Prior Authorization Creates Hurdle in Hepatitis C Treatment

Patient access to curative hepatitis C medications remains a challenge.
The study used t-tests to compare continuous variables and chi-square tests for categorical variables. Significant predictors of PA approval and PA process times were identified by univariate and multivariate analyses using linear and logistic regression modeling with forward selection logistic regression.

Prior Authorization Approval Rates for Harvoni

One hundred of 129 PA requests for Harvoni (77.5%) received initial approval, while an additional 17 patients (13.9%) received approval through an appeals process.  Initial approval was granted to a higher proportion of patients with Medicare/Medicaid coverage (92.2% versus 71.4%; P = .002) and with baseline viral load ≥ 6 million IU/mL (84.1% versus 62.5%; P = .04). Authors believe the difference observed for Medicare/Medicaid coverage, however, might be a time-limited anomaly driven by the absence of PA guidelines until December 2014 and January 2015, respectively.

Faster approval times were observed for patients with Child-Pugh Class B disease (14.4 versus 24.7 days; P = .048).

Predictors for Prior Authorization

Significant predictors for shorter decision and approval times were advanced fibrosis, high Model Of End Stage Liver Disease (MELD) score, and female gender. Linear regression determined Medicare/Medicaid coverage and high viral load to be significant predictors for initial approval, but the authors note that Medicare/Medicaid coverage may no longer be significant under current guidelines.


Authors conclude that delays in the initiation of DAA treatment with Harvoni were a potential barrier for nearly 1 of 4 patients included in this study. This accounts for 13.9% of treatment cases forced to appeal a PA denial and patients without measurably advanced liver disease who experienced significantly longer approval times.

Authors acknowledge that this study is limited to the state of Connecticut and to data captured when PA guidelines for DAA were either nonexistent or in flux. Further studies are warranted to examine insurance PA decisions nationwide within the context of current restrictions.


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