Lo Re Vincent, Gowda Charitha, Urick Paul N, Halladay Joshua T, Binkley Amanda, Carbonari Dena M, Battista Kathryn, Peleckis Cassandra, Gilmore Jody, Roy Jason A, Doshi Jalpa A, Reese Peter P, Reddy K Rajender, Kostman Jay R
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Clin Gastroenterol Hepatol. 2016 Jul;14(7):1035-43. doi: 10.1016/j.cgh.2016.03.040. Epub 2016 Apr 5.
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.
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 a lack of approval of a prescription fill by the insurer, according to type of insurance (US Medicaid, US Medicare, or commercial insurance). Multivariable Poisson regression was used to estimate adjusted relative risks of absolute denial associated with patient characteristics.
Among 2321 patients prescribed a DAA regimen (503 covered by Medicaid, 795 covered by Medicare, and 1023 covered 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 relative risk, 4.14; 95% confidence interval, 3.38-5.08) and absence of cirrhosis (adjusted relative risk, 1.96; 95% confidence interval, 1.53-2.50) were associated with absolute denial.
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.
直接抗病毒（DAA）药物治疗慢性丙型肝炎病毒（HCV）感染的高昂成本导致治疗被拒，但尚不清楚患者获得这些疗法的机会是否因保险类型而异。
我们对2014年11月1日至2015年4月30日期间向伯曼专科药房提交DAA处方的所有患者进行了一项前瞻性队列研究，该药房为特拉华州、马里兰州、新泽西州和宾夕法尼亚州的患者提供HCV药房服务。我们根据保险类型（美国医疗补助、美国医疗保险或商业保险）确定了DAA处方被绝对拒绝的发生率，定义为保险公司未批准处方配药。多变量泊松回归用于估计与患者特征相关的绝对拒绝的调整后相对风险。
在2321例开具DAA治疗方案的患者中（503例由医疗补助覆盖，795例由医疗保险覆盖，1023例由商业保险覆盖），377例（16.2%）被绝对拒绝。绝对拒绝的最常见原因是评估医疗需求的信息不足（134例[35.5%]）和缺乏医疗必要性（132例[35.0%]）。与由医疗保险覆盖的患者（40例[5.0%]；P <.001）或商业保险覆盖的患者（104例[10.2%]；P <.001）相比，由医疗补助覆盖的患者中绝对拒绝的比例更高（233例[46.3%]）。医疗补助保险（调整后相对风险，4.14；95%置信区间，3.38 - 5.08）和无肝硬化（调整后相对风险，1.96；95%置信区间，1.53 - 2.50）与绝对拒绝相关。
不同类型保险的患者在获得基于DAA的HCV感染治疗方面存在显著差异。在特拉华州、马里兰州、新泽西州和宾夕法尼亚州，近一半的医疗补助受益人被拒绝获得这些用于慢性HCV感染的药物。
