Increasing Access to Hepatitis C Medications: A Program Model to Obtain Prior Authorization Approval

Joelle Ayoub, Pharm.D., Coborn’s Pharmacy-CHI St. Gabriel’s Health Family Medical Center

Background: Direct-acting antivirals (DAAs) have been shown to be effective and tolerable in treating hepatitis C virus (HCV) infections. Unfortunately, the high cost of these medications has resulted in insurance companies requiring a prior authorization (PA) in order for patients to receive access to these medications. Many insurers, including Medicaid, can limit access of DAAs to patients with liver fibrosis. The PA process includes a health insurance provider determining if a specific medication treatment is necessary for a patient, and approving or denying the medication to be covered by insurance. This process is time consuming for providers and can cause the patient to be in an uncertain waiting period without access to their antiviral medication. Each individual insurer may have different policies for determining which patients qualify for oral DAA treatments, which is why obtaining approval efficiently and successfully requires expertise. The Respectful and Equitable Access to Comprehensive Healthcare (REACH) program, which is based in Mount Sinai Hospital, uses an interprofessional team model to provide a variety of services to reduce barriers to successful treatment (such as mental health and social work) for HCV-infected patients. The PA process is managed by a nurse and a specialty pharmacy, to lessen physician and patient burden.

Objective: The aim of this study is to analyze the number of successful PA approvals for DAA hepatitis C medications by analyzing specific factors that may predict a PA’s approval success.

Study Design: A retrospective chart review of program databases and medical records of all patients in the REACH program whose DAA HCV medications were ordered between November 1, 2014, and October 31, 2015 was performed. A total of 197 patients were followed for 180 days, or until PA approval was obtained. Patient clinical characteristics, number of steps in the PA process, and time until medication approval were  analyzed The steps involved in the processed included a program nurse, specialty pharmacy and patient navigators.

Results: The primary outcome measured was the number of steps in the medication approval process required to obtain PA approval, while the secondary outcome was the time needed to obtain approval of the medication in number of days. The main medication applied for was ledipasvir/sofosbuvir (84.3%). The program obtained HCV medication approval for 93% of the prescriptions (95%CI 88%-96%). The mean time to approval was 59.8 days (SD=64.5). When analyzing the time to approval, 37% were approved on first submission with a mean of 30.7 days to approval, while approval after internal appeal (2 steps) was around 45% with 66.8 mean days. It was determined that Medicare or Medicaid/Medicare compared to Medicaid solely resulted in fewer steps in the PA cascade. A P value <0.200 determined independent predictors of time to approval by 180 days. The statistically significant predictors of time in relation to fewer steps in the process were comorbid hypertension, comorbid diabetes, older age, being domiciled and HCV genotype 1. Lastly, those with highest fibrosis scores (FIB-4 range >3.25) had slower medication approval than those with midrange fibrosis (P=0.005).

Conclusions: The REACH program demonstrated the role of patient navigators, nurses and specialty pharmacies coordinating PA approvals. Insurance status was found to be a factor determining the amount of work required, as was time required to obtain PA approval. Medicaid insurance and HCV genotype 2 were associated with increased steps to PA approval, while Medicare insurance and mid-range fibrosis were associated with less time to PA approval.

Key Point: This study demonstrates a collaborative model used to increase PA approvals for DAA medications for HCV infections in an urban primary care clinic. Patient specific factors such as insurance type, co-morbid conditions, and HCV genotype were found to decrease time to PA approval in this study.


  1. Vu TM, Toribio W, Riazi F, et al. Increasing access to hepatitis C virus medications: A program model using patient navigators and specialty pharmacy to obtain prior authorization approval. JMCP. 2018;24(4):329-33.