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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IQVIA

Durham, North Carolina, 27703, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percentage of patients who had SAC/VAL prescriptions filled

    Time frame: Up to 3 months

  2. Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions

    Time frame: Up to 3 months

  3. Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer

    Time frame: Up to 3 months

Secondary outcomes

  1. Percentage of patients who utilized a heart failure-related treatment in the follow-up period

    Time frame: Up to 12 months

  2. 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

    Time frame: Up to 12 months

  3. Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 8, 2023
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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