More privately insured cancer patients seeking to participate in clinical trials received approval since the passage of the Affordable Care Act (ACA), according to a new study.
The passage of the ACA in 2010 mandated that private insurers cover standard-of-care costs of clinical trial participation, effective January 1, 2014. Before that, patients who were covered by private insurers often faced a patchwork of coverage options.
“Clinical trials are crucially important in helping get drugs to the patients that need them. This study is one piece of evidence that the ACA is helping more patients get access to these trials,” said senior author David S. Hong, MD, deputy chair and associate professor in the department of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center in Houston.
The researchers published their results in Clinical Cancer Research.
The future of the ACA itself has become an open question; therefore, assessment of the impact of its various provisions is increasingly important for subsequent policymaking.
Hong and colleagues analyzed 2,404 referrals from the departmental database of the Clinical Center for Targeted Therapy at MD Anderson, comparing rates of insurance clearance and the time to clearance in three separate time periods: July 2012 to June 2013; July 2013 to December 2013; and January 2014 to June 2015.
The results show that approval rates climbed steadily to 95% for privately insured patients after the mandate from about 85% prior to the ACA mandate. Importantly, privately insured patients experienced fewer delays in being cleared for participation.
There was no significant association between the referral time period or insurance clearance rates among patients with Medicare or Medicaid coverage.
“It is therefore possible that the ACA clinical trial coverage requirement may be facilitating insurance clearance for clinical trials participation among privately insured patients at our institution,” the researchers stated.
Timely approvals are crucial for patients who want to participate in clinical trials, said Hong. He pointed out that fewer delays indicate that the ACA provision that requires private insurers to cover clinical trial participation had a direct benefit for those patients.
“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. 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,” Hong said.
With the ACA in a state of flux due to Congressional Republican plans to repeal and replace it, the study’s findings indicate that any replacement for the ACA should include provisions to ensure patient access to clinical trials.
The study’s main limitation is that it was conducted solely at MD Anderson, although the researchers believe that the overall trend of increased coverage would hold true at other institutions. Further study at other cancer centers with different patient populations would add to the analysis of the overall impact of the ACA.