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Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade.
- Source :
-
PloS one [PLoS One] 2015 Aug 27; Vol. 10 (8), pp. e0135645. Date of Electronic Publication: 2015 Aug 27 (Print Publication: 2015). - Publication Year :
- 2015
-
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.<br />Materials and 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.<br />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.<br />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.
- Subjects :
- Aged
Antiviral Agents economics
Benzimidazoles economics
Female
Fluorenes economics
Hepatitis C, Chronic complications
Hepatitis C, Chronic drug therapy
Humans
Logistic Models
Male
Middle Aged
Retrospective Studies
Sofosbuvir
Time Factors
United States
Uridine Monophosphate economics
Uridine Monophosphate therapeutic use
Antiviral Agents therapeutic use
Benzimidazoles therapeutic use
Fluorenes therapeutic use
Insurance Claim Review
Insurance, Pharmaceutical Services
Uridine Monophosphate analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1932-6203
- Volume :
- 10
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- PloS one
- Publication Type :
- Academic Journal
- Accession number :
- 26312999
- Full Text :
- https://doi.org/10.1371/journal.pone.0135645