PAH is a rare, life-threatening disorder marked by considerable morbidity and mortality. Despite the availability of a wide array of drugs for PAH, substantial unmet need remains for more-effective, more-tolerable agents. Based on our survey results and physician interviews, we discuss the relative attractiveness of various drug attributes and the implications for PAH drug development. In our conjoint analysis, we reveal the key trade-offs that surveyed cardiologists and pulmonologists are willing to make when considering new treatment options for PAH. Understanding the influence of key efficacy, safety/tolerability, and nonclinical attributes on physicians’ prescribing behavior can pave the way to commercial success in this competitive landscape.

QUESTIONS ANSWERED

  •  What are the key treatment drivers and goals within PAH? How do the current therapies perform on these goals?
  • What attributes drive decision-making when treating PAH patients, which have limited impact, and which are hidden opportunities?
  • Based on a conjoint analysis and TPP simulation, what trade-offs across different clinical attributes and prices are acceptable to U.S. and European cardiologists and pulmonologists for a hypothetical PAH drug?

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. One market scenario is profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany.

Primary research: Survey of 60 U.S. and 32 European cardiologists and pulmonologists fielded in June 2020.

Key companies: Actelion, Bayer, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Pfizer, United Therapeutics.

Key drugs: Adempas, Uptravi, Opsumit, remodulin/epoprostenol, Tyvaso/ventavis, Orenitram, Tadalafil.

Table of contents

  • Pulmonary Hypertension - Unmet Need - Detailed, Expanded Analysis ( US/EU)
    • Executive Summary
      • Unmet Need - Pulmonary Arterial Hypertension - Executive Summary - August 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Pulmonary Arterial Hypertension and Rationale for Drug Selection
      • Treatment Drivers and Goals
        • Key Findings: Attribute Importance
        • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Pulmonologists'/Cardiologists' Prescribing Decisions in Pulmonary Arterial Hypertension
        • Importance of Efficacy Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: 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 Pulmonary Arterial Hypertension: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Pulmonary Arterial Hypertension: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Pulmonary Arterial Hypertension: United States
        • Overall Performance of Key Therapies for Pulmonary Arterial Hypertension: Europe
        • Mean Overall Performance of Key Therapies for Pulmonary Arterial Hypertension: United States and Europe
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Pulmonary Arterial Hypertension Across Select Convenience of Administration Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Pulmonary Arterial Hypertension
        • Surveyed Pulmonologists'/Cardiologists’ Satisfaction with the Performance of Key Therapies for Pulmonary Arterial Hypertension on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Pulmonologists'/Cardiologists’ Satisfaction with the Performance of Key Therapies for Pulmonary Arterial Hypertension on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Pulmonary Arterial Hypertension: United States
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Pulmonary Arterial Hypertension: Europe
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Pulmonary Arterial Hypertension: United States
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Pulmonary Arterial Hypertension: Europe
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Pulmonary Arterial Hypertension: United States
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Pulmonary Arterial Hypertension: Europe
        • Key Findings: Unmet Need in Pulmonary Arterial Hypertension and Related Indications
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need in Pulmonary Arterial Hypertension and Related Indications: United States
        • Surveyed Pulmonologists'/Cardiologists' Ascribed Level of Unmet Need in Pulmonary Arterial Hypertension and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Pulmonary Arterial Hypertension Market and Emerging Therapy Insights
          • Opportunity: A Novel Therapy That Provides Improvements in 6MWD over Current Agents
          • Opportunity: A Novel Pulmonary Arterial Hypertension Therapy with a Disease-Modifying Mechanism of Action
      • 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 Pulmonary Arterial Hypertension
        • Attribute Importance and Part-Worth Utilities
          • Pulmonary Arterial Hypertension Target Product Profile: Attribute Importance
          • Reduction in All-Cause Mortality Rate at One Year
          • Reduction in Hospitalization Rate for Worsening PAH
          • Percentage of Patients Who Improve at Least One NYHA / WHO Functional Class
          • Improvement in 6MWD (placebo-adjusted, meters)
          • Patient Tolerability
          • Dosing Burden (formulation and frequency)
          • Price Per Day of Therapy ($/day)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Pulmonary Arterial Hypertension Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Pulmonary Arterial Hypertension Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Pulmonary Arterial Hypertension Market Simulation: Target Product Profiles Included in the Market Scenario
          • Market Scenario 2
          • Pulmonary Arterial Hypertension Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Pulmonary Arterial Hypertension Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Pulmonary Arterial Hypertension Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations

    Author(s): Kahkashan Resham, Ph.D

    Kahkashan Resham is a senior research associate in the Cardiovascular, Metabolic and Renal disorders team at Decision Resources Group. Her current work is focused on writing treatment algorithm reports, key opinion leader identification, clinical trial pipeline pulls, as well as secondary research across multiple cardiovascular and metabolic indications.

    Prior to joining DRG, Resham obtained her doctorate in Pharmacology from National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, India. She completed her M. Pharm. from the NIPER Hyderabad and was awarded a gold medal for securing 1st rank in the Institute. She holds a bachelor’s degree in Pharmacy from Birla Institute of Technology, Ranchi, India. Resham has also published several peer-reviewed research articles in the area of drug metabolism, diabetes and chemotherapy-induced peripheral neuropathic pain.


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