DID YOU KNOW… Uninsured patients represent only 5.4% of all trial participants, according to a study of NCI-sponsored cancer treatment trials.
Want to learn more about the high stakes of oncology trials and barriers that prevent participation and enrollment in oncology trials? Check out our detailed infographic filled with eye-opening statistics, such as:
In clinical trials in the US, costs associated with treatments that are part of standard of care are usually—but not always—covered by health insurance companies. Coverage depends upon laws within individual states and policies of individual providers. Research costs, which are the costs associated with investigational treatments or evaluations, are often not covered by health insurance companies and must be covered by the company sponsoring the trial. This increased cost to the sponsoring company may lead to selection of different trial sites or patients for study participation.
However, barriers also exist for patients with health insurance. Some insurance companies only cover participation in clinical studies where the efficacy of a treatment is evaluated. Oftentimes phase I studies focus on issues related to the safety and tolerability of a medicine rather than efficacy, making them unqualified for coverage.
Even in interventional trials patients can be denied coverage for participation. The Patient Protection and Affordable Care Act (PPACA), enacted by Congress in March 2010, requires health insurers to provide coverage for routine patient care costs for patients taking part in federally funded or approved cancer clinical trials. These requirements apply to plans or coverage sold after 2013 and do not apply to those initiated before the PPACA was enacted. Therefore, it may be some time before the act causes changes in enrollment in oncology clinical trials.