Introduction
Introduction of the direct acting antiviral (DAA) sofosbuvir (SOV) in 2013 offered significant improvement over previous options for hepatitis C virus (HCV) treatment. Initial uptake was low in Medicaid and other populations, perhaps in part due to high drug cost and prior authorization (PA) restrictions related to fibrosis stage, prescribing provider specialty, and sobriety. Both the subsequent introduction of ledipasvir/sofosbuvir (LDV/SOV), an all-oral regimen for most genotypes, and lifting of PA restrictions were expected to increase overall uptake, but little is known about recent prescribing patterns. We examined trends in DAA uptake in a Medicaid population and identified the effect of these two events on treatment initiation.
Study Design
An interrupted time series (ITS) design utilized enrollment, medical, and pharmacy claims from Medicaid enrollees in three New England states, 12/2013-12/2017. Trends in treatment uptake, defined as 1+ pharmacy claim for a DAA, were examined overall, by demographic characteristics, and prior to and after two time points: 10/2014 (LDV/SOV approval date) and 7/2016 (date PA restrictions affecting two-thirds of members were lifted). Chi-square evaluated demographic differences, segmented regression models examined trends.
Study Population
The population included members ages 18-64 years with HCV (2+ claims with ICD-9/10 code for HCV or 1+ claim for chronic HCV). Eligible individuals remained in the sample until treatment initiation or Medicaid disenrollment.
Findings
The analytic sample averaged 30,433 members with HCV per month, mean age 42.9 years, 60% male. In 2014 3.3% of eligible members initiated treatment, increasing to 7.7% in 2017 (p =
Conclusion
While initial uptake of DAAs was low in this multi-state Medicaid population, treatment initiation among eligible members increased through 2017. Introduction of new medications and lifting of PA restrictions led to an immediate increase in uptake followed by relatively flat monthly utilization.
Policy implications
Sharp increases in uptake after LDV/SOV introduction may indicate warehousing of members in anticipation of LDV/SOV approval; increases after PA restrictions were lifted indicates demand for treatment among those affected by restrictions. As a large percentage of the Medicaid HCV population remains untreated, planned provider interviews will help to understand barriers and facilitators of treatment for HCV
