Rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) are chronic and, in many cases, debilitating diseases requiring lifelong treatment. Costs associated with biologic treatment for RA patients not successfully managed on conventional disease-modifying antirheumatic drugs (DMARDs) can be in excess of $30,000 per year. In the effort to curb escalating drug costs associated with treating these chronic, progressive conditions, many health insurers have turned to narrow provider network arrangements and clinical pathways that encourage prescribers to use preferred agents and to achieve cost-control targets. This report focuses on the effect of narrow provider networks and clinical pathways on the use of branded drugs treating moderate to severe RA and SLE. RA is a crowded category of branded biologic drugs, led by three of the longest-used biologic agents: etanercept (Amgen/Pfizer‘s Enbrel), infliximab (Janssen’s Remicade), and adalimumab (AbbVie’s Humira)—all TNF-alpha inhibitors. More-recent agents studied include certolizumab pegol (UCB’s Cimzia), tocilizumab, (Roche’s Actemra), abatacept (Bristol-Myers Squibb’s Orencia), and rituximab (Biogen Idec/Roche’s Rituxan). An oral nonbiologic, tofacitinib (Pfizer’s Xeljanz), is the most recent arrival on the market (2012). Treatment of advanced SLE includes off-label use of DMARDs including Genentech’s CellCept and the B-cell modulator Rituxan, as well as a relatively new rheumatologic agent, belimumab (GlaxoSmithKline’s Benlysta).

Questions Answered:

  • Clinical pathways—which identify preferred drugs for use at each stage of treatment—are mostly known for their use in oncology indications; however, some health plans and providers are also using pathways for RA and SLE, and many anticipate doing so within the next ten years. What outcomes related to clinical pathways have been noted by payers that have used them for autoimmune conditions? How do plans encourage physicians to follow clinical pathways and what is the average targeted compliance rate? What attributes of a drug are important to payers and physicians when determining which drugs should be included in pathways?
  • Survey results show that clinical pathways often follow the step therapy profile of the insured member’s health plan. What are the most common restrictions on RA and SLE drugs imposed by payers? What are the successes and stumbles of specific drugs to treat these conditions, based on physicians’ reactions to access and reimbursement issues?
  • Narrow networks—a network of healthcare providers that is a smaller subset of a broader provider network—have become a familiar feature in low-cost health plans for individuals and small groups. How do managed care organizations (MCOs) select rheumatologists to participate in their narrow networks and what conditions must they meet to stay in these networks? What impacts on prescribing patterns do MCO officials expect to result from narrow network participation, and what are the actual impacts as reported by rheumatologists for drugs treating RA and SLE? Are separate formularies used for narrow network plans?

“Scope:

Markets covered: United States.

Primary research: Online survey of 101 rheumatologists, 37 MCO medical directors, and 26 MCO pharmacy directors.

Commercial context: Epidemiology tables, drug-treatment algorithms, and managed care background information.

Therapies covered: Drugs used for the treatment of RA and SLE in the following categories: TNF-alpha inhibitors, B-cell-targeted therapies, selective costimulation moderators, IL-6 inhibitors, IL-1 inhibitors, and Jak inhibitors.”

Table of contents

  • Rheumatoid Arthritis - Access & Reimbursement - Detailed, Expanded Analysis Rheumatoid Arthritis And Systemic Lupus Erythematosus (US)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New RA and SLE Therapies in the US
    • Successes and Stumbles
      • Successes and Stumbles Among Autoimmune Therapies in the US
      • United States: Reimbursement Successes and Stumbles
        • Reimbursement Successes or Stumbles for Autoimmune Drugs
    • Key Stakeholders in the Road to Market Access
      • Key Stakeholders in the Path to Formulary Access
      • Stakeholder Dynamics in the Road to Reimbursement
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for RA and SLE Therapies
    • Reimbursement Dynamics
      • United States: Commercial Managed Care Organizations
        • Lessons Learned and Key Takeaways
        • Most Influential Factor in Formulary Placement for RA and SLE Drugs
        • Key P&R Drivers Within Clinical Pathways and Narrow Network Formularies
        • Key Findings
        • Restrictions for RA
        • Restrictions for SLE
        • Most Common Step Therapy Requirements for RA Drugs
        • Physician-Reported Conditions for Narrow Network Involvement
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Patient Share in Key Payer Channel
        • Patient Share for Rheumatoid Arthritis Drugs
        • Patient Share for Systemic Lupus Erythematosus Drugs
        • Rheumatologists’ Top Three Metrics for Including RA and SLE Drugs in Pathways
      • Prescriber Preference
        • Clinical Pathway Preference for RA: MCOs and Rheumatologists
      • Impact of Payer Policy on Prescribing
        • Physician-Reported Restrictions Encountered for TNF-α Inhibitors in RA
        • Key Levers and Constraints on Current Therapies
    • Methodology
      • Abbreviations
      • Primary Market Research Methodology - Physicians
        • Survey Design Overview
        • Specialty of Surveyed Physicians
        • Surveyed Physicians' Opinion on Justification for Clinical Pathways for RA and SLE
        • Surveyed Physicians' Participation in Narrow Networks
        • Physician Practice By Region
      • Primary Market Research Methodology - MCOs
        • Survey Design Overview
        • MCO Participation in Clinical Pathways that Include RA and SLE Drugs
        • Percentage of MCOs Operating a Clinical Pathways Program That Includes Rheumatologists
        • Types of Health Plans Offered by MCOs
        • Number of Formulary Tiers for MCOs’ Largest Risk-based Commercial Plans
        • Tier Definitions in MCOs’ Largest Risk-Based Commercial Plans
    • Appendix
      • Physician Survey
        • Physician-Reported Prescribing for SLE
        • Physician-Reported Prescribing for RA
        • Patient Share in First- and Second-Line Treatment of RA
        • Physician-Reported Frequency of UM Controls for RA Drugs
        • Physician-Reported Patient Share for Drugs Treating SLE
        • Prescribing Scenarios for Benlysta in the Treatment of SLE
        • Physician-Reported Frequency of UM Controls for SLE Drugs
        • Clinical Pathways’ Influence Beyond the MCO’s Program Population
        • Percentage of Patients to Which Clinical Pathways Apply
        • Leading Role in the Development of Clinical Pathways for RA and SLE
        • Challenges Faced by Physicians Participating in Clinical Pathways
        • Targeted Compliance Rate for Clinical Pathways in RA and SLE
        • Incentives for Clinical Pathway Compliance
        • Rheumatologists’ Top Three Metrics for Drug Inclusion in Pathways for RA and SLE
        • Rheumatologists' Objection to Pathways Encouraging Use of TNF-alpha Inhibitors for RA
        • Rheumatologists’ Objection to Pathways Incentivizing Immunosuppressant Use Before Benlysta
        • Emergence of New Biologics for SLE as a Reason for SLE Pathways
        • Pathway-Participating Rheumatologists’ Recommendation of RA Drugs for Clinical Pathway Inclusion
        • Pathway Nonparticipants’ Recommendation of RA Drugs for Clinical Pathways
        • Recommended Approach for Developing Clinical Pathway for SLE, as Reported by Physicians Not Participating in a CPP
        • Rheumatologists’ Timing for Joining Narrow Network
        • Number of Narrow Networks in Which Rheumatologists Participate
        • Number of Narrow Networks in Which Rheumatologists Expect to Participate
        • Rheumatologists’ Reasons for Not Joining a Narrow Network
        • Use of Separate Formularies in Narrow Networks Reported by Participating Rheumatologists
        • Use of Separate Formularies in Narrow Networks Reported by Rheumatologists Expecting to Participate in Narrow Networks
        • Conditions for Rheumatologists’ Inclusion in Narrow Networks
        • Impact of Rheumatologists’ Participation in Narrow Networks
        • Acceptable Conditions for Future Narrow Network Participants
        • Anticipated Impact of Narrow Network Participation in the Future
        • Impact of Narrow Network Participation on Prescribing of Specific Drugs for RA
        • Impact of Narrow Network Participation on Prescribing of Specific Drugs for SLE
        • Anticipated Impact of Narrow Network Participation on Prescribing of Specific Drugs for RA
        • Anticipated Impact of Narrow Network Participation on Prescribing of Specific Drugs for SLE
        • Rheumatologists: Reasonable Compliance Level for Pathways
      • MCO Survey
        • Size of MCOs’ P&T Committees
        • Meeting Frequency of MCOs’ P&T Committees
        • Top Three Influencers on MCO Formulary Decisions
        • Formulary Creation/Maintenance Responsibility for MCOs’ Largest Risk-Based Commercial Plans
        • PBM Formulary Use by MCOs: Standard or Custom
        • Custom PBM Formulary Users: Degree of Customization
        • Top Three Factors Influencing Formulary Placement/Reimbursement of RA and SLE Drugs
        • Essential Information for P&T Committee Review of RA Drugs
        • Drug Copays/Coinsurance for Formulary Tiers in MCOs’ Largest Commercial Plans
        • Coinsurance Levels for Tiers Carrying Coinsurance in MCOs’ Largest Commercial Plans
        • Indications for Which MCOs Now Have Clinical Pathways Programs
        • Indications for Which MCOs Expect to Have Clinical Pathways Programs
        • Top Three Reasons for MCOs’ Adoption of Clinical Pathways Programs
        • Results Observed in Various MCOs’ Clinical Pathways Programs
        • Potential Future Justification for Clinical Pathways in RA and SLE
        • Degree of Stakeholder Influence in Determining Drugs on Clinical Pathways
        • Three Biggest Challenges Encountered by MCOs During Clinical Pathway Development
        • MCOs’ Top Three Anticipated Challenges in Implementing Clinical Pathways
        • MCOs’ Strategies for Overcoming Resistance to Pathways by Rheumatologists
        • MCOs’ Predicted Compliance Target for Clinical Pathways
        • MCOs’ Incentives for Reaching Compliance with Clinical Pathways
        • Ways Pharma Can Help Make Clinical Pathways Work
        • MCOs’ Tier Placement of RA Therapies in Largest Commercial Plan
        • MCOs’ Tier Placement of SLE Therapies in Largest Commercial Plan
        • Preferred Status of RA Therapies on MCOs’ Largest Commercial Plans
        • Preferred Status of SLE Therapies on MCOs’ Largest Commercial Plans
        • Cost Controls for Specific RA Therapies on MCOs’ Largest Commercial Plans
        • MCOs’ Step Therapy Requirements for Specific RA Drugs
        • Cost Controls for Specific SLE Therapies on MCOs’ Largest Commercial Plans
        • Top Metrics Used by MCOs to Determine Drug Inclusion in Clinical Pathways
        • MCOs’ Clinical Pathway Approaches Used for RA and SLE
        • RA Drugs Included in Clinical Pathways After Failure on Conventional DMARD, by Treatment Line
        • MCOs’ Clinical Pathway Requirements for Use of Benlysta for SLE
        • Impact of New Biologics on Potential Creation of Clinical Pathways for SLE
        • MCOs’ Reasons for Developing Narrow Networks
        • Percentage of MCOs’ Members Within Narrow Network
        • MCOs’ Projected Narrow Network Membership in 12 Months
        • Characteristics of MCOs’ Narrow Networks
        • Size of MCOs’ Narrow Network Relative to Its Traditional Network
        • Average Percentage of Cost Savings Achieved Through Narrow Network
        • Approaches Used by MCOs in Developing Narrow Networks
        • MCOs’ Method of Targeting Physician Groups for Narrow Network Participation
        • Conditions for Physician Participation in MCOs’ Narrow Networks
        • MCOs’ Use of Separate Formulary within Narrow Network
        • MCOs’ Required Use of Separate Narrow Network Formulary for RA and SLE Drugs
        • Expected Prescribing Impact of Separate Narrow Network Formulary on Specific RA and SLE Drugs
      • Additional Information
        • Clinical Pathways for RA
        • Clinical Pathways for SLE
        • Narrow Network Participation
        • MCO Reasons for Creating Narrow Networks
        • Impact of Rheumatologists’ Participation in Narrow Networks
        • Impact of Narrow Networks on RA Prescribing
        • Impact of Narrow Networks on SLE Prescribing
        • MCOs’ Approaches to Clinical Pathways and MCO Results Seen in Autoimmune CPPs
        • Ways in Which MCOs Incentivize Physicians to Reach Desired Rate of Pathway Compliance*
        • MCO Reimbursement for SLE Drugs
        • Preferred Status for SLE Drugs – Now and in 12 Months
        • Physician-Reported Restrictions Encountered for SLE Drugs
      • Commercial Context
        • U.S. Prevalent Cases of RA, 2014-2018
        • Timeline for Launches of Marketed RA Biologics
        • Approved RA Therapies in the United States
        • 2014 Annual Cost of Therapy, United States

Author(s): Paula Wade

Paula Wade tracks and analyses the national trends in the U.S. health insurance industry for Decision Resources Group. She produces the company’s Managed Care Organization Analyzer products and has authored several of DRG’s Physician Payer Dynamics reports.

A former newspaper journalist with a background in survey research, Ms. Wade has also worked in healthcare advocacy and for the Tennessee Department of Commerce and Insurance.


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