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.

Novartis

Status: Completed

Conditions: Chronic Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT05848206

CLCZ696BUS34

Details and patient eligibility

About

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.

Enrollment: 251,831 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

251,831 participants in 2 patient groups

Primary LAAD Cohort

Description:

Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD

Secondary LAAD Cohort

Description:

Patients with SAC/VAL abandonment or rejection identified in LAAD