Chronic Heart Failure
Conditions
Brief 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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who had SAC/VAL prescriptions filled | Up to 3 months |
| Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions | Up to 3 months |
| Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer | Up to 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who utilized a heart failure-related treatment in the follow-up period | Up to 12 months |
| 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 |
| Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period | Up to 12 months |
Countries
United States
Outcome results
None listed