MARKET OUTLOOK

Roche/Genentech achieved a clinical and regulatory milestone with the approval of Ocrevus for the treatment of primary-progressive multiple sclerosis (PP-MS), the first of its kind. According to DRG research and company reports, uptake of the drug for PP-MS has been swift, and the revenue generated has been significant. Nevertheless, opportunity remains because the drug may not be appropriate for all patients. Ocrevus targets neuroinflammation, which may not be present in all PP-MS patients; in addition, according to some KOLs interviewed by DRG, it has only a modest clinical effect. This report examines neurologists’ satisfaction with Ocrevus and the disease-modifying therapies used off-label for PP-MS and gauges the opportunity and value drivers for alternatives to treat this perennially underserved MS subpopulation. With only a handful of therapies in late-stage development that are aimed at halting disability progression in PP-MS—such as MediciNova’s ibudilast—this market is primed for new investment and drug discovery.

QUESTIONS ANSWERED

  • What are the top unmet needs in the treatment of PP-MS, and which therapies in development, if any, are poised to meet these needs?
  • Which clinical end points and drug attributes are most influential in prescribing for PP-MS? How does the only approved agent, Ocrevus, and other MS disease-modifying therapies perform on these attributes?
  • What magnitude of reduction in disease progression will result in a novel therapy being considered the gold-standard treatment for PP-MS?
  • Based on conjoint analysis and TPP simulation, what trade-offs between efficacy, safety, and price are neurologists willing to make for a hypothetical new PP-MS 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. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Geographies: United States, France, Germany, United Kingdom

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

Key drugs covered: Avonex, Aubagio, glatiramer acetate (Copaxone, generics), Gilenya, Ocrevus, Tecfidera, Tysabri

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.

Table of contents

  • Multiple Sclerosis - Unmet Need - Detailed, Expanded Analysis: Primary Progressive Multiple Sclerosis
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products Used for PP-MS
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Neurologists' Prescribing Decisions in PP-MS
      • Importance of Efficacy Attributes to Prescribing Decisions in PP-MS: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in PP-MS: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in PP-MS: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in PP-MS: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in PP-MS: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in PP-MS: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in PP-MS: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in PP-MS: 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 PP-MS: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in PP-MS: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for PP-MS: United States
      • Overall Performance of Key Therapies for PP-MS: Europe
      • Mean Overall Performance of Key Therapies for PP-MS: United States and Europe
      • Relative Performance of Key Therapies for PP-MS Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for PP-MS Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for PP-MS Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for PP-MS Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for PP-MS Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for PP-MS Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for PP-MS Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for PP-MS Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in PP-MS
      • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for PP-MS on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for PP-MS on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in PP-MS: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in PP-MS: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in PP-MS: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in PP-MS: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in PP-MS: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in PP-MS: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in PP-MS: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in PP-MS: Europe
      • Key Findings: Unmet Need in PP-MS and Related Indications
      • Surveyed Neurologists' Ascribed Level of Unmet Need in PP-MS and Related Indications: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need in PP-MS and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the PP-MS Market and Emerging Therapy Insights
        • Opportunity: Disease-Modifying Therapies That Are More Effective than Ocrevus in the Treatment of PP-MS
        • Opportunity: Other Avenues for Differentiation
    • 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 PP-MS
      • Attribute Importance and Part-Worth Utilities
        • PP-MS Target Product Profile: Attribute Importance
        • Reduction in Risk of EDSS Progression vs. Placebo: United States
        • Reduction in Risk of EDSS Progression vs. Placebo: Europe
        • Relative Difference in T25FW Performance vs. Placebo: United States
        • Relative Difference in T25FW Performance vs. Placebo: Europe
        • Reduction of Brain Volume Loss vs. Placebo: United States
        • Reduction of Brain Volume Loss vs. Placebo: Europe
        • Incidence of Nausea: United States
        • Incidence of Nausea: Europe
        • Overall Risk of PML: United States
        • Overall Risk of PML: Europe
        • Delivery Profile: United States
        • Delivery Profile: Europe
        • Price per Day: United States
        • Price per Day: Europe
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • PP-MS Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • PP-MS Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • PP-MS Market Simulations: Target Product Profiles Included in Scenario 1
        • PP-MS Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • PP-MS Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • PP-MS Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations

Author(s): Sarah Soucy

Sarah Soucy, M.S., is a Business Insights Analyst with the central nervous system/ophthalmology disorders group at Decision Resources Group. She has authored primary research and insights for dry and wet age-related macular degeneration and multiple sclerosis.

Prior to joining DRG, Ms. Soucy spent six years on the client side as a scientist at Pfizer in the inflammation and immunology research group with both in vitro and in vivo experience. She earned her B.S. in Animal Science with a Bioscience and Technology option and her M.S. in Nutritional Sciences from the University of New Hampshire, Durham, where she studied disordered metabolism


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