Assessing Prior Authorization for Harvoni as a Barrier to Hepatitis C Care


Research addresses whether the prior authorization process creates a barrier to timely and effective care for hepatitis C.

With the flood of curative medications for hepatitis C hitting the market, the cost of these drugs remains problematic for patient access to treatment.

Research published in PLoS ONE conducted a retrospective chart review of patients in Connecticut receiving sofosbuvir/ledipasvir (SOF/LED; Harvoni) to see if the prior authorization (PA) process created a potential barrier to timely and effective care for hepatitis C virus (HCV) infection.

Authors noted that the treatment of HCV infection in the United States has been revolutionized by novel direct-acting antiviral (DAA) therapies. Compared with interferon-based therapies, DAA agents such as Harvoni have demonstrated better tolerability, adherence, rates of sustained virologic response, and cure rates.

This advance, they said, has expanded the population of individuals with HCV infection who are potentially treatable.

The researchers add that the American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of American (IDSA) have recognized the efficacy of Harvoni by including it as a recommended first-line therapy for HCV genotype-1 infection, the most prevalent strain in the United States.

The Hepatitis C Care Cascade

The concept of a care cascade first was applied to the treatment of patients with HIV as a means of identifying care gaps and setting goals in antiviral therapy. It represents the chain of necessary steps leading to therapeutic success: diagnosis, linkage to care, retention in care, prescription of antiretroviral therapy, and viral suppression.

The care cascade has been adopted to identify barriers in the antiviral treatment of HIV, HCV—HIV co-infection, and most recently, HCV mono-infected individuals.

With the emergence of DAAs, prior authorization has become a crucial factor in the care cascade for HCV infection, the authors said. DAA therapy is very expensive, with a 12-week treatment course of Harvoni costing approximately $94,500, or $1125 per pill.

The combination of prohibitive cost and limited availability means that PA guidelines often prioritize approval for patients with the highest need, usually defined as advanced fibrosis (≥ grade F3) or cirrhosis.

To determine how these conditions may impact the care cascade for all patients receiving Harvoni, their research objective was to look at PA approval rates for Harvoni over a 3-month period and try to identify factors associated with PA approval, time to PA decision, and time to PA approval.

What Predicts Prior Authorization Approval?

Investigators looked at the medical charts of all patients at Yale Liver Center who filed an insurance PA request for Harvoni between October 11, 2014 and December 31, 2014. Patients who received a prescription for HCV therapy other than Harvoni were excluded from the study, yielding a final sample of 129 individuals.

In addition to data on PA decisions and the timing of those decisions, researchers collected data on patient characteristics (age, race, body mass index, comorbid hypertension, psychiatric illness, diabetes, renal disease, hepatitis B, or HIV co-infection, and baseline biochemical markers), HCV viral characteristics (genotype, viral load, IL28B gene variant, and prior regimens), and severity of HCV infection (progression of hepatic fibrosis) as possible predictors.

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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