Many More Patients Will Now Be Able to Afford This Life-Saving “Living Drug” — Medicare Will Cover CAR T-Cell Therapy Nationwide

Previously, the decision as to whether Medicare would pay for CAR T-cell therapywhich can cost up to $475,000 for the drug alone, plus the cost of the hospital stay and administering the treatmentwas left to regional Medicare administrators. The decisions weren't always consistent, leaving many people who get their health insurance through Medicare unable to afford the lifesaving treatment.

Now, the Trump Administration is requiring that the coverage rules are standardized across the board. Medicare will cover CAR T-cell therapy for patients with the cancers that the U.S. Food and Drug Administration (FDA) has approved: specific types of non-Hodgkin lymphoma and acute lymphoblastic leukemia. The two CAR T-cell therapies currently on the market, Kymriah and Yescarta, are products of the pharmaceutical companies Novartis and Gilead Pharmaceuticals, respectively.

The CMS also announced that Medicare will pay for “off-label” uses of CAR T-cell therapy, meaning it will cover costs for patients who could benefit from the treatment, but who aren't technically included in the FDA approvals. This is encouraging news, especially given the rapid pace of advancements in the field. CAR T-cell therapy has shown promise in treating several other cancersincluding chronic lymphocytic leukemia (CLL) and multiple myeloma.

What is CAR T-cell Therapy and How Does it Treat Cancer?

CAR T-cell therapy (short for "chimeric antigen receptor T-cell therapy) is something called a "living drug." It's far from the prescription pill bottle that people think of when they hear "drug," though. The treatment involves a remarkable process during which doctors extract T-cells (immune system cells) from a patient's body, then genetically modify the cells so that, when they're infused back into the body, they're able to recognize and attack the cancerous cells.

"The T cell is the cell that's usually responsible for killing tumor cells," Dr. Nina Shah, a hematologist at the University of California San Francisco, explained to SurvivorNet in a previous conversation about CAR T-cell therapy. "Unfortunately, for people with cancer, a lot of times their T cells just don't function well. And so we have to change how the T cells work and reprogram them with new genes … You're bringing the patient's immune system directly to the tumor."

Dr. Shah spoke to us about CAR T-cell therapy in the context of multiple myelomaone of the cancers that doesn’t technically fall under the FDA’s approved uses for CAR T-cell therapy. Having said that, Dr. Shah shared that clinical trial results have been promising in multiple myeloma. As researchers improve upon the treatment, she hopes, patient responses will only get better.

"It's first-generation," Dr. Shah said of the current CAR T-cell therapy. "It's a very promising technology. But it's a platform upon which many new attempts are being made to enhance the potency, make it more safe … and have long-term disease-free survival and potentially cure."

With New Cancer Drugs, Cost and Coverage Can Stand in the Way of Survival

There's a tremendous amount of hope and progress in cancer drug development, especially when it comes to immunotherapy. But whenever new drugs hit the market, many patients face the painful realization that the treatments that could save their lives are off-limitsnot because their cancers make them ineligible, but because their insurance won't pay.

Even in cases where insurers do cover the costs of the drugs themselves, the other costs associated with treatment can add up, leaving patients with debilitating medical bills. This has been an issue for CAR T-cell therapy in particular, in part because the "drug" is also, in a way, a procedure; the patient must be admitted to the hospital to have their cells extracted, genetically modified, and re-infused into their bodies. Insurance companiesincluding Medicarehandle in-patient procedures differently than they handle "regular drugs," and often, the hospital stay can raise costs dramatically.

With CAR T-cell therapy, which has the potential to cause dangerous side effects, it is vital that patients remain under the supervision of a medical team during and after the therapy. For this reason, the CMS has also announced that Medicare coverage will require that patients receive their CAR T-cell treatments in health care facilities that are part of an FDA-mandated safety monitoring program.

Getting Help With the Bills

Dr. Shah told us that when it comes to the high costs associated with cancer treatmentsometimes called "financial toxicity"it can be helpful for patients to speak with social workers.

"The best way to look at this and find the resources that are available is to speak with the social worker associated with [your cancer center], because that person usually knows what resources are available and what you can do to access them," Dr. Shah said, adding that some drug companies may help patients pay for drugs they can't afford through their patient assistance programswhich both Novartis and Gilead Pharmaceuticals do have.

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