As the prevalence of chronic pain associated with numerous indications (e.g., osteoarthritis, cancer) and of idiopathic origin (e.g., chronic back pain) continues to increase in the United States, obtaining favorable market access and reimbursement for branded analgesics will become increasingly challenging. The current analgesic market contains a wide variety of well-entrenched and established therapeutic options across several drug classes, frequently available in generic forms, and continues to see entry of new analgesics that are most often either abuse-deterrent formulations of existing opioid analgesics or reformulations of existing products. Despite the quantity of analgesic options available, surveyed payers and physicians are united in their acknowledgement of the continuing clinical shortcomings of many therapies and in their support for new analgesics. Emerging analgesics that are able to differentiate from current products on clinical factors and are able to present persuasive pharmacoeconomic data will be most likely to obtain favorable market access/reimbursement conditions from MCOs, which will then facilitate use among prescribers who are particularly sensitive to the impact of cost-sharing on their chronic pain patients.

Questions Answered:

  • In light of the expanding genericization of current analgesics, branded agents are frequently subject to reimbursement restrictions and utilization controls. What reimbursement restrictions and utilization controls are the most commonly used for key analgesics? How restrictive do prescribers perceive these controls to be? How do utilization controls impact prescribing and treatment selection? 
  • Abuse/misuse of opioid analgesics are a prominent concern to both payers and physicians. How does the availability of ADFs of opioid analgesics impact physicians’ prescribing? How do ADFs of opioid analgesics currently fare in market access given the variety of branded and generic opioid analgesics without abuse-deterrence?
  • Despite the crowded analgesic market for the treatment of chronic pain, emerging analgesics such as those from Depomed/Grünenthal (cebranopadol) and Pfizer/Eli Lilly (tanezumab) are likely to receive formulary coverage in most MCOs. What reimbursement restrictions and utilization controls are these agents most likely to incur? What actions can drug developers undertake to lessen the impact of these controls on prescribers? How will various degrees of control impact physician willingness to prescribe these agents?

Scope:

Markets covered: United States.

Methodology: Surveys of 143 PCPs and pain specialists and 30 managed care company officials, including 15 pharmacy directors and 15 medical directors, in January 2017.

Indication coverage: Chronic pain.

Key drugs covered: Celebrex, Cymbalta, Hysingla ER, Lyrica, Nucynta ER, OxyContin, Targiniq ER, Zohydro ER, cebranopadol, tanezumab.

Key companies mentioned: Acorda, Depomed, Eli Lilly, Endo, Grünenthal, Horizon, Janssen, NeurogesX, Pernix, Pfizer, Purdue, Zogenix.

Table of contents

  • Chronic Pain - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Key Updates
      • December 2017
        • September 2017
          • May 2017
          • Market Access Overview
            • Actionable Recommendations to Optimize Market Access
              • Successes and Stumbles
                • Overview of Successes & Stumbles for Chronic Pain
                • Successes Among Chronic Pain Therapies in the United States: Physicians
                • Stumbles Among Chronic Pain Therapies in the United States: Physicians
                • Best-Performing Drug Class in Clinical Factors: Physicians
                • Overall Best-Performing Drug Class in Market Access Themes: Physicians
                • Best-Performing Drug Class in Market Access Factors: Physicians
                • Successes Among Chronic Pain Therapies in the United States: MCOs
                • Stumbles Among Chronic Pain Therapies in the United States: MCOs
              • Key Stakeholders in the Road to Market Access
                • Stakeholder Influence on Physician Prescribing
                • United States: Stakeholder Dynamics in the Road to Reimbursement
                • Healthcare Coverage in the United States
                • Healthcare Coverage in the United States
                • Major Commercial Insurers in the United States
              • Key Market Access Roadblocks
                • Reimbursement Dynamics
                  • United States: Commercial Managed Care Organizations
                    • Current Reimbursement of Select Therapies Treating Chronic Pain
                    • Current Reimbursement of Select Opioid Analgesics Treating Chronic Pain
                    • Reimbursement of Select Therapies Treating Chronic Pain in 12 Months' Time
                    • Reimbursement of Select Opioid Analgesics Treating Chronic Pain in 12 Months' Time
                    • Reimbursement Summary
                    • Lessons Learned and Key Takeaways
                    • Pricing and Reimbursement Drivers
                    • Key Findings: Pricing and Reimbursement
                    • Drivers of Formulary Placement and Reimbursement for Chronic Pain
                    • Value Assessment and Pharmacoeconomics
                    • Percentage of Payers Indicating Company Submitted Pharmacoeconomic Data for Select Analgesics
                    • Types of Pharmacoeconomic Data Payers Find Most Compelling for a New Analgesic
                    • Quality of Pharmacoeconomic Data for Select Analgesics
                    • Impact of Pharmacoeconomic Data on Formulary Placement
                    • Pricing and Contracting for Chronic Pain
                    • Cost-Sharing for Key Therapies Treating Chronic Pain
                    • Copay and Coinsurance Rates for Key Chronic Pain Therapies
                    • Restrictions Affecting Treatment of Chronic Pain
                    • Restrictions Used in Commercial Plans
                    • Impact of Prior Authorization
                • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                  • Patient Share in Key Payer Channel
                    • Key Findings
                    • Patient Share of Key Brands Across Pain Subpopulations: PCPs
                    • Patient Share of Key Brands Across Pain Subpopulations: Pain Specialists
                    • Treatment Decision Drivers
                    • Factors Affecting Choice of Therapy for the Treatment of Chronic Pain
                  • Prescriber Preference
                    • Prescriber Preferences for Chronic Pain
                    • Impact of Reimbursement on Prescribing of Antidepressants
                    • Impact of Reimbursement on Prescribing of Antiepileptics
                    • Impact of Reimbursement on Prescribing of NSAIDs/COX-2 selective NSAIDs
                    • Impact of Reimbursement on Prescribing of Opioid Analgesics
                    • Impact of Reimbursement on Prescribing of Opioid Analgesic Combinations
                    • Impact of Reimbursement on Prescribing of Dual-Acting Opioid Analgesics
                    • Impact of Reimbursement on Prescribing of Local Anesthetics
                    • Reasons for Not Prescribing Preferred Therapy by Class
                    • Prescribing vs. Preference
                  • Impact of Restrictions on Prescribing
                    • Payer Policy Impact on Prescribing: Key Findings
                    • Restrictions Impacting Prescribing of Key Brands: PCPs
                    • Restrictions Impacting Prescribing of Key Brands: PCPs (Cont.)
                    • Restrictions Impacting Prescribing of Key Brands: PCPs (Cont.)
                    • Restrictions Impacting Prescribing of Key Brands: Pain Specialists
                    • Restrictions Impacting Prescribing of Key Brands: Pain Specialists (Cont.)
                    • Restrictions Impacting Prescribing of Key Brands: Pain Specialists (Cont.)
                    • Anticipated Restrictions Impacting Prescribing Within 12 Months
                  • Prescribing of Abuse-Deterrent Formulations of Opioid Analgesics
                    • Physicians' Opinion on the FDA Requiring All Opioid Analgesics to Be ADFs
                    • Percentage of Patients Receiving ADFs of Opioid Analgesics With and Without Reimbursement Restrictions
                    • Reimbursement Restrictions That Limit Prescribing of ADFs of Opioid Analgesics
                    • Physician Comfort Prescribing ADFs of Opioid Analgesics
                    • Likelihood to Prescribe ADFs of Opioid Analgesics
                • Market Access Landscape for Emerging Therapies
                  • Impact of Emerging Therapies on Prescribing
                    • Likely Impact of Emerging Therapies for Chronic Pain
                    • Patient Share for Therapies if Recent/Emerging Agents Are on Preferred vs. Nonpreferred Tier
                    • Anticipated Prescribing Scenarios for Targiniq ER
                    • Factors Inhibiting the Anticipated Prescribing of Targiniq ER
                    • Anticipated Prescribing Scenarios for Cebranopadol
                    • Factors Inhibiting the Anticipated Prescribing of Cebranopadol
                    • Anticipated Prescribing Scenarios for Tanezumab
                    • Factors Inhibiting the Anticipated Prescribing of Tanezumab
                  • Potential Placement of Emerging Therapy at Various Prices
                    • Potential Reimbursement of Emerging Therapies for Chronic Pain
                    • Potential Placement of Targiniq ER at Various Price Points
                    • Potential Placement of Cebranopadol at Various Price Points
                    • Potential Placement of Tanezumab at Various Price Points
                  • Prescriber and MCO Priorities for Emerging Therapy Evaluation
                    • Key Findings
                    • Areas for Future Opportunity for Chronic Pain: Physicians
                    • Areas for Future Opportunity for Chronic Pain: MCOs
                • Methodology
                  • Primary Market Research Methodology: Physicians
                    • Physician Respondents' Specialty
                    • Average Number of Years Practiced Postresidency
                    • Average Number of Chronic Pain Patients Under Management per Month
                    • Chronic Pain Patients' Insurance Coverage
                    • Practice Location
                    • Distribution of Medical Practice by Region
                  • Primary Market Research Methodology: MCOs
                    • Percentage of MCO PDs/MDs
                    • Distribution of MCO PDs/MDs by Region
                    • Operation of MCOs
                    • MCOs' Covered Plans
                    • Distribution of MCOs by Number of Covered Lives
                    • Average Number of Lives That Surveyed MCOs Manage
                • Appendix
                  • Physician Survey
                    • Physician Prescribing Rates of Key Drug Classes by Specialty
                    • Physician Prescribing Rates of Key Analgesics by Specialty
                    • Percentage of Patients Who Have Each Chronic Pain Indication
                    • Percentage of Patients Receiving Drug Treatment in Each Chronic Pain Indication by Specialty
                    • First-Line Therapy Share by Class in Subpopulations: PCPs
                    • First-Line Therapy Share by Class in Subpopulations: Pain Specialists
                    • Percentage of Patients Who Physicians Initiate with First-Line Treatment by Specialty
                    • Second-Line Therapy Share by Class in Subpopulations: PCPs
                    • Second-Line Therapy Share by Class in Subpopulations: Pain Specialists
                    • Percentage of Patients Who Physicians Initiate with Second-Line Treatment by Specialty
                    • Impact of Formal ADF Label on Prescribing of ER/LA Opioid Analgesics
                    • Impact of DEA Rescheduling on Prescribing of Hydrocodone Plus Acetaminophen Products
                    • Impact of CDC Guidance on PCPs' Opioid Analgesic Prescribing
                    • Physician Perception of Belbuca Compared with BuTrans
                    • Reasons for Not Prescribing Vimovo by Specialty
                    • Factors Impacting Prescribing of Vimovo by Specialty
                    • Reasons for Not Prescribing Hysingla ER or Zohydro ER by Specialty
                    • Factors Impacting Selection of Prescribing Either Hysingla ER or Zohydro ER: PCPs
                    • Factors Impacting Selection of Prescribing Either Hysingla ER or Zohydro ER: Pain Specialists
                    • Impact of Hysingla ER and Zohydro ER in Chronic Pain Prescribing: PCPs
                    • Impact of Hysingla ER and Zohydro ER in Chronic Pain Prescribing: Pain Specialists
                    • Chronic Pain Indications for Which Targiniq ER Will Likely Be Prescribed by Specialty
                    • Effect of Formulary Placement on Anticipated Prescribing of Targiniq ER
                    • Chronic Pain Indications for Which Cebranopadol Will Likely Be Prescribed by Specialty
                    • Anticipated Positioning of Cebranopadol in Prescribing by Specialty
                    • Chronic Pain Indications for Which Tanezumab Will Likely Be Prescribed by Specialty
                    • Anticipated Positioning of Tanezumab in Prescribing by Specialty
                    • Analgesic Class That Would Likely Be Prescribed in Addition to Tanezumab
                    • Tanezumab Access for Prescribers by Specialty
                    • Impact of SC Tanezumab on Anticipated Prescribing
                    • Impact of Patient Out-of-Pocket Costs for Tanezumab on Prescribing
                    • Impact of IV Tanezumab on Anticipated Prescribing
                  • MCO Survey
                    • Reasons for Excluded or Blocked Analgesics on Commercial Plans Not Being Reimbursed
                    • Reasons for Analgesics' Nonpreferred Status on Commercial Plans
                    • Current Reimbursement of Select Analgesics in Chronic Pain Subpopulations on Commercial Plans
                    • Restrictions Used for Select Analgesics in Commercial Plans
                    • Prior Authorization for Select Analgesics in Commercial Plans
                    • Step Therapy Requirements for Select Analgesics on Commercial Plans
                    • Medicare PDPs' Formulary Placement of Key Brands
                    • Reasons for Excluded or Blocked Analgesics on Medicare PDPs Not Being Reimbursed
                    • Reasons for Analgesics' Nonpreferred Status on Medicare PDPs
                    • Current Reimbursement of Select Analgesics in Chronic Pain Subpopulations on Medicare PDPs
                    • Restrictions Used for Select Analgesics on Medicare PDPs
                    • Prior Authorization for Select Analgesics in Medicare PDPs
                    • Step Therapy Requirements for Select Analgesics on Medicare PDPs
                    • Best-Performing Drug Class in Market Access Themes: MCOs
                    • Overall Best-Performing Drug Class in Market Access Themes: MCOs
                    • Most Commonly Used Pricing and Contracting Mechanisms for Select Analgesics on Commercial Plans
                    • Most Commonly Used Pricing and Contracting Mechanisms for Select Analgesics on Commercial Plans (Cont.)
                    • Most Commonly Used Pricing and Contracting Mechanisms for Select Analgesics on Commercial Plans (Cont.)
                    • Qutenza Reimbursement on Commercial Plans
                    • Medical Benefit Cost-Sharing for Qutenza on Commercial Plans
                    • Average Coinsurance Rate for Qutenza
                    • MCO Use of Deductibles
                    • Average Amount of Brand-Name Deductible
                    • External or Internal Management of Formulary Benefits
                    • Use of Custom or Standard External PBM Formulary
                    • Degree of Customization in Formulary
                    • Most Influential P&T Committee Members
                    • P&T Committee Time to Review and Rule on New Analgesics
                    • Materials Required for P&T Committee Chronic Pain Drug Review
                    • Reimbursement Status of Chronic Pain Drugs Under P&T Committee Review
                    • Mandatory Generic Substitution of Select Branded Analgesics
                    • Current and Future MCO Requirements for ADF Opioid Analgesics
                    • MCO Coverage of ADF Opioid Analgesics
                    • Role of Patient History in MCO Coverage and Substitution of ADF Opioid Analgesics
                    • Importance of FDA Labeling for ADF Opioid Analgesics in MCO Reimbursement Decisions
                    • Minimum Level of ADF Evidence Required by MCOs
                    • Impact of Competitors on MCO Coverage of BuTrans
                    • Reasons for Prioritizing Hysingla ER or Zohydro ER on MCO Formularies
                    • Impact of Competitors on MCO Coverage of Zohydro ER
                    • Anticipated MCO Coverage of Targiniq ER
                    • Preferred Models for Cost-Effectiveness for Emerging Analgesics
                    • Appropriate Comparators by Drug Class for Emerging Therapies in Cost-Minimization Model: Antidepressants
                    • Appropriate Comparators by Drug Class for Emerging Therapies in Cost-Minimization Model: Antiepileptics
                    • Appropriate Comparators by Drug Class for Emerging Therapies in Cost-Minimization Model: ER/LA Opioid Analgesics
                    • Appropriate Comparators by Drug Class for Emerging Therapies in Cost-Minimization Model: Dual-Acting Opioid Analgesics
                    • Appropriate Comparators by Drug Class for Emerging Therapies in Cost-Minimization Model: Local Anesthetics
                    • Impact of Tanezumab's Delivery Method on Formulary Coverage
                    • Likely Cost Controls for Tanezumab
                    • Chronic Pain Indications for Which Emerging Therapies Will Likely Be Reimbursed
                    • Likely Cost-Containment Measures for Emerging Therapies
                    • Impact of Emerging Therapies on Chronic Pain Treatment
                  • Bibliography
                  • Webinars
                    • A Snapshot of the Current and Future Reimbursement Landscape for Chronic Pain Analgesics in the U.S.
                      • December 2017

                Author(s): Joyce Spadafora, ALM

                Joyce is a business insights analyst in Decision Resources Group’s central nervous systems and ophthalmology division, where she provides expert insight into commercial aspects of drug development and market sizing across psychiatric and pain indications. She has worked extensively in DRG’s schizophrenia and chronic pain content.

                Prior to joining DRG, Joyce spent several years in the biotech industry focused in research and development and in biotech consulting. Her project experience covered indications including psychiatry, pain, infectious diseases, respiratory, and ophthalmology. Beyond my therapeutic and industry knowledge, she holds a Masters in Extension Studies in Psychology from Harvard University and a B.S in Mechanical Engineering with Biology from the Massachusetts Institute of Technology.


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