Management of Congestive Heart Failure

Action Guide and Resource Compendium

[Table of Contents]

December 2015

About this Guide/Table of Contents

This Action Guide and Resource Compendium provides a list of recommendations and resources to help clinicians, payers, and policymakers address the management of congestive heart failure (CHF). It is intended to serve as a companion document to the ICER report, CardioMEMS HF System™ (St Jude Medical) and Sacubitril/Valsartan (Entresto™, Novartis) for Management of Congestive Heart Failure. All accompanying materials are available on the CTAF website.

How to use this Action Guide: Each section contains key recommendations from the report, accompanied by resources to provide further background and implementation support to help stakeholders translate and apply the guidance to practice and policy.

A more detailed explanation of the recommendations contained within this guide is presented in section 7 of the ICER report.

Table of Contents

Subject Audience

Clinical Effectiveness: CardioMEMS..……..……..……..…...…..…..…..3 Payers, Clinicians, Policymakers

Clinical Effectiveness: Entresto………………..……..……..…........……..4 Payers, Clinicians, Policymakers

Value-Based Price Benchmarks…………..……..……..………..…………..5 Payers, Policymakers

Recommendation: Entresto Coverage Criteria…………………………6 Payers

Recommendation: CardioMEMS Patient Selection…………….…….7 Clinicians, Payers

Recommendation: CardioMEMS and Centers of Excellence…….8 Clinicians, Payers, Policymakers

Recommendation: Innovative Payment Models…………..………....9 Payers, Policymakers

Recommendation: Heart Failure Prevention…………………..……..10 Clinicians, Policymakers

Quality Improvement…………………………………………………………….11 Clinicians, Policymakers

Clinician Resources……………………………………………………….……….12 Clinicians

Recommendation: Future Research Needs……………………….…..13 Clinicians, Policymakers

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Clinical Effectiveness: CardioMEMS

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In May 2014, the FDA approved the CardioMEMS HF System™ (St. Jude Medical) for the monitoring of pulmonary artery pressure in patients with New York Heart Association (NYHA) Class III CHF and a hospitalization in the past year.

Effect: In the CHAMPION trial, CardioMEMS reduced the number of CHF-related hospitalizations and the duration of hospital stays compared to a control group implanted with an inactivated device. The CHAMPION trial was not powered to detect mortality differences, however, and it is reasonable to surmise that post-marketing trials may demonstrate a wide variety in outcomes.

ICER considers the current evidence on the CardioMEMS HF device to be promising but inconclusive.

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Image source: http://s1.q4cdn.com/494833052/files/images/media_kit/Heart%20Failure/CardioMEMS-Miniaturized-Sensor-St-Jude-Medical-4096X1896.jpg

Clinical Effectiveness: Entresto

Effect: In the PARADIGM-HF trial, Entresto reduced the number of deaths from cardiovascular causes, lowered the likelihood of first CHF-related hospitalization, lowered the number of emergency department visits, and slowed loss of quality of life compared to enalapril, an ACE inhibitor. The trial has been criticized for comparing Entresto to an ACE inhibitor rather than to valsartan alone, and questions have been raised as to whether patients in the control arm received the maximum goal dose of enalapril. There are additional concerns that neprilysin inhibition can cause angioedema.

ICER considers Entresto to provide incremental or better improvements to clinical effectiveness compared to an ACE inhibitor.

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The FDA approved Entresto™ (Novartis), a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB), in July 2015 for patients with NYHA Class II, III, and IV CHF and reduced ejection fraction.

Image source: http://healthpopuli.com/wp-content/uploads/2015/07/Entresto.png

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Value-Based Price Benchmarks

The table at right provides value-based price benchmarks for CardioMEMS and Entresto. The value based price benchmark considers the price at which the drug would meet commonly accepted cost-effectiveness thresholds, as well as an analysis of the potential short-term budget impact. The value-based price benchmark represents the price needed to remain within accepted thresholds. Any price beyond the benchmark will likely create a need for extra mechanisms to manage affordability. Details of the assumptions and calculations that go into our value-based price benchmarks are available on ICER’s website.

The value-based price benchmark for CardioMEMS is $10,665, which represents a 40% discount from the Medicare price of $17,750. The value-based price benchmark for Entresto is $4,168, which represents a 9% discount from the wholesale acquisition cost.

PopulationPrice to Achieve

$100,000/QALY

Price to Achieve

$150,000/QALY

Maximum Price at

Potential Budget

Impact Threshold

Value-Based Price

Benchmark

CardioMEMS

(n=358,738)$30,293 $45,202 $10,665 $10,665

Entresto

(n=1,669,235)$9,480/year $14,472/year $4,168/year $4,168/year

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Value-Based Price Benchmarks for CardioMEMS Device and Entresto Therapy

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Cost of Entresto: The annual wholesale acquisition cost of Entresto is $4,560 for twice-daily administration regardless of dose.

Cost of CardioMEMS: The price of CardioMEMS to Medicare is $17,750, not including costs associated with device implantation or monitoring.

Recommendation: Entresto Coverage Criteria

Recommendation: Provider groups and payers may wish to limit prescribing of Entresto to cardiologists or, at a minimum, require other clinicians to prescribe in consultation with a cardiologist, due to the potential for side effects at initiation, importance of selecting appropriate patients, and relatively large expense when compared to generic ACE inhibitors or ARBs.

Recommendation: Based on the combination of its clinical benefits, pricing aligned with patient benefit, and short-term affordability, payers and purchasers should consider placing Entresto in the "preferred brand" category, especially if discounts can be obtained that bring the price in line with thresholds for health-system affordability.

The utilization management policy at right provides sample language for prior authorization criteria.

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Prior Authorization Policy Example: Humana’s Policy for Coverage of Entresto

1. Patient must have NYHA Class II, III, or IV systolic heart failure

2. Patient must have documented left ventricular ejection fraction ≤35%

3. Patient must be 18 years or older

4. Entresto must be prescribed by or in consultation with a cardiologist

5. Patient must currently be stable on beta-blocker or ARB therapy for at least 4 weeks on a maximally tolerated dose

View Humana’s full coverage policy here

Recommendation: CardioMEMS Patient Selection

Recommendation: Within the labeled indications, clinicians should carefully select patients for whom CardioMEMS would offer the best chance of clinical benefit and reduced costs.

The table at right provides sample criteria for determining which Class III heart failure patients would benefit the most from CardioMEMS.

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CardioMEMS Appropriate Use Criteria

Unstable disease course despite optical medication regimens

One or more hospitalizations within a short period of time

Likely to engage with providers and participate in interactions required to gather and act on information

provided by CardioMEMS

For patients whose CHF might become more severe (i.e., from Class III to Class IV), centers implanting the device should discuss the associated risks along with odds of disease progression and what care would be provided if the underlying CHF progressed (i.e., palliative care options).

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Recommendation: CardioMEMS and Centers of Excellence

Recommendation: Provider groups that are starting to use CardioMEMS should explore providing care within a Center of Excellence paradigm, as should payers that are considering covering it.

The resources at right contain recommendations for quality improvement and advanced certification for heart failure. Additional resources related to general quality improvement initiatives can be found on page 11.

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Center of Excellence Resources

Cardiovascular Care High Performers, prepared for the Centers for Disease Control and Prevention (CDC) by the National Committee for Quality Assurance (NCQA)

Report on the elements of practices and health plans that deliver effective cardiovascular care, including details on the strategies each practice or plan used to ensure high-quality care.

Advanced Certification in Heart Failure, American Heart Association (AHA)

Information on the AHA's program to recognize hospitals that meet quality standards related to CHF care.

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Recommendation:Innovative Payment Models

Recommendation: Manufacturers and payers should consider performance-based agreements (i.e., reduced costs or refunds) for both Entresto and CardioMEMS.

The resources at right provide information on alternative payment models such as risk-sharing agreements and value-based pricing, as well as details on how to implement these types of payment models.

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Implementation Resources

Performance-Based Risk-Sharing Arrangements -Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force, International Society For Pharmacoeconomics and Outcomes Research (ISPOR)

Report on best practices for implementing performance-based risk-sharing agreements.

Private Sector Risk-Sharing Agreements in the United States: Trends, Barriers, and Prospects, American Journal of Managed Care

Article describing current trends in risk-sharing agreements, including an exploration of barriers, logistical considerations, and successful and unsuccessful approaches.

Value-based pricing for pharmaceuticals: Implications of the shift from volume to value, Deloitte

Comprehensive description of value-based pricing arrangements and why they are important; includes analyses of current, publicly disclosed arrangements.

Recommended Reading

Rising Cost of Drugs: Where Do We Go From Here, Health Affairs

Health Affairs blog post describing multiple innovative payment approaches for new, expensive drugs.

Performance-Based Risk-Sharing Arrangements for Drugs and Other Medical Products, University of Washington

Slide deck detailing the history behind, reasons for, and examples of performance-based risk-sharing arrangements.

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Recommendation:Heart Failure Prevention

Recommendation: Clinicians and patients should work together to prevent and intensively manage health conditions that are a precursor to CHF, as this may improve patient outcomes including quality of life and reduce costs.

The resources at right will aid in the implementation of effective public health initiatives to prevent CHF. Resources to promote healthy behaviors in individuals who already have heart failure are also included. Additional resources for providers and policymakers are listed on the following two pages.

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Prevention Resources

Indicators Spotlight, CDC, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Division for Heart Disease and Stroke Prevention (DHDSP)

Two-page stepwise guide to implementing strategies to reduce sodium intake on a population level, including a list of indicators to track success.

Roadmap for State Program Planning, CDC NCCDPHP DHDSP

Guide for policymakers on how to implement and maintain Heart Disease and Stroke Prevention (HDSP) programs.

California's Master Plan for Heart Disease and Stroke Prevention and Treatment, 2007-2015, California Department of Public Health

Comprehensive guide to California-specific efforts to prevent and treat heart disease and stroke, including CA-specific data related to CHF.

Stakeholder Discussion to Reduce Population-Wide Sodium Intake and Decrease Sodium in the Food Supply, AHA

Results from the AHA Sodium Conference 2013 planning group, including overviews of the evidence supporting lower sodium intake, private efforts to reduce salt consumption, and innovative methods to reduce the amount of sodium in food through technology.

The Public Health Action Plan to Prevent Heart Disease and Stroke: Ten-Year Update,National Forum for Heart Disease and Stroke Prevention

Comprehensive strategy to prevent heart disease and stroke.

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Quality Improvement

The resources at right contain recommendations for improving the quality of care for patients with CHF.

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Quality Improvement Resources

Get With The Guidelines®-HF Clinical Tools Library, AHA

Resources to aid practices in efforts to implement the AHA Get With The Guidelines program, including order sets, algorithms, patient education materials, and information on advanced certification in heart failure.

Heart Failure Fact Sheet, AHAList of measures related to achievement, quality, and reporting designed to support heart failure quality improvement efforts.

Getting Started with H2H, American College of Cardiology (ACC)

Main page for resources to aid in implementing the ACC’s Hospital to Home program, which aims to improve the transition of patients from the inpatient setting.

How-to Guide: Improved Care for Patients with CHF, Institute for Healthcare Improvement (IHI)

Guide to developing and implementing systems to provide evidence-based care for heart failure patients.

Transitional Care Interventions to Prevent Readmissions for People with Heart Failure, Agency for Healthcare Research and Quality (AHRQ)

Systematic review of the evidence regarding the efficacy, comparative effectiveness, and harms of multiple strategies to reduce readmissions and mortality for patients hospitalized with CHF.

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Clinician Resources

The resources at right include tools to help clinician efforts to prevent cardiovascular disease and to communicate with and care for patients with CHF.

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General Resources

2013 ACCF/AHA Guideline for the Management of Heart Failure, American College of Cardiology Foundation (ACCF) / AHA

Most recent version of the joint ACCF/AHA guidelines for the management of heart failure.

Best Practices Center Heart Failure, AHAMain page for best practices for CHF care, including information on using electronic medical records to improve care, protocols to improve rates of CHF identification, and information on implementing mandatory use of order sets.

Clinical Tools, ACC

Compendium of ACC tools to aid physicians in efforts to prevent cardiovascular disease, covering blood pressure control; lifestyle, cholesterol, and diabetes management; and a list of therapies that are ineffective to treat cardiovascular disease.

Patient Communication Tips, ACCAdvice for physicians on how best to discuss goals and treatment options with CHF patients.

Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors: Behavioral Counseling, United States Preventive Services Task Force (USPSTF)

Recommendation statement that provides guidance on how clinicians can help patients lose weight and develop healthy behaviors, with additional guidance on implementation considerations.

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Recommendation: Future Research Needs

Recommendation: Further research into the benefits of CardioMEMS is needed to address some of the uncertainties that impact its adoption by clinicians and coverage by payers.

Recommendation: Further research and real-world experience with Entresto are needed to help identify the most appropriate patients among those who have Class II-IV heart failure and reduced ejection fraction.

The research areas at right were identified as priorities during the policy roundtable discussion at the October 29, 2015 public meeting of CTAF.

Research Areas

Additional trials are needed to conclusively determine the benefit provided by CardioMEMS

Research is needed to demonstrate whether providing pulmonary artery (PA) pressure data to patients empowers and engages them

Additional trials are needed to examine Entresto’s effects on cognitive function compared to valsartan and to further study angioedema complications among black patients

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