Atopic Dermatitis/Atopic Eczema – Access & Reimbursement – Detailed, Expanded Analysis (EU)

Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin disease that usually affects children but can persist or start in adulthood. For many years, the treatment landscape has remained stagnant, with topical agents dominating the treatment algorithm and systemic immunosuppressants such as azathioprine and cyclosporin largely used in patients whose disease is inadequately controlled. Expected approval of Sanofi/Regeneron’s IL-4/IL-13 inhibitor dupilumab in 2018 should give moderate to severe atopic dermatitis patients a promising targeted therapy option, with AstraZeneca/Leo Pharma’s tralokinumab and Roche/Gladerma’s lebrikizumab potentially strengthening the field in 2021. However, uptake of these premium-priced agents will strongly depend on EU5 payers’ willingness to reimburse, and on country-specific prescribing controls.

Questions Answered in  this Report:

  •  The topical agents are the mainstay of the AD market. The conventional systemics are mainly used in moderate to severe patients who respond inadequately to topicals. What are the current prescribing practices for AD in the EU5, and how, if at all, are these impacted by payer policy? 
  • Currently, no biologics are approved for AD; however, European AD guidelines do recommend off-label use of some biologics in severe patients if they are refractory to topicals and conventional systemics. To what extent are off-label conventional systemics such as methotrexate and off-label biologics like Novartis/Roche’s Xolair (omalizumab) used for moderate to severe AD? How do payers cover any such off-label prescribing?
  • Currently available AD therapies are inexpensive and therefore payers are generally not too concerned about the cost of overall AD treatment. However, this situation will change soon with the potential entry of the first biologic in 2018. What are payer and physician perspectives on promising but costly emerging agents such as dupilumab? What key market access challenges will manufacturers of novel AD therapies face? What can they do to encourage optimal pricing and reimbursement terms, and to drive uptake?

Scope:

  • Markets covered: France, Germany, Italy, Spain, and United Kingdom
  • Methodology: Surveys of 250 dermatologists and 10 country-specific interviews with European payers
  • Indication coverage: atopic dermatitis (AD)
  • Key drugs covered:  prescription topical corticosteroids, topical calcineurin inhibitors, methotrexate, cyclosporin, azathioprine, mycophenolate mofetil, Toctino, dupilumab, tralokinumab, and lebrikizumab
  • Key companies mentioned:  Sanofi, Regeneron,  AstraZeneca, Leo Pharma,  Roche,  and Novartis

Table of contents

  • Atopic Dermatitis/Atopic Eczema - Access & Reimbursement - Detailed, Expanded Analysis (EU)
    • Key Updates
      • December 2017
      • September 2017
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Optimizing Market Access Opportunity for Atopic Dermatitis in the EU5
      • Successes and Stumbles
        • Successes Among Atopic Dermatitis Therapies in the EU5
        • Stumbles Among Atopic Dermatitis Therapies in the EU5
        • Overview of Successes and Stumbles Among Atopic Dermatitis Therapies in the EU5
      • Key Stakeholders in the Road to Market Access
        • France
        • Germany
        • Italy
        • Spain
        • United Kingdom
      • Key Market Access Roadblocks
        • Reimbursement Dynamics
          • France
            • France: Crucial HTA Criteria
            • France: P&R Drivers and Key HTA Considerations
            • France: HTA Review Details
            • France: Reimbursement Regulations and Prescribing Parameters
            • France: Key Takeaways
          • Germany
            • Germany: Crucial HTA Criteria
            • Germany: P&R Drivers and Key HTA Considerations
            • Germany: HTA Review Details
            • Germany: Reimbursement Regulations and Prescribing Parameters
            • Germany: Key Takeaways
          • Italy
            • Italy: Crucial HTA Criteria
            • Italy: P&R Drivers and Key HTA Considerations
            • Italy: HTA Review Details
            • Italy: Reimbursement Regulations and Prescribing Parameters
            • Italy: Key Takeaways and Lessons Learned
          • Spain
            • Spain: Crucial HTA Criteria
            • Spain: P&R Drivers and Key HTA Considerations
            • Spain: HTA Review Details
            • Spain: Reimbursement Regulations and Prescribing Parameters
            • Spain: Key Takeaways and Lessons Learned
          • United Kingdom
            • United Kingdom: Crucial HTA Criteria
            • United Kingdom: P&R Drivers and Key HTA Considerations
            • United Kingdom: HTA Review Details
            • United Kingdom: Reimbursement Regulations and Prescribing Parameters
            • United Kingdom: Key Takeaways
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences for Atopic Dermatitis
            • Patient Share of Different Treatment Options in Atopic Dermatitis
            • Prescriber Preferences for Patients with Mild Atopic Dermatitis
            • Segmentation of Atopic Dermatitis Patients Based on Disease Severity
            • Patient Share of Prescription Drugs in Mild Atopic Dermatitis Patients
            • Prescriber Preferences for Patients with Moderate to Severe Atopic Dermatitis
            • Patient Share of Prescription Drugs in Moderate to Severe Atopic Dermatitis
            • Patient Share of Select Biologics in Atopic Dermatitis
          • Impact of Payer Policy on Prescribing for Atopic Dermatitis
            • Overall Impact of EU5 Payer Policy on Prescribing for Atopic Dermatitis
            • Nonclinical Factors Restricting Prescription of Topical Calcineurin Inhibitors
            • Nonclinical Factors Restricting Prescription of Conventional Systemic Treatments
            • Impact of Country-Specific Payer Policy on Prescribing for Atopic Dermatitis
            • Impact of Reimbursement Deficit on Patient Access to Atopic Dermatitis Drugs: France
            • Impact of Richtgroben on Patient Access to Atopic Dermatitis Drugs: Germany
            • Impact of Regional Guidelines/Directives on Patient Access to Atopic Dermatitis Drugs: Italy
            • Impact of Regional Guidelines/Directives or OOP Costs/Copays on Patient Access to Atopic Dermatitis Drugs: Spain
            • Impact of CCG or Local Formulary on Patient Access to Atopic Dermatitis Drugs: United Kingdom
          • Top Prescribing Drivers in Atopic Dermatitis
            • Current Lines of Therapy with Atopic Dermatitis Conventional Systemic Treatments: EU5 Total
            • Current Lines of Therapy with Atopic Dermatitis Conventional Systemic Treatments by Country
            • Most Influential Reason for Selecting Methotrexate as First-Line Systemic Agent in Atopic Dermatitis
            • Most Influential Reason for Selecting Cyclosporin as First-Line Systemic Agent in Atopic Dermatitis
            • Most Influential Reason for Selecting Toctino as First-Line Systemic Agent in Atopic Dermatitis
            • Most Influential Reason for Selecting First-Line Systemic Agent in Atopic Dermatitis: EU5 Total
            • Top Three Reasons for Not Prescribing Biologics to Atopic Dermatitis Patients: EU5 Total
            • Nonprescribers: Top Three Reasons for Not Prescribing Biologics to Atopic Dermatitis Patients by Country
            • Prescribers: Top Three Reasons for Not Prescribing Biologics to Atopic Dermatitis Patients by Country
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies for Atopic Dermatitis
            • Attributes Likely to Persuade Prescribing of Biologics in Atopic Dermatitis by Country
            • Factors Influencing Prescription of Emerging Biologics in Atopic Dermatitis by Country
            • Treatment History of Patients Likely to Receive Dupilumab by Country
            • Attributes Likely to Persuade Prescribing of a Topical Agent if Approved for Atopic Dermatitis by Country
            • Attributes Likely to Persuade Prescribing of a Topical Agent if Approved for Atopic Dermatitis by EU5 Total
          • Overview of the Atopic Dermatitis Treatment Landscape by Year-End 2020
            • Patient Share of Prescription Drug-Treated Mild Atopic Dermatitis Patients in 2017 and 2020 by Country
            • Patient Share of Prescription Drug-Treated Moderate to Severe Atopic Dermatitis Patients in 2017 and 2020 by Country
          • Market Access Challenges for Emerging Atopic Dermatitis Therapies
            • Key Drivers for Prescribing Atopic Dermatitis Therapies by Country
            • Reasons for Not Expecting to Prescribe Dupilumab by EU5 Total
            • Physician Perspective on HTA Challenges for Dupilumab
            • ASMR Rating to Be Received by Emerging Atopic Dermatitis Biologics: France
            • Benefit Rating to Be Received by Emerging Atopic Dermatitis Biologics: Germany
            • Innovation Rating to Be Received by Emerging AD Biologics: Italy
            • Anticipated Reimbursement of Emerging Atopic Dermatitis Biologics: Spain
            • Anticipated Reimbursement of Emerging Atopic Dermatitis Biologics: United Kingdom
            • Likely Difference Between EU and US Prescribing of Dupilumab
            • Most Likely Patient Groups for Dupilumab Use-EU5
            • Most Likely Patient Groups for Dupilumab Use-US
            • Anticipated Dupilumab Patient Share at Year-End 2020/2021
          • Payer Opinion on Emerging Therapies for Atopic Dermatitis
            • Payer Opinion on Emerging Atopic Dermatitis Therapies
        • Appendix
          • Country-Specific Reimbursement Background Details
            • France: Key Background Details of the Healthcare System
            • France: P&R Process
            • Germany: Key Background Details of the Healthcare System
            • Germany: P&R Process
            • Italy: Key Background Details of the Healthcare System
            • Italy: P&R Process
            • Italy: Additional Funding Mechanisms for Off-Label Use
            • Spain: Key Background Details of the Healthcare System
            • Spain: P&R Process
            • Spain: HTA Bodies
            • Spain: Autonomic Evaluation Committees
            • Spain: Commissions for Pharmacy and Therapeutics
            • Spain: Commissions for Pharmacy and Therapeutics
            • United Kingdom: Key Background Details of the Healthcare System
            • United Kingdom: P&R Process
          • Key Therapies for Atopic Dermatitis
            • Profiles of Key Current Therapies for Atopic Dermatitis in the EU5
            • Emerging Therapies Profiles
            • Sanofi/Regeneron's Dupilumab
            • AstraZeneca/Leo Pharma's Tralokinumab
            • Roche's Lebrikizumab
          • Physician Survey Data
            • Segmentation of Atopic Dermatitis Patients Based on Age
            • Most Influential Reason for Selecting Azathioprine as First-Line Systemic Agent in Atopic Dermatitis
            • Most Influential Reason for Selecting Mycophenolate Mofetil as First-Line Systemic Agent in Atopic Dermatitis
            • Percentage of Moderate to Severe Atopic Dermatitis Patients Refractory to Current Treatments by Country
            • Percentage of Moderate to Severe Atopic Dermatitis Patients Refractory to Current Treatments by EU5 Total
            • Nonclinical Factors Restricting Prescription of Atopic Dermatitis Drugs in the EU5
            • Impact of Reimbursement Deficit on Atopic Dermatitis Patients' Access to Drugs: France
            • Impact of Richtgroben on Patient Access to Atopic Dermatitis Drugs: Germany- Version 2
            • Impact of Regional Guideline/Directives or OOP Costs/Copays on Atopic Dermatitis Patients' Access to Drugs: Spain
            • Familiarity with Emerging Atopic Dermatitis Therapies by Country
            • Familiarity with Emerging Atopic Dermatitis Therapies by EU5 Total
            • Key Drivers for Prescribing Atopic Dermatitis Therapies by EU5 Total
            • Attributes Likely to Persuade Prescribing of Biologics in Atopic Dermatitis by EU5 Total
            • Factors Influencing Prescription of Emerging Biologics in Atopic Dermatitis by EU5 Total
            • Likelihood of Prescribing Dupilumab for Atopic Dermatitis
            • Anticipated Prescribing of Dupilumab in Atopic Dermatitis
            • Reasons for Not Expecting to Prescribe Dupilumab Within First Year on the Market by Country
            • Reasons for Not Expecting to Prescribe Dupilumab Within First Year on the Market by EU5 Total
            • Reasons for Not Expecting to Prescribe Dupilumab by Country
            • Reasons for Not Expecting to Prescribe Dupilumab by EU5 Total
            • Reasons for Prescribing Dupilumab by Country
            • Reasons for Prescribing Dupilumab by EU5 Total
            • Current Therapies Likely to Be Replaced by Dupilumab
            • Patient Share of Prescription Drug-Treated Atopic Dermatitis Patients in 2017 and 2020 by EU5 Total