By
Matthew Ballo
July 16, 2019 at 5:00 am ET
Cancer care has improved rapidly in recent decades, and one of the more promising breakthrough treatments is tumor treating fields, also known as TTFields. TTFields is a Food and Drug Administration-approved treatment for glioblastoma, the aggressive form of brain cancer that claimed the life of Sen. John McCain.
While the FDA, physicians and private health insurances have embraced this new treatment, the Medicare program has denied reimbursement to date and is now proposing very limited access to the treatment. That needs to change.
TTFields therapy is based on transformative science that harnesses the electrical properties of cells as an anti-cancer target. The concept is similar to how researchers have previously targeted a cell’s chemical and biological properties to stop tumor growth, and the data supporting the use of TTFields in glioblastoma is compelling.
Research on TTFields began in 2000 and progressed from bench top studies to animal studies, to pilot human trials, and then finally to large randomized controlled trials. Clinical investigators demonstrated the benefit of TTFields in the EF-14 trial, the largest successful randomized controlled trial ever completed for glioblastoma. The combination of TTFields and chemotherapy significantly increased patient survival compared to treatment with chemotherapy alone.
Through improvements in surgery and radiation, the introduction of temozolomide chemotherapy in 2005, and now the introduction of TTFields in 2015, we are talking about long-term survival from glioblastoma for the first time. In the EF-14 trial, patients treated with TTFields had a 13 percent chance of surviving for five years, compared to only a 5 percent chance for patients treated with chemotherapy alone. To put those survival statistics into perspective, when I entered clinical practice 20 years ago, we did not talk about a five-year survival rate for glioblastoma because it was effectively zero.
Although we have made great strides, the work continues as we further optimize the delivery of TTFields. Several colleagues and I have recently published an analysis of dose and dose-response from the EF-14 trial. The data indicate that optimizing the delivery of TTFields directly to tumors has the potential to increase survival by 25 percent. Researchers are also planning to study combinations of TTFields with other chemotherapies and with radiation.
Further improvements in glioblastoma treatments will not be meaningful, however, if patients and the doctors who treat them do not have access to these treatments. Medicare patients are the most at risk of not receiving such treatments because Medicare currently denies all access to TTFields therapy.
Medicare has finally proposed, in a draft policy issued in May, to allow coverage for TTFields therapy in glioblastoma but with extraordinarily restrictive limitations. In my view, these restrictions are unnecessarily onerous and will only widen the gap in health care inequalities.
As one example, Medicare wants to limit the use of TTFields to hospitals that are National Cancer Institute-designated Cancer Centers. These NCI-designated institutions receive public funding primarily to identify new treatments through cancer research, not for clinical cancer care. Why would we develop new treatments and then withhold them from the broader medical community once the research is done?
Furthermore, there are only 70 NCI-designated Cancer Centers in the United States, and more than a dozen states do not have such a center. My patients in Memphis will be driving six hours roundtrip to Nashville or Birmingham under this proposed Medicare policy. Why would Medicare force this burden on patients when the clinical trial data indicates that the therapy can effectively be used by a much broader group of cancer centers?
Medicare’s other restrictions on the use of TTFields are equally troubling to me. Medicare wants to require that patients use the device delivering the therapy for 18 hours per day, even if patients need a break because of minor skin complications arising from therapy. This is akin to a patient missing a single dose of chemotherapy due to nausea or low blood counts and then having the rest of the treatments canceled or not paid for.
Moreover, there is no support for this 18-hour daily use requirement in the clinical literature. To the contrary, the EF-14 trial data actually indicate that patient survival increases in a stepwise fashion as the time a patient uses the device increases. Why would Medicare refuse to pay for a cancer treatment based on how the patient uses the device for a single day when the data suggest otherwise?
I am a fellow within the American College of Radiology and a board-certified radiation oncologist with a practice focused on treating brain tumor patients. My practice is at the West Cancer Center and Research Institute, the largest adult cancer center in the mid-South, where we treat more than 37,000 cancer patients per year and have the largest clinical trials program for cancer patients. I have also published the most recent and comprehensive analysis of the dose-response effect for treatment with TTFields in glioblastoma.
And yet, Medicare says that I am not qualified to use TTFields because our center is not NCI designated. And even if they did allow me to use the therapy, the proposed policy contains onerous restrictions that very few of my Medicare patients would meet the requirements for coverage.
The simple and straightforward solution is for Medicare to drop all restrictions on access to TTFields and instead cover the product in a manner consistent with its FDA-approved labelling. The hard decisions of treating cancer should remain with the patients and their physicians.
Dr. Matthew Ballo is a radiation oncologist at the West Cancer Center and Research Institute.
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