04/09/2024

MSHO Comments on Insurance Coverage Following CAR T Denial

Michigan Legislators Pushing to Change Insurance Coverage Laws Following CAR T Denial

Apr 04, 2024 | Catherine Shaffer

NEW YORK – Michigan state Senator Jeff Irwin (D-Ann Arbor) has introduced a bill to the legislature hoping to close a legal loophole that at least one insurance company used to deny coverage of a potentially life-saving CAR T-cell therapy for a cancer patient.

Senate Bill 738 would amend the existing Michigan insurance code that requires health insurance companies to cover US Food and Drug Administration-approved cancer drugs and specify that genetic medicines and immunotherapies, including, but not limited to, CAR T-cell therapies, are also "drugs."

Irwin said he was inspired to write the bill after reading a November 2023 ProPublica story about a lymphoma patient in Michigan who was denied coverage for Novartis' CD19-directed CAR T-cell therapy Kymriah (tisagenlecleucel) in 2020 after failing chemotherapy. Kymriah was FDA-approved as a large B-cell lymphoma treatment in 2018. The list price for the treatment is $475,000.

Insurance company Priority Health's rationale for not covering the costly cell therapy was that technically it wasn't a "drug," but a gene therapy, and therefore didn't fall under the Michigan insurance code mandating coverage. The patient, 50-year-old Forrest VanPatten, died three weeks after Priority Health denied coverage for Kymriah. It is unknown whether the treatment would have prolonged his life had he received it.

Although Michigan insurance regulators have since issued a bulletin clarifying that Priority Health's reason for denying coverage for the CAR T-cell therapy didn't align with their interpretation of the state code, Irwin said he wanted to add more specific language to the law and make sure another payor couldn't exploit that loophole again.

Irwin and nine co-sponsors introduced the bill in early March and are aiming to discuss it within the Financing, Insurance, and Consumer Protection committee soon. "We're soliciting input from various stakeholders, making sure that the payors, folks in the insurance industry have a chance to read it and give us their feedback," Irwin said. "I'm hopeful that this will be easy to pass because the bulletin [from the state's insurance regulators] is already out there, so there's a good argument to be made that this is just codifying the current reality."

At the prompting of the Michigan Society of Hematology and Oncology (MSHO), an advocacy group that works with policy makers and payors to address challenges in cancer care, Irwin is considering further adjusting the bill language so it comprises innovative cancer therapies that are likely to pass through the FDA in the future. "The concern is that some other insurer might come along and say, 'This isn't a chemical formulation. This is more of a biologic, therefore it's not a drug,'" Irwin explained. "We're trying to cover the waterfront of these newer therapies that aren't [small molecule] drugs but are clearly FDA-approved treatments for cancer."

"The concept of what a drug is, is evolving," said Jerome Winegarden, an oncologist at Trinity Health Michigan and president of MSHO's board of directors. "This idea that an insurer would not cover a therapy because it wasn't designated as an intravenous injection or a pill is really unfortunate."

Autologous CAR T-cell therapies like Kymriah are derived from a patient's own T cells, which are engineered in the lab so they express chimeric antigen receptors that can recognize and attack cancer cells, and then these engineered T-cells are infused back into the patient. The MSHO hopes to see the bill language expanded to stipulate coverage of not just CAR T-cell therapies, but also other FDA-approved treatments such as immunotherapies and genomically driven precision medicines.

Winegarden noted the need to ensure access to costly gene therapies, for example, which are making advances not just in hematology but have already come to market for treating inherited conditions like sickle cell disease. He worries that if patients have to "fight a battle for each new treatment" coming to market, then others will run up against the same loophole as VanPatten. "That's unacceptable," Winegarden said. "I would like to see broadening of the legislation, but this is a great place to start."

In addition to cancer treatments, Winegarden said diagnostics are another medical product category that may need more coverage protection, particularly tests used to guide the use of biomarker-informed precision medicines.

More than a dozen US states including California, Indiana, Texas, and others have enacted legislation that requires health insurance plans to cover comprehensive biomarker testing that meets certain evidence criteria for cancer patients, and another dozen states have had similar legislation introduced. Winegarden said he personally has not had difficulty getting biomarker testing covered for patients, but he believes it could become an issue as test utilization continues to increase. "We have started to have conversations [within MSHO] about what we need to do about that," Winegarden said, "But so far, it hasn't been an issue in Michigan."

Neither Irwin nor Winegarden were aware of any other patients in Michigan who have been denied coverage for CAR T-cell or other innovative cancer therapies based on insurers' interpretation that they are not drugs. "People don't always know what their rights are against [what] their insurance companies [are saying]," Irwin said, speculating that this may be one reason policymakers haven't heard from more patients who have been denied coverage. "When they get these denials, it's very hard for them to fight against the insurance companies that have so many resources."

"We want to make sure that people who deserve these therapies can get them, but not in such a way that for the rest of their lives, they're paying for these treatments," Winegarden said. Patients are already heavily burdened, emotionally and physically, when they're undergoing cancer treatment, he reflected, and they don't need the added financial toll of paying for expensive cell therapies and biologics out of pocket.