Role of Sacubitril/Valsartan in Improving Provider Performance in Managing Heart Failure Under Medicare Alternative Payment Models

NCT05096039 | Completed

• 1 other identifier: CLCZ696BUS29
• Study Type: observational
• Target: 1,614,719
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the association between sacubitril/valsartan utilization and HF patients' Part A \& B expenditures within the reimbursement framework of BPCI and MSSP, and identified BPCI/MSSP participants with the greatest potential for performance improvement (with respect to improving quality and efficiency of care for HF patients) through optimized utilization of sacubitril/valsartan.

Conditions

Heart Failure

Keywords

Heart failure,; Medicare,; Alternative Payment Models,; HFrEF,; Healthcare Expenditures

Outcome Measures

Primary Outcomes (1)

• Bundled Payments for Care Improvement (BPCI) Congestive Heart Failure (CHF) episode costs

  BPCI CHF episode costs defined as the sum of expenditures for Part A \& B covered medical services during the CHF episode

  90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)

Secondary Outcomes (5)

• Medicare Shared Savings Program (MSSP) beneficiary annual Medicare

  Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)

• Outpatient utilization of sacubitril/valsartan during 90-day post-discharge period of the CHF episode

  90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)

• Difference in actual Congestive Heart Failure (CHF) episode costs vs. benchmark CHF episode costs

  90 days following the episode index date (episode index date differed by patient depending on when they were admitted to the hospital (triggering a HF clinical episode), ranging from Jan. 1, 2016 through Oct. 1, 2018)

• Outpatient utilization of sacubitril/valsartan among Medicare Shared Savings Program (MSSP) Heart Failure (HF) patients

  Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)

• Difference in actual HF patient annual Medicare Part A & B expenditures vs. benchmark HF patient annual Medicare Part A & B expenditures

  Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)

Study Arms (6)

Treatment Group 1 (use of sacubitril/valsartan)

Beneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Drug: Sacubitril/valsartan

Treatment Group 2 (use of ACEI or ARB and no use of sacubitril/valsartan)

Beneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window (for BPCA) and CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Drug: ACEI or ARB and no sacubitril/valsartan

Treatment Group 3 (no use of ACEI, ARB, or sacubitril/valsartan)

Beneficiaries who did not qualify for Group 1 or Group 2 were assigned a value of '1'; patients that did not meet this criteria were assigned a value of '0'

Cohort Group 1 (Overall cohort)

The beneficiaries who met the inclusion criteria and were divided into the three treatment groups were considered Cohort Group 1 or the "overall cohort."

Cohort Group 2 (subgroup 1)

Patients with evidence of systolic HF defined as: having at least 2 medical claims (on different dates) with an ICD-9/-10 diagnosis code for systolic HF in any position during the lookback period and/or during the entire 90-day episode window (for BPCA) and CY2017 and/or CY2018 (for MSSP). Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Cohort Group 3 (subgroup 2)

Patients with evidence of Heart Failure Reduced Ejection Fraction (HFrEF) identified based on a published algorithm

Interventions

Sacubitril/valsartan DRUG

Beneficiaries with one or more prescription claim with an NDC for sacubitril/valsartan (from the PDE file) during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Treatment Group 1 (use of sacubitril/valsartan)

ACEI or ARB and no sacubitril/valsartan DRUG

Beneficiaries with one or more prescription claim with an NDC for any ACEI/ARB and no prescription claims for sacubitril/valsartan during the 90-day episode window. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Treatment Group 2 (use of ACEI or ARB and no use of sacubitril/valsartan)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Medicare FFS beneficiaries diagnosed with HF and who received care from a BPCI or MSSP participant

You may qualify if:

• ≥18 years old during year of index date with valid gender and geographic information
• Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
• CE with medical and pharmacy benefits for ≥18 months (540ii days) beginning on the index date (post-index period)
• All patients had uniform 6-month pre-index and 18-month post-index periods
• ≥1 medical claim with an MS diagnosis codeiii in any position during the pre-or post-index periods
• ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)

You may not qualify if:

• ≥1 pharmacy or medical claim for any MS DMT during the pre-index period

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for CLCZ696BUS29 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination; Angiotensin-Converting Enzyme Inhibitors; Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 27, 2021
• Study Start: April 10, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (1)