MARKET OUTLOOK

Tumor necrosis factor-alpha (TNF-α) inhibitors (AbbVie’s Humira, Amgen’s Enbrel, Janssen’s Remicade and Simponi, UCB’s Cimzia) are approved for the treatment of nonradiographic axial spondyloarthritis (nr-AxSpA) in Europe and are increasingly used off-label for the disease in the United States, where Cimzia is striving to be the first therapy to gain FDA approval for nr-AxSpA. Novartis’s IL-17 inhibitor, Cosentyx, is seeking approval for this indication in both regions and is also used off-label. In this report, the first to focus on this AxSpA subpopulation, we examine areas of unmet need in the treatment of nr-AxSpA, including inefficacy, mechanism of action, safety and tolerability, delivery, and price. Backed by quantitative insight into U.S. and European rheumatologists’ assessment of the unmet needs in nr-AxSpA, we discuss the commercial opportunities associated with treating this enigmatic indication and how emerging therapies may capitalize on these opportunities.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for nr-AxSpA?
  • Which drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for nr-AxSpA?
  • What are the prevailing areas of unmet need and opportunity in nr-AxSpA?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European rheumatologists for a hypothetical new nr-AxSpA drug?

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

Primary research: Survey of 60 U.S. and 30 European rheumatologists fielded in January 2019

Key companies: AbbVie, Amgen, Janssen, UCB, Novartis

Key drugs: Humira, Enbrel, Remicade, Simponi, Cimzia, Cosentyx

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 the indication and related indications.
  • Analysis of remaining drug development opportunities.

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

  • Axial Spondyloarthritis - Unmet Need - Detailed, Expanded Analysis (US & EU) : Non-radial Axial Spondyloarthritis : (US & EU5)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for Nonradiographic Axial Spondyloarthritis
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Rheumatologists' Prescribing Decisions in Nonradiographic Axial Spondyloarthritis
      • Importance of Efficacy Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: 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 Nonradiographic Axial Spondyloarthritis: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: United States
      • Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: Europe
      • Mean Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: United States and Europe
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Nonradiographic Axial Spondyloarthritis
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Nonradiographic Axial Spondyloarthritis: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Nonradiographic Axial Spondyloarthritis: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Nonradiographic Axial Spondyloarthritis: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Nonradiographic Axial Spondyloarthritis: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Nonradiographic Axial Spondyloarthritis: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Nonradiographic Axial Spondyloarthritis: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Nonradiographic Axial Spondyloarthritis: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Nonradiographic Axial Spondyloarthritis: Europe
      • Key Findings: Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Nonradiographic Axial Spondyloarthritis Market and Emerging Therapy Insights
        • Opportunity: Treatments with Sustained Efficacy
        • Opportunity: Treatment with Alternative Mechanisms of Action
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • Attribute Importance and Part-Worth Utilities
        • Nonradiographic Axial Spondyloarthritis Target Product Profile: Attribute Importance
        • % of nr-AxSpA Patients Achieving ASAS 20 Response at 12 Weeks
        • % of nr-AxSpA Patients Achieving ASAS Partial Remission at 12 Weeks
        • Average Improvement in the ASQoL Questionnaire from Baseline at 24 Weeks
        • % of Patients Reporting Serious Adverse Events (e.g., IBD, Uveitis) at 12 Weeks
        • Mechanism of Action
        • Route and Frequency of Administration
        • Price per Day (Relative to Cosentyx)
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Target Product Profiles Included in Scenario 1
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Nonradiographic Axial Spondyloarthritis Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Experts Interviewed
      • Bibliography

Author(s): Maria Genco, Ph.D

Maria Genco, Ph.D., is an analyst on the Immune and Inflammatory Disorders group at Decision Resources Group, primarily focusing on rheumatoid arthritis and axial spondyloarthritis. She has authored market research reports on the RA disease landscape and commercial outlook of drugs, unmet needs in RA, and market access and reimbursement for RA targeted therapies. Prior to joining Decision Resources, Dr. Genco received her M.S. and Ph.D. in neuroscience from Brandeis University and a B.A. in neuroscience from Wellesley College.


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