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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Sacubitril/valsartan; Drug: ACEI or ARB and no 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.

• Study Type: Observational
• Enrollment (Actual): 1614719

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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)
• By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used.

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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'	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'
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medicare Shared Savings Program (MSSP) beneficiary annual Medicare	MSSP beneficiary annual Medicare Part A & B expenditures defined as the sum of all Part A & B expenditures within the calendar year (CY)	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	yes/no binary variable	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	A benchmark was created to assess performance and determine savings for the BPCI. Difference in actual Congestive Heart Failure (CHF) episode costs vs. benchmark CHF episode costs were reported	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	yes/no binary variable	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	A benchmark was created to assess performance and determine savings for the MSSP. Difference in actual HF patient annual Medicare Part A & B expenditures vs. benchmark HF patient annual Medicare Part A & B expenditures were reported	Baseline (Calender Year 2017) and Calender Year 2018 (01/01/2018 to 31/12/2018)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLCZ696BUS29 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure,; Medicare,; Alternative Payment Models,; HFrEF,; Healthcare Expenditures
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696BUS29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No