Study Finds Rising Insurer Approvals for Cancer Clinical Trials Since ACA

After the Affordable Care Act (ACA) required private insurers to pay the standard-of-care costs for patients participating in approved clinical trials, the rate of patients cleared by their insurer to take part in early-phase oncology trials has increased, a new study has found.

The study, published in Clinical Cancer Research, looked at both, rates of insurance clearance and prolonged time to clearance (a wait of at least 14 days) at the clinical trial center of MD Anderson Cancer Center in Houston, Texas. The study authors noted that the provision of the ACA had been intended to expand access to clinical trials, but little research had been conducted to analyze the law’s actual impact on cancer trial participation.

Although the ACA mandated that insurers allow patients to enroll in approved trials and cover the standard-of-care medical costs incurred during the trial, patients could still be barred from participating if their coverage network excluded the institution conducting the trial. Further, the ACA provision did not apply to all Medicaid plans, and only some states require Medicaid to pay the costs of partaking in cancer clinical trials.

The ACA’s trial coverage provision went into effect in 2014, so researchers used MD Anderson’s records to identify over 2400 patients referred to participate in a clinical trial between July 2012 and June 2015. The database included rates of insurance approval and time to clearance, and also specified whether the patient had private insurance or government insurance (ie, Medicare or Medicaid).

Researchers found that 95% of referred patients received insurance clearance to participate in a trial. Among patients with private insurance, those referred from January 2014 to June 2015 were nearly 5 times as likely to be approved than those referred from July 2012 to June 2013 (odds ratio [OR], 4.72; P<.001). There were no significant associations observed between time period and insurance approval rate among patients with government insurance.

Privately insured patients also had significantly lower rates of prolonged time to clearance if they were referred from January 2014 to June 2015 compared with those referred in the July 2012 to June 2013 period (OR, 0.57; P = .007). Among Medicare and Medicaid beneficiaries, those referred between January 2014 and June 2015 were even less likely to experience prolonged time to treatment than those referred from July 2012 to June 2013 (OR, 0.39).

Based on these findings, the study authors wrote that it appeared that the ACA’s clinical trial coverage mandate had facilitated insurance clearance among privately insured patients seeking to participate in cancer trials at MD Anderson. They acknowledged that secular trends within their institution could have accounted for some of the changes, so a larger study of multiple cancer centers would be needed to strengthen the broader significance of these findings.

“If validated in other settings, these results will provide context for subsequent efforts to increase overall clinical trial participation within the context of an evolving health care system,” the study authors concluded.

In a statement from the American Association for Cancer Research, which publishes Clinical Cancer Research, researchers emphasized the importance of access to clinical trials and urged lawmakers to include a similar provision in any replacement for the ACA.

“In a phase I trial, many patients are in a state of advanced disease, so a single day can matter a great deal to them,” said senior author David S. Hong, MD, of MD Anderson Cancer Center. “We are in a golden era of new drugs, but the only way to get them approved and available to patients is to get more people into clinical trials.”