Rheumatoid Arthritis – Unmet Need – Detailed, Expanded Analysis: TNF-Alpha Refractory Rheumatoid Arthritis (US & EU)
Rheumatoid arthritis (RA) patients who are refractory to one or more tumor necrosis factor-alpha (TNF-α) inhibitors are generally prescribed a non-TNF-targeted therapy (e.g., Bristol Myers Squibb’s Orencia, Roche’s Actemra / RoActemra, Roche’s Rituxan / MabThera, AbbVie’s Rinvoq, Pfizer’s Xeljanz, Eli Lilly / Incyte’s Olumiant). The launch of non-invasive targeted therapies like JAK inhibitors offer more treatment options to rheumatologists. However, recent safety data raise new concerns about JAK inhibitors, highlighting an unmet need for less risk of serious infections, cardiovascular events, and/or malignancy and restricting these drugs’ use in older patients with comorbidities. Although the RA therapy market offers multiple efficacious and relatively safe agents, patients refractory to TNF-α inhibitors still have limited options; therefore, a substantial unmet need remains in the treatment of TNFi-refractory RA.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for TNFi-refractory RA?
- What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
- How do current therapies perform on key treatment drivers and goals for TNFi-refractory RA?
- What are the prevailing areas of unmet need and opportunity in TNFi-refractory RA?
- What trade-offs across different clinical attributes and prices are acceptable to U.S. and European rheumatologists for a hypothetical new TNFi-refractory RA drug?
PRODUCT DESCRIPTION
Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, France, Germany, United Kingdom
Primary research: Survey of 61 U.S. and 30 European rheumatologists fielded in December 2021
Key companies: Amgen, Pfizer, Roche, Biogen, Bristol Myers Squibb, Eli Lilly, AbbVie
Key drugs: Enbrel, Rituxan / MabThera, Orencia, Actemra / RoActemra, Xeljanz, Olumiant, Rinvoq
Table of contents
- Rheumatoid Arthritis - Unmet Need - Detailed, Expanded Analysis: TNF-Alpha Refractory Rheumatoid Arthritis (US & EU)
- Executive summary
- Unmet Need - TNAi-Refractory RA - Executive Summary - March 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for RA 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 rheumatologists' prescribing decisions in TNFi-refractory RA
- Importance of efficacy attributes to prescribing decisions in TNFi-refractory RA: United States
- Importance of efficacy attributes to prescribing decisions in TNFi-refractory RA: Europe
- Importance of safety and tolerability attributes to prescribing decisions in TNFi-refractory RA: United States
- Importance of safety and tolerability attributes to prescribing decisions in TNFi-refractory RA: Europe
- Importance of convenience of administration attributes to prescribing decisions in TNFi-refractory RA: United States
- Importance of convenience of administration attributes to prescribing decisions in TNFi-refractory RA: Europe
- Importance of nonclinical factors to prescribing decisions in TNFi-refractory RA: United States
- Importance of nonclinical factors to prescribing decisions in TNFi-refractory RA: 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 TNFi-refractory RA: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in TNFi-refractory RA: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for TNFi-refractory RA: United States
- Overall performance of key therapies for TNFi-refractory RA: Europe
- Mean overall performance of key therapies for TNFi-refractory RA: United States and Europe
- Relative performance of key therapies for TNFi-refractory RA across select efficacy attributes: United States
- Relative performance of key therapies for TNFi-refractory RA across select efficacy attributes: Europe
- Relative performance of key therapies for TNFi-refractory RA across select safety and tolerability attributes: United States
- Relative performance of key therapies for TNFi-refractory RA across select safety and tolerability attributes: Europe
- Relative performance of key therapies for TNFi-refractory RA across select convenience of administration attributes: United States
- Relative performance of key therapies for TNFi-refractory RA across select convenience of administration attributes: Europe
- Relative performance of key therapies for TNFi-refractory RA across select nonclinical attributes: United States
- Relative performance of key therapies for TNFi-refractory RA across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in TNFi-refractory RA
- Surveyed rheumatologistsu2019 satisfaction with the performance of key therapies for TNFi-refractory RA on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed rheumatologists' satisfaction with the performance of key therapies for TNFi-refractory RA on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key efficacy attributes in TNFi-refractory RA: United States
- Surveyed rheumatologists' ascribed level of unmet need across key efficacy attributes in TNFi-refractory RA: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key safety and tolerability attributes in TNFi-refractory RA: United States
- Surveyed rheumatologists' ascribed level of unmet need across key safety and tolerability attributes in TNFi-refractory RA: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in TNFi-refractory RA: United States
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in TNFi-refractory RA: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key nonclinical factors in TNFi-refractory RA: United States
- Surveyed rheumatologists' ascribed level of unmet need across key nonclinical factors in TNFi-refractory RA: Europe
- Key findings: unmet need in TNFi-refractory RA and related indications
- Surveyed rheumatologists' ascribed level of unmet need in TNFi-refractory RA and related indications: United States
- Surveyed rheumatologists' ascribed level of unmet need in TNFi-refractory RA and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the TNFi-refractory RA market and emerging therapy insights
- Opportunity: a novel therapy demonstrating sustained efficacy
- Opportunity: a novel therapy offering better safety in TNFi-refractory RA
- Opportunity: an effective therapy offering a new mechanism of action
- Areas of opportunity in the TNFi-refractory RA 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 TNFi-refractory RA
- Attribute importance and part-worth utilities
- TNFi-refractory RA target product profile: attribute importance
- ACR 20 response in TNFi-refractory patients at 6 months (% of patients)
- Remission (DAS28 < 2.6) in TNFi-refractory patients at 6 months (% of patients)
- Change from baseline in SF-36 physical component score at 6 months
- Rate of serious infections (% of patients)
- Length of postmarketing safety surveillance (time on market)
- Delivery burden (route and frequency of administration)
- Price per day (relative to SC Orencia)
- Conjoint analysis-based simulation of a market scenario
- TNFi-refractory RA market simulation: share of preference of target product profiles included in the market scenario
- Market simulation: likelihood to prescribe target product profiles included in the market scenario
- TNFi-refractory RA market simulation: target product profiles included in the market scenario
- Appendix
- Key Abbreviations
- Bibliography
- Executive summary
Sheema Kher, M.Pharm., is an associate analyst on the Immune and Inflammatory Disorders team at Clarivate. Ms. Kher has much experience in the U.S. market access and payer landscape and has analyzed formulary and payer restrictions in multiple therapy areas for diverse lines of business, including commercial, HIX, managed Medicaid, state Medicaid, and Medicare. She holds a master’s degree in drug regulatory affairs from Amity University in Noida.