Dermatologists have many years of experience with the tumor necrosis factor-alpha (TNF-α) inhibitors Humira (AbbVie) and Enbrel (Pfizer) as first-line biologics for the treatment of psoriasis. Janssen’s interleukin (IL)-12/23 inhibitor Stelara has also gained traction in early lines of therapy. However, the market penetration of more-effective biologics, such as IL-17 inhibitors Cosentyx (Novartis) and Taltz (Eli Lilly), is now threatening the first-line dominance of TNF-α inhibitors, and further competition is expected, with the highly efficacious IL-23 inhibitors, led by Janssen’s guselkumab, set to enter the fray in 2017. With the added availability of biosimilars, EU5 payers and prescribers must carefully balance clinical superiority with cost-effectiveness, and drug marketers must be well equipped to navigate a complex road to reimbursement.

Questions Answered in This Report:

  • The EU5 psoriasis market will see continued uptake of the six approved biologics and targeted oral agent Otezla. How do reimbursement terms for psoriasis biologics and oral agent Otezla vary across the EU5? How do payers regulate use of these premium-priced agents? How do prescribing patterns for key psoriasis therapies differ between and within EU5 countries, and to what extent does payer policy impact uptake?
  • As biologics use in psoriasis continues to grow, EU5 payers increasingly emphasize the importance of biosimilars for curbing healthcare expenditures; the first two biosimilars in psoriasis, biosimilar infliximab and biosimilar etanercept, entered the European markets in early 2015 and 2016, respectively. How has the launch of biosimilar versions of infliximab and etanercept altered payer preferences and mandates, and what has the actual impact of biosimilar availability been on physician prescribing?
  • The psoriasis market will become increasingly crowded with the anticipated entry of five additional biologics by 2020. What key market access challenges do emerging psoriasis agents face? What lessons have been learned, and what market access levers can drug developers take advantage of to optimize the positioning of their products?

Scope:

  • Markets covered: France, Germany, Italy, Spain, United Kingdom.
  • Methodology: Surveys of 250 dermatologists and 10 country-specific interviews with European payers.
  • Indication coverage: Psoriasis.
  • Key drugs covered: Humira, Enbrel, Remicade, Stelara, Otezla, Cosentyx, Taltz, brodalumab, guselkumab, tildrakizumab, risankizumab, Cimzia.
  • Key companies mentioned: AbbVie, Pfizer, Merck, Janssen, Celgene, Novartis, Eli Lilly, Leo Pharma, Amirall, Sun Pharmaceutical, Boehringer Ingelheim, UCB, Dermira.

Table of contents

  • Psoriasis - 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 Psoriasis Therapies
      • Successes and Stumbles
        • Successes Among Psoriasis Therapies in the EU5
        • Stumbles Among Psoriasis Therapies in the EU5
        • Overview of Successes and Stumbles Among Psoriasis 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
          • 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
          • 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 Psoriasis
            • Current Patient Share of Psoriasis Biologics and Otezla
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed, EU5 Total
          • Impact of Payer Policy on Prescribing for Psoriasis
            • Overall Impact of EU5 Payer Policy on Prescribing for Psoriasis
            • Reasons Eligible Psoriasis Patients Are Not Receiving Biologics/Otezla
            • Nonclinical Factors Restricting Prescription of Biologics/Otezla, by Country
            • Measures Taken by Payers to Promote Prescription of Biosimilars, by Country
            • Impact of Country-Specific Payer Policy on Prescribing for Psoriasis
            • Impact of Reimbursement Deficit on Patient Access to Psoriasis Biologics and Otezla: France
            • Impact of Richtgrößen on Patient Access to Psoriasis Biologics and Otezla: Germany
            • Impact of Regional Guidelines/Directives on Patient Access to Psoriasis Biologics and Otezla: Italy
            • Impact of Regional Guidelines/Directives or Out of Pocket Costs/Copays on Patient Access to Psoriasis Biologics and Otezla: Spain
            • Impact of CCG or Local Formulary on Patient Access to Psoriasis Biologics and Otezla: United Kingdom
          • Top Prescribing Drivers for Psoriasis
            • Most Influential Reason for Selecting First-Line Psoriasis Biologics/Otezla, EU5 Total
            • Factors Influencing Prescription of Cosentyx and Taltz, EU5 Total
            • Reasons for Prescribing Biosimilar Infliximab or Biosimilar Etanercept, EU5 Total
        • Market Access Landscape for Emerging Therapies
          • Overview of the Evolving Market Access Landscape in Psoriasis
            • Anticipated Patient Share of Psoriasis Biologics and Otezla in 2020, EU5 Total
            • Anticipated Lines of Therapy with Psoriasis Biologics and Otezla in 2020, EU5 Total
          • Likely Impact of Emerging Therapies for Psoriasis
            • Likely Impact of Brodalumab for Psoriasis
            • Physicians' Likelihood to Prescribe IL-17 Inhibitors for Psoriasis, by Country
            • Reasons for Prescribing Brodalumab Ahead of Other IL-17 Inhibitors, EU5 Total
            • Likely Impact of Emerging IL-23 Inhibitors for Psoriasis
            • Anticipated Usage of Emerging IL-23 Inhibitors by 2020, by Country
            • Physicians' Likelihood to Prescribe Emerging IL-23 Inhibitors for Psoriasis, by Country
            • Reasons for Prescribing Guselkumab Ahead of Other IL-23 Inhibitors, EU5 Total
          • Market Access Challenges for Emerging Psoriasis Therapies
            • Key Drivers for Prescribing New Psoriasis Therapy, by Country
            • Reasons for Not Expecting to Prescribe IL-23 Inhibitors by 2020, EU5 Total
            • Patient Groups Most Likely to Receive Brodalumab, by Country
            • Patient Groups Most Likely to Receive Emerging IL-23 Inhibitors, by Country
          • Payer Opinion on Emerging Therapies for Psoriasis
            • Payer Opinion on Emerging Psoriasis Therapies
        • Methodology
          • Abbreviations
          • Primary Research Design
          • Background of Payers and Payer-Advising KOLs
          • Physician Demographics and Practice Setting
            • Distribution of Medical Practice by Country
            • Average Number of Years Practiced Postresidency
            • Physician Practice Setting
            • Average Number of Adult Psoriasis Patients Under Management per Month
        • 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: Autonomic Evaluation Committees (CAEs)
            • 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 Psoriasis
            • Profiles of Key Current Therapies for Psoriasis in the EU5
            • Emerging Therapy Profiles
            • Leo Pharma's Brodalumab
            • Janssen's Guselkumab
            • Almirall/Sun Pharmaceutical's Tildrakizumab
            • AbbVie/Boehringer Ingelheim's Risankizumab
            • UCB/Dermira's Cimzia (certolizumab pegol)
          • Physician Survey Data
            • Percentage of Psoriasis Patients by Severity
            • Current Patient Share of Key Psoriasis Drug Classes in Mild Patients
            • Current Patient Share of Key Psoriasis Drug Classes in Moderate to Severe Patients
            • Percentage of Psoriasis Patients Currently Eligible and Currently Receiving Biologics/Otezla
            • Physician Prescribing of Psoriasis Biologics and Otezla
            • Treatment Satisfaction with Key Psoriasis Drug Classes
            • Current Lines of Therapy with Psoriasis Biologics and Otezla, by Country
            • Current Lines of Therapy with Psoriasis Biologics and Otezla, EU5 Total
            • Reasons for Prescribing TNF-Alpha Inhibitor as First-Line Agent, by Country
            • Reasons for Prescribing TNF-Alpha Inhibitor as First-Line Agent, EU5 Total
            • Reasons for Prescribing Non-TNF-Alpha Biologic as First-Line Agent, by Country
            • Reasons for Prescribing Non-TNF-Alpha Biologic as First-Line Agent, EU5 Total
            • Reasons for Prescribing Enbrel as First-Line Agent, by Country
            • Reasons for Prescribing Enbrel as First-Line Agent, by EU5 Total
            • Reasons for Prescribing Biosimilar Etanercept as First-Line Agent, EU5 Total
            • Reasons for Prescribing Humira as First-Line Agent, by Country
            • Reasons for Prescribing Humira as First-Line Agent, by EU5 Total
            • Reasons for Prescribing Remicade as First-Line Agent, EU5 Total
            • Reasons for Prescribing Biosimilar Infliximab as First-Line Agent, EU5
            • Reasons for Prescribing Stelara as First-Line Agent, by Country
            • Reasons for Prescribing Stelara as First-Line Agent, EU5 Total
            • Reasons for Prescribing Otezla as First-Line Agent, by Country
            • Reasons for Prescribing Otezla as First-Line Agent, EU5 Total
            • Reasons for Prescribing Cosentyx as First-Line Agent, by Country
            • Reasons for Prescribing Cosentyx as First-Line Agent, EU5 Total
            • Reasons for Prescribing Taltz as First-Line Agent, EU5 Total
            • Nonclinical Factors Restricting Prescription of Biologics/Otezla: EU5 Total
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed: France
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed: Germany
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed: Italy
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed: Spain
            • Patient Groups Most Commonly Treated with Non-TNF Agents Currently and If Reimbursement Restrictions Were Removed: United Kingdom
            • Factors Influencing Prescription of Cosentyx, by Country
            • Factors Influencing Prescription of Taltz, by Country
            • Reasons for Not Prescribing Otezla, Cosentyx, or Taltz, by Country
            • Reasons for Not Prescribing Otezla, Cosentyx, or Taltz, EU5 Total
            • Treatment History of Patients Receiving Biosimilar Infliximab or Biosimilar Etanercept, by Country
            • Treatment History of Patients Receiving Biosimilar Infliximab or Biosimilar Etanercept, EU5 Total
            • Reasons for Prescribing Biosimilar Infliximab or Biosimilar Etanercept, by Country
            • Measures Taken by Payers to Promote Prescription of Biosimilars, EU5 Total
            • Reasons for Not Prescribing Biosimilar Infliximab or Biosimilar Etanercept, by Country
            • Reasons for Not Prescribing Biosimilar Infliximab or Biosimilar Etanercept, EU5 Total
            • Impact of Reimbursement Deficit on Patient Access to Psoriasis Biologics and Otezla: France (Version 2)
            • Impact of Richtgrößen on Patient Access to Psoriasis Biologics and Otezla: Germany (Version 2)
            • Impact of Regional Guidelines/Directives or Out of Pocket Costs/Copays on Patient Access to Psoriasis Biologics and Otezla: Spain (Version 2)
            • Familiarity with Emerging Psoriasis Therapies, by Country
            • Familiarity with Emerging Psoriasis Therapies, EU5 Total
            • Key Drivers for Prescribing New Psoriasis Therapy, EU5 Total
            • Physicians' Likelihood to Prescribe IL-17 Inhibitors for Psoriasis, EU5 Total
            • Reasons for Prescribing Cosentyx Ahead of Other IL-17 Inhibitors, by Country
            • Reasons for Prescribing Cosentyx Ahead of Other IL-17 Inhibitors, EU5 Total
            • Reasons for Prescribing Taltz Ahead of Other IL-17 Inhibitors, by Country
            • Reasons for Prescribing Taltz Ahead of Other IL-17 Inhibitors, EU5 Total
            • Reasons for Prescribing Brodalumab Ahead of Other IL-17 Inhibitors, by Country
            • Reasons Brodalumab is Anticipated to Be Least Likely Prescribed IL-17 Inhibitor, by Country
            • Reasons Brodalumab is Anticipated to Be Least Likely Prescribed IL-17 Inhibitor, EU5 Total
            • Anticipated Usage of Emerging IL-23 Inhibitors by 2020, EU5 Total
            • Reasons for Not Expecting to Prescribe IL-23 Inhibitors by 2020, by Country
            • Physicians' Likelihood to Prescribe Emerging IL-23 Inhibitors for Psoriasis, EU5 Total
            • Reasons for Prescribing Guselkumab Ahead of Other IL-23 Inhibitors, by Country
            • Reasons for Prescribing Tildrakizumab Ahead of Other IL-23 Inhibitors, by Country
            • Reasons for Prescribing Tildrakizumab Ahead of Other IL-23 Inhibitors, EU5 Total
            • Reasons for Prescribing Risankizumab Ahead of Other IL-23 Inhibitors, by Country
            • Reasons for Prescribing Risankizumab Ahead of Other IL-23 Inhibitors, EU5 Total
            • Reasons Guselkumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, by Country
            • Reasons Guselkumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, EU5 Total
            • Reasons Tildrakizumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, by Country
            • Reasons Tildrakizumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, EU5 Total
            • Reasons Risankizumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, by Country
            • Reasons Risankizumab Is Anticipated to Be Least Likely Prescribed IL-23 Inhibitor, EU5 Total
            • Patient Groups Most Likely to Receive Brodalumab, EU5 Total
            • Patient Groups Most Likely to Receive Emerging IL-23 Inhibitors, EU5 Total
            • Likelihood of Prescribing Cimzia for Psoriasis
            • Reasons for Expecting to Prescribe Cimzia for Psoriasis, by Country
            • Reasons for Expecting to Prescribe Cimzia for Psoriasis, EU5 Total
            • Reasons for Not Expecting to Prescribe Cimzia for Psoriasis, by Country
            • Reasons for Not Expecting to Prescribe Cimzia for Psoriasis, EU5 Total
            • Anticipated Patient Share of Psoriasis Biologics and Otezla in 2020, by Country
            • Anticipated Lines of Therapy with Psoriasis Biologics and Otezla in 2020, by Country
            • ASMR Rating Worthy of and Likely to Be Received by Emerging Psoriasis Biologics: France
            • Benefit Rating Worthy of and Likely to Be Received by Emerging Psoriasis Biologics: Germany
            • Innovation Rating Worthy of and Likely to Be Received by Emerging Psoriasis Biologics: Italy
            • Anticipated Reimbursement of Emerging Psoriasis Biologics: Spain
            • Anticipated Reimbursement of Emerging Psoriasis Biologics: United Kingdom

      Author(s): Yulia Privolnev, MA; Ronnie Yoo

      Yulia Privolnev is a manager on the Global Market Access Insights team at Decision Resources Group, primarily focusing on European market access. She is responsible for monitoring, analyzing, and reporting on global market access through the production of DRG’s Global Market Access Solution (GMAS) and Access & Reimbursement products. Yulia’s specific focus is on all aspects of market access in Western and Eastern Europe, as well as external reference pricing (ERP) and managed entry agreements (MEAs) on a global scale. Yulia holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.


      Related Reports

      Psoriasis - Landscape & Forecast - Disease Landscape & Forecast

      The psoriasis therapy market has become increasingly lucrative owing to the growing use of targeted agents. The dominance of the tumor necrosis factor (TNF

      View Details

      Psoriasis - Current Treatment - Detailed, Expanded Analysis Pediatric Psoriasis - Treatment Algorithms - Claims Data Analysis (US)

      Psoriasis is a chronic, inflammatory, autoimmune skin disease that can affect children, adolescents, and adults. Although adult psoriasis and pediatric psoriasis are similar, effective management o...

      View Details

      Psoriasis | Disease Landscape and Forecast | G7 | 2020

      The psoriasis therapy market is becoming increasingly lucrative owing to the growing number of approved biologics. Although TNF-alpha inhibitors continue to dominate the market, their premier posit...

      View Details

      Psoriasis - Geographic Focus: China - Psoriasis|China In-Depth|China

      Psoriasis is an incurable chronic skin condition known to affect more than 8 million people in China. China’s psoriasis market has grown significantly over the last few years owing to the gro...

      View Details