Multiple Sclerosis – Unmet Need – Detailed, Expanded Analysis: Primary-Progressive Multiple Sclerosis (US/FR/DE/UK)
Roche / Genentech achieved a clinical and regulatory milestone with the approval of Ocrevus for the treatment of primary-progressive multiple sclerosis (PP-MS)—making it the first agent to approved for this MS subpopulation. According to Clarivate research and company reports, uptake of the drug in PP-MS has been understandably strong, with significant revenue coming from the PP-MS market. Nevertheless, opportunity in the space remains because the drug may not be appropriate for all patients. Ocrevus targets neuroinflammation, which is not observed in all PP-MS patients, and according to some KOLs interviewed by Clarivate, it imparts a modest clinical effect in PP-MS. This report will examine neurologists’ satisfaction with Ocrevus and DMTs used off-label today in PP-MS, and gauge the opportunity and value-drivers for alternatives to treat this underserved MS subpopulation. Ocrevus could soon face competition in PP-MS from Sanofi’s tolebrutinib, Roche’s fenebrutinib, and AB Science’s masitinib. However, with only a handful of therapies aimed at halting disability progression in PP-MS in late-phase development, this market segment is primed for new investment and drug discovery.
QUESTIONS ANSWERED
- What are the top areas of unmet need in PP-MS, and which therapies in development, if any, are poised to meet these needs?
- Which clinical endpoints and drug attributes are most influential in prescribing for PP-MS? How do Ocrevus (the only approved agent) and other MS DMTs perform on these attributes?
- What magnitude of reduction in disease progression will result in a novel therapy being considered the gold standard for treating PP-MS?
- Based on conjoint analysis and TPP simulation, which 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. One market scenario is profiled in detail by Clarivate 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 61 U.S. and 32 European neurologists fielded in January 2023
Key companies: Sanofi, Teva, Novartis, Merck KGaA / EMD Serono, Roche / Genentech, Biogen
Key drugs: Aubagio, Copaxone / glatiramer acetate, Gilenya, Mavenclad, Ocrevus, Tecfidera / dimethyl fumarate, Tysabri
Table of contents
- Multiple Sclerosis - Unmet Need - Detailed, Expanded Analysis: Primary-Progressive Multiple Sclerosis (US/FR/DE/UK)
- Executive summary
- Unmet need - Primary-Progressive Multiple Sclerosis - executive summary - April 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for PP-MS 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 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 neurologistsu2019 satisfaction with the performance of key therapies for PP-MS on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed neurologistsu2019 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: Novel PP-MS DMTs offering a larger reduction in CDP than Ocrevus
- Opportunity: Additional effective DMTs that would support a personalized approach to PP-MS treatment
- Opportunity: Development of DMTs or adjunctive therapies that improve cognition
- Areas of opportunity in the PP-MS 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 PP-MS
- Attribute importance and part-worth utilities
- PP-MS target product profile: attribute importance
- Reduction in risk of EDSS progression vs. placebo
- Reduction in risk of T25FW worsening vs. placebo
- Decrease in 9-HPT time vs. placebo
- % of patients with improvement in cognitive processing speed (SDMT) vs. placebo
- Risk of serious adverse events
- Delivery profile
- Price per day
- Conjoint analysis-based simulation of a market scenario
- Market scenario
- PP-MS market simulation: share of preference of target product profiles included in the market scenario
- PP-MS market simulation: likelihood to prescribe of target product profiles included in the market scenario
- PP-MS market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Executive summary
Grant Nix, M.B.A., Healthcare Research & Data Analyst. His focus is the multiple sclerosis market. In this role, he conducts primary and secondary research to analyze pharmaceutical markets, with a focus on neurology indications, including multiple sclerosis. Prior to joining Clarivate, he worked as an operations analyst at UNC Health, positioned on a behavioral health unit. He earned his M.B.A. at North Carolina Central University, where he specialized in finance. He also holds a B.S. in chemistry from Campbell University.