S1479 Accessing Escalated Risankizumab in Crohn’s Disease: How Long Does It Take?

Introduction: Risankizumab (RZB) doses above 360 mg or 180 mg subcutaneous (SC) injection every 8 weeks are not FDA-approved for Crohn’s disease (CD) but may improve disease control. Escalated doses can be challenging to access from payors or manufacturer patient assistance programs (PAP), though the process has not been well described. Methods: A retrospective observational single-center cohort study evaluated patients with CD who had at least one escalated dose of RZB between June 2022 and April 2024. Outcomes included time from escalated dosing referral to medication coverage (via insurance approval or manufacturer assistance) and method of medication coverage. Descriptive statistics summarized continuous variables and categorical variables (Median (IQR) or Mean (SD) and frequencies as percents respectively). A multivariable Cox regression model evaluated time from referral to coverage controlling for age, sex, insurance type, and number of previous therapies tried. Results: In the 63 patients included, over half (57%) were women, mostly White (94%), with an average disease duration of 17 years (SD 11), with mostly commercial insurance (75%). All patients received the 360 mg dose; 51 (81%) were escalated to every 6 weeks and 13 (21%) were escalated to every 4 weeks. Patients had tried and failed a median of 4 (IQR 2, 4.5) previous therapies. The median time from referral to coverage was 14 days (IQR 3, 36). Patients were approved via no prior authorization (PA) required (32%), PA (24%), first level appeal (16%), second level appeal/external review/peer to peer (22%), or manufacturer PAP (6%). Time to coverage increased with each additional step required, median time was 6 days (IQR 1, 14) if no PA needed, 10 days (IQR 3, 18) if PA needed, 32 days (IQR 14, 60) if first level appeal needed, 43 days (IQR 35, 61) if second level appeal/external review/peer to peer needed, and 0 days for PAP (all 4 patients were enrolled pre-escalation). Patients with government insurance and patients who had tried and failed more therapies were more likely to receive coverage faster (HR 1.93, P = 0.039 and HR 1.2, P = 0.018, respectively). Conclusion: In patients who received at least one dose of escalated RZB, accessing escalated RZB dosing took about 2 weeks but often up to a month. The lengthy access process often required steps beyond a PA, highlighting the difficulties faced by patients who require escalation to achieve clinical remission.