A Pre-post Analysis of Healthcare Resource Utilization and Costs of Care in a New User Cohort of Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,230
- 试验地点
- 1
- 主要终点
- Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
研究概览
简要总结
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).
详细描述
This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.
Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).
The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1 - Adult HFrEF patients
- •Newly initiated sacubitril/valsartan during the cohort identification period;
- •Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- •That are ≥ 18 years old at index date;
- •That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- •That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
- •Cohort 2 - Adult CHF patients
- •Newly initiated sacubitril/valsartan during the cohort identification period;
- •Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- •That are ≥ 18 years old at index date;
- •That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- •That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
排除标准
- •Patients who died during the post-index period will be excluded.
研究组 & 干预措施
Cohort 1 - Adult HFrEF patients
adult HFrEF patients who newly initiated sacubitril/valsartan
干预措施: sacubitril/valsartan (Drug)
Cohort 2 - Adult CHF patients
adult CHF patients who newly initiated sacubitril/valsartan
干预措施: sacubitril/valsartan (Drug)
结局指标
主要结局
Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
时间窗: Baseline, 12 months post initiation of sacubitril/valsartan
Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.
次要结局
- Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)
- Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan(Baseline, 12 months post initiation of sacubitril/valsartan)