Heart Failure Clinical Trial

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.

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

251831

Study ID:

NCT05848206

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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IQVIA
Durham North Carolina, 27703, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

251831

Study ID:

NCT05848206

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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