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.

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT05848206
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2023-04
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Study First Posted: 2023-05-08
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251831

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions	Up to 3 months
Percentage of patients who had SAC/VAL prescriptions filled	Up to 3 months
Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
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
Percentage of patients who utilized a heart failure-related treatment in the follow-up period	Up to 12 months

Trial Locations

Locations (1)

IQVIA; 🇺🇸 Durham, North Carolina, United States