Multi-State, Mixed-Methods Evaluation of the Uptake of new Direct Acting Antiviral Regimens for the Treatment of Hepatitus C Virus

项目摘要/摘要 慢性丙型肝炎病毒(丙型肝炎病毒)在美国影响大约350万人。给定 主要传播方式是通过受感染的针头，正在进行的全国范围内的阿片类药物流行将 继续导致新病例的增加。直接作用抗病毒(DAA)药物，于 2013年11月及以后，在治疗丙型肝炎方面明显更有效，副作用更少，但也更多 比以干扰素为基础的旧疗法更昂贵。然而，早期证据表明，这些药物 并没有在整个医疗系统中迅速采用。由于成本较高，一些付款人最初 拒绝承保或实施事先授权(PA)限制，将治疗限制在晚期患者 疾病或无活性物质使用障碍(SUD)，或所需的特定处方提供者专业。帕 然而，限制并不是患者接受治疗的唯一障碍。我们进行了一项分析 索索布韦和西美普韦，DAA药物，于2013年底在马萨诸塞州医疗补助计划中推出 计划，该计划不基于这些标准中的任何一个来限制报销。尽管限制较少 在推出的前八个月，保单的使用率很低(5%)。患者和提供者因素 与治疗相关的疾病被确认。这些结果表明，新的DAA药物在 医疗补助人群是复杂的，存在患者护理障碍、提供者优先顺序、提供者知识以及 组织因素都可能在决定哪些患者接受治疗方面发挥作用。 利用创新扩散框架，拟议项目将使用混合方法方法，包括 索赔分析和案例研究，以扩展马萨诸塞州的初步调查结果，以检查对 较新的DAA方案跨越多个州。我们将执行多个州的医疗补助索赔分析以：检查 医疗补助人群接受新的DAA药物的趋势(具体目标1)；以及确定患者， 提供者，以及预测治疗的背景因素(具体目标2)。此外，我们还将进行关键的 线人访谈，以深入了解关键决定因素如何以及为什么与更高的 符合条件的患者接受治疗(具体目标3)。我们项目背后的中心假设是 多种因素，包括患者、提供者和政策层面的因素，都会影响这些新技术的传播 药物。 该项目将帮助医疗补助机构和医疗保健实践将循证护理转化为临床 练习一下。调查结果将提供关于提供者如何选择候选治疗并将确定 患者或提供者群体，他们可能从扩大服务中受益，以改善访问。结果可能有助于支付者和 提供者确定加强护理协调和改善患者预后的机会。最后，该项目 将提供一个在医疗补助人群中采用突破性疗法的例子，这可能有助于国家 医疗补助机构、其他付款人和提供者正在规划未来药物的引入。

PROJECT SUMMARY/ABSTRACT Chronic hepatitis C virus (HCV) affects approximately 3.5 million individuals in the United States. Given the primary mode of transmission is through infected needles, the ongoing nationwide opioid epidemic will continue to result in an increase in new cases. Direct-acting antiviral (DAA) medications, introduced in November 2013 and later, are significantly more effective in treating HCV with fewer side effects but also more expensive than older interferon-based regimens. Early evidence suggests, however, that these medications have not been rapidly adopted throughout the healthcare system. Due to high cost, some payers initially declined coverage or enacted prior authorization (PA) restrictions to limit treatment to patients with advanced disease or no active substance use disorder (SUD), or required specific prescribing provider specialties. PA restrictions, however, are not the only barrier to patients receiving treatment. We conducted an analysis of sofosbuvir and simeprevir uptake, DAA medications introduced in late 2013, in the Massachusetts Medicaid program, a program that did not restrict reimbursement based on any of these criteria. Despite less restrictive policies, uptake was low (5%) during the first eight months of their availability. Patient and provider factors associated with treatment were identified. These results suggest that diffusion of new DAA medications in a Medicaid population is complex, with patient barriers to care, provider prioritization, provider knowledge, and organizational factors all potentially playing a role in determining which patients receive treatment. Using a diffusion of innovation framework, the proposed project will use a mixed methods approach, including claims analysis and case studies, to expand upon the initial Massachusetts findings to examine uptake of newer DAA regimens across multiple states. We will perform multi-state Medicaid claims analyses to: examine trends in uptake of new DAA medications in the Medicaid population (Specific Aim 1); and identify patient, provider, and contextual factors that predict treatment (Specific Aim 2). In addition, we will conduct key informant interviews to provide insight into how and why key determinants are associated with higher rates of eligible patients getting treatment (Specific Aim 3). The central hypothesis underlying our project is that multiple factors, including, patient, provider and policy-level factors all affect diffusion of these new medications. The project will help Medicaid agencies and health care practices translate evidence-based care into clinical practice. Findings will provide insight as to how providers choose candidates for treatment and will identify patient or provider groups who may benefit from outreach to improve access. Results may help payers and providers identify opportunities to enhance care coordination and improve patient outcomes. Finally, the project will provide an example of uptake of a breakthrough therapy in Medicaid populations, which may assist state Medicaid agencies, other payers, and providers in planning for the introduction of future medications.