Asthma is a chronic inflammatory disorder of the airways affecting millions of people across the EU5 countries under study and representing a costly health expense for payers. Symptoms can often be controlled through the use of long-acting inhalers, with long-acting beta2 agonist/inhaled corticosteroid fixed-dose combinations (LABA/ICS FDCs) dominating the EU5 markets. Limited availability of true generic alternatives in the LABA/ICS FDC class, owing to patented delivery systems, has kept drug prices high; however, these agents face growing competition from generic/branded generic LABA/ICS FDCs and additional downward pricing pressure from payers, which together create a challenging market access environment for current and future inhaled therapies. High unmet need exists for severe, refractory asthma patients, for whom Xolair has been the only licensed biologic available since 2005. However, the entry of additional expensive biologics targeting this patient population will be met with increasing reimbursement restrictions and coverage limitations, particularly at a subnational level in some markets; the launch of a less-expensive omalizumab biosimilar could further change the dynamics of this market. Thus, drug makers must carefully navigate the road to reimbursement in order to optimize uptake.

Table of contents

  • Detailed, Expanded Analysis (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New Asthma Therapies in the EU5
    • Successes and Stumbles
      • Successes Among Asthma Therapies in the EU5
      • Stumbles Among Asthma Therapies in the EU5
      • France: Reimbursement Successes and Stumbles
      • Germany: Reimbursement Successes and Stumbles
      • Italy: Reimbursement Successes and Stumbles
      • Spain: Reimbursement Successes and Stumbles
      • United Kingdom: Reimbursement Successes and Stumbles
    • Key Stakeholders in the Road to Market Access
      • France
      • Germany
      • Italy
      • Spain
      • United Kingdom
    • Key Market Access Roadblocks for Asthma Therapies in the EU5
      • Key Market Access Roadblocks
      • France: Key Market Access Roadblocks
      • Germany: Key Market Access Roadblocks
      • Italy: Key Market Access Roadblocks
      • Spain: Key Market Access Roadblocks
      • United Kingdom: Key Market Access Roadblocks
    • Reimbursement Dynamics
      • France
        • France: Crucial HTA Criteria
        • France: P&R Drivers and Key HTA Considerations
        • France: Lessons Learned and Key Takeaways
        • France: Reimbursement Background
      • Germany
        • Germany: Crucial HTA Criteria
        • Germany: P&R Drivers and Key HTA Considerations
        • Germany: Lessons Learned and Key Takeaways
        • Germany: Reimbursement Background
      • Italy
        • Italy: Crucial HTA Criteria
        • Italy: P&R Drivers and Key HTA Considerations
        • Italy: Lessons Learned and Key Takeaways
        • Italy: Reimbursement Background
      • Spain
        • Spain: Crucial HTA Criteria
        • Spain: P&R Drivers and Key HTA Considerations
        • Spain: Lessons Learned and Key Takeaways
        • Spain: Reimbursement Background
      • United Kingdom
        • United Kingdom: Crucial HTA Criteria
        • United Kingdom: P&R Drivers and Key HTA Considerations
        • United Kingdom: Lessons Learned and Key Takeaways
        • United Kingdom: Reimbursement Background
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Prescriber Preferences for Asthma
        • Prescriber Preferences for Asthma Maintenance Therapy
        • Prescriber Preferences for Individual LABA/ICS FDCs in Asthma
      • Impact of Payer Policy on Prescribing for Asthma
        • Impact of Payer Policy on Prescribing of LABA/ICS FDCs and Spiriva
        • Impact of Payer Policy on Prescribing of Xolair
        • Impact of Payer Policy on Prescribing of Generic Inhaled Therapies for Asthma
      • Top Prescribing Drivers: Novel Biologics for Asthma
        • Top Prescribing Drivers for Novel Asthma Biologics
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Emerging Therapies on Asthma
        • Likely Impact of Emerging Therapies on Asthma Treatment
      • Market Access Challenges for Emerging Asthma Therapies
        • Market Access Challenges for Nucala
        • Market Access Challenges for Benralizumab
        • Market Access Challenges for Lebrikizumab
        • Market Access Challenges for Dupilumab
      • Payer Opinion of Emerging Therapies for Asthma
        • France: Payer Opinion of Emerging Therapies for Asthma
        • Germany: Payer Opinion of Emerging Therapies for Asthma
        • Italy: Payer Opinion of Emerging Therapies for Asthma
        • Spain: Payer Opinion of Emerging Therapies for Asthma
        • United Kingdom: Payer Opinion of Emerging Therapies for Asthma
    • Methodology
      • Primary Research Design
      • Physician Demographics and Practice Setting
      • Pricing Methodology
    • Appendix
      • Key Therapies for Asthma
        • Nucala (Mepolizumab)
        • Reslizumab
        • Benralizumab
        • Lebrikizumab
        • Dupilumab
      • Physician Survey Data

Author(s): Elena Kozhemyakina, PhD; Eun-Jin Yang, PhD; Laurie J. Dimodica, MS

Elena Kozhemyakina, PhD, is a Senior Business Insight Analyst at Decision Resources, Inc., specializing in pharmaceutical market analysis of the immune system disorders with expertise in Systemic Lupus Erythematosus, asthma, Crohn’s disease and ulcerative colitis. Prior to joining Decision Resources, Dr. Kozhemyakina completed a postdoctoral fellowship at Harvard Medical School, where she investigated molecular mechanisms involved in limb patterning, cartilage formation and pathogenesis of osteoarthritis. She published multiple peer-reviewed papers focused on molecular signalling of developmental disorders.

Eun-Jin Yang, . is a senior business insights analyst at Decision Resources Group. She has authored market research reports analyzing physician, payer, and market trends in asthma, COPD, Lupus, and other autoimmune diseases. Her prior experience includes publishing pharmaceutical and biotechnology company-focused industry research articles as a cofounding analyst in the Harvard Biotechnology Club and helping to commercialize inventions in various therapeutic areas from Massachusetts General Hospital and Brigham and Women’s Hospital. She finished her postdoctoral fellowships at Boston Children’s Hospital, Harvard University, and Columbia University. She received her at the University of Texas at Austin.

Laurie DiModica has more than two decades of experience in healthcare and biopharmaceutical market research in the major and emerging markets. She currently works on DRG’s Access & Reimbursement series (formerly European Physician and Payer Forum ) and its Global Market Access Solutions product. Ms. DiModica was previously a Medical Publications and Conference Director for the Institute for International Research, specializing in the managed care market. She has an from Simmons College in ;


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