Tu1064 Insurance Approval Patterns for IFN-Free Regimens in HCV: Impact of National Guidelines

Introduction: Patients infected with the hepatitis C virus (HCV) have long been awaiting interferon-free regimens. The possibility of using two Direct Acting Antivirals (DAAs) became a possibility in clinical practice in December 2013, albeit at a significant financial cost. Guidelines were released in part by the AASLD on January 30th, 2014 with specific treatment recommendations in various patient populations. Included in these recommendations was that patients who have received a liver transplant should be treated with 12 or 24 weeks of daily sofosbuvir and simeprevir. We examined approval patterns for DAAs and factors affecting patient access. Methods: This was an IRB approved retrospective review. Two hundred and forty-five consecutive patients whose prescriptions for IFN-free regiments submitted by the University of Miami Hepatology Faculty were included and 82 pending prescriptions were not included. Most patients (96%) were genotype 1a or 1b, and 66 were post-transplant. 86% of prescriptions were for 12 weeks of sofosbuvir and simeprevir, and the remainder was for sofosbuvir and ribavirin. Type of insurance was noted. Those who required foundation assistance were excluded from the analysis. Statistical analysis with parametric, non-parametric or multivariate analysis was performed using JMP SAS software. Results: 71% of prescriptions were filled at an estimated cost of $26,090,000. A prior authorization was submitted to every insurance company on each case. There was a significant change in the approval pattern after the release of the AASLD guidelines (80 vs. 64%, p= 0.0057). After this date, post-liver transplant patients were also significantly more likely to have an IFN-free regimen approved (90 vs. 69%, p=0.04). There was also significant variation by medical insurance company. Patients with Medicare or Medicaid were most likely to have their drug approved compared with private insurance (85 vs. 68%, p=0.01). Conclusions: National guidelines appear to affect insurance company approval process. Approval rates in liver transplant patients significantly increased after AASLD guidelines indicated that they should be treated with interferon-free regimens. Those with public insurance were most likely to be approved compared to private insurance. National societies need to continue to make specific recommendation for the benefit of patient care.