Gleason Patrick P, Starner Catherine I, Gunderson Brent W, Schafer Jeremy A, Sarran H Scott
Prime Therapeutics, 1305 Corporate Center Dr., Eagan, MN 55121, USA.
J Manag Care Pharm. 2009 Oct;15(8):648-58. doi: 10.18553/jmcp.2009.15.8.648.
In 2008, specialty medications accounted for 15.1% of total pharmacy benefit medication spending, and per member expenditures have increased by 11.1% annually from 2004 to 2008 within a commercially insured population of 8 million members. Insurers face increasing pressure to control specialty medication expenditures and to rely on increasing member cost share through creation of a fourth copayment tier within the incentive-based formulary pharmacy benefit system. Data are needed on the influence that member out-of-pocket (OOP) expense may have on prescription abandonment (defined as the patient never actually taking possession of the medication despite evidence of a written prescription generated by a prescriber).
To explore the relationship between prescription abandonment and OOP expense among individuals newly initiating high-cost medication therapy with a tumor necrosis factor (TNF) blocker or multiple sclerosis (MS) biologic agent.
This observational cross-sectional study queried a midwestern and southern U.S. database of 13,172,480 commercially insured individuals to find members with a pharmacy benefit-adjudicated claim for a TNF blocker or MS specialty medication during the period from July 2006 through June 2008. Prescription abandonment was assessed among continuously enrolled members newly initiating TNF blocker or MS therapy. Prescription abandonment was defined as reversal of the adjudicated claim with no evidence of a subsequent additional adjudicated paid claim in the ensuing 90 days. Separate analyses for MS and TNF blocker therapy were performed to assess the association between member OOP expense and abandonment rate using the Cochran-Armitage test for trend and multivariate logistic regression. Members were placed into 1 of the 7 following OOP expense groups per claim: $0-$100, $101-$150, $151-$200, $201-$250, $251-$350, $351-$500, or more than $500. The association of MS or TNF blocker abandonment rate with OOP expense was tested with logistic regression models using the $0-$100 OOP as the reference group and adjusting for age, gender, formulary status, ZIP code-level income and education, earliest specialty medication claim, and methotrexate use for the TNF blocker analysis.
Of 2,791 members presenting a prescription to newly initiate high-cost MS therapy, 1,985 (71.1%) of the claims were for a 1-month supply with most of the remainder for a 3-month supply; 2,303 (82.5%) had an OOP expense of $0-$100, and 5.4% had an OOP expense greater than $500. The abandonment rate increased as OOP increased (test for trend, P < 0.001). Members with an OOP expense of $100 or less had an abandonment rate of 5.7%. Among members in all OOP expense groups greater than $200, the abandonment rate was significantly higher, with more than 1 in 4 members abandoning their MS claims (P < 0.001). In the multivariate logistic regression analysis, the abandonment rate became significantly higher at OOP expenses of $201 to $250 compared with an OOP expense of $100 or less (odds ratio [OR] = 7.3, 95% confidence interval [CI] = 3.3- 16.2). The odds ratios ranged between 6.1 and 7.3 for OOP expense groups greater than $200. Of 7,313 members presenting a prescription to newly initiate TNF blocker therapy, 5,809 (79.4%) of claims were for a 1-month supply with most of the remainder for a 3-month supply; 6,123 (83.7%) had an OOP expense of $0-$100 and 5.7% had an OOP expense greater than $500. The abandonment rate increased as OOP expense increased (test for trend, P < 0.001). In the multivariate logistic regression analysis, the TNF blocker medication abandonment rate was significantly higher for all OOP expense groups greater than $100, with abandonment odds ratios of 2.3 to 4.4 for OOP expense between $101 and $500 compared with OOP expense of $0-$100. The odds of abandonment at OOP expense of greater than $500 were 7-fold higher (OR = 7.0, 95% CI = 5.4-9.1).
This is the first study to perform a focused assessment of an association between specialty medication OOP expense and new therapy prescription abandonment. The study found that per claim OOP expenses greater than $100 for TNF blocker medication and greater than $200 for MS medication were associated with increased prescription abandonment. These findings coupled with previous research identifying a negative relationship between OOP expense above $100 per month and adherence, and the commercial insurance market response to fourth-tier OOP expenses, suggests that insurers should consider the impact that specialty OOP expense may have on adherence and member satisfaction. Further prospective research should be performed to confirm these findings and assess the clinical outcomes associated with prescription abandonment.
2008年,专科药物占药房福利药物总支出的15.1%,在800万商业保险参保人群中,2004年至2008年期间每位参保人的支出每年增长11.1%。保险公司面临着越来越大的压力,需要控制专科药物支出,并通过在基于激励的处方集药房福利系统中设立第四层共付费用来增加参保人的费用分担。需要了解参保人的自付费用(OOP)对处方弃用(定义为尽管有开处方者开具的书面处方,但患者从未实际拿到药物)可能产生的影响的数据。
探讨新开始使用肿瘤坏死因子(TNF)阻滞剂或多发性硬化症(MS)生物制剂进行高成本药物治疗的个体中,处方弃用与OOP费用之间的关系。
这项观察性横断面研究查询了美国中西部和南部一个包含13172480名商业保险个体的数据库,以找出在2006年7月至2008年6月期间有药房福利判定的TNF阻滞剂或MS专科药物索赔的参保人。在新开始TNF阻滞剂或MS治疗的持续参保成员中评估处方弃用情况。处方弃用定义为判定索赔被撤销,且在随后的90天内没有后续额外判定付费索赔的证据。对MS和TNF阻滞剂治疗分别进行分析,使用 Cochr an - Armitage趋势检验和多变量逻辑回归评估参保人OOP费用与弃用率之间的关联。每个索赔将参保人分为以下7个OOP费用组之一:0 - 100美元、101 - 150美元、151 - 200美元、201 - 250美元、251 - 350美元、351 - 500美元或超过500美元。使用以0 - 100美元OOP为参照组的逻辑回归模型,对年龄、性别、处方集状态、邮政编码级别的收入和教育程度、最早的专科药物索赔以及TNF阻滞剂分析中的甲氨蝶呤使用情况进行调整,测试MS或TNF阻滞剂弃用率与OOP费用之间的关联。
在2791名新开始高成本MS治疗并提交处方的参保人中,1985份(71.1%)索赔是1个月的供应量,其余大部分是3个月的供应量;2303名(82.5%)的OOP费用为0 - 100美元,5.4%的OOP费用超过500美元。弃用率随着OOP的增加而增加(趋势检验,P < 0.001)。OOP费用为100美元或更低的参保人的弃用率为5.7%。在所有OOP费用高于200美元的参保人群中,弃用率显著更高,超过四分之一的参保人放弃了他们的MS索赔(P < 0.001)。在多变量逻辑回归分析中,与OOP费用为100美元或更低相比,OOP费用为201至250美元时弃用率显著更高(优势比[OR] = 7.3,95%置信区间[CI] = 3.3 - 16.2)。对于OOP费用高于200美元的组,优势比在6.1至7.3之间。在7313名新开始TNF阻滞剂治疗并提交处方的参保人中,5809份(79.4%)索赔是1个月的供应量,其余大部分是3个月的供应量;6123名(83.7%)的OOP费用为0 - 100美元,5.7%的OOP费用超过500美元。弃用率随着OOP费用的增加而增加(趋势检验,P < 0.001)。在多变量逻辑回归分析中,所有OOP费用高于100美元的TNF阻滞剂药物弃用率显著更高,与OOP费用为0 - 100美元相比,OOP费用在101至500美元之间时弃用优势比为2.3至4.4。OOP费用超过500美元时弃用的几率高7倍(OR = 7.0,95% CI = 5.4 - 9.1)。
这是第一项对专科药物OOP费用与新疗法处方弃用之间的关联进行重点评估的研究。该研究发现,TNF阻滞剂药物每份索赔的OOP费用超过100美元以及MS药物超过200美元与处方弃用增加相关。这些发现加上之前确定每月OOP费用高于100美元与依从性之间存在负相关关系的研究,以及商业保险市场对第四层OOP费用的反应,表明保险公司应考虑专科OOP费用可能对依从性和参保人满意度产生的影响。应进行进一步的前瞻性研究以证实这些发现并评估与处方弃用相关的临床结果。