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

项目总结/摘要 慢性丙型肝炎病毒（HCV）影响美国约350万人。鉴于 主要传播方式是通过受感染的针头，正在进行的全国性阿片类药物流行病将 继续导致新病例增加。直接作用的抗病毒（DAA）药物， 2013年11月及以后，在治疗HCV方面显着更有效，副作用更少，但也更多 比以前的基于干扰素的治疗方案更昂贵。然而，早期的证据表明， 并没有在整个医疗体系中迅速普及。由于成本高，一些付款人最初 拒绝承保或颁布事先授权（PA）限制，以限制对晚期 疾病或无活性物质使用障碍（SUD），或需要特定的处方提供者专业。PA 然而，限制并不是患者接受治疗的唯一障碍。我们分析了 sofosbuvir和simeprevir摄取，DAA药物在2013年底推出，在马萨诸塞州医疗补助 计划，一个不限制基于任何这些标准的报销的计划。尽管限制较少 在这些政策推出后的前八个月，采用率很低（5%）。患者和提供者因素 与治疗相关的疾病。这些结果表明，新的DAA药物的扩散， 医疗补助人群是复杂的，有患者的护理障碍，提供者的优先顺序，提供者的知识， 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，拟议项目将采用混合方法，包括 索赔分析和案例研究，以扩大初步马萨诸塞州的调查结果，以检查吸收 更新的DAA方案在多个州。我们将进行多州医疗补助索赔分析，以： Medicaid人群中新DAA药物的使用趋势（具体目标1）;并识别患者， 提供者和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 知情人访谈，以深入了解关键决定因素如何以及为什么与较高的 合格患者接受治疗（具体目标3）。我们项目的核心假设是， 多种因素，包括患者，提供者和政策层面的因素都影响这些新的 药物治疗 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 实践调查结果将提供有关供应商如何选择治疗候选人的见解，并将确定 患者或提供者群体，他们可能会受益于扩大服务范围，以改善服务。结果可能会帮助付款人， 提供者确定加强护理协调和改善患者结果的机会。最终该项目 将提供一个在医疗补助人群中采用突破性治疗的例子，这可能有助于国家 医疗补助机构，其他付款人和供应商计划引入未来的药物。

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.