The U.S. therapy market for the SpA indications PsA, AS, and nr-AxSpA is becoming increasingly crowded as new biologics and SMIs offering novel MOAs enter the market and compete for preferential formulary placement and market share against established TNF-α inhibitors. With the additional threat of biosimilar versions of market leaders on the horizon, this research aims to provide a detailed, expanded analysis of the market access environment for SpA in the United States. Insight on the interaction between physicians and payers, the impact of reimbursement decisions on drug uptake, and the expectations for emerging SpA therapies will help clarify the current—and future—state of the SpA therapy market for drug developers hoping to penetrate this space.

Table of contents

  • Psoriatic Arthritis - Access & Reimbursement - Detailed, Expanded Analysis Spondyloarthritis (US)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes Among Spondyloarthritis Therapies in the United States
        • Stumbles Among Spondyloarthritis Therapies in the United States
        • United States: Reimbursement Successes and Stumbles
        • Key Stakeholders in the Road to Market Access
          • United States: Stakeholder Dynamics in the Road to Reimbursement
        • Key Market Access Roadblocks
          • Reimbursement Dynamics
            • United States: Commercial Managed Care Organizations
              • Lessons Learned and Key Takeaways
              • Drivers of Reimbursement for Spondyloarthritis
              • Drivers
              • Key Findings
              • Restrictions Used in Commercial Plans
              • Key Prior Authorization Requirements
              • Prior Authorization: Most Common Rules to Satisfy for Select Biologics/SMIs
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Patient Share in Key Payer Channel
              • Key Findings
              • Patient Share Among Commercially Insured Biologic/SMI-Treated PsA, AS, and Nr-AxSpA Patients
              • Top Prescribing Drivers
              • Factors Affecting Choice of a Biologic/SMI for the Treatment of PsA, AS, and Nr-AxSpA
            • Prescriber Preference
              • Prescriber Preferences for Spondyloarthropathies
              • Most Prescribed vs. Most Preferred Biologic/SMI for PsA, AS, and Nr-AxSpA
              • Key Reasons Why Physicians' Most Prescribed Biologic/SMI Differs from Their Preferred Biologic/SMI
            • Impact of Payer Policy on Prescribing
              • Impact of Payer Policy on Prescribing for Spondyloarthropathies
              • Physician-Reported Most-Important Restrictions Preventing Use of Biologics/Otezla by Biologics-Eligible PsA Patients
              • Physician-Reported Most-Important Restrictions Preventing Use of Biologics/Otezla by Biologics-Eligible AS Patients
              • Physician-Reported Most-Burdensome Restrictions to Prescribing for PsA or AS
              • Physician-Reported Most-Important Restrictions Preventing Use of Biologics/Otezla in Biologics-Eligible Nr-AxSpA Patients
              • Physician-Reported Most-Burdensome Restrictions to Prescribing for Nr-AxSpA
              • Payer-Reported Restrictions for SpA: Commercial Health Plans
              • Key Levers and Constraints on Select Biologics/SMIs Prescribed for SpA
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapies
              • Percentage of Biologic/SMI Share for PsA Therapies if Emerging Agents Are on a Preferred vs. Nonpreferred Tier
              • Likely Impact of Emerging Therapies for AS
              • Percentage of Biologic/SMI Share for AS Therapies if Emerging Agents Are on a Preferred vs. Nonpreferred Tier
            • Potential Placement of Emerging Therapies at Various Prices
              • Potential Tier Placement of Ixekizumab at Various Price Points
              • Potential Tier Placement of Brodalumab at Various Price Points
              • Potential Tier Placement of Xeljanz at Various Price Points
              • Utilization Management Criteria Likely to Be Applied to Ixekizumab and Brodalumab at Various Price Points on Payers' Commerical Health Plans
              • Utilization Management Criteria Likely to Be Applied to Xeljanz at Various Price Points on Payers' Commercial Health Plans
            • Prescriber and MCO Opinion on Remaining Unmet Need
              • Key Findings
              • Mean R&D Spending by Physicians
              • Mean R&D Spending by MCOs
          • Methodology
            • Key Abbreviations Related to SpA
            • Brands, Marketers of Key Biologics/SMIs for SpA in the United States
            • Primary Market Research Methodology: Physicians
              • Specialty of Surveyed Physicians
              • Average Number of Years Practiced Postresidency
              • Practice Setting of Surveyed Rheumatologists
              • Distribution of Medical Practice by Region
              • Distribution of Medical Practice by State
              • Average Number of PsA, AS, and Nr-AxSpA Patients Under Management per Month
              • Insurance Coverage for PsA, AS, and Nr-AxSpA Patients
              • Current Prescribing of Select Biologics/SMIs for PsA, AS, and Nr-AxSpA
            • Primary Market Research Methodology: MCOs
              • Number of MCO PDs/MDs
              • Distribution of MCOs by Region
              • Distribution of MCOs by State
              • The Operation of MCOs: National, Regional, or Single State
              • Types of Health Plans MCOs Offer
              • Distribution of MCOs by Number of Covered Lives
              • Average Number of Lives Surveyed MCOs Manage
              • Types of Formulary MCOs Use in Commercial Plans
              • Average Number of Voting Members in MCOs' P&T Committee
              • Frequency of P&T Committee Meetings
          • Appendix
            • Physician Survey
              • Percentage of Biologics/SMI-Eligible Patients vs. Percentage Currently Treated
              • Most Influential Reason Why Certain Biologics/SMI-Eligible Patients Are Not Receiving Biologics/SMI Treatment
              • [Q3]
              • Top Patient Cost-Related Issues Preventing Biologics/SMI Treatment to Certain Biologics/SMI-Eligible Patients
              • Most Prescribed Biologic/SMI Agents: PsA
              • Most Prescribed Biologic/SMI Agents: AS
              • Most Prescribed Biologic/SMI Agents: Nr-AxSpA
              • Most Preferred Biologic/SMI Agents: PsA
              • Most Preferred Biologic/SMI Agents: AS
              • Most Preferred Biologic/SMI Agents: Nr-AxSpA
              • Key Drivers for Expecting to Prescribe Cosentyx to PsA, AS, or Nr-AxSpA Patients Within the First Year of Availability
              • Top Reasons for Prescribing Cosentyx to PsA Patients
              • Earliest Line of Treatment Cosentyx Is Most Often Covered for Commercially Insured PsA Patients
              • Earliest Line of Treatment Cosentyx Is Most Often Covered for Commercially Insured AxSpA Patients
              • Surveyed Rheumatolgists' Expectation to Prescribe Cosentyx When It Becomes Available
              • Most Common Reason Cosentyx Is Consistently Denied Coverage for PsA and/or AxSpA Patients
              • Non-Clinical Factors Preventing Use of Cosentyx to PsA, AS, and Nr-AxSpA Patients
              • Reasons Rheumatologists Do Not Expect to Prescribe Cosentyx to Their PsA or AxSpA Patients
              • Most Preferred Patient Type for Emerging PsA Therapies if Reimbursement and Patient Costs Were Not an Issue
              • Primary Reasons for Expecting to Prescribe Xeljanz for PsA by 2019
              • Primary Reasons for Not Expecting to Prescribe Xeljanz for PsA by 2019
              • Expected Prescribing of Emerging IL-17 Inhibitors for PsA by 2019
              • Most Important Factors Driving Preference Among IL-17 Inhibitors for Treatment of PsA
              • Primary Reasons for Not Expecting to Prescribe Ixekizumab and/or Brodalumab for PsA by 2019
              • Most Preferred Patient Type for Emerging AS Therapies if Reimbursement and Patient Costs Were Not an Issue
              • Expectation to Prescribe Stelara or Otezla to AS and/or Nr-AxSpA Patients by 2019
              • Primary Reasons for Expecting to Prescribe Stelara and/or Otezla to AS and/or Nr-AxSpA Patients by 2019
              • Expectation to Prescribe Biosimilar Infliximab or Biosimilar Adalimumab Within One Year of Availability
              • Time Frame for Expectation to Prescribe Biosimilar Inflixmab or Biosimilar Adalimumab Within One Year of Availability
              • Most Important Reason Driving Expectation to Prescribe Biosimilars to SpA Patients Within One Year of Availability
              • Most Likely Patient Type for Prescription of Biosimilar Infliximab or Biosimilar Adalimumab
              • Expectation to Prescribe Biosimilar Infliximab or Biosimilar Adalimumab After One Year of Availability
              • Reasons Surveyed Rheumatologists Do Not Expect to Prescribe Biosimilar Infliximab or Adalimumab to Their PsA, AS, or Nr-AxSpA Patients
              • Physician Perception of Biologics/SMIs Access for Nr-AxSpA Compared with PsA and AS
              • Insurance-Related Factors Limiting Access of Biologics/SMIs for Nr-AxSpA More Than for PsA or AS
              • Impact of ACR Guidelines on Prescription of Biologics/SMIs to AxSpA Patients
              • Physician Awareness of Copay Assistance Programs
              • Perceived Impact of Copay Assistance Programs
            • MCO Survey
              • Necessary Items for Formulary Review Submission by MCO P&T Committees
              • Current Coverage of Biologics/SMIs for the Treatment of SpA on Payers' Largest Commercial Health Plan
              • Formulary Tier of Biologics/SMIs Covered on Payers' Largest Commercial Health Plan
              • Reasons for Exclusion or NDC Block of Select Biologics/SMIs on MCO Commercial Health Plans
              • MCO Coverage of Biologics/SMIs for Nr-AxSpA
              • Reasons Select Biologics/SMIs for Nr-AxSpA Are Not Covered on MCO Commercial Health Plans
              • Restrictions Used for Select Biologics/SMIs in Commerical Plans
              • Required Criteria Needed to Satisfy Prior Authorization Protocols
              • Expected Coverage in 12 Months of Biologics/SMIs for the Treatment of SpA
              • Most Important Criteria for an Emerging Agent to Be Placed on an Equivalent or Lower Tier Compared with TNF-Alpha Inhibitors
              • Preferred Comparator for an Emerging Agent for PsA, AS, and Nr-AxSpA
              • Current Coverage of Biologics/SMIs for the Treatment of SpA on Payers' Largest Medicare Advantage Plan
              • MCOs Carrying OOP Maximums That Include Drugs
              • How an MCO OOP Maximum Is Calculated
              • Average OOP Maximums per Time Frame
              • Most Influential Members in the P&T Committee
              • Time Until P&T Committee Reviews and Decides UM Criteria of a Newly Launched Product
              • MCO P&T Committee's Next Planned Review of Immunomodulators
              • MCO Views on the Use of Biologics/SMIs for the Treatment of Moderate to Severe PsA
              • MCO Views on the Use of Biologics/SMIs for the Treatment of Moderate to Severe PsA (Cont.)
              • MCO Views on the Use of Biologics/SMIs for the Treatment of AS
              • MCO Views on the Use of Biologics/SMIs for the Treatment of AS (Cont.)
              • MCO Views on the Use of Biologics/SMIs for the Treatment of Nr-AxSpA
              • MCO Views on the Use of Biologics/SMIs for the Treatment of Nr-AxSpA (Cont.)
              • Familiarity with Recently Published ACR Guidelines for the Treatment of AS and Nr-AxSpA
              • Expected Impact of ACR Guidelines on Expected Coverage of Biologics/SMIs for AS or Nr-AxSpA
              • Most Common Action MCOs Take for Newly FDA Approved SpA Drugs Yet to Complete Formulary Review
              • Most Preferred Models for Cost-Effectiveness Analysis in Determining Reimbursement Status of Emerging Therapies
              • Average of Highest Acceptable ICER per QALY for Emerging Therapies Deemed to Be Cost-Effective for SpA
              • Average Minimum Number of Diagnosed MCO Members Before Requirement of a Cost-Utility Model
              • Preferred Therapy That an Emerging Agent Must Prove Non-inferiority and Lower Cost Against in Cost-Minimization Models
              • MCO Expectation for Coverage of Biosimilar Infliximab and Biosimilar Adalimumab
              • Likely Coverage of Biosimilar Infliximab and Biosimilar Adalimumab in the First Year of Availability
              • Entity with Main Responsibility for Development and Maintenance of Formulary on Largest Commercial Health Plans
              • Use of PBM Standard vs. Custom Formulary
              • Degree of Customization by MCOs Using an External PBM Custom Formulary
              • Pharmacoeconomic Data MCOs Would Find Most Compelling for an Emerging SpA Therapy
              • MCO Knowledge of Pharmacoeconomic/Health Outcomes Data Submissions for Biologics/SMIs
              • Quality of Pharmacoeconomic/Health Outcomes Data Submitted for Biologics/SMIs in the Treatment of SpA
              • Effects of Pharmacoeconomic/Health Outcomes Data on MCO Decisions
              • Most Common Coinsurance Percentage for Biologics/SMIs on Pharmacy Tier or Medical Benefit Only
              • Most Common Copayment Amount for Biologics/SMIs on Pharmacy Tier or Medical Benefit Only

        Author(s): Michael Darcy, PhD

        Originally from the Windy City, Michael made his way over to Genetown to be immersed in the rich life science/biotech environment. At DRG, he provides valuable market insights for DRG’s core primary research products across multiple immune indications with expertise in both forms of inflammatory bowel disease (Crohn’s disease and ulcerative colitis).

        Prior to joining DRG, Michael obtained his Ph.D. in Neuroscience from Florida State University in 2010 and was a fellow at Tufts University School of Medicine where he performed research on adult neurogenesis and the transgenerational effects of chronic stress.  


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