Heart Failure – Unmet Need – Detailed, Expanded Analysis Heart Failure: Preserved Ejection Fraction (US/EU)
Heart failure with preserved ejection fraction (HFpEF) accounts for approximately half of all chronic heart failure (CHF) cases. Our understanding of the pathophysiology of the disease has improved, but pharmacological treatments with proven outcomes benefits in HFpEF have proved elusive thus far. Current clinical guidelines focus on the management of comorbidities with angiotensin-converting enzyme (ACE) inhibitors, beta blockers, and diuretics, but despite the long list of clinical trial failures, promising drugs are in Phase III trials.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for HFpEF?
- What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for HFpEF?
- What are the prevailing areas of unmet need and opportunity in HFpEF?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European cardiologists for a hypothetical new HFpEF drug?
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 30 European cardiologists fielded in August 2019
Key companies: Novartis, Eli Lilly, Boehringer Ingelheim, AstraZeneca
KEY METRICS INCLUDED
- Target Product Profile (TPP) simulator based on conjoint analysis methodology.
- Stated versus derived importance of product attributes on prescribing behavior.
- Assessment of current drug performance against treatment drivers and goals.
- Physician perceptions of unmet needs in HFpEF and related indications.
- Analysis of remaining drug development opportunities.
Key drugs:ACE inhibitors, angiotensin II receptor blockers,beta blockers, calciumchannel blockers, diuretics, spironolactone, Entresto (sacubitril/valsartan)
PRODUCT DESCRIPTION
Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.
Table of contents
- Heart Failure - Unmet Need - Detailed, Expanded Analysis Heart Failure: Preserved Ejection Fraction (US/EU)
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Efficacy
- Safety and Tolerability
- Convenience of Administration
- Rationale for Drug Selection
- Products for Heart Failure with Preserved Ejection Fraction
- Treatment Drivers and Goals
- Key Findings: Attribute Importance
- Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Cardiologists' Prescribing Decisions in Heart Failure with Preserved Ejection Fraction
- Importance of Efficacy Attributes to Prescribing Decisions in Heart Failure with Preserved Ejection Fraction: United States
- Importance of Efficacy Attributes to Prescribing Decisions in Heart Failure with Preserved Ejection Fraction: Europe
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Heart Failure with Preserved Ejection Fraction: United States
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Heart Failure with Preserved Ejection Fraction: Europe
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Heart Failure with Preserved Fraction: United States
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Heart Failure with Preserved Fraction: Europe
- Key Findings: Stated vs. Derived Importance
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Heart Failure with Preserved Fraction: United States
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Heart Failure with Preserved Fraction: Europe
- Product Performance Against Treatment Drivers and Goals
- Key Findings
- Overall Performance of Key Therapies for Heart Failure with Preserved Ejection fraction: United States
- Overall Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction: Europe
- Mean Overall Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction: United States and Europe
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Efficacy Attributes: United States
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Efficacy Attributes: Europe
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Safety and Tolerability Attributes: United States
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Safety and Tolerability Attributes: Europe
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Convenience of Administration Attributes: United States
- Relative Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction Across Select Convenience of Administration Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in Heart Failure with Preserved Ejection Fraction
- Surveyed Cardiologistsu2019 Satisfaction with the Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
- Surveyed Cardiologistsu2019 Satisfaction with the Performance of Key Therapies for Heart Failure with Preserved Ejection Fraction on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Heart Failure with Preserved Ejection Fraction: United States
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Heart Failure with Preserved Ejection Fraction: Europe
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Heart Failure with Preserved Ejection Fraction: United States
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Heart Failure with Preserved Ejection Fraction: Europe
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Heart Failure with Preserved Ejection Fraction: United States
- Surveyed Cardiologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Heart Failure with Preserved Ejection Fraction: Europe
- Key Findings: Unmet Need in Heart Failure with Preserved Ejection Fraction and Related Indications
- Surveyed Cardiologists' Ascribed Level of Unmet Need in Heart Failure with Preserved Ejection Fraction and Related Indications: United States
- Surveyed Cardiologists' Ascribed Level of Unmet Need in Heart Failure with Preserved Ejection Fraction and Related Indications: Europe
- Opportunity Analysis
- Areas of Opportunity in the Heart Failure with Preserved Ejection Fraction Market and Emerging Therapy Insights
- Opportunity: A Novel Agent That Improves CV Mortality and Lowers Rate of Hospitalization in HFpEF Patients
- Opportunity: A Novel Agent That Improves Quality-of-Life Measures and Exercise Capacity in HFpEF Patients
- Areas of Opportunity in the Heart Failure with Preserved Ejection Fraction Market and Emerging Therapy Insights
- Target Product Profiles
- Assessing Drug Development Opportunities
- Target Product Profile Methodology
- Attributes and Attribute Levels
- Attributes of Key Current and Late-Phase Emerging Therapies for Heart Failure with Preserved Ejection Fraction
- Attribute Importance and Part-Worth Utilities
- Heart Failure with Preserved Ejection Fraction Target Product Profile: Attribute Importance
- Rate of Cardiovascular Mortality
- Rate of Hospitalization for Heart Failure
- Change in Kansas City Cardiomyopathy Questionnaire Score
- Rate of Adverse Renal Outcomes (End-Stage Renal Disease, 50% Drop in Estimated Glomerular Filtration Rate, Renal Death)
- Change in Six-Minute Walk Distance (Meters)
- Dosing Burden
- Price per Year
- Conjoint Analysis-Based Simulations of Market Scenarios
- Heart Failure with Preserved Ejection Fraction Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
- Heart Failure with Preserved Ejection Fraction Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
- Heart Failure with Preserved Ejection Fraction Market Simulations: Target Product Profiles Included in Scenario 1
- Heart Failure with Preserved Ejection Fraction Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
- Heart Failure with Preserved Ejection Fraction Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
- Heart Failure with Preserved Ejection Fraction Market Simulations: Target Product Profiles Included in Scenario 2
- Appendix
- Key Abbreviations
- Bibliography
- Introduction
Kahkashan Resham, Ph.D., is a senior research associate on the Cardiovascular, Metabolic, and Renal Disorders team at DRG, part of Clarivate. She obtained her doctorate in pharmacology from the National Institute of Pharmaceutical Education and Research (NIPER) in Nagar, India. She completed her M. Pharm. at NIPER in Hyderabad and was awarded a gold medal for securing first rank at the institute. She holds a bachelor’s degree in pharmacy from the Birla Institute of Technology in Ranchi, India. Dr. Resham has also published several peer-reviewed research articles on drug metabolism, diabetes, and chemotherapy-induced peripheral neuropathic pain.