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J Manag Care Spec Pharm. 2014 Dec;20(12):1227-34. doi: 10.18553/jmcp.2014.20.12.1227.
Although the recommended treatment of hepatitis C continues to evolve as newer and more effective medications are made available, hepatitis C drug regimens consisting of a 3-drug combination of a protease inhibitor, pegylated interferon, and ribavirin were recommended by the American Association for the Study of Liver Diseases for the HCV genotype I beginning in 2011. Although more effective than the earlier standard of care, these regimens have complex dosing schedules, prolonged duration, and deleterious side effects. It has been shown that patients tend to discontinue these regimens prematurely. Specialty pharmacies offer specialized care management programs to hepatitis C patients, consisting of such services as regularly scheduled patient counseling, assessing regimen appropriateness, monitoring treatment progress, scheduling refill reminders, and coordinating patient care with prescribers. The use of specialty pharmacies by hepatitis C patients may improve persistence on the 3-drug hepatitis C regimens.
To examine the association of pharmacy dispensing channel (specialty pharmacy or retail pharmacy) and hepatitis C regimen persistence among patients on a 3-drug hepatitis C regimen containing telaprevir, a widely used hepatitis C protease inhibitor.
A retrospective, observational study was conducted using pharmacy claims data from a national pharmacy benefits manager for the period July 2011 to June 2013. Continuously eligible patients who started a new 3-drug regimen containing telaprevir were included in the study and followed for up to 12 months after the index hepatitis C claim. The study outcome was persistence to the 3-drug regimen at treatment week 24 (day 168), representing the completion of an important milestone in the regimen. Patients were defined as persistent if they filled 84 days' supply of telaprevir and 168 days' supply of pegylated interferon and ribavirin each, as required by the regimen protocol. Multivariate logistic regression was used to evaluate the association between dispensing channel and persistence, controlling for differences in demographics, medication burden, out-of-pocket spend per 30-day adjusted hepatitis C prescription, and average days' supply per unadjusted hepatitis C prescription.
The final study sample consisted of 1,475 patients-1,182 in the specialty pharmacy group and 293 in the retail pharmacy group. A significantly greater proportion of patients were persistent to the 3-drug hepatitis C regimen containing telaprevir in specialty pharmacy, compared with retail pharmacy (56.0% vs. 39.9%, P less than 0.001). After multivariate adjustment, patients in the specialty pharmacy group had 1.89 times greater odds of being persistent to 3-drug hepatitis C regimens containing telaprevir compared with patients in the retail group (95% CI=1.44-2.48).
Patients who used a specialty pharmacy offering refill reminders, care management, and care coordination with prescribers were significantly more likely to be persistent to 3-drug hepatitis C regimens, compared with patients using a retail pharmacy.
随着新型、更有效的药物的问世，丙型肝炎的推荐治疗方法不断发展。自 2011 年起，美国肝病研究协会建议对 HCV 基因型 I 患者采用由蛋白酶抑制剂、聚乙二醇干扰素和利巴韦林组成的三联药物治疗方案。虽然这些方案比以前的标准治疗更有效，但它们的剂量方案复杂，持续时间长，且具有有害的副作用。研究表明，患者往往会过早地停止这些方案。专科药房为丙型肝炎患者提供专门的护理管理计划，包括定期的患者咨询、评估方案的适当性、监测治疗进展、安排药物补充提醒以及与处方医生协调患者护理等服务。丙型肝炎患者使用专科药房可能会提高对包含替拉瑞韦的三联丙型肝炎方案的坚持率。
研究丙型肝炎患者在使用包含替拉瑞韦的三联丙型肝炎方案（一种广泛使用的丙型肝炎蛋白酶抑制剂）时，药房配药渠道（专科药房或零售药房）与丙型肝炎方案坚持率之间的关系。
采用全国药房福利管理者的药房理赔数据进行回顾性、观察性研究，研究期间为 2011 年 7 月至 2013 年 6 月。纳入新开始使用包含替拉瑞韦的三联丙型肝炎方案且持续符合条件的患者，并在索引丙型肝炎理赔后最多随访 12 个月。研究结局为治疗第 24 周（第 168 天）时对三联方案的坚持率，这代表完成了方案的一个重要里程碑。如果患者按方案要求分别填充了 84 天的替拉瑞韦供应和 168 天的聚乙二醇干扰素和利巴韦林供应，则定义为坚持治疗。采用多变量逻辑回归来评估配药渠道与坚持率之间的关系，同时控制了人口统计学、药物负担、每 30 天调整后的丙型肝炎处方自付费用、以及未经调整的丙型肝炎处方平均供应天数方面的差异。
最终研究样本包括 1475 例患者，其中 1182 例在专科药房组，293 例在零售药房组。在专科药房组，坚持包含替拉瑞韦的三联丙型肝炎方案的患者比例显著高于零售药房组（56.0%比 39.9%，P<0.001）。经过多变量调整后，与零售药房组相比，专科药房组患者坚持包含替拉瑞韦的三联丙型肝炎方案的可能性要高出 1.89 倍（95%CI=1.44-2.48）。
与使用零售药房的患者相比，使用提供药物补充提醒、护理管理以及与处方医生进行护理协调的专科药房的患者，坚持三联丙型肝炎方案的可能性显著更高。
