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

  • Asthma - Access & Reimbursement - 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: P&R Drivers and Key HTA Considerations
                  • France: HTA Review Details for Key Asthma Therapies
                  • France: Lessons Learned and Key Takeaways
                  • France: Key Background Details of the Healthcare System
                  • France: P&R Process
                  • France: P&R Process
                  • France: Reimbursement Details and Mechanisms
                  • France: Prescribing Restrictions, Dispensations, and Monitoring
                  • France: Payer Perception of Biosimilar Omalizumab
                • Germany
                  • Germany: Crucial HTA Criteria
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: HTA Review Details for Key Asthma Therapies
                  • Germany: Lessons Learned and Key Takeaways
                  • Germany: Key Background Details of the Healthcare System
                  • Germany: P&R Process
                  • Germany: P&R Process
                  • Germany: Reimbursement Details and Mechanisms
                  • Germany: Prescribing Controls and Monitoring
                  • Germany: Payer Perception of Biosimilar Omalizumab
                • Italy
                  • Italy: Crucial HTA Criteria
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: HTA Review Details for Key Asthma Therapies
                  • Italy: Lessons Learned and Key Takeaways
                  • Italy: Key Background Details of the Healthcare System
                  • Italy: P&R Process
                  • Italy: P&R Process
                  • Italy: Reimbursement Details and Mechanisms
                  • Italy: Payer Perception of Biosimilar Omalizumab
                • Spain
                  • Spain: Crucial HTA Criteria
                  • Spain: P&R Drivers and Key HTA Considerations
                  • Spain: P&R Drivers and Key HTA Considerations
                  • Spain: HTA Review Details for Key Asthma Therapies
                  • Spain: Lessons Learned and Key Takeaways
                  • Spain: Key Background Details of the Healthcare System
                  • Spain: P&R Process
                  • Spain: P&R Process
                  • Spain: Reimbursement Details and Mechanisms
                  • Spain: Payer Perception of Biosimilar Omalizumab
                • United Kingdom
                  • United Kingdom: Crucial HTA Criteria
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: HTA Review Details for key Asthma Therapies
                  • United Kingdom: Lessons Learned and Key Takeaways
                  • United Kingdom: Key Background Details of the Healthcare System
                  • United Kingdom: P&R Process
                  • United Kingdom: P&R Process
                  • United Kingdom: Reimbursement Details and Budget Controls
                  • United Kingdom: Prescribing Controls and Monitoring
                  • United Kingdom: Payer Perception of Biosimilar Omalizumab
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Prescriber Preferences for Asthma
                  • Prescriber Preferences for Asthma Maintenance Therapy
                  • Key Maintenance Drug Classes' Patient Share in Asthma
                  • Prescriber Preferences for Individual LABA/ICS FDCs in Asthma
                  • Current Prescribing of LABA/ICS FDCs for Asthma, by Drug
                  • Primary Reasons Driving Physicians' Choice of LABA/ICS FDC
                • 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 LABA/ICS FDCs and Spiriva
                  • Impact of Payer Policy on Prescribing of Xolair
                  • Primary Reasons Eligible Patients Are Not Receiving Xolair
                  • Nonclinical Factors That Most Influence Use of Xolair
                  • Impact of Payer Policy on Prescribing of Generic Inhaled Therapies for Asthma
                  • Select Drivers of Future Prescribing of Generic Inhaled Therapies for Asthma
                • Top Prescribing Drivers: Novel Biologics for Asthma
                  • Top Prescribing Drivers for Novel Asthma Biologics
                  • Most-Influential Prescribing Drivers of New Asthma Biologics
              • Market Access Landscape for Emerging Therapies
                • Likely Impact of Emerging Therapies on Asthma
                  • Likely Impact of Emerging Therapies on Asthma Treatment
                  • Patient Share of Novel Biologics for Severe, Refractory Asthma in 2019
                • Market Access Challenges for Emerging Asthma Therapies
                  • Market Access Challenges for Nucala
                  • Patient Groups Most Likely to Receive Nucala
                  • Market Access Challenges for Benralizumab
                  • Reasons to Prefer Benralizumab to the Other IL-5 Inhibitors
                  • Market Access Challenges for Lebrikizumab
                  • Most Likely Reasons to Prescribe Lebrikizumab Ahead of Other Emerging Biologics
                  • Reasons Why Physicians Do Not Expect to Prescribe Lebrikizumab
                  • Market Access Challenges for Dupilumab
                  • Most Likely Reasons to Prescribe Dupilumab Ahead of Other Emerging Biologics
                  • Reasons Why Physicians Do Not Expect to Prescribe Dupilumab
                • Payer Opinion of Emerging Therapies for Asthma
                  • France: Payer Opinion of Emerging Therapies for Asthma
                  • France: Payer Opinion of Emerging Therapies for Asthma
                  • Germany: Payer Opinion of Emerging Therapies for Asthma
                  • Germany: Payer Opinion of Emerging Therapies for Asthma
                  • Italy: Payer Opinion of Emerging Therapies for Asthma
                  • Italy: Payer Opinion of Emerging Therapies for Asthma
                  • Spain: Payer Opinion of Emerging Therapies for Asthma
                  • Spain: Payer Opinion of Emerging Therapies for Asthma
                  • United Kingdom: Payer Opinion of Emerging Therapies for Asthma
                  • United Kingdom: Payer Opinion of Emerging Therapies for Asthma

            Author(s): Elena Kozhemyakina, Ph.D.; Eun-Jin Yang, PhD; Laurie J. Dimodica, M.S.

            Elena Kozhemyakina, Ph.D., is a director on the Immune and Inflammatory Disorders team at Clarivate. She manages a team of analysts generating syndicated market research products on asthma, COPD, systemic lupus erythematosus, and urticaria. Previously, 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 has authored multiple peer-reviewed publications on molecular signaling in developmental disorders. She received her Ph.D. from the West Virginia University School of Medicine.

            Eun-Jin Yang, Ph.D. 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 Ph.D. 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 U.S. managed care market. She has an M.S. from Simmons College in Boston. 


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