Groupe d'analyse, Ltée, Montréal, QC, Canada.
Analysis Group, Inc., Denver, CO.
J Manag Care Spec Pharm. 2024 Feb 3;30(2):118-128. doi: 10.18553/jmcp.2024.30.2.118.
Formulary restrictions, intended to limit inappropriate medication use and decrease pharmacy costs, may prevent or delay patients with bipolar I disorder from initiating cariprazine, a dopamine D-preferring D/D and serotonin 5HT receptor partial agonist that is approved to treat manic/mixed or depressive episodes associated with bipolar I disorder. Little is known about the downstream consequences of formulary-related cariprazine prescription rejections.
To evaluate the impact of formulary-related cariprazine claim rejections on health care resource utilization (HCRU) and treatment patterns among patients newly prescribed cariprazine for bipolar I disorder.
Symphony Health Integrated Dataverse was used to identify commercially insured adults (aged ≥18 years) with bipolar I disorder and at least 1 pharmacy claim for cariprazine (rejected because of formulary restrictions or approved; date of the first claim is the index date) from March 2015 through October 2020. Formulary-related rejection reasons included noncoverage, prior authorization requirement, and step therapy requirement. Baseline characteristics were evaluated during the 12 months pre-index and balanced between rejected and approved cohorts using 1:2 propensity score matching. HCRU outcomes included all-cause and mental health (MH)-related hospitalizations, emergency department (ED) visits, and outpatient visits. Treatment patterns were analyzed descriptively and included treatment delay and atypical antipsychotic use. HCRU was reported per patient-year and compared between cohorts using rate ratios; 95% CIs and values were calculated using nonparametric bootstrap procedures.
The matched rejected and approved cohorts comprised 1,554 and 3,108 patients, respectively. The rejected cohort had 22% more all-cause and 24% more MH-related hospitalizations per patient-year vs the approved cohort (rate ratio [95% CI], all-cause: 1.22 [1.01-1.48], = 0.024; MH-related: 1.24 [1.01-1.55], = 0.044). ED and outpatient visits were numerically, but not significantly, greater in the rejected cohort. Of patients in the rejected cohort, 34.7% never received an atypical antipsychotic and 76.8% never received cariprazine. For those who later received cariprazine or another atypical antipsychotic, the average treatment delay was approximately 6 months (188 days) and approximately 4 months (123 days) after the initial rejection, respectively.
Patients with bipolar I disorder and formulary-related cariprazine claim rejections experienced significantly more hospitalizations than patients whose initial claim was approved; ED and outpatient visits were similar between cohorts. Less than a quarter of patients whose initial claim was rejected later received cariprazine, and more than one-third never received any atypical antipsychotic. To our knowledge, this is the first study to evaluate the impact of formulary-related rejections of cariprazine on HCRU and treatment patterns in patients with bipolar I disorder.
为限制不当用药和降低药房成本，处方集限制可能会阻止或延迟双相 I 型障碍患者启动卡利拉嗪，卡利拉嗪是一种多巴胺 D 优先 D/D 和 5HT 受体部分激动剂，已被批准用于治疗与双相 I 型障碍相关的躁狂/混合或抑郁发作。对于与处方集相关的卡利拉嗪处方拒绝的下游后果知之甚少。
评估与处方集相关的卡利拉嗪理赔拒绝对新处方卡利拉嗪治疗双相 I 型障碍患者的医疗资源利用 (HCRU) 和治疗模式的影响。
使用 Symphony Health Integrated Dataverse 确定了 2015 年 3 月至 2020 年 10 月期间至少有一次卡利拉嗪（因处方集限制而拒绝或批准；首次索赔日期为索引日期）药房索赔的商业保险成年人（年龄≥18 岁）患有双相 I 型障碍。与处方集相关的拒绝原因包括无覆盖范围、事先授权要求和阶梯治疗要求。在索引前 12 个月内评估基线特征，并使用 1:2 倾向评分匹配在拒绝和批准队列之间进行平衡。HCRU 结果包括全因和精神健康 (MH) 相关住院、急诊 (ED) 就诊和门诊就诊。使用率比（95%CI）和 值通过非参数自举程序报告了队列之间的比较；报告了每患者年的 HCRU，并使用率比进行了比较；95%CI 和 值使用非参数自举程序计算。
匹配的拒绝和批准队列分别包括 1554 名和 3108 名患者。与批准队列相比，拒绝队列的全因和 MH 相关住院率分别高出 22%和 24%/患者年（率比[95%CI]，全因：1.22[1.01-1.48]，=0.024；MH 相关：1.24[1.01-1.55]，=0.044）。ED 和门诊就诊次数在拒绝队列中数值上更多，但无统计学意义。在拒绝队列的患者中，34.7%的患者从未接受过非典型抗精神病药物，76.8%的患者从未接受过卡利拉嗪。对于后来接受卡利拉嗪或另一种非典型抗精神病药物的患者，平均治疗延迟时间分别约为 6 个月（188 天）和约 4 个月（123 天）。
患有双相 I 型障碍且与处方集相关的卡利拉嗪理赔被拒绝的患者比初始理赔获得批准的患者经历了更多的住院治疗；ED 和门诊就诊次数在队列之间相似。约四分之一的初始理赔被拒绝的患者后来接受了卡利拉嗪治疗，超过三分之一的患者从未接受过任何非典型抗精神病药物治疗。据我们所知，这是第一项评估与处方集相关的卡利拉嗪理赔拒绝对双相 I 型障碍患者 HCRU 和治疗模式影响的研究。
