Increasing Access to Hepatitis C Virus Medications: A Program Model Using Patient Navigators and Specialty Pharmacy to Obtain Prior Authorization Approval.

Abstract

Obtaining prior authorization (PA) approval for the new direct-acting antiviral (DAA) hepatitis C medications is time consuming and requires specific expertise. Our primary care-based program treats hepatitis C virus (HCV)-infected patients at an urban academic medical center and employs patient navigators trained in the PA process who collaborate with a nurse and specialty pharmacy to manage the PA process. To demonstrate the rate of PA approvals for our programmatic model and determine potential predictors of PA approval. We conducted a review of program databases and medical records of patients for whom DAA hepatitis C medications were ordered between November 1, 2014, and October 31, 2015 (n = 197). We first evaluated patient characteristics associated with the number of steps to approval. Then we used a multivariable ordinal regression to determine independent predictors of fewer steps to approval. Using Kaplan-Meier methods, we assessed patient characteristics associated with approval time and then fit a multivariable Cox regression model to determine independent predictors of time to approval. Of the 197 patients, 69% (n = 136) had Medicaid; 12% (n = 24) had Medicare; 10% (n = 19) had both Medicaid and Medicare; 5% (n = 10) had private insurance; and 4% (n = 8) were uninsured. Ninety-three percent of the patients were eventually approved for HCV treatment. The steps in the PA cascade were approval on first submission (37%; mean days = 30.7; SD = 29.9); approval after internal appeal (45%; mean days = 66.8; SD = 70.5); approval after external appeal (11%; mean days = 124.7; SD = 60.2); and no approval obtained (7%). Unadjusted factors found to have a P value < 0.200 in relation to fewer steps in the PA cascade were older age, female gender, non-Medicaid insurance, comorbid hypertension, comorbid diabetes, being domiciled, and being nongenotype 2. After adjustment, non-Medicaid insurance and nongenotype 2 remained significant. In survival analysis, non-Medicaid insurance and mid-range fibrosis were associated with fewer days to PA approval. Our program obtained 93% of PA approvals for hepatitis C medications. Patient navigators collaborating with a nurse and specialty pharmacy as a program may improve the PA approval process, although further research with a control group is necessary. The Respectful & Equitable Access to Comprehensive Healthcare (REACH) program receives funding from the Robin Hood Foundation and the New York State Department of Health AIDS Institute. Weiss receives grant support from Gilead Sciences and has served as a consultant for AbbVie and Gilead Sciences. Vu reports speaker fees from Peer View Institute. All other authors report no conflict of interest. Study design and concept were contributed by Chasan, Sigel, Vu, and Weiss. Riazi, Ciprian, Giardina, and Gibbs collected the data, which were interpreted by Toribio, Amory, Chasan, and Sigel. The manuscript was written by Vu and Weiss and revised by Parrella, Cambe, Camacho, and Vu. Research from this study was presented as an abstract poster on November 14, 2016, at the AASLD Liver Meeting in Boston, Massachusetts.