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.
Completed
Conditions studied: Chronic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT05848206
- Run by
- Novartis Pharmaceuticals
- People needed
- 251831
- Starts
- 2022-03-11
- Expected to finish
- 2022-04-29
- Last updated by the study team
- 2023-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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:
- 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.
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).
Where it is running
- IQVIA — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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