Clinical trial NCT05613140: Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: Heart failure,
Medicare Advantage,
Commercial,
HFrEF,
Chronic heart failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 9230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients with chronic heart failure (CHF)

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

- Patients who died during the post-index period will be excluded.

Primary outcomes:
measure: Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
Secondary outcomes:
measure: Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
measure: Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan
timeFrame: Baseline, 12 months post initiation of sacubitril/valsartan
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: