The American Society of Clinical Oncology proposed four ways to lower financial barriers that impede cancer patients’ ability to participate in clinical trials, including a recommendation to improve payer clinical trial coverage policies.
According to a 2017 ASCO report, only 3% of cancer patients enter clinical trials. In a policy statement published Thursday, ASCO wrote that low participation is partly due to the rising cost of cancer care, a lack of transparency in coverage policies and the perception of ethical, compliance or institutional impediments to patient financial support. The authors said the distress caused by the patient-level cost of cancer care can inhibit a patient’s ability to enroll or continue participating in a clinical trial.
“Addressing these financial barriers may not only improve enrollment in clinical trials, but also improve the generalizability of research findings through broader trial participation,” the authors wrote.
To reduce financial burdens and prevent surprise costs, ASCO said clinical trial coverage policies, such as those under the Medicare Clinical Trials National Coverage Determination, should be revised so they are consistent, streamlined and transparent. The policy statement also called for a universal mandate for state Medicaid programs to guarantee coverage of routine care costs of clinical trials, and encouraged CMS’s Innovation Center to explore alternative payment models for clinical trials.
To ease patient concerns regarding financial support, ASCO said clinical trial sponsors should perform a comprehensive, prospective coverage analysis during trial development and provide patients with clear, transparent information about potential trial-related out-of-pocket costs during the enrollment process. Sponsors should also define mechanisms to provide targeted financial support for patients at risk of financial hardship, and research sites should offer in-house financial counseling to educate patients of these options.
ASCO also sought to debunk “misplaced” concerns that providing patients with financial support for participating in trials could be considered undue inducement. “Indeed, patients who contribute to science and therapeutic advancement by participating in trials should be protected from incremental financial costs as a matter of justice,” the authors wrote. They called on the Office for Human Research Protections to develop guidance on targeted financial support.
Because the current economic burden associated with cancer clinical trial participation remains largely unknown, the authors recommend incentivizing research to characterize the costs patients incur during trials. They also recommended funding the development of tools to identify and mitigate the risk of trial-associated financial hardship.
ASCO has also been working with FDA to overcome another barrier to cancer trial participation — stringent enrollment criteria. During a session at ASCO’s meeting in June, FDA, ASCO and Friends of Cancer Research unveiled a set of recommendations for expanding enrollment in cancer trials to four populations who are usually excluded, including patients with brain metastases or HIV, children aged 12 and up, and patients with prior malignancies or organ damage (see “Out-thinking Industry”).