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

NCT ID: NCT05096039

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1614719 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2020-09-30

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.

Detailed Description

This drug utilization study employed a retrospective cohort design using the 100% files of 2015-2018 Medicare enrollment and Part A, B & D claims data in conjunction with publicly available information on providers participating in Bundled Payments for Care Improvement (BPCI) and/or Medicare Shared Savings Program (MSSP).

BPCI Study Design The unit of analysis for addressing study objectives was a unique Congestive Heart Failure (CHF) episode of care, which encompassed an initial acute inpatient stay plus all Part A & B covered medical services during the 90 days post hospital discharge. Episode index date was defined as the date of a beneficiary's initial acute hospital stay with a qualifying Medicare Severity-Diagnosis Related Group (MS-DRG) for CHF, triggering a CHF episode of care. Beneficiaries were followed longitudinally from episode index date through episode end date to measure their utilization of sacubitril/valsartan and Part A & B expenditures during the CHF episode of care. A 12-month lookback period, based on when the episode was initiated, was utilized to capture beneficiaries' baseline characteristics. For example, episodes initiated on 2/1/2018 will have a 2/1/2017 to 1/31/2018 baseline lookback period. Balancing the need for data recency, all qualifying CHF episodes from 2016-2018 were included in the analysis. Given this is an episode-level analysis, a beneficiary may have contributed multiple CHF episodes to the data analysis. To account for potential within-subject clustering, a generalized linear model with a gamma distribution was applied for estimating the association between sacubitril/valsartan use and CHF episode costs.

MSSP Study Design The unit of analysis for addressing study objectives was a HF patient's Part A & B expenditures within the MSSP. Given the most recent year of data available at the time the study was conducted was 2018, the study population included HF patients for whom the MSSP participants were accountable in 2018 per Centers for Medicare & Medicaid Services (CMS) assignment. These beneficiaries' utilization of sacubitril/valsartan and annual Part A & B expenditures was measured from January 1, 2018 - December 31, 2018. Data from CY 2017 was leveraged for capturing these patients' baseline characteristics.

Conditions

Heart Failure

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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'

Sacubitril/valsartan

Intervention Type: 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 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'

ACEI or ARB and no sacubitril/valsartan

Intervention Type: 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 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'

No interventions assigned to this group

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."

No interventions assigned to this group

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'

No interventions assigned to this group

Cohort Group 3 (subgroup 2)

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

No interventions assigned to this group

Interventions

Sacubitril/valsartan

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'

Intervention Type: DRUG

ACEI or ARB and no 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. Patients who met these criteria were assigned a value of '1'; patients that did not meet these criteria were assigned a value of '0'

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ≥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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

Related Links

http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17867

Results for CLCZ696BUS29 from the Novartis Clinical Trials Website

Other Identifiers

CLCZ696BUS29

Identifier Type: -

Identifier Source: org_study_id