Asthma – Unmet Need – Detailed, Expanded Analysis – Severe Asthma (US/EU)
Several effective anti-inflammatory agents and bronchodilators are available for controlling mild or moderate asthma. However, despite the availability of long-acting muscarinic antagonists (LAMAs) (e.g., Boehringer Ingelheim’s Spiriva), long-acting beta2 agonist (LABA)/LAMA/inhaled corticosteroid (ICS) fixed-dose combinations (FDCs) (e.g., GlaxoSmithKline (GSK)’s Trelegy, Chiesi’s Trimbow), and novel biologics (e.g., AstraZeneca’s Fasenra, Teva’s Cinqair / Cinqaero, Sanofi / Regeneron’s Dupixent, GSK’s Nucala), there is still a need for effective therapies for severe disease, especially for patients whose symptoms are not adequately controlled with current therapies or who depend on frequent SABA and/or oral corticosteroid use to experience relief. This Unmet Need report provides quantitative insights into key treatment drivers and goals and the current level of unmet need in severe asthma, based on the perceptions of U.S. and European physicians. We analyze the commercial opportunities and how emerging therapies can capitalize on these opportunities.
QUESTIONS ANSWERED
- What are the drivers and goals in the treatment of severe asthma?
- 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 severe asthma?
- What are the prevailing areas of unmet need and opportunity in severe asthma?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European physicians for a hypothetical new drug for severe asthma?
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, France, Germany, United Kingdom
Primary research: Survey of 30 U.S. pulmonologists, 32 U.S. allergists, and 32 European pulmonologists fielded in December 2022.
Key companies: Amgen, AstraZeneca, Chiesi, GlaxoSmithKline, Novartis, Regeneron, Roche, Sanofi
Key drugs: Dupixent, Fasenra, Nucala, Tezspire (tezepelumab), Xolair, LABA/ICS FDCs, LABA/LAMA/ICS FDCs
Table of contents
- Asthma - Unmet Need - Detailed, Expanded Analysis - Severe Asthma (US/EU)
- Executive summary
- Unmet need - severe asthma - executive summary - March 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products / regimens for severe asthma 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' and allergists' prescribing decisions in severe asthma
- Importance of efficacy attributes to prescribing decisions in severe asthma: United States - pulmonologists
- Importance of efficacy attributes to prescribing decisions in severe asthma: United States - allergists
- Importance of efficacy attributes to prescribing decisions in severe asthma: Europe
- Importance of safety and tolerability attributes to prescribing decisions in severe asthma: United States - pulmonologists
- Importance of safety and tolerability attributes to prescribing decisions in severe asthma: United States - allergists
- Importance of safety and tolerability attributes to prescribing decisions in severe asthma: Europe
- Importance of convenience of administration attributes to prescribing decisions in severe asthma: United States - pulmonologists
- Importance of convenience of administration attributes to prescribing decisions in severe asthma: United States - allergists
- Importance of convenience of administration attributes to prescribing decisions in severe asthma: Europe
- Importance of nonclinical factors to prescribing decisions in severe asthma: United States - pulmonologists
- Importance of nonclinical factors to prescribing decisions in severe asthma: United States - allergists
- Importance of nonclinical factors to prescribing decisions in severe asthma: 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 severe asthma: United States - pulmonologists
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in severe asthma: United States - allergists
- Stated vs. derived Importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in severe asthma: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for severe asthma: United States - pulmonologists
- Overall performance of key therapies for severe asthma: United States - allergists
- Overall performance of key therapies for severe asthma: Europe
- Mean overall performance of key therapies for severe asthma: United States and Europe
- Relative performance of key therapies for severe asthma across select efficacy attributes: United States - pulmonologists
- Relative performance of key therapies for severe asthma across select efficacy attributes: United States - allergists
- Relative performance of key therapies for severe asthma across select efficacy attributes: Europe
- Relative performance of key therapies for severe asthma across select safety and tolerability attributes: United States - pulmonologists
- Relative performance of key therapies for severe asthma across select safety and tolerability attributes: United States - allergists
- Relative performance of key therapies for severe asthma across select safety and tolerability attributes: Europe
- Relative performance of key therapies for severe asthma across select convenience of administration attributes: United States - pulmonologists
- Relative performance of key therapies for severe asthma across select convenience of administration attributes: United States - allergists
- Relative performance of key therapies for severe asthma across select convenience of administration attributes: Europe
- Relative performance of key therapies for severe asthma across select nonclinical attributes: United States - pulmonologists
- Relative performance of key therapies for severe asthma across select nonclinical attributes: United States - allergists
- Relative performance of key therapies for severe asthma across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in severe asthma
- Surveyed pulmonologistsu2019 satisfaction with the performance of key therapies for severe asthma on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed allergistsu2019 satisfaction with the performance of key therapies for severe asthma on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed pulmonologistsu2019 satisfaction with the performance of key therapies for severe asthma on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key efficacy attributes in severe asthma: United States
- Surveyed allergists' ascribed level of unmet need across key efficacy attributes in severe asthma: United States
- Surveyed pulmonologists' ascribed level of unmet need across key efficacy attributes in severe asthma: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key safety and tolerability attributes in severe asthma: United States
- Surveyed allergists' ascribed level of unmet need across key safety and tolerability attributes in severe asthma: United States
- Surveyed pulmonologists' ascribed level of unmet need across key safety and tolerability attributes in severe asthma: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key convenience of administration attributes in severe asthma: United States
- Surveyed allergists' ascribed level of unmet need across key convenience of administration attributes in severe asthma: United States
- Surveyed pulmonologists' ascribed level of unmet need across key convenience of administration attributes in severe asthma: Europe
- Surveyed pulmonologists' ascribed level of unmet need across key nonclinical factors in severe asthma: United States
- Surveyed allergists' ascribed level of unmet need across key nonclinical factors in severe asthma: United States
- Surveyed pulmonologists' ascribed level of unmet need across key nonclinical factors in severe asthma: Europe
- Key findings: unmet need in severe asthma and related indications
- Surveyed pulmonologists' ascribed level of unmet need in severe asthma and related indications: United States
- Surveyed allergists' ascribed level of unmet need in severe asthma and related indications: United States
- Surveyed pulmonologists' ascribed level of unmet need in severe asthma and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the severe asthma market and emerging therapy insights
- Opportunity: treatments with robust efficacy in reducing exacerbation rates
- Opportunity: treatments offering less-burdensome administration
- Opportunity: treatments with demonstrated efficacy in non-TH2 asthma
- Areas of opportunity in the severe asthma 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 severe asthma
- Attribute importance and part-worth utilities
- Severe asthma target product profile: attribute importance
- Decrease in annual AER in TH2-high (e.g., u2265 300 eos/u00b5L) subpopulation (%, placebo-adj.)
- Decrease in annual AER in TH2-low (e.g., u2264 150 eos/u00b5L) subpopulation (%, placebo-adj.)
- Improvement in baseline FEV1 at 24 weeks (mL, placebo-adj.)
- Percentage of patients with u2265 50% reduction in OCS use at 24 weeks (%, placebo-adj.)
- Rate of severe adverse events over 48 weeks (% of patients, placebo-adj.)
- Dosing burden (drug formulation and frequency)
- Price per day
- Conjoint analysis-based simulation of a market scenario
- Severe asthma market simulation: likelihood to prescribe of target product profiles included in the market scenario
- Severe asthma market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Debismitha Priyanka Barua, M.P.H., Healthcare Research & Data Analyst, Immune and Inflammation. Prior to joining Clarivate, Ms. Barua was an epidemiologist for the Massachusetts Department of Public Health. She holds a master’s degree in epidemiology and biostatistics from Boston University’s School of Public Health and a bachelor’s degree in molecular, cellular, and developmental biology from the University of Kansas.