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.
NCT ID: NCT05848206
Last Updated: 2023-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
251831 participants
OBSERVATIONAL
2022-03-11
2022-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Primary LAAD Cohort
Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD
No interventions assigned to this group
Secondary LAAD Cohort
Patients with SAC/VAL abandonment or rejection identified in LAAD
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 data quality issues (e.g., missing gender).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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IQVIA
Durham, North Carolina, United States
Countries
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Other Identifiers
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CLCZ696BUS34
Identifier Type: -
Identifier Source: org_study_id
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