NCT05848206已完成不适用
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251,831
- 试验地点
- 1
- 主要终点
- Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions
研究概览
简要总结
This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)
- •Patients with ≥1 transaction for SAC/VAL in LAAD between 01 January 2017 and 30 November 2019 (index period). Date of the 1st SAC/VAL prescription transaction during this period was the index date.
- •Patients from the Novartis-provided list of 21 plans and formularies of interest (mapping to LAAD data was based data elements such as plan name, payer name, and pharmacy benefit manager [PBM] name) as of the index date.
- •Patients aged ≥18 years on the index date.
- •Patients with 12-months of data visibility pre-index.
- •Patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation).
- •For comorbidity data only:
- •Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
- •Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
- •Secondary LAAD Cohort (for secondary objective)
- •Among patients from the Primary LAAD Cohort remaining in Step 6, patients who abandoned their 1st SAC/VAL prescription or did not receive SAC/VAL due to claim rejection in LAAD between 01 January 2017 and 28 February 2019 (index period). Date of the 1st abandoned/rejected SAC/VAL prescription transaction during this period is the index date.
- •Patients aged ≥18 years on the index date.
- •Patients with 12-months of data visibility pre-index.
- •Patients with 12-months of data visibility post-index.
- •For comorbidity data only:
- •Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
- •Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
排除标准
- •Patients with a SAC/VAL transaction during the 12-month pre-index period.
- •Patients with data quality issues (e.g., missing gender).
结局指标
主要结局
Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions
时间窗: Up to 3 months
Percentage of patients who had SAC/VAL prescriptions filled
时间窗: Up to 3 months
Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer
时间窗: Up to 3 months
次要结局
- Time to first angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blockers (ARB), or angiotensin-receptor neprilysin inhibitors (ARNI, i.e., SAC/VAL) in the follow-up period(Up to 12 months)
- Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period(Up to 12 months)
- Percentage of patients who utilized a heart failure-related treatment in the follow-up period(Up to 12 months)
研究者
研究点 (1)
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