Use of prior authorization for both branded and generic oral oncology drugs has surged over the past decade, but there is little evidence characterizing the implications for patient care. In a recent Journal of Clinical Oncology (JCO) study, Michael Anne Kyle, PhD, RN, and Nancy Keating, MD, MPH, investigated how prior authorization for oral cancer drugs affects patient care. They recently discussed their findings with HMS News and the JCO Afterhours podcast.

This analysis used a national sample of Medicare Part D prescription drug data from 2010 to 2020. The study analyzed eleven oral anticancer drugs on Medicare Part D, looking at patients who consistently took the medication for at least three refills. They then compared patients whose plan introduced new prior authorization to patients without the introduction of new authorization to determine how the new introduction affected their treatment.

The study found that for Medicare Part D beneficiaries already established on an oral anticancer drug, the introduction of a new prior authorization policy on that drug increased the odds of discontinuation within 120 days by 7.1 times and was associated with an average delay of 10 days in refilling the first prescription after the policy change, compared with Medicare beneficiaries whose plans did not change the prior authorization policy on those drugs. The clinical implications likely vary by drug. Even if a patient is ultimately able to resume their medication, interruptions in access can be stressful. The period during which the medication is delayed may involve considerable behind-the-scenes effort on the part of physicians to troubleshoot and complete approvals.

Additionally, the study found that significant delays and discontinuation were linked to patient characteristics such as age <65 years, female sex, non-White race, and living in high-poverty areas. These characteristics increased delays refilling medications, raising concern regarding access, impacting patients differently based on their abilities and availability.

In her interview with HMS News, Kyle emphasized concern that such delays are more than mere annoyances, “It could be impossible to distinguish a systems failure from structural discrimination or targeted discrimination, or some combination.”

Currently there are discussions to modernize prior authorization systems, suggesting process improvements such as standardized forms to improve access, equity, and reduce provider administrative burdens. Findings support a more nuanced approach to prior authorization policies, calling for policy changes, particularly for established and effective treatments. The authors hope that this research can offer evidence to help inform and clarify ongoing state and federal efforts to reform prior authorization processes.