1 QuintilesIMS, Plymouth Meeting, Pennsylvania.
2 Applied Health Outcomes, Grand Island, New York.
J Manag Care Spec Pharm. 2017 Aug;23(8):902-912. doi: 10.18553/jmcp.2017.16307. Epub 2017 Jun 8.
Health plans use formulary restrictions (e.g., prior authorization, step therapy, tier change, nonformulary status) in an effort to control cost and promote quality, safety, and appropriate prescription utilization. Some Medicare payers perceive that the inclusion of certain agents, such as branded oxycodone HCl extended-release tablets (OERs), on their formularies is associated with attracting high-cost members to the plan.
To evaluate disenrollment rates, patient migration, and subsequent health care costs among OER users who disenrolled from a national Medicare Advantage Prescription Drug plan (study-MAPD) in the plan year following OER nonformulary restriction.
A retrospective, longitudinal cohort study using IMS pharmacy and medical claims data between July 1, 2011, and December 31, 2014, was conducted. In the study-MAPD, adults aged ≥ 18 years who were chronic OER users with ≥ 2 OER claims 6 months before the nonformulary restriction date on January 1, 2013 (index date) and with continuous activity in pharmacy and medical claims for 6 months pre- and post-index were included in the study. Comparison years of 2012 and 2014 prerestriction/postrestriction were selected. All groups were followed for 6 months postindex. Year-to-year disenrollment rates of OER patients and the overall plan, as well as patient characteristics and costs of those who disenrolled from and those who remained with the plan, were measured. Costs were compared using a difference-in-differences approach.
This study identified 2,935 eligible OER users from the study-MAPD population after imposing nonformulary restrictions on OERs on January 1, 2013. Mean age was 62.1 years, and 59.8% were female. The mean Charlson Comorbidity Index score was 1.83 for those 1,001 patients with medical claims data. For comparison years 2012 (prerestriction) and 2014 (postrestriction), 2,248 and 2,222 OER patients were identified, respectively. Patient characteristics were similar across patient cohorts in all 3 study years. Disenrollment rates for OER users (12.9%, 5.5%, and 14.3% for years 2012, 2013, and 2014, respectively) were lower or similar to those of the overall plan (18.3%, 7.6%, and 14.1%, respectively, for the same 3 years). Approximately 40% of OER users who disenrolled from the study-MAPD migrated to plans also imposing a nonformulary restriction on OERs, while about 25% moved to plans with less restrictive OER coverage. The majority (59.9%) of patients continued OER use irrespective of their disenrollment from the study-MAPD in 2013. Although a nonsignificant decrease ($117; P = 0.340) in per patient per month (PPPM) cost was observed among OER patients postrestriction (from 2012 to 2013), the difference-in-difference analysis indicated a net postrestriction increase of $124 (P = 0.461) in PPPM for OER patients.
This study found little evidence to support any consistent directional effect on patient enrollment behavior as a result of an OER non-formulary restriction. Implementation of an OER nonformulary restriction did not lead to higher OER patient disenrollment or lower patient costs in the study-MAPD.
Funding for this study was provided by Purdue Pharma. De, Chen, and Wade are employees of QuintilesIMS, a for-profit company that was contracted by Purdue Pharma to undertake this research. Sweet was a paid consultant for Purdue Pharma at the time of this study. Study concept and design were contributed by Chen, Wade, and De. Chen, De, and Wade collected the data, which were interpreted by all the authors. The manuscript was written by Chen and De, along with Sweet and Wade, and revised by all the authors.
健康计划通过使用处方限制(例如,事先授权、分步治疗、等级变更、非处方状态)来控制成本并促进质量、安全性和适当的处方使用。一些医疗保险支付方认为,将某些药物(如品牌羟考酮盐酸盐缓释片(OERs))纳入其处方集与吸引高成本成员加入该计划有关。
评估在 OER 非处方限制后的计划年度中,从全国医疗保险优势处方药计划(研究-MAPD)中退出的 OER 用户的退出率、患者迁移和随后的医疗保健费用。
使用 IMS 药房和医疗索赔数据进行回顾性、纵向队列研究,时间范围为 2011 年 7 月 1 日至 2014 年 12 月 31 日。在研究-MAPD 中,纳入年龄≥18 岁、在 2013 年 1 月 1 日(索引日期)前≥2 次 OER 索赔且在索引日期前 6 个月在药房和医疗索赔中有连续活动的慢性 OER 用户,并将其纳入研究。选择了 2012 年和 2014 年作为限制前和限制后比较年份。所有组均在索引后随访 6 个月。测量 OER 患者和整个计划的年度退出率,以及退出和留在计划中的患者的特征和成本。使用差异中的差异方法比较成本。
这项研究从研究-MAPD 人群中确定了 2935 名符合条件的 OER 用户,在 2013 年 1 月 1 日对 OER 实施非处方限制后。平均年龄为 62.1 岁,59.8%为女性。1001 名有医疗索赔数据的患者中,平均 Charlson 合并症指数评分为 1.83。在比较年份 2012 年(限制前)和 2014 年(限制后),分别确定了 2248 名和 2222 名 OER 患者。在所有 3 个研究年度中,各患者队列的患者特征相似。OER 用户的退出率(2012 年为 12.9%、2013 年为 5.5%、2014 年为 14.3%)与整体计划(2012 年为 18.3%、2014 年为 7.6%、2014 年为 14.1%)相似或较低。大约 40%的 OER 用户从研究-MAPD 中退出,转而加入了对 OER 也实施非处方限制的计划,而约 25%的患者转而加入了 OER 覆盖范围较窄的计划。大多数(59.9%)患者在 2013 年继续使用 OER,无论他们是否从研究-MAPD 中退出。尽管 OER 患者的每月每患者成本(PPPM)在限制后(从 2012 年到 2013 年)略有下降($117;P=0.340),但差异中的差异分析表明,OER 患者的 PPPM 净增加了$124(P=0.461)。
这项研究没有发现任何证据支持 OER 非处方限制会导致患者入组行为出现一致的方向性影响。在研究-MAPD 中实施 OER 非处方限制并没有导致 OER 患者退出率更高或患者成本更低。
这项研究的资金由普渡制药公司提供。De、Chen 和 Wade 是 QuintilesIMS 的员工,这是一家营利性公司,受普渡制药公司委托进行这项研究。Sweet 在这项研究时是普渡制药公司的付费顾问。Chen、Wade 和 De 提出了研究概念和设计。Chen、De 和 Wade 收集了数据,所有作者对数据进行了解释。手稿由 Chen 和 De 撰写,同时还有 Sweet 和 Wade,并由所有作者修订。