Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT05848206
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251831}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who had SAC/VAL prescriptions filled', 'timeFrame': 'Up to 3 months'}, {'measure': 'Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions', 'timeFrame': 'Up to 3 months'}, {'measure': 'Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who utilized a heart failure-related treatment in the follow-up period', 'timeFrame': 'Up to 12 months'}, {'measure': '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', 'timeFrame': 'Up to 12 months'}, {'measure': 'Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period', 'timeFrame': 'Up to 12 months'}]}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)\n\n* 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.\n* 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.\n* Patients aged ≥18 years on the index date.\n* Patients with 12-months of data visibility pre-index.\n* Patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation).\n\nFor comorbidity data only:\n\n* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.\n* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.\n\nSecondary LAAD Cohort (for secondary objective)\n\n* 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.\n* Patients aged ≥18 years on the index date.\n* Patients with 12-months of data visibility pre-index.\n* Patients with 12-months of data visibility post-index.\n* For comorbidity data only:\n* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.\n* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.\n\nExclusion Criteria:\n\n* Patients with a SAC/VAL transaction during the 12-month pre-index period.\n* Patients with data quality issues (e.g., missing gender).'}, 'identificationModule': {'nctId': 'NCT05848206', 'briefTitle': '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.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CLCZ696BUS34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary LAAD Cohort', 'description': 'Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD'}, {'label': 'Secondary LAAD Cohort', 'description': 'Patients with SAC/VAL abandonment or rejection identified in LAAD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'IQVIA', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}