Introduction: This research explores the reimbursement and utilization landscape for anti-osteoporotic drugs. The osteoporosis market is characterized by the availability of low-cost generic oral bisphosphonates that are effective and dominate the earlier lines of osteoporosis treatment. More costly branded drugs, including Prolia (Amgen’s denosumab), Forteo (Eli Lilly’s teriparatide), and Tymlos (Radius Health’s abaloparatide SC), are injectable and have been shown to have efficacy superior to the bisphosphonates. Branded injectable therapies typically feature in second or later lines of therapy, reserved for the most severe cases of osteoporosis. With generics giving payers leverage to control drug prices in osteoporosis, this report’s data-driven analysis helps developers of novel anti-osteoporotic drugs understand the influence of clinical and economical factors affecting market access and medical practice in the United States.

Questions Answered in This Report:

  • Which anti-osteoporotic drugs commonly receive favorable formulary placement, and what approaches do payers employ to manage utilization and costs?
  • How are MCOs performing value assessments for anti-osteoporotic drugs, and what are the preferred pharmacoeconomic models?
  • How successful is Radius Health in gaining market access for its recently launched parathyroid hormone analogue Tymlos?
  • How will emerging anti-osteoporotic drugs be reimbursed and prescribed in a market dominated by generic oral bisphosphonates?

Scope:

  • Markets covered: United States.
  • Methodology: Surveys of 50 PCPs, 32 endocrinologists, and 22 rheumatolgists as well as 30 managed care organization (MCO) officials in September 2017.
  • Indication coverage: Osteoporosis.
  • Key Drugs covered: Prolia, Forteo, Tymlos, alendronate (Fosamax), risedronate (Actonel), zoledronate (Reclast), ibandronate (Boniva).
  • Key companies mentioned: Amgen, Eli Lilly, Radius Health, Merck, Novartis, Roche/GlaxoSmithKline.

Table of contents

  • Osteoporosis - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Market Access Overview
      • Overview of Market Access in Osteoporosis
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Overview of Successes and Stumbles for Osteoporosis
        • Successes Among Osteoporosis Therapies in the United States: Physicians
        • Stumbles Among Osteoporosis Therapies in the United States: Physicians
        • Best-Performing Bisphosphonate Therapies on Clinical Factors
        • Best-Performing Bisphosphonate Therapies on Market Access Factors
        • Best-Performing Non-Bisphosphonate Therapies on Clinical Factors
        • Best-Performing Non-Bisphosphonate Therapies on Market Access Factors
        • Successes Among Osteoporosis Therapies in the United States: MCOs
        • Stumbles Among Osteoporosis Therapies in the United States: MCOs
        • Best-Performing Branded Anti-Osteoporotic Drug on Various Attributes
      • Key Stakeholders in the Road to Market Access
        • Stakeholder Influence on Physicians' Prescribing for Osteoporosis
        • United States: Stakeholder Dynamics in the Road to Reimbursement
        • Physician-Reported Healthcare Coverage of Osteoporosis
        • Healthcare Coverage in the United States
        • Healthcare Coverage in United States
        • Major Commercial Insurers in the United States
      • Key Market Access Roadblocks
        • Reimbursement Dynamics
          • United States: Commercial Managed Care Organizations
            • Lessons Learned and Key Takeaways
            • Current Reimbursement of Drugs Treating Osteoporosis: Commercial Plans
            • Current Reimbursement of Drugs Treating Osteoporosis: Medicare Advantage Plans
            • Anticipated Reimbursement of Drugs Treating Osteoporosis in 12 Months Time: Commercial Plans
            • Anticipated Reimbursement of Drugs Treating Osteoporosis in 12 Months Time: Medicare Advantage Plans
            • Pricing and Reimbursement Drivers
            • Key Findings: Pricing and Reimbursement
            • Clinical Factors: Drivers of Reimbursement/Formulary Placement of Anti-Osteoporotic Drugs
            • Economic Factors: Drivers of Reimbursement/Formulary Placement of Anti-Osteoporotic Drugs
            • Value Assessment and Pharmacoeconomics
            • Preferred Pharmacoeconomic Model for Assessing Emerging Anti-Osteoporotic Therapies
            • Preferred Comparator Therapy in Cost-Minimization Model
            • Most Compelling PE/HE Data for Anti-Osteoporotic Therapy
            • Contracting Agreements for Select Branded Anti-Osteoporotic Drugs
            • Rebate Collected for Select Branded Anti-Osteoporotic Drugs
            • Possibility of Risk-Based Contracts for Select Branded Anti-Osteoporotic Drugs in Next Two Years
            • Cost Sharing for Key Therapies Treating Osteoporosis
            • Average Copayment (in dollars) for Drugs for Osteoporosis in Commercial Plans
            • Average Coinsurance Percentage for Drugs for Osteoporosis in Commercial Plans
            • Average Copayment (in dollars) for Drugs for Osteoporosis in MA Plans
            • Average Coinsurance Percentage for Drugs for Osteoporosis in MA Plans
            • Restrictions Affecting Treatment of Osteoporosis
            • Restrictions Used in Commercial Plans
            • MCO-Reported UM Restrictions on Anti-Osteoporotic Drugs in Commercial Plans
            • MCO-Reported UM Restrictions on Anti-Osteoporotic Drugs in MA Plans
            • Prior Authorization Restrictions in Commercial Plans
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Patient Share in Key Payer Channel
            • Key Findings
            • Share of Pharmacological Treatment Among Commercially Insured Osteoporosis or Osteopenia Patients
            • Share of Individual Drugs Among Commercially Insured Osteoporosis or Osteopenia Patients
            • Treatment Decision Drivers
            • Factors Influencing Choice of Bisphosphonate Therapies in Osteoporosis
            • Factors Influencing Choice of Non-Bisphosphonate Therapies in Osteoporosis
          • Prescriber Preference
            • Prescriber Preferences for Osteoporosis
            • Drugs Prescribed to Various Types of Osteoporosis/Osteopenia Patients
            • Changes in Prescribing of Drugs for Osteoporosis If Patient Cost Share or Utilization Restrictions Are Not Imposed
            • Prescribing of Anti-Osteoporotic Drugs Across Various Lines of Therapy
          • Impact of Restrictions on Prescribing
            • Payer Policy Impact on Prescribing: Key Findings
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Prolia (denosumab)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Forteo (teriparatide)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Tymlos (abaloparatide SC)
            • Prior Authorization Requirements Limiting Prescribing of Drugs for Osteoporosis
        • Market Access Landscape for Emerging Therapies
          • Impact of Emerging Therapies on Prescribing
            • Likely Impact of Emerging Therapies for Osteoporosis
            • Anticipated Prescribing of Tymlos (abaloparatide SC) on Preferred vs. Non-Preferred Tier
            • Anticipated Prescribing of Evenity (romosozumab) on Preferred vs. Non-Preferred Tier
            • Anticipated Prescribing of Abaloparatide TD patch on Preferred vs. Non-Preferred Tier
            • Anticipated Patient Shares of Anti-Osteoporotic Drugs in 2020
            • Anticipated Prescribing of Anti-Osteoporotic Drugs Across Various Lines of Therapy in 2020
          • Potential Placement of Emerging Therapy at Various Prices
            • Potential Reimbursement of Emerging Therapies for Osteoporosis
            • Potential Placement of Evenity (romosozumab) at Various Price Points
            • Potential UM Approaches for Evenity (romosozumab) at Various Price Points
            • Potential Placement of Abaloparatide TD Patch at Various Price Points
            • Potential UM Approaches for Abaloparatide TD Patch at Various Price Points
          • Prescriber and MCO Priorities for Emerging Therapy Evaluation
            • Key Findings
            • Areas for Future Opportunity for Osteoporosis: Physicians
            • Areas for Future Opportunity for Osteoporosis: MCOs
            • Emerging Therapy with Greatest Impact on Treatment of Osteoporosis According to Payers
            • Emerging Therapy That Physicians Would Like to Be Included in MCO Formularies
        • Methodology
          • Primary Market Research Methodology: Physicians
            • Split by Specialty
            • Number of Osteoporosis Patients Under Management
            • Years in Practice Postresidency
            • Regional Demographics
            • Northeast Region Demographics
            • Prescription of Anti-Osteoporotic Drugs by Physician Specialty
            • Familiarity with Tymlos, Evenity, and Abaloparatide TD
          • Primary Market Research Methodology - MCOs
            • Percentage of MCO Medical Directors vs. Pharmacy Directors
            • Regional Demographics of Surveyed MCOs
            • Regional Demographics of MCOs in the Northeast
            • MCO Territory Size
            • MCO Plan Types
            • MCO Membership
            • MCO Mean Lives Covered
            • Separation of Preferred and Non-Preferred Tiers: Commercial Plans
            • Likelihood of Switching to Preferred and Non-Preferred Tiering in 12 Months: Commercial Plans
            • Separation of Preferred and Non-Preferred Tiers: MA Plans
            • Likelihood of Switching to Preferred and Non-Preferred Tiering in 12 Months: MA Plans
        • Appendix
          • Physician Survey
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Ibandronate Oral
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Risedronate (Actonel)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Salmon Calcitonin (Miacalcin)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Raloxifene (Evista)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Duavee
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Premarin
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Prempro
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Zoledronate (Reclast)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Ibandronate IV (Boniva)
            • Physician-Reported Cost-Control Measures Limiting Prescribing of Alendronate (Fosamax)
            • Osteoporosis Patient Groups Most Likely Prescribed Prolia (denosumab)
            • Osteoporosis Patient Groups Most Likely Prescribed Forteo (teriparatide)
            • Osteoporosis Patient Groups Most Likely Prescribed Tymlos (abaloparatide SC)
            • Osteoporosis Patient Groups Most Likely Prescribed Ibandronate IV (Boniva)
            • Osteoporosis Patient Groups Most Likely Prescribed Zoledronate (Reclast)
            • Top Three Reasons Limiting Prescribing of Prolia (denosumab)
            • Top Three Reasons Limiting Prescribing of Forteo (teriparatide)
            • Top Three Reasons Limiting Prescribing of Tymlos (abaloparatide SC)
            • Top Three Reasons Limiting Prescribing of Ibandronate IV (Boniva)
            • Top Three Reasons Limiting Prescribing of Zoledronate (Reclast)
            • Physician-Reported Reasons for Expecting to Prescribe Tymlos (abaloparatide SC)
            • Physician-Reported Reasons for Expecting to Not Prescribe Tymlos (abaloparatide SC)
            • Physician-Reported Reasons for Expecting to Prescribe Evenity (romosozumab)
            • Physician-Reported Reasons for Expecting to Not Prescribe Evenity (romosozumab)
            • Physician-Reported Reasons for Expecting to Prescribe Abaloparatide TD Patch
            • Physician-Reported Reasons for Expecting to Not Prescribe Abaloparatide TD Patch
            • Abaloparatide TD patch vs. Abaloparatide SC (Tymlos): Patient Groups
            • Physicians' Familiarity with Emerging Therapies for Osteoporosis
            • Discontinuation Rates for Anti-Osteoporotic Drugs
            • Reasons for Discontinuing Anti-Osteoporotic Drugs
          • MCO Survey
            • Status of P&T Committee's Decision on UM Controls on Tymlos
            • MCO MDs/PDs Familiarity with Emerging Therapies for Osteoporosis
            • Payer-Reported Preferred Comparator Therapy for Emerging Osteoporosis Drugs
            • MCOs' Management of Specialty Drugs for Osteoporosis
            • Presence of Cap on Out-of-Pocket Costs for Specialty Drugs
            • Factors That May Lead MCOs to Include Tymlos as a Preferred Agent on Commercial Plans
            • MCOs’ Timing Between Drug Launch and UM Decisions
            • Interim Status Applied to Newly Launched Drugs Yet to Undergo MCOs' Complete Formulary Review Process
            • Delegation of Responsibility for Formulary Development and Maintenance of MCOs’ Commercial Plans
            • Type of PBM Formulary Used by MCOs for Formulary Development
            • Customization of Formulary by MCO Directors
            • MCO P&T Committee Members with Greatest Influence on Formulary Decisions
            • Information Required for Formulary Review of Anti-Osteoporosis Drugs by MCO P&T Committees
            • Status of Review of Tymlos by MCO's P&T Committee
            • Time for Completion of P&T Review of Tymlos

      Author(s): Surbhi Gupta, Masters in Pharmacy

      Surbhi Gupta is an Insights analyst in the Cardiovascular, Metabolic and Renal disorders team at Decision Resources Group and has worked on contents on pulmonary hypertension and obesity.

      She completed her Masters with specialization in Pharmacology, and a Bachelor's degree in Pharmacy from the University Of Delhi. Before joining DRG, she has worked as a Senior Business Analyst at the research firm Evalueserve, where she was involved in competitive intelligence projects across multiple indications (such as atrial fibrillation, ACS, VTE, renal anemia, and several oncology indications). She also worked as a Medical writer at the clinical research organization, Apcer Pharma.


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