Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

Abstract

BackgroundNew treatments for hepatitis C (HCV) infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications.Materials and MethodsWe performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/LED) from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times.ResultsOf 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of whom 100 (77.5%) received initial approval, and an additional 17 patients (13.9%) ultimately received approval through the appeals process. Faster approval times were seen in patients with Child-Pugh Class B disease (14.4 vs. 24.7 days, p = 0.048). A higher proportion of patients were initially approved in those with Medicare/Medicaid coverage (92.2% vs. 71.4%, p = 0.002) and those with baseline viral load ≥6 million IU/mL (84.1% vs. 62.5%, p = 0.040). Linear regression modeling identified advanced fibrosis, high Model of End Stage Liver Disease (MELD) score, and female gender as significant predictors of shorter decision and approval times. On logistic regression, Medicare/Medicaid coverage (OR 5.96, 95% CI 1.66–21.48) and high viral load (OR 4.52, 95% CI 1.08–19.08) were significant predictors for initial approval.ConclusionsEarly analysis of real-world drug authorization outcomes between October-December 2014 reveals that nearly one in four patients are initially denied access to SOF/LED upon initial prescription, although most patients are eventually approved through appeal, which delays treatment initiation. Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times. More studies are needed to determine factors resulting in higher likelihood of denial and to evaluate approval rates and times after implementation of restrictive prior authorization guidelines.

Hepatitis C Virus: A Review of Treatment Guidelines, Cost-effectiveness, and Access to Therapy

“…These results echo some of the results from a study by Do et al,24 which found that one in four patients were initially denied access to sofosbuvir and ledipasvir, although most were eventually approved. The initial denial led to delays in the initiation of treatment, however.…”

“…Although DAAs have been shown to be, for the most part, cost-effective, they have not proven to be affordable 6. Data from the IFN era reveals that ∼16% of HCV-infected individuals were prescribed antiviral treatment, with only 9% achieving SVR 24. Given the significant number of undiagnosed patients with chronic HCV infection, this number is sobering and illustrates that cost is not the only barrier to DAAs.…”

“…Given the significant number of undiagnosed patients with chronic HCV infection, this number is sobering and illustrates that cost is not the only barrier to DAAs. Certain barriers can be seen worldwide and regardless of income, which include diagnosis, lack of knowledge of treatment options, medical eligibility, infrastructure for vulnerable populations and high cost 24,25…”

Long-term outcomes of liver transplantation in patients with hepatitis C infection are not affected by HCV positivity of a donor

“…Since the progression rate increases with age [2], and given that the highest prevalence of HCV infection in the U.S. has been reported in the baby boomer population [3] who are currently between 50 and 70 years of age, the need for liver transplantation in HCV-infected patients is likely to remain high in the coming years. It is unclear whether the recently approved direct-acting antiviral (DAA) regimens for HCV, for which their high efficacy and minimal contraindications are at this point counter-balanced by access-related barriers [4–6], are able to reverse this trend at the national level any time soon.…”

Evaluating a Collaborative Approach to Improve Prior Authorization Efficiency in the Treatment of Hepatitis C Virus

“…DAA therapy usually requires prior authorization or preapproval from third-party payers due to high costs. Do et al8 found in a real-world HCV-infected cohort that 1 in 5 patients were denied access to these medications upon initial request. The majority of these initially denied patients eventually did receive prior authorization through the appeals process, with only 10% of patients unable to receive approval, indicating a potential administrative barrier that delays treatment of those who should be eligible 8…”