Pharmacy Dispensing Channel and Specialty Drug Adherence and Outcomes among Medicare Beneficiaries

项目摘要 特种药物是用于治疗复杂慢性疾病（如癌症）的创新、高成本疗法， 类风湿性关节炎（RA）和多发性硬化症（MS）。尽管这些技术提供了医学上的进步 药物，研究表明，坚持专业药物是次优;负面结果 与依从性差相关的不良反应也有详细记录。考虑到病人经常会坚持 障碍，并需要额外的支持，以获得治疗的全部好处，专业制药专业 分销渠道，以处理特殊药物治疗-已迅速成为一个有价值的工具，以改善 坚持使用特殊药物。这些药房提供的支持服务（例如，识别财务 援助，提供额外的病人教育）持有特别的承诺，医疗保险受益人，谁往往面临 独特的环境使坚持成为更大的挑战。尽管有潜在的有用的服务 由专业药房提供，现有证据表明，大多数医疗保险受益人继续填补 他们的专业药物在正规的零售药店。此外，迄今为止关于依从性改善的研究 与专科药房使用相关的方法在方法和对医疗保险的普遍性方面都受到限制 人口医疗保险受益人使用专科药房的经验证据及其对 需要坚持服药。因此，本研究的目的是（1）检查趋势和地理 医疗保险中使用专科药房作为专科药物分发渠道的变化 2013年至2017年的受益人;（2）确定专科药房使用对依从性的影响， 使用工具变量，新开始使用专科药物的医疗保险受益人之间的治疗差距 允许“因果”推断的分析;（3）确定专科药房使用对 新开始使用特殊药物的医疗保险受益人的结果。这项研究将首次使用 国家医疗保险索赔数据和工具变量分析，以解决这些研究问题， 医疗保险患者开始使用慢性粒细胞白血病，慢性淋巴细胞白血病， 风湿性关节炎和多发性硬化症我们的研究将提供强有力的证据， 专业药房在提高医疗保险人群的依从性和结果，并确定患者 最有可能受益于使用这些药房的亚群体。强有力的经验证据表明， 医疗保险受益人的专业药房可能会促使政策制定者重新评估任何愿意的药房 (AWP)医疗保险D部分的规定，这可能会无意中推动零售药店的高使用率 专门的药品供应商最后，我们的研究结果将指导后续的R系列赠款 确定最有效的特定专业药房类型和/或支持服务，目标是 确定和传播有效的战略，并可能制定干预措施，以增加其使用。

PROJECT SUMMARY Specialty drugs are innovative, high-cost therapies used to treat complex, chronic conditions such as cancer, rheumatoid arthritis (RA), and multiple sclerosis (MS). Despite the medical advances offered by these medications, studies have shown that adherence to specialty drugs is suboptimal; the negative outcomes associated with poor adherence are also well documented. Given that patients often experience adherence barriers and require extra support to reap the full benefits of treatment, specialty pharmacies—specialized distribution channels to handle specialty drug treatment—have quickly emerged as a valuable tool to improve adherence to specialty drugs. The support services offered by these pharmacies (e.g., identifying financial assistance, offering extra patient education) hold particular promise for Medicare beneficiaries, who often face unique circumstances that make adherence a greater challenge. Despite the potentially helpful services offered by specialty pharmacies, available evidence suggests that most Medicare beneficiaries continue to fill their specialty drugs at regular retail pharmacies. Further, studies till date on adherence improvements associated with specialty pharmacy use are limited in both methodology and generalizability to the Medicare population. Empirical evidence on the use of specialty pharmacy by Medicare beneficiaries and the impact on medication adherence is needed. Thus, the aims of this study are (1) to examine trends and geographic variations in the use of specialty pharmacy as the dispensing channel for specialty drugs among Medicare beneficiaries from 2013 to 2017; (2) to determine the impact of specialty pharmacy use on adherence and treatment gaps among Medicare beneficiaries newly initiating a specialty drug, using an instrumental variable analysis that allows for “causal” inference; and (3) to determine the impact of specialty pharmacy use on outcomes among Medicare beneficiaries newly initiating a specialty drug. This study will be the first to use national Medicare claims data and instrumental variable analysis to address these research questions in Medicare patients initiating specialty drugs for chronic myeloid leukemia, chronic lymphocytic leukemia, rheumatoid arthritis, and multiple sclerosis. Our study will offer robust evidence on the effectiveness of specialty pharmacies at improving adherence and outcomes in the Medicare population and identify patient subgroups most likely to benefit from use of such pharmacies. Strong empirical evidence on the benefit of specialty pharmacies for Medicare beneficiaries may spur policymakers to reassess the Any Willing Pharmacy (AWP) provision under Medicare Part D, which may inadvertently drive the high rates of retail pharmacy use for specialty drug fills in this population. Finally, the results of our study will guide subsequent R series grants to identify specific specialty pharmacy types and/or support services that are most effective, with the goal of identifying and disseminating effective strategies and potentially developing interventions to increase their use.