Interstitial cystitis/bladder pain syndrome (ICBPS) is a disorder characterized by chronic pain, discomfort, and pressure in the pelvic region that often includes symptoms of urinary frequency and urgency. Janssen/bene-Arzneimittel’s Elmiron and Mylan’s intravesical dimethyl sulfoxide (RIMSO-50) are the only two pharmacological treatments approved for ICBPS, but other antihistamines, antidepressants, and antiepileptics may be used off-label to ameliorate symptoms. Because pharmacological treatments are usually only partially effective, they are often combined with nonpharmacological therapies in a trial-and-error approach. As such, substantial unmet need persists for more effective treatment options.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for ICBPS?
- What 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 ICBPS?
- What are the prevailing areas of unmet need and opportunity in ICBPS?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European urologists for a hypothetical new ICBPS drug?
PRODUCT DESCRIPTION
Unmet Need: 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, United Kingdom, France, Germany.
Primary research: Survey of 60 U.S. and 30 European urologists fielded in March 2018.
Key companies: bene-Arzneimittel, Janssen, Mylan, Pfizer.
Key drugs: Elmiron, amitriptyline, hydroxyzine, duloxetine, Lyrica, gabapentin, intravesical medications (lidocaine, heparin, dimethyl sulfoxide, hyaluronic acid, others).
Key metrics included:
- Stated versus derived analysis of U.S. and European physician prescribing behavior.
- Conjoint analysis with U.S. and European physicians, including market simulator.
- Assessment of current drug performance against treatment drivers and goals.
- Physician perceptions of unmet need in disease/subpopulation covered and related diseases/subpopulations.
- Chronic Pain - Unmet Need - Detailed, Expanded Analysis: Interstitial Cystitis (US/EU)
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Efficacy
- Safety and Tolerability
- Convenience of Administration
- Rationale for Drug Selection
- Products for Interstitial Cystitis
- Treatment Drivers and Goals
- Key Findings: Attribute Importance
- Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Urologists' Prescribing Decisions in Interstitial Cystitis
- Importance of Efficacy Attributes to Prescribing Decisions in Interstitial Cystitis: United States
- Importance of Efficacy Attributes to Prescribing Decisions in Interstitial Cystitis: Europe
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Interstitial Cystitis: United States
- Importance of Safety and Tolerability Attributes to Prescribing Decisions in Interstitial Cystitis: Europe
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Interstitial Cystitis: United States
- Importance of Convenience of Administration Attributes to Prescribing Decisions in Interstitial Cystitis: 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 Interstitial Cystitis: United States
- Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Interstitial Cystitis: Europe
- Product Performance Against Treatment Drivers and Goals
- Key Findings
- Overall Performance of Key Therapies for Interstitial Cystitis: United States
- Overall Performance of Key Therapies for Interstitial Cystitis: Europe
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Efficacy Attributes: United States
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Efficacy Attributes: Europe
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Safety and Tolerability Attributes: United States
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Safety and Tolerability Attributes: Europe
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Convenience of Administration Attributes: United States
- Relative Performance of Key Therapies for Interstitial Cystitis Across Select Convenience of Administration Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in Interstitial Cystitis
- Surveyed Urologistsu2019 Satisfaction with the Performance of Key Therapies for Interstitial Cystitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
- Surveyed Urologistsu2019 Satisfaction with the Performance of Key Therapies for Interstitial Cystitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Interstitial Cystitis: United States
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Interstitial Cystitis: Europe
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Interstitial Cystitis: United States
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Interstitial Cystitis: Europe
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Interstitial Cystitis: United States
- Surveyed Urologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Interstitial Cystitis: Europe
- Key Findings: Unmet Need in Unmet Need and Related Indications
- Surveyed Urologists' Ascribed Level of Unmet Need in Interstitial Cystitis and Related Indications: United States
- Surveyed Urologists' Ascribed Level of Unmet Need in Interstitial Cystitis and Related Indications: Europe
- Opportunity Analysis
- Areas of Opportunity in the Interstitial Cystitis Market and Emerging Therapy Insights
- Opportunity: A Therapy That More Effectively Reduces Bladder Pain
- Opportunity: A Therapy That Improves Quality of Life
- Target Product Profiles
- Assessing Drug Development Opportunities
- Target Product Profile Methodology
- Attributes and Attribute Levels
- Attribute Importance and Part-Worth Utilities
- Interstitial Cystitis Target Product Profile: Attribute Importance
- Reduction in Average Daily Pain Intensity from Baseline as Measured by 11-point NRS
- Reduction in Interstitial Cystitis Symptom Index Score from Baseline
- Reduction in Urinary Frequency/Urgency from Baseline
- Percentage of Patients Experiencing Any Non-Serious Treatment Emergent Adverse Events
- Percentage of Patients Experiencing Any Serious Treatment Emergent Adverse Events
- Delivery Burden
- Price Per Treated Day
- Conjoint Analysis-Based Simulations of Market Scenarios
- Interstitial Cystitis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
- Interstitial Cystitis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
- Interstitial Cystitis Market Simulations: Target Product Profiles Included in Scenario 1
- Interstitial Cystitis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
- Interstitial Cystitis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
- Interstitial Cystitis Market Simulations: Target Product Profiles Included in Scenario 2
- Appendix
- Key Abbreviations
- Experts Interviewed
- Bibliography
Natalie Taylor, Ph.D.
Natalie Taylor, Ph.D., is a principal business insights analyst on the CNS/Ophthalmology Disorders team at Clarivate. She has more than ten years of experience authoring primary and market research reports for pharmaceutical industry clients in the fields of psychiatry, pain, neurology, and ophthalmology. Previously, Dr. Taylor worked at QuintilesIMS as manager of its CNS portfolio. She completed her Ph.D. in physiology at Dartmouth College in New Hampshire, where she studied the role of serotonergic neurons in the medullary raphe on modulating respiratory responses in mammals. She holds a B.S. in biology from Dickinson College in Pennsylvania.