Hepatitis C Direct Acting Antiviral Therapies in a New York City HIV/AIDS Special Needs Plan: Uptake and Barriers.

Hepatitis C virus (HCV) co-infection is common among HIV-infected (HIV) patients in the United States (US) and worldwide, with HCV prevalence rates >20% seen in some HIV patient populations. HCV-related liver disease progression is accelerated in HIV patients compared to HCV mono-infected patients, and liver decompensation and hepatocellular carcinoma (HCC) have emerged as leading causes of morbidity and mortality in many HIV patient populations. Until recently, HCV was an incurable chronic infection for most HIV patients. Recently, however, clinical trials have shown that >90% of HCV/HIV co-infected patients can eradicate HCV with interferon (IFN)-free direct acting antiviral (DAA) regimens. It is believed—but not yet shown in long-term follow-up studies—that most patients co-infected with HCV and HIV will benefit from receipt of DAA therapy. Consequently clinicians show considerable interest in providing DAAs to their HIV patients, with an eventual goal of eradicating HCV from their patient populations. However, because of the great expense and limited availability—in some settings—of DAAs, it is not well understood what types of HIV patients are being prioritized for DAA therapy and whether current clinical practices are most effective in terms of reducing morbidity, mortality, and HCV-associated medical care costs. To provide insight into these questions, we used insurance claims data from a not-for-profit Medicaid Special Needs Health Plan designed exclusively for persons living with HIV/AIDS in New York City to: (a) assess the uptake of DAAs among HIV/ HCV co-infected persons, and (b) compare patients receiving DAAs to those who are not to identify potential barriers and enablers to DAA uptake. We used insurance claims data from Amida Care, a not-forprofit Medicaid Special Needs Health Plan exclusively designed for persons living with HIV/AIDS in New York City. Amida Care began approving claims for DAAs in December 2013. We examined the Amida Care claims database for demographic, clinical, and pharmacy information among persons with claims consistent with chronic HCV infection (CPT-4, ICD-9, or ICD10) during December 1, 2013 to September 30, 2014, and entered into the claims database through March 1, 2015. T-tests and chi-square tests were used for statistical comparisons. The study procedures were approved by the institutional review board of the Albert Einstein College of Medicine. Current New York State Department of Health (NYSDOH) Medicaid fee-for-service guidelines related to DAA therapy stipulate that patients who are HIV should have HIV viral load levels below the lower limit of quantification (LLQ) for 6 months before authorization for DAA therapy is sought on their behalf by their clinical care providers. These NYSDOH guidelines are, to our knowledge, not shared directly with clinical care providers but are shared with approved Medicaid Managed Care health plans such as Amida Care. Medicaid health plans including Amida Care have the authority to set their own DAA authorization criteria but reimbursement by the NYSDOH Medicaid program for DAA costs may be based on the NYSDOH Medicaid guidelines. When clinical providers communicate with Amida Care to seek prior authorization for DAA therapy, Amida Care staff provides information on the types of documentation it needs to evaluate the prior authorization request. For Amida Care claims, this includes documentation of HIV viral load levels. During the study time period, 1756 individuals were active Amida Care participants, with a diagnosis consistent with chronic HCV infection based on claims data. Of these participants, 6% (n = 109) received sofosbuvir (SOF) and/or simeprevir (SIM) during the study time period. Approval requests submitted to Amida Care by clinical care providers included evidence that all of these patients—with one exception—were