Background & Aims The high costs of direct-acting antiviral (DAA) agents to treat chronic hepatitis C virus (HCV) infection have resulted in denials of treatment, but it is not clear whether patients’ access to these therapies differs with their type of insurance. Methods We conducted a prospective cohort study among all patients who had a DAA prescription submitted between November 1, 2014 and April 30, 2015 to Burman’s Specialty Pharmacy, which provides HCV pharmacy services to patients in Delaware, Maryland, New Jersey, and Pennsylvania. We determined the incidence of absolute denial of DAA prescription, defined as lack of approval of prescription fill by the insurer, according to type of insurance (US Medicaid, US Medicare, commercial insurance). Multivariable Poisson regression was used to estimate adjusted relative risks (RRs) of absolute denial associated with patient characteristics. Results Among 2321 patients prescribed a DAA regimen (503 covered by Medicaid; 795 by Medicare; 1023 by commercial insurance), 377 (16.2%) received an absolute denial. The most common reasons for absolute denial were insufficient information to assess medical need (134 [35.5%]) and lack of medical necessity (132 [35.0%]). A higher proportion of patients covered by Medicaid received an absolute denial (233 [46.3%]) than those covered by Medicare (40 [5.0%]; P<.001) or commercial insurance (104 [10.2%]; P<.001). Medicaid insurance (adjusted RR, 4.14; 95% confidence interval, 3.38–5.08) and absence of cirrhosis (adjusted RR, 1.96; 95% confidence interval, 1.53–2.50) were associated with absolute denial. Conclusions There are significant disparities in access to DAA-based treatments for HCV infection among patients with different types of insurance. Nearly half of Medicaid beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania were denied access to these drugs for chronic HCV infection.

BackgroundDespite the availability of new direct-acting antiviral (DAA) regimens, changes in DAA reimbursement criteria, and a public health focus on hepatitis C virus (HCV) elimination, it remains unclear if public and private insurers have increased access to these therapies over time. We evaluated changes in the incidence of absolute denial of DAA therapy over time and by insurance type.MethodsWe conducted a prospective cohort study among patients who had a DAA prescription submitted from January 2016 to April 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services across the United States. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. We calculated the incidence of absolute denial, overall and by insurance type (Medicaid, Medicare, commercial), for the 16-month study period and each quarter.ResultsAmong 9025 patients from 45 states prescribed a DAA regimen (4702 covered by Medicaid, 1821 Medicare, 2502 commercial insurance), 3200 (35.5%; 95% confidence interval, 34.5%–36.5%) were absolutely denied treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than Medicaid (34.5%, P < .001) or Medicare (14.7%, P < .001). The incidence of absolute denial increased across each quarter of the study period, overall (27.7% in first quarter to 43.8% in last quarter; test for trend, P < .001) and for each insurance type (test for trend, P < .001 for each type).ConclusionsDespite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.

In both his published work and business activities, Kleinke has been an eloquent champion of a health care system reengineered around the principles of sound data, improved access to proven medicines, empowered but accountable doctors and patients, and a streamlined, functioning health insurance marketplace. He received his MSB degree in finance from Johns Hopkins University. Daniel C. Malone, RPh, PhD, is an associate professor of pharmacy and public health at the University of Arizona College of Pharmacy. His area of research over the past 4 years has been drug-drug interactions and their prevention from a systems perspective. He is the coprincipal investigator for the University of Arizona Center for Education and Research on Therapeutics (CERT) grant from the Agency for Healthcare Quality and Research and is the director of the pharmaceutical outcomes core that is focusing on drug-drug interactions.Malone was the coprincipal investigator for drug-drug interaction study funded by the Centers for Disease Control and Prevention that was examining ways to make drug-drug interaction information more relevant to prescribers in the context of computerized physician order entry (CPOE). He is currently conducting an evaluation of the Department of Veterans Affairs CPOE system with respect to the user interface and interaction alerts. Malone has published more than 50 articles and been successful in obtaining more than $8 million in extramural support for research and policy development programs.Paul N. Urick, RPh, is vice president, pharmacy services, for Independence Blue Cross, Philadelphia, Pennsylvania. In this role, he directs the strategy for successful pharmacy benefit management, including executing manufacturer agreements and retail pharmacy contract negotiations, acting as chairman of committees within the health plan, and overseeing the health plan' s mail-order facility, with 30 full-time employees.Urick has broad professional experience in areas including hospital clinical practice, surgical medicine, and long-term care consultation and as a staff pharmacist in managed care, manager of a health maintenance organization, and director of pharmacy. He is an active member of the Academy of Managed Care Pharmacy, where he currently serves on several committees. He also served as president for a local chapter of the Pennsylvania Society of Health-System Pharmacists. Urick received his bachelor of science degree in pharmacy from the Philadelphia College of Pharmacy and Science. The advocates of EBM concede that their approach can lead to increased costs in the case of some individual patients or diseases. Dealing with costs is, however, part of the work of the pharmacy and therapeutics (P&T) committees that have to decide which therapies are best suited to their institutions. This is a job that is complicated by differences in clinical test design and the absence of a standard threshold of what is cost effective. A new therapy that has demonstrated great effectiveness in clinical trials may not always be the...

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