The wet age-related macular degeneration (AMD) therapy market in the United States is unique in that the key approved therapies—Roche/Genentech’s Lucentis 0.5 mg and Regeneron’s Eylea—face competition from an off-label agent, Avastin (Roche/Genentech). All three therapies belong to the same drug class: vascular endothelial growth factor (VEGF) inhibitors. Although the approved therapies are effective and safe, their premium prices place a substantial burden on payers, and, hence, the drugs are subject to access and reimbursement restrictions, which, in turn, influence ophthalmologists’ prescribing decisions for wet AMD. Competition in this market is set to increase further with the expected launch of two late-phase VEGF inhibitors: Novartis’s brolucizumab (RTH-258) and Allergan’s abicipar pegol. These emerging agents may offer a dosing advantage relative to the current VEGF inhibitors, but to encourage their uptake, their developers may need to price them competitively with current therapies and use various strategies to obtain favorable market access/reimbursement conditions from managed care organizations (MCOs). Additionally, biosimilar versions of Eylea and Lucentis 0.5 mg are anticipated to launch in the United States in the coming years and may be favored by cost-sensitive payers, thereby posing further challenges to both current and emerging players in this market.

Questions Answered:

  • In light of the availability of low-priced off-label Avastin, approved anti-VEGF agents are subject to reimbursement restrictions and cost-control measures. What reimbursement restrictions and utilization controls are most commonly used for key VEGF inhibitors? Does their coverage for wet AMD differ on MCOs’ largest MA and commercial insurance plans? How do various cost-control measures affect prescribing of approved wet AMD therapies Eylea and Lucentis 0.5 mg and off-label Avastin? Is there still an opportunity for currently approved therapies to increase their patient share in wet AMD?
  • Despite the need for less-frequently dosed therapies for wet AMD, the late-phase therapies brolucizumab (RTH-258) and abicipar pegol are likely to encounter reimbursement challenges from payers if approved. At what price points would payers consider granting favorable coverage to these emerging therapies? What is the expected patient share for these therapies if placed on preferred and nonpreferred tiers? What type of pharmacoeconomic/health economic data would be most compelling to payers for a new wet AMD drug, and what type of cost-effectiveness assessment would be preferred by payers?
  • The expected U.S. launches of biosimilar versions of Eylea and Lucentis 0.5 mg could affect wet AMD market dynamics. What impact is the availability of these biosimilars likely to have on access to and reimbursement of their branded counterparts and other approved anti-VEGF agents? Are ophthalmologists willing to prescribe these therapies, and, if approved and reimbursed by payers, what is their maximum expected patient share in wet AMD?
  • Emerging wet AMD therapies that are differentiated from current products on clinical factors will most likely obtain favorable market access/reimbursement conditions from MCOs. What are the various drivers of reimbursement/formulary placement for wet AMD therapies? What are the potential areas of future opportunity in wet AMD?

Scope:

Markets covered: United States.

Methodology: Surveys of 102 ophthalmologists and 30 MCO officials (i.e., 20 pharmacy directors [PDs] and 10 medical directors [MDs]) in December 2016.

Indication coverage: Wet AMD.

Key drugs covered: Avastin, Eylea, Lucentis 0.5 mg, abicipar pegol, brolucizumab (RTH-258), squalamine, Fovista.

Key companies mentioned: Roche/Genentech, Regeneron, Allergan, Novartis, Ohr Pharmaceutical, Ophthotech.

Table of contents

  • Dry And Wet Age-Related Macular Degeneration - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Key Updates
      • November 2017
        • July 2017
          • May 2017
          • Market Access Overview
            • Overview of Market Access in Wet AMD
          • Actionable Recommendations to Optimize Market Access
            • Successes and Stumbles
              • Overview of Successes and Stumbles for Wet AMD
              • Successes Among Wet AMD Therapies in the United States: Physicians
              • Stumbles Among Wet AMD Therapies in the United States: Physicians
              • Best-Performing Anti-VEGF Agent on Clinical and Reimbursement Factors
              • Successes Among Wet AMD Therapies in the United States: MCOs
              • Stumbles Among Wet AMD Therapies in the United States: MCOs
            • Key Stakeholders in the Road to Market Access
              • Stakeholder Influence on Ophthalmologists' Prescribing for Wet AMD
              • United States: Stakeholder Dynamics in the Road to Reimbursement
              • Ophthalmologist-Reported Healthcare Coverage of Wet AMD Patients
              • 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: Managed Care Organizations
                  • Lessons Learned and Key Takeaways
                  • Current Reimbursement of Anti-VEGF Agents Treating Wet AMD: MCOs' MA Plans
                  • Current Reimbursement of Anti-VEGF Agents Treating Wet AMD: MCOs' Commercial Plans
                  • Anticipated Reimbursement of Anti-VEGF Agents Treating Wet AMD in 12 Months' Time: MCOs' MA Plans
                  • Pricing and Reimbursement Drivers
                  • Key Findings: Pricing and Reimbursement
                  • Drivers of Reimbursement/Formulary Placement of Wet AMD Drugs on MA Plans
                  • Value Assessment and Pharmacoeconomics
                  • Preferred Cost-Effectiveness Assessment for Emerging Wet AMD Therapies in MCOs' MA Plans
                  • PE/HE Data Viewed as Most Compelling for a New Wet AMD Therapy
                  • Cost-Sharing for Key Therapies Treating Wet AMD
                  • Copay and Coinsurance Rates for Anti-VEGF Agents Used for Wet AMD
                  • Average Copayment for Anti-VEGF Agents for Wet AMD in MCOs' MA Plans
                  • Average Coinsurance Percentage for Anti-VEGF Agents for Wet AMD in MCOs' MA Plans
                  • Restrictions Affecting Treatment of Wet AMD
                  • Restrictions Used in MA Plans
                  • Cost-Control Approaches for Anti-VEGF Agents for Wet AMD in MCOs' MA Plans
                  • Other Cost-Control Measures
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Patient Share in Key Payer Channels
                  • Key Findings
                  • IVT Pharmacotherapy Share of Wet AMD Patients with Medicare and Commercial Insurance
                  • Treatment Decision Drivers
                  • Clinical Factors Affecting Prescribing of Anti-VEGF Therapy for the Treatment of Wet AMD
                  • Nonclinical Factors Affecting Prescribing of Anti-VEGF Therapy for the Treatment of Wet AMD
                  • Key Reasons Why More Wet AMD Patients Are Not Treated with Avastin, Eylea, or Lucentis 0.5 mg
                • Prescriber Preference
                  • Prescriber Preferences for Wet AMD
                  • Effect of Removing Coverage Restrictions on IVT Pharmacotherapy Patient Shares for Wet AMD
                • Impact of Restrictions on Prescribing
                  • Impact of Payer Policy on Prescribing: Key Findings
                  • Physician-Reported Cost-Control Measures for Anti-VEGF Agents for Wet AMD: Medicare
                  • Physician-Reported Cost-Control Measures for Anti-VEGF Agents for Wet AMD: Commercial Insurance
                  • Other Cost-Control Measures
              • Market Access Landscape for Emerging Therapies
                • Impact of Emerging Therapies on Prescribing
                  • Likely Impact of Emerging Therapies for Wet AMD
                  • Anticipated Patient Share of Therapies If Emerging Agents and Biosimilar Ranibizumab Are on a Preferred vs. Nonpreferred Tier: Medicare
                  • Potential Impact of Biosimilar Ranibizumab 0.5 mg and Biosimilar Aflibercept on Physician Prescribing for Wet AMD
                • Potential Placement of Emerging Therapies at Various Prices
                  • Potential Reimbursement of Emerging Therapies for Wet AMD
                  • Potential Placement of RTH-258 at Various Price Points for Wet AMD: MCOs' MA Plans
                  • Potential Placement of Abicipar Pegol at Various Price Points for Wet AMD: MCOs' MA Plans
                  • Expected Coverage of Biosimilar Ranibizumab 0.5 mg and Biosimilar Aflibercept for Wet AMD
                • Prescriber and MCO Priorities for Emerging Therapy Evaluation
                  • Key Findings
                  • Physician-Reported Areas of Future Opportunity for Wet AMD
                  • Payer-Reported Areas of Future Opportunity for Wet AMD
                  • Emerging Therapies Expected to Have the Most Impact on Wet AMD Treatment
              • Methodology
                • Primary Market Research Methodology: Physicians
                  • Percentage of Ophthalmologists Who Completed a Retina Fellowship Lasting 12 Months or More
                  • Years in Ophthalmology Practice Postresidency
                  • Average Number of Wet AMD Patients Currently Under Management
                  • Practice Settings of Surveyed Ophthalmologists
                  • Regional Demographics of Surveyed Ophthalmologists
                • Primary Market Research Methodology: MCOs
                  • Percentage of MCO MDs and PDs
                  • Regional Demographics of MCOs of Surveyed PDs/MDs
                  • MCO Territory Size
                  • MCO Plan Types
                  • Number of Covered Lives in PDs/MDs' MCO
                  • Average Number of Individual Covered Lives in PDs/MDs' MCO
                  • PDs/MDs' Level of Familiarity with Their MCO's Coverage of Anti-VEGF Agents for Wet AMD
              • Appendix
                • Physician Survey
                  • Percentage of AMD Patients with Wet AMD in Physician Practices
                  • Treatment Approaches for Medicare-Covered and Commercially Insured Wet AMD Patients
                  • Main Reasons for Not Administering IVT Pharmacotherapy to Some Wet AMD Patients
                  • Physician-Reported Use of Buy and Bill and Specialty Pharmacy for Anti-VEGF Agents for Wet AMD
                  • Reasons for Using Specialty Pharmacy for Anti-VEGF Agents
                  • Reimbursement to Surveyed Ophthalmologists via Bundled Payment Arrangements
                  • Impact on Prescribing of Bundled Payments for Anti-VEGF Agents
                  • Influence of Reimbursement Restrictions on Surveyed Ophthalmologists' Prescribing to Medicare-Covered Wet AMD Patients
                  • Influence of Reimbursement Restrictions on Surveyed Ophthalmologists' Prescribing to Commercially Insured Wet AMD Patients
                  • Step-Therapy Requirement Before Prescribing an Anti-VEGF Agent to Medicare-Covered Wet AMD Patients
                  • Scenarios Under Which Ophthalmologists Would Prescribe Biosimilar Ranibizumab 0.5 mg and Biosimilar Aflibercept for Wet AMD
                  • Maximum Expected Patient Share for Biosimilar Ranibizumab 0.5 mg and Biosimilar Aflibercept for Wet AMD
                  • Maximum Expected Patient Share for RTH-258 and Abicipar Pegol for Wet AMD
                  • Most Likely Wet AMD Patient Types for RTH-258 and Abicipar Pegol
                  • Current Wet AMD Therapies Most Likely to Be Displaced by RTH-258 and Abicipar Pegol
                  • Maximum Expected Patient Share for Adjunctive Fovista and Adjunctive Squalamine for Wet AMD
                  • Most Likely Wet AMD Patient Types for Adjunctive Fovista and Adjunctive Squalamine
                  • Current Anti-VEGF Agent to Which Adjunctive Fovista and Adjunctive Squalamine Would Most Likely Be Added
                  • Expected Impact of Fovista's Phase II Expansion Trials on Its Prescribing for Wet AMD
                  • Impact of Cost-Control Measures on the Prescribing of New Therapies for Wet AMD
                  • Anticipated IVT/Ophthalmic Pharmacotherapy for Wet AMD Patients by the End of 2021
                  • Physician Attentiveness to Cost-Effectiveness Studies for Emerging Therapies for Wet AMD
                  • Anticipated Impact of Cost-Effectiveness Studies on the Prescribing of Emerging Therapies for Wet AMD
                • MCO Survey
                  • Delegation of Responsibility for Formulary Development and Maintenance of MCOs' MA and Commercial Plans
                  • PBM Formulary Used by MCOs' MA and Commercial Plans
                  • Degree of Customization of PBM Formulary in MCOs' MA and Commercial Plans
                  • MCO P&T Committees’ Plan to Review Wet AMD Therapies
                  • MCO P&T Committee Members with the Most Influence on Formulary Decisions for Wet AMD
                  • Formulary Status of Newly Launched Drugs Prior to Complete MCO Review
                  • Information Required for Formulary Review of Wet AMD Drugs by MCO P&T Committee
                  • Assessment for Inclusion of Avastin on Formulary in MCOs' MA and Commercial Plans
                  • Coverage of Anti-VEGF Agents for Wet AMD as Pharmacy Benefit Only or Both Medical and Pharmacy Benefit in MCOs' MA Plans
                  • Cost-Share for Anti-VEGF Agents for Wet AMD Separate from the Office Visit Charge in MA Plans
                  • Average Copayment for Wet AMD Therapies Covered Under Medical Benefit with Separate Cost-Share Beyond the Office Visit Charge in MCOs' MA Plans
                  • Average Coinsurance Percentage for Wet AMD Therapies Covered Under Medical Benefit with Separate Cost-Share Beyond the Office Visit in MCOs' MA Plans
                  • Reasons Why Wet AMD Therapies Are Excluded/NDC Blocked in a Minority of MCOs' MA Plans
                  • Reasons Why Wet AMD Therapies Are Not Preferred in Some MCOs' MA Plans
                  • Step-Therapy Requirement for Anti-VEGF Agents for Wet AMD on MCOs’ MA Plans
                  • Major Distribution Channels for Anti-VEGF Agents for Wet AMD in MCOs' MA Plans
                  • MCOs' Current and Future Use of Buy and Bill for Anti-VEGF Agents for Wet AMD
                  • MCOs' Current and Future Use of Bundled Payments for Wet AMD
                  • Anti-VEGF Agents for Wet AMD Included as Part of Bundled Payments
                  • PE/HE Outcomes Data Submitted to MCOs for Anti-VEGF Agents for Wet AMD
                  • Quality of PE/HE Outcomes Data Submitted for Eylea and Lucentis for Wet AMD
                  • Impact of Submitted PE/HE Outcomes Data for Eylea and Lucentis for Wet AMD
                  • Payers’ Opinions About Coverage of Biosimilar Ranibizumab 0.5 mg for Wet AMD on MA and Commercial Plans
                  • Payers’ Opinions About Coverage of Biosimilar Aflibercept for Wet AMD on MA and Commercial Plans
                  • Coverage of Biosimilar Ranibizumab 0.5 mg and Biosimilar Aflibercept at Various Price Discounts for Wet AMD
                  • Preferred Comparator for an Emerging Therapy for Wet AMD
                  • Potential Placement of Adjunctive Fovista at Various Price Points for Wet AMD: MCOs' MA Plans
                  • Expected Impact of Fovista's Phase II Expansion Trials on Its Reimbursement/Formulary Placement for Wet AMD
                  • Payers’ Expectation on Encouragement to Use Adjunctive Fovista with Individual Anti-VEGF Agents for Wet AMD
                  • Potential Placement of Adjunctive Squalamine at Various Price Points for Wet AMD: MCOs' Medicare PDPs
                  • Emerging Therapies Expected to Have Greatest Impact on Wet AMD Treatment: MCOs
                • Abbreviations
                  • Bibliography

                Author(s): Himanshu Jain, M.S. Pharm

                Himanshu joined the CNS / ophthalmology team at Decision Resources Group in 2016. He has authored content for psychiatry and ophthalmology (retinal / nonretinal) indications, including schizophrenia, age-related macular degeneration, diabetic retinopathy / diabetic macular edema, dry eye disease, glaucoma, and uveitis.

                Himanshu has more than ten years of experience working in market research and consulting firms, and has managed multiple market assessment projects, including bottom-up forecasts, across multiple therapy areas. He holds a M.S. degree in Pharmacology and Toxicology from the National Institute of Pharmaceutical Education and Research in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.


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