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).
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.
Study Type
OBSERVATIONAL
Enrollment
9,230
Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).
Novartis Investigative Site
East Hanover, New Jersey, United States
Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with 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.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Number of HF-related hospitalizations was defined as the number of acute inpatient hospitalizations with a discharge diagnosis of HF in any position.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Number of all-cause hospitalizations was as the number of acute inpatient hospitalizations for any reason.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan
An UHF visit was defined as any of the following: i) a patient with a place of service (POS) code 20, which corresponds to urgent care facility ii) a patient with an ER visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0450, 0451, 0452, 0456 or 0459 iii) a patient with an urgent care clinic visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0516 or 0526 iv) a patient with a hospital observational stay (POS code = 22, 23), identified from revenue code 0762
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan
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Number of WHF episodes was defined as a composite outcome of HF-specific hospitalizations and UHF visits.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of HF-specific hospitalizations was defined as the sum of payer paid amounts for acute inpatient hospitalizations with a primary discharge diagnosis of HF.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of HF-related hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations with a discharge diagnosis of HF in any position.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of all-cause hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations for any reason.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan
Costs of UHF visits were defined as the sum of payer paid amounts for UHF visits.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan
Costs of WHF episodes were defined as the sum of payer paid amounts for HF-specific hospitalizations and UHF visits.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan
HF-related costs were defined as the sum of payer paid amounts for medical claims with a diagnosis of HF in any position.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan
All-cause medical costs were defined as the sum of payer paid amounts for all medical claims.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan
All-cause pharmacy costs were defined as the sum of payer paid amounts for all pharmacy claims.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan
All-cause total cost of care were defined as the sum of all-cause medical costs and all-cause pharmacy costs.
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan