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.

Chronic Heart Failure Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848206
• Other study ID #: CLCZ696BUS34
• Status: Completed
• Start date: March 11, 2022
• Est. completion date: April 29, 2022

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251831
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	IQVIA	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who had SAC/VAL prescriptions filled		Up to 3 months
Primary	Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions		Up to 3 months
Primary	Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer		Up to 3 months
Secondary	Percentage of patients who utilized a heart failure-related treatment in the follow-up period		Up to 12 months
Secondary	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
Secondary	Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period		Up to 12 months