LAUSR

OBJECTIVE To examine trends in direct acting antiviral (DAA) uptake in a multi-state Medicaid population with hepatitis C virus (HCV) prior to and after ledipasvir/sofosbuvir (LDV/SOF) approval and changes in prior authorization (PA) requirements. DATA SOURCES Analyses utilized enrollment, medical, and pharmacy claims in four states, 12/2013-12/2017. STUDY DESIGN An interrupted time series examined trends in uptake (1+ claim for a DAA) before and after two events: LDV/SOV approval (10/2014) and lifting of PA requirements for 40% of members (7/2016). Analyses were also performed in subgroups defined by number and dates of change in PA requirements in members' Medicaid plans. DATA COLLECTION/EXTRACTION METHODS Members ages 18-64 years with an ICD code for HCV were included in the sample from diagnosis date until treatment initiation or Medicaid disenrollment. PRINCIPAL FINDINGS The annual sample size ranged from 38,303-45,005, with approximately 30% ages 18-34 years and 40% female. In 12/2013, 0.08% were treated, rising to 0.74% in 12/2017 (p<0.001). Uptake increased from 0.34%/month in 10/2014 to 0.70%/month after LDV/SOF approval, (p< 0.001), and increased relative to pre-LDV/SOV trend through 6/2016 (p=0.03). Uptake increased to 1.18%/month after PA change, (p<0.001) and remained flat through 2017 (p=0.64). Cumulatively, 20.1% were treated by 12/2017. In plans with few/no requirements through 2017, uptake increased to 1.19%/month after LDV/SOF approval (p<0.001) and remained flat through 2017 (p=0.11), with 22.2% cumulatively treated. Among plans that lifted PA requirements from three to zero in mid-2016, uptake did not increase after LDV/SOF approval (p=0.36) but did increase to 1.41%/month (p< 0.001) after PA change, with 18.1% cumulatively treated. CONCLUSIONS HCV Treatment increased through 2017. LDV/SOF approval and lifting PA requirements led to an increase in uptake followed by flat monthly utilization. Cumulative uptake was higher in plans with few/no PA requirements relative to those with three requirements through mid-2016.