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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with a SAC/VAL transaction during the 12-month pre-index period. Patients with data quality issues (e.g., missing gender).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary LAAD Cohort<br>Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD | |
| Secondary LAAD Cohort<br>Patients with SAC/VAL abandonment or rejection identified in LAAD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who had SAC/VAL prescriptions filled |  | Up to 3 months | 
| Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions |  | Up to 3 months | 
| Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who utilized a heart failure-related treatment in the follow-up period |  | Up to 12 months | 
| 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 |