How to Pay for Proton Therapy in Cancer Clinical Trials
It’s a classic Catch-22: many insurers will not cover expensive proton therapy for some cancers because there’s little proof that it’s more beneficial or less harmful than standard treatment; meanwhile, patients cannot enroll in the clinical trials to test its comparative effectiveness because their insurers won’t cover the therapy. In a commentary in the Journal of Clinical Oncology, LDI Senior Fellow Justin Bekelman and colleagues point out the dilemma and suggest a way forward.
Seven randomized trials are now underway to test the effectiveness of proton therapy in treating cancers of the breast, lung, prostate, glioblastoma, esophageal, low-grade glioma, and liver. All have had problems in enrolling patients because of restrictions on insurance coverage. In a review of coverage policies, Bekelman and colleagues found that few commercial insurers or Medicaid plans cover proton therapy for the conditions under study; Medicare typically does, through local determinations.
There’s a lot of money at stake here: Medicare reimbursement for a course of proton therapy is $10,000-$20,000 greater than for photon (radiation) therapy. The difference is even greater in the commercial insurance market.
Bekelman and colleagues point to a few successful compromises between payers and providers. Some insurers, including Cigna, Independence Blue Cross, and Blue Cross Blue Shield of Florida, cover proton therapy for selected cancers being studied, sometimes with study participation. Some proton therapy centers, such as the University of Pennsylvania, Mayo Clinic, and University of Maryland, have sometimes set the price of proton therapy equal to intensity-modulated radiation therapy, while evidence is being developed. But these payment policies are the exception, not the norm.
The path forward, the authors say, leverages and builds upon these successful strategies. They call on commercial insurers, proton therapy centers, hospitals, and patient advocates to come together to establish coverage with a trial participation program for patients who enroll in the NCI- or PCORI-funded randomized trials. Such a program would distribute the costs across stakeholders with clinical and financial interests in both types of radiation and the outcomes of the trials, including radiation therapy manufacturers, who could also participate—perhaps by helping to limit the financial burden on patients during evidence development.
They recommend pairing this program with other strategies to overcome physician and patient barriers to enrollment in clinical trials. Physician barriers include inadequate reimbursement for trial operational costs, time pressures that hinder trial discussions with patients, and under-recognition of these efforts in the academic promotion process. Patients may decline to enroll in randomized trials, sometimes citing preference for one therapy or another—a challenge across the hundreds of randomized trials funded by the NCI. The authors call on study sites to achieve higher enrollment rates through strategies that recognize and reward active clinician investigators, and more fully engage patients in the enrollment process.
Dr. Bekelman’s co-authors are Andrea Denicoff, MS, RN, head of Clinical Trials Operations for the NCI's National Clinical Trials Network, and Jeffrey Buchsbaum, MD, PhD, AM, medical officer and program director in the Radiation Research Branch at the NCI.