Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

Novartis

Status

Completed

Conditions

Chronic Heart Failure

Treatments

Drug: sacubitril/valsartan

Study type

Observational

Funder types

Industry

Identifiers

NCT05613140

CLCZ696BUS33

Details and patient eligibility

About

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).

Full 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.

Enrollment

9,230 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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