access%20effective%2C%20individualized%20cancer%20treatments.}