The landscape of prescription drugs to manage pain in the postoperative setting represents a sizable but fragmented and challenging environment for drug marketers given the abundance of generically available analgesics. As the treatment landscape for postoperative pain becomes increasingly complex, we explore the market access opportunities and challenges for drug marketers, particularly in an era of ever-tightening reimbursement in the United States. Research and analysis in this report will assess physician prescribing practices of current analgesics for postoperative pain treatment, including drugs delivered by patient-controlled administration (i.e., The Medicines Company’s Ionsys), the impact of hospital protocols and other restrictions on prescribing, and the expected uptake and formulary coverage of emerging pain therapies.

Questions answered:

  • With many generics available, hospital pharmacies use a variety of measures to control utilization of branded therapies. Which postoperative pain agents and classes commonly receive favorable hospital formulary placement, and what approaches are employed to manage utilization and costs? Which restrictions are most common for selected branded agents?
  • The costs of many surgical procedures and associated aftercare are often reimbursed via bundled payments from payers.  What is the impact of payment bundling for surgical procedures on prescribing and reimbursement practices related to postoperative pain management?
  • Throughout the pharmaceutical industry, pharmacoeconomic assessments are becoming more commonplace. How are hospital PDs performing value assessment for postoperative pain agents, and what are the preferred pharmacoeconomic models? Is cost-effectiveness data required for P&T committee formulary coverage reviews?
  • A number of ETs are in development for the treatment of moderate to severe postoperative pain. How do hospital PDs anticipate including emerging pain therapies on formularies at various price points, and how do physicians anticipate incorporating them in the treatment of postoperative pain?
  • Scope:
    • Markets covered: United States.
    • Methodology: Survey of 52 surgical specialists, 54 anesthesiologists, and 30 hospital PDs in the United States, completed in April 2017.
    • Indication coverage: Moderate to severe postoperative pain.
    • Key drugs covered: Caldolor, Dyloject, Exparel, Ionsys, Ofirmev, Opana (parenteral), Sprix.
    • Key companies mentioned: Cumberland Pharmaceuticals, Pfizer, Pacira Pharmaceuticals, The Medicines Company, Mallinckrodt Pharmaceuticals, Endo Pharmaceuticals, Egalet.

Table of contents

  • Postoperative Pain - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Key Updates
      • December 2017
        • September 2017
        • Market Access Overview
          • Actionable Recommendations to Optimize Market Access
            • Successes and Stumbles
              • Overview of Successes and Stumbles for Postoperative Pain
              • Successes Among Postoperative Pain Therapies in the United States: Physicians
              • Stumbles Among Postoperative Pain Therapies in the United States: Physicians
              • Physician-Reported Best Performing Analgesics on Market Access Factors, by Physician Specialty
              • Successes Among Postoperative Pain in the United States: Hospital PDs
              • Stumbles Among Postoperative Pain in the United States: Hospital PDs
              • Hospital PD-Reported Highest Performing Postoperative Pain Analgesic in Terms of Market Access Factors
            • Key Stakeholders in the Road to Market Access
              • Stakeholder Influence on Prescribing in Postoperative Pain by Physician Specialty
              • 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: Hospital Pharmacies
                  • Lessons Learned and Key Takeaways
                  • Hospital PD-Reported Hospital Formulary Status of Select Postoperative Pain Analgesics
                  • Hospital PD-Reported Anticipated Hospital Formulary Status of Select Postoperative Pain Analgesics
                  • Drivers of Formulary Decisions
                  • Key Findings
                  • Hospital PD-Reported Importance of Key Drug Attributes in P&T Formulary Decision-Making for Moderate to Severe Postoperative Pain Analgesics
                  • Value Assessment and Pharmacoeconomics
                  • Hospital PD-Reported Preferred Model for Examining Cost-Effectiveness of a New Postoperative Pain Drug
                  • Bundled Payments for Postoperative Pain
                  • Hospital PD-Reported Impact of Payment Bundling on Treatment of Moderate to Severe Postoperative Pain
                  • Hospital PD-Reported Formulary Restrictions for Select Postoperative Pain Analgesics
                  • Hospital Restrictions for Postoperative Pain Analgesic Prescribing
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Patient Share in Key Payer Channel
                  • Key Findings
                  • Commercially Insured Patients' Share of Postoperative Pain Therapies, by Physician Specialty
                  • Treatment Decision Drivers
                  • Physician-Reported Factors Affecting Choice of Therapy for Moderate to Severe Postoperative Pain by Physician Specialty
                • Prescriber Preference
                  • Prescriber Preferences for Postoperative Pain
                  • Physician-Reported Potential Changes in Prescribing Select Postoperative Pain Analgesics If Hospital Restrictions Were Not in Place, by Physician Specialty
                  • Physician-Reported Impact of Hospital Prescribing Protocols on Use of Select Analgesics, by Physician Specialty
                • Impact of Restrictions on Prescribing
                  • Payer Policy Impact on Prescribing: Key Findings
                  • Physician-Reported Formulary Prescribing Restrictions for Select Postoperative Pain Analgesics, by Physician Specialty (Part 1)
                  • Physician-Reported Formulary Prescribing Restrictions for Select Postoperative Pain Analgesics, by Physician Specialty (Part 2)
              • Market Access Landscape for Emerging Therapies
                • Impact of Emerging Therapies on Prescribing
                  • Likely Impact of Emerging Therapies on Postoperative Pain
                  • Physician-Reported Anticipated Postoperative Pain Patient Share in 2020 If Emerging Therapies Were Included or Not Included on Hospital Formulary, by Physician Specialty
                • Potential Placement of Emerging Therapies at Various Prices
                  • Potential Reimbursement of Emerging Therapies for Postoperative Pain
                  • Hospital PD-Reported Anticipated Formulary Inclusion of Zalviso and Prescribing Restrictions at Various Price Points
                  • Hospital PD-Reported Anticipated Formulary Inclusion of Oliceridine and Prescribing Restrictions at Various Price Points
                  • Hospital PD-Reported Anticipated Formulary Inclusion of Posimir and Prescribing Restrictions at Various Price Points
                  • Hospital PD-Reported Anticipated Formulary Inclusion of IV Meloxicam and Prescribing Restrictions at Various Price Points
                • Prescriber and Hospital PD Priorities for Emerging Therapy Evaluation
                  • Key Findings
                  • Physician-Reported Most Important Attributes in the Development of Emerging Therapies to Treat Postoperative Pain, by Physician Specialty
                  • Hospital PD-Reported Most Important Attributes in the Development of Emerging Therapies to Treat Postoperative Pain
              • Methodology
                • Primary Market Research Methodology: Physicians
                  • Respondent Breakdown by Physician Specialty
                  • Primary Specialty Among Surgical Specialists
                  • Number of Surgeries Performed Monthly Among Surgical Specialists
                  • Percentage of Surgeries Requiring Analgesic Administration for Moderate to Severe Postoperative Pain Management: Surgical Specialists
                  • Percentage of Surgeries Requiring Analgesic Administration for Moderate to Severe Postoperative Pain Management: Anesthesiologists
                  • Average Length in Practice Postresidency by Physician Specialty
                  • Percentage of Practice That Is Hospital, Inpatient-Based, by Physician Specialty
                  • Type of Healthcare Coverage Among Surveyed Physicians' Postoperative Pain Patients, by Physician Specialty
                  • Respondent Breakdown by Region and Physician Specialty
                  • Hospital Stocking of Analgesic Drug Classes, by Physician Specialty
                  • Hospital Stocking of Select Analgesics, by Physician Specialty
                  • Nature of Physician Employment, by Physician Specialty
                  • Organization of Physician Practice, by Physician Specialty
                  • Hospital Size, by Physician Specialty
                  • Characterization of Hospital, by Physician Specialty
                • Primary Market Research Methodology: Hospital PDs
                  • Hospital PDs' Number of Years on P&T Committee
                  • Hospital PD Breakdown by Region
                  • Hospital Stocking of Analgesic Drug Classes, According to Hospital PDs
                  • Hospital Stocking of Select Analgesics, According to Hospital PDs
                  • Hospital Size, According to Hospital PDs
                  • Characterization of Hospital, According to Hospital PDs
              • Appendix
                • Key Abbreviations
                • Physician Survey
                  • Physician-Reported Presence of Acute Pain Service in Hospital, by Physician Specialty
                  • Acute Pain Service Membership, by Physician Specialty
                  • Physician-Reported Impact of Acute Pain Service, by Physician Type
                  • Physician-Reported Influence of Treatment Guidelines, by Physician Type
                  • Presence of a Hospital Protocol Guiding Prescribing in Postoperative Pain, by Physician Specialty
                  • Adherence to a Hospital Protocol Guiding Prescribing in Postoperative Pain, by Physician Specialty
                  • Prescribing Autonomy and Protocol Adherence Statement Agreement, by Physician Specialty
                  • Physician-Reported Hospital Reimbursement via Bundled Payments for Surgical Procedures, by Physician Specialty
                  • Physician-Reported Percentage of Postoperative Pain Patients Having Treatment Reimbursed Through Bundled Payments, by Physician Specialty
                  • Physician-Reported Impact of Payment Bundling on Treatment of Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Impact of Payment Bundling on Prescribing of Select Analgesics, by Physician Specialty
                  • Physician-Reported Impact of Hospital Ratings and/or Patient Satisfaction Surveys on Treatment Practices in Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Best Performing Analgesics on Clinical Factors, by Physician Specialty
                  • Physician-Reported Best Overall Performer on Market Access Factors, by Physician Specialty
                  • Physician-Reported Hospital Formulary Status of Select Postoperative Pain Drug Classes, by Physician Specialty
                  • Physician-Reported Hospital Formulary Status of Select Postoperative Pain Analgesics, by Physician Specialty
                  • Physician-Reported Formulary Prescribing Restrictions for Select Postoperative Pain Drug Classes, by Physician Specialty
                  • Physician-Reported Anticipated Prescribing of Zalviso for Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Top Three Current Analgesics Most Likely to Be Replaced with Zalviso, by Physician Specialty
                  • Physician-Reported Reasons for Not Expecting to Prescribe/Administer Zalviso, by Physician Specialty
                  • Physician-Reported Anticipated Prescribing of Oliceridine for Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Top Three Current Analgesics Most Likely to Be Replaced with Oliceridine, by Physician Specialty
                  • Physician-Reported Reasons for Not Expecting to Prescribe/Administer Oliceridine, by Physician Specialty
                  • Physician-Reported Anticipated Prescribing of Posimir for Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Top Three Current Analgesics Most Likely to Be Replaced with Posimir, by Physician Specialty
                  • Physician-Reported Reasons for Not Expecting to Prescribe/Administer Posimir, by Physician Specialty
                  • Physician-Reported Anticipated Prescribing of IV Meloxicam for Moderate to Severe Postoperative Pain, by Physician Specialty
                  • Physician-Reported Top Three Current Analgesics Most Likely to Be Replaced with IV Meloxicam, by Physician Specialty
                  • Physician-Reported Reasons for Not Expecting to Prescribe/Administer IV Meloxicam, by Physician Specialty
                • Hospital PD Survey
                  • Hospital PD-Reported Hospital Use of GPO for Drug Procurement
                  • Hospital PD-Reported Restriction on Analgesic Availability as a Result of GPO Use
                  • Hospital PD-Reported Presence of Acute Pain Service in Hospital
                  • Hospital PD-Reported Impact of Acute Pain Service
                  • Hospital PD-Reported Hospital Reimbursement Via Bundled Payments for Surgical Procedures
                  • Hospital PD-Reported Payment Bundling for Select Surgical Procedures
                  • Hospital PD-Reported Potential Impact of Payment Bundling on Treatment of Moderate to Severe Postoperative Pain
                  • Hospital PD-Reported Bundled Payment Models
                  • Hospital PD-Reported Starting Event for Episode of Care in Payment Bundling
                  • Hospital PD-Reported Ending Event for Episode of Care in Payment Bundling
                  • Hospital PD-Reported Ranking of P&T Committee Member Influence
                  • Hospital PD-Reported Items Required for P&T Committee Review for Postoperative Pain Drug
                  • Hospital PD-Reported Influence of Efficacy Attributes in P&T Formulary Decision-Making for Moderate to Severe Pain Analgesics
                  • Hospital PD-Reported Influence of Safety and Tolerability Attributes in P&T Formulary Decision-Making for Moderate to Severe Pain Analgesics
                  • Hospital PD-Reported Influence of Drug Cost Attributes in P&T Formulary Decision-Making for Moderate to Severe Pain Analgesics
                  • Hospital PD-Reported Influence of Cost-Effectiveness Attributes in P&T Formulary Decision-Making for Moderate to Severe Pain Analgesics
                  • Hospital PD-Reported Influence of Administration and Delivery Attributes in P&T Formulary Decision-Making for Moderate to Severe Pain Analgesics
                  • Hospital PD-Reported Percentage of Hospital Pharmacy Budget Dedicated to Postoperative Pain Therapies
                  • Hospital PD-Reported Time to Initiation of P&T Committee Review and Time to Decision on UM Criteria for New Postoperative Pain Drugs
                  • Hospital PD-Reported Reasons for Formulary Exclusion of Select Postoperative Pain Analgesics
                  • Hospital PD-Reported Interim Status for Postoperative Pain Analgesics Prior to Complete Formulary Review
                  • Hospital PD-Reported Preferred Comparator for Emerging Oral Opioid Analgesic
                  • Hospital PD-Reported Preferred Comparator for Emerging Local Anesthetic
                  • Hospital PD-Reported Highest Acceptable Incremental Cost per QALY Gained for Postoperative Pain
                  • Hospital PD-Reported Ranking of Pharmacoeconomic Outcomes Data for a New Postoperative Pain Therapy
                  • Hospital PD-Reported Highest Performing Postoperative Pain Analgesic on Select Factors
                  • Hospital PD-Reported Reasons for Not Anticipating Inclusion of Zalviso at Given Price Points
                  • Hospital PD-Reported Agent Most Likely to Be Replaced with Zalviso on Hospital Formulary
                  • Hospital PD-Reported Reasons for Not Anticipating Inclusion of Oliceridine at Given Price Points
                  • Hospital PD-Reported Agent Most Likely to Be Replaced with Oliceridine on Hospital Formulary
                  • Hospital PD-Reported Reasons for Not Anticipating Inclusion of Posimir at Given Price Points
                  • Hospital PD-Reported Agent Most Likely to Be Replaced with Posimir on Hospital Formulary
                  • Hospital PD-Reported Reasons for Not Anticipating Inclusion of IV Meloxicam at Given Price Points
                  • Hospital PD-Reported Agent Most Likely to Be Replaced with IV Meloxicam on Hospital Formulary
                  • Hospital PD-Reported Emerging Therapy with Greatest Anticipated Impact in Treatment of Postoperative Pain
                • Bibliography

            Author(s): Margaret M. Weigel; Emma McFadden, PhD

            Margaret Weigel, M.B.A., is a Business Insights Analyst on the CNS/Ophthalmology Disorders team at Decision Resources Group. Her specialties are diabetic retinopathy/diabetic macular edema, postoperative pain, and multiple sclerosis; she has authored numerous primary and secondary market research products on these indications. Ms. Weigel obtained her B.A. from Washington and Lee University, where she studied psychology and conducted research in the neuroscience department, and her M.B.A. in pharmaceutical and healthcare business from the University of the Sciences in Philadelphia.

            Emma McFadden, Ph.D., is a Director within the Central Nervous System/Ophthalmology disorders group. Her main focus is on ophthalmic indications, such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema, although she has authored research across a number of other indications, including multiple sclerosis and epilepsy. 

            Prior to joining Decision Resources Group, Emma earned a B.A. in neuroscience and a Ph.D. in biochemistry from Trinity College Dublin.