Clinical trial NCT05848206: 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.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 251831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


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).

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA
state: North Carolina
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: