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.

NCT05848206 | Completed

• 1 other identifier: CLCZ696BUS34
• Study Type: observational
• Target: 251,831
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Primary LAAD Cohort

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

Secondary LAAD Cohort

Patients with SAC/VAL abandonment or rejection identified in LAAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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:

You may not qualify if:

• Patients with a SAC/VAL transaction during the 12-month pre-index period.
• Patients with data quality issues (e.g., missing gender).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

IQVIA

Durham, North Carolina, 27703, United States

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: March 11, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-04

Locations

US (1)