Background: The past decade has seen a dramatic increase in the number of Food and Drug Administration approvals of oral anti-cancer drugs (OACDs). Most OACD prescriptions require coordination between payers and providers, which can delay drug receipt. In May 2021, two bills were introduced in the US House of Representatives (HR 3173 and HR 3258) to streamline the prior authorization (PA) process. In this study, we examined clinical and process-related factors associated with PA and time to drug receipt (TTR) for patients who received a new OACD prescription. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients from 1/1/2018 to 12/31/2019. We collected patient demographic, medical, and insurance data, drug type (hormonal, chemotherapy, targeted), and specialty pharmacy interactions with payers and financial assistance groups, including PA information. TTR was defined as the number of days from OACD prescription to patient receipt of the drug. We used multivariable logistic regression to separately assess factors associated with TTR and factors associated with PA for patients who received a new OACD prescription. Results: The cohort for both models included 883 patients who were prescribed 1014 new OACDs. Of these prescriptions, 72.3% (N=733) required PA. The median age was 66 and 44% identified as White. The median TTR was 7 days (IQR 0 – 142; 25% ≥ 14 days; and 5% ≥ 30 days). In unadjusted analyses, PA was associated with insurance and drug type and delayed TTR was associated with PA and insurance type. In a multivariable analysis, patients with Medicaid insurance were more likely to require PA compared to patients with Medicare (OR 1.93 (1.14 – 3.32), p=0.03). In addition, patients prescribed targeted and hormone therapies were more likely to require PA than those prescribed oral chemotherapy (targeted: OR 3.33 [2.38 – 4.68], p<0.001; hormone: OR 4.26 [2.45 – 7.65], p<0.001). A separate multivariable analysis showed that PA is associated with delayed TTR (OR 1.62 [1.18 – 2.24], p=0.003) and that Medicaid is associated with a shorter TTR (OR 0.59 [0.37 – 0.94], p=0.03). Conclusions: The current process for obtaining OACDs is complex and multifaceted. Seventy two percent of delivered OACDs require PA, which is associated with delayed TTR. Earlier intervention and new health policies are needed to reduce time to OACD receipt.

*p<0.05; Model also includes age, sex, and race/ethnicity.