title: Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade.
abstract: BACKGROUND
  New 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  Early 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.
authors: Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, United States of America.
authors: Albert
authors: A
authors: Do
authors: Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, United States of America.
authors: Yash
authors: Y
authors: Mittal
authors: Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, United States of America; Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America; Liver Transplantation Program, Yale-New Haven Hospital, New Haven, CT, United States of America.
authors: AnnMarie
authors: A
authors: Liapakis
authors: Liver Transplantation Program, Yale-New Haven Hospital, New Haven, CT, United States of America.
authors: Elizabeth
authors: E
authors: Cohen
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Hong
authors: H
authors: Chau
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Claudia
authors: C
authors: Bertuccio
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Dana
authors: D
authors: Sapir
authors: Apothecary and Wellness Center, Yale-New Haven Hospital, New Haven, CT, United States of America.
authors: Jessica
authors: J
authors: Wright
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Carol
authors: C
authors: Eggers
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Kristine
authors: K
authors: Drozd
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Maria
authors: M
authors: Ciarleglio
authors: Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America.
authors: Yanhong
authors: Y
authors: Deng
authors: Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, United States of America; Yale Liver Center, Section of Digestive Diseases, New Haven, CT, United States of America; Liver Transplantation Program, Yale-New Haven Hospital, New Haven, CT, United States of America.
authors: Joseph K
authors: JK
authors: Lim
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000191:economics / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy; D006801:Humans; D007345:Insurance Claim Review; D007356:Insurance, Pharmaceutical Services; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069474:Sofosbuvir; D013997:Time Factors; D014481:United States; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D014542:Uridine Monophosphate; D000069474:Sofosbuvir