The chronic obstructive pulmonary disease market is becoming increasingly crowded, and market access in the EU5 is a growing concern as manufacturers attempt to achieve favorable reimbursement status. In 2015, several new combination therapies have been approved for the treatment of COPD, payers are becoming stricter on HTA evaluations, requiring active comparators in clinical trials. Additionally, cost-conscious EU payers anticipate the launch of generic version of market leaders Spiriva and Seretide, which may displace or force these therapies to accept a lower price. Emerging FDCs will also compete against open combinations of older therapies, making favorable reimbursement a requirement to achieve market uptake.

Table of contents

  • Chronic Obstructive Pulmonary Disease - Access & Reimbursement - Detailed, Expanded Analysis (EU)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New COPD Therapies in the EU5
    • Successes and Stumbles
      • Successes Among COPD Therapies in the EU5
      • Stumbles Among COPD 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 COPD 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
                  • France: HTA Review Details for Key COPD 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, Dispensation, and Monitoring
                • 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
                  • Germany: HTA Review Details for Key COPD 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
                • 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
                  • Italy: HTA Review Details for Key COPD Therapies
                  • Italy: Lessons Learned and Key Takeaways
                  • Italy: Key Background Details of the Healthcare System
                  • Italy: P&R Process
                  • Italy: P&R Process
                  • Italy: Additional Funding Mechanisms for Off-Label Use
                  • Law 648/1996 on Off-Label Prescribing
                  • Compassionate Use Programs
                • 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
                  • Spain: HTA Review Details for Key COPD Therapies
                  • Spain: Lessons Learned and Key Takeaways
                  • Spain: Key Background Details of the Healthcare System
                  • Spain: P&R Process
                  • Spain: P&R Process
                  • Spain: Autonomic Evaluation Committees
                  • Spain: Autonomic Evaluation Committees
                  • Spain: Commissions for Pharmacy and Therapeutics
                  • Spain: Commissions for Pharmacy and Therapeutics
                • 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
                  • United Kingdom: HTA Review Details for Key COPD 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 Control
                  • United Kingdom: Prescribing Controls and Monitoring
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Prescriber Preferences for COPD
                  • Prescriber Preferences in COPD Among Major Drug Classes
                  • Distribution of LAMA and LABA/ICS Prescriptions in 2016
                  • Current Prescribing of LABA/LAMA FDCs, by Drug
                • Impact of Payer Policy on Prescribing for COPD
                  • Non-Clinical Restrictions on Prescribing of Selected Therapies
                  • Selected Drivers of Generic Prescribing
                  • Generic Share of LABA/ICS FDC Prescriptions in the EU5 Countries
                • Top Prescribing Drivers of Therapies for COPD
                  • Top Prescribing Drivers of FDCs for COPD
                  • Most Influential Prescribing Drivers of the Top LABA/LAMA FDC in Each Country
                  • Clinical Drivers of LAMA and LABA/ICS FDC Preference
              • Market Access Landscape for Emerging Therapies
                • Likely Impact of Emerging Therapies on COPD
                  • Anticipated Prescribing of Selected COPD Therapies in 2019, by Class
                  • Therapies That Will Be Replaced by LABA/LAMA/ICS FDCs
                  • Selected Impacts of the Launch of LABA/LAMA/ICS FDCs on Physicians' Practice
                • Market Access Challenges for Emerging Therapies for COPD
                  • Anticipated Step Therapy Requirements for LABA/LAMA/ICS FDCs
                  • Anticipated Lines of Therapy in 2019
                  • Impact of Discounting on LABA/LAMA/ICS Prescribing Rates
                • Payer Opinion on Emerging Therapies for COPD
                  • France: Payer Opinion on Emerging Therapies for COPD
                  • France: Payer Opinion on Emerging Therapies for COPD
                  • Germany: Payer Opinion on Emerging Therapies for COPD
                  • Germany: Payer Opinion on Emerging Therapies for COPD
                  • Italy: Payer Opinion on Emerging Therapies for COPD
                  • Italy: Payer Opinion on Emerging Therapies for COPD
                  • Spain: Payer Opinion on Emerging Therapies for COPD
                  • Spain: Payer Opinion on Emerging Therapies for COPD
                  • United Kingdom: Payer Opinion on Emerging Therapies for COPD
                  • United Kingdom: Payer Opinion on Emerging Therapies for COPD
              • Methodology
                • Primary Research Design
                • Background of Payers and Payer-Advising KOLs
                • Physician Demographics and Practice Setting
                  • Distribution of Medical Practice by Country
                  • Distribution of Medical Practice by Country: United Kingdom
                  • Physicians' Specialty
                  • Years Practiced Post-Residency
                  • Average Number of COPD Patients Under Management per Month
                  • Physicians' Prescribing of LABA/ICS FDCs and LAMAs for COPD
                  • Physician Practice Setting
              • Appendix
                • Key Current Therapies for COPD
                  • Profiles of Key Agents for COPD in the EU5
                  • Maintenance Price per Treated Day for Key COPD Therapies
                  • Ultibro
                  • Ultibro (indacaterol/glycopyrronium)
                  • Anoro
                  • Anoro (vilanterol/umeclidinium)
                  • Duaklir
                  • Duaklir (formoterol/aclidinium)
                  • Spiolto
                  • Spiolto (olodaterol/tiotropium)
                  • Bevespi
                  • Bevespi (formoterol/glycopyrronium)
                  • LABA/LAMA/ICS FDCs
                  • Emerging LABA/LAMA/ICS FDCs
                • Physician Survey Data
                  • Current Prescribing of COPD Therapies, by Class
                  • Current Prescribing of LABA/ICS FDCs, by Drug
                  • Reasons Formodual Is Preferred
                  • Reasons Relvar Is Preferred
                  • Reasons Seretide Is Preferred
                  • Reasons Symbicort Is Preferred
                  • Drivers of Generic Prescribing
                  • Reasons Generics Will Not Be Prescribed
                  • COPD Management and Referral Practices
                  • Use of Therapies in Combination
                  • Proportion of Patients Receiving LABA/ICS FDCs, by Severity
                  • Proportion of Patients Receiving LABA/LAMA FDCs, by Severity
                  • Proportion of Patients Receiving LAMAs, by Severity
                  • Percentage of Patients Receiving LAMAs, by Drug
                  • Reasons Eklira Is Preferred
                  • Reasons Incruse Is Preferred
                  • Reasons Seebri Is Preferred
                  • Reasons Spiriva HandiHaler Is Preferred
                  • Reasons Spiriva Respimat Is Preferred
                  • Future LABA/LAMA Prescribing Habits of Current Nonprescribers
                  • Reasons LABA/LAMAs Will Not Be Prescribed
                  • Factors That Will Encourage Future LABA/LAMA FDC Use
                  • Reasons LABA/LAMAs Have Not Yet Been Prescribed
                  • Current Prescribing of LABA/LAMA FDCs, by Drug
                  • Reasons Anoro Is Preferred
                  • Reasons Duaklir Is Preferred
                  • Reasons Spiolto Is Preferred
                  • Reasons Ultibro Is Preferred
                  • Cost Restrictions on Patient Access to Therapies, by Class
                  • Restrictions on ICS Use
                  • Restrictions on LABA/ICS Use
                  • Restrictions on Prescribing Relvar
                  • Restrictions on LABA Use
                  • Restrictions on LAMA Use
                  • Restrictions on Prescribing Eklira
                  • Restrictions on Prescribing Incruse
                  • Restrictions on Prescribing Seebri
                  • Restrictions on LABA/LAMA Use
                  • Restrictions on Prescribing Anoro
                  • Restrictions on Prescribing Duaklir
                  • Restrictions on Prescribing Spiolto
                  • Restrictions on Prescribing Ultibro
                  • Step Therapy Requirements for Anoro
                  • Step Therapy Requirements for Duaklir
                  • Step Therapy Requirements for Eklira
                  • Step Therapy Requirements for Incruse
                  • Step Therapy Requirements for Relvar
                  • Step Therapy Requirements for Seebri
                  • Step Therapy Requirements for Spiolto
                  • Step Therapy Requirements for Ultibro
                  • Impact of ALD on Prescribing in France
                  • Reimbursement Restrictions on Patient Access to LABA/LAMA FDCs, in France
                  • Reimbursement Restrictions on Patient Access to COPD Therapies, in Germany
                  • Reimbursement Restrictions on Patient Access to COPD Therapies, in Italy
                  • Reimbursement Restrictions on Patient Access to COPD Therapies, in Spain
                  • Reimbursement Restrictions on Patient Access to COPD Therapies, in the United Kingdom
                  • Current and Anticipated Switches to Generic Seretide
                  • Anticipated Switches to Generic Spiriva
                  • Current and Anticipated Switches to Generic Symbicort
                  • Impact of the Launch of LABA/LAMA/ICS FDCs on Physicians' Practice
                  • Regimens Replaced by LABA/LAMA/ICS FDCs
                  • Anticipated Step Therapy Requirements for LABA/LAMA/ICS FDCs
                  • Factors That Will Encourage LABA/LAMA/ICS FDC Use, by Country
                  • Impact of Discounting on LABA/LAMA/ICS FDC Prescribing Rates
                  • Anticipated Prescribing of COPD Therapies in 2019, by Class
                  • Anticipated Lines of Therapy in 2019
                  • Distribution of LABA/LAMA FDC Prescriptions in 2016
                  • Distribution of LABA/LAMA FDC Prescriptions in 2019
                  • Reasons to Prefer Anoro in 2019
                  • Reasons to Prefer Duaklir in 2019
                  • Reasons to Prefer Bevespi in 2019
                  • Reasons to Prefer Spiolto in 2019
                  • Reasons to Prefer Ultibro in 2019
                  • Open-Ended Responses to Survey Questions

            Author(s): Kristine Mackin, PhD

            Kristine Mackin, Ph.D., is an analyst on the immune and inflammatory disorders team at Decision Resources Group. She currently focuses on respiratory diseases, including asthma and COPD.

            She holds a doctorate in biochemistry from Brandeis University, where she studied the evolution of bacteriorhodopsin and the relationship between type I and type II rhodopsins. During her B.A. in Chemistry at Carleton College, she researched proinsulin processing. Prior to joining DRG, Dr. Mackin was involved with literature and market research for a new company pitch during an internship at Puretech Ventures in Boston, MA.


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