High unmet need exists for severe, refractory asthma patients, for whom Genentech/Novartis’s Xolair is currently the only therapeutic option. Together with a number of newly approved agents for the wider asthma population, including GlaxoSmithKline/Theravance’s Relvar, and the anticipated approval of Boehringer Ingelheim/Pfizer’s Spiriva, novel brands seeking to address such need are likely to drive market growth despite increasing generic and branded-generic erosion of current key players. Specifically, interleukin-5 (IL-5)-targeting biologics in Phase III clinical development—Cephalon/Teva’s Cinquil, GSK’s Bosatria and MedImmune/AstraZeneca/BioWa’s benralizumab—will infuse a competitive dynamic to the severe, disease-refractory market segment in asthma. However, the entry of expensive biologics into the asthma market will be met with increasing reimbursement restrictions and other market access challenges owing to payers’ heightened cost-consciousness in the current economic climate across the EU5 countries under study.
Questions Answered in This Report:
- Impact of reimbursement and payer policy on current prescribing trends in asthma: How does reimbursement of approved asthma therapies vary among countries? How do prescribing patterns for key asthma brands vary by country, and how do product labeling and/or local, regional, or institutional prescribing restrictions differentially impact uptake? What have been the main cost/clinical constraints to the uptake of Xolair in the European asthma market?
- Payer and physician perspectives on emerging agents for asthma: What are payers’ reactions to the first entrant of once-daily LABA/ICS fixed-dose combination? How are recently approved asthma agents faring in increasingly convoluted health technology assessments and P&R negotiations? What clinical advantages could secure reimbursement for emerging agents? What role will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of emerging agents versus current mainstays? To what degree will eosinophil screening tests present a future hurdle for novel biologics in the EU5?
- Market access outlook for emerging asthma therapies: How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel agents? What market access levers can drug developers take advantage of to better position new asthma products in the EU5? How will prescribing patterns change with the launch of new agents, and the availability of generic and/or branded-generic LABA/ICS FDCs and biosimilar omalizumab?
Decision Resources’ European Physician & Payer Forum report, “Asthma in the EU5: What Are the Expectations for Optimal Positioning of New and Emerging Inhaled and Biological Therapies in Market Access Systems?” seeks to assess international, national, and local market access factors that impact the current and future treatment of asthma in the EU5. We draw on insights from 250 surveyed pulmonologists in the EU5 and from interviews with 15 European payers, all of whom have influence at a national or regional level. Interviewed payers include the following:
- France: Hospital pharmacy director who advises the Haute Autorité de Santé (HAS); pharmacy director and member of regional hospitals’ formulary committee who advises the HAS; pharmacy director and member of hospital formulary committee who advises the HAS.
- Germany: Head of region’s Institute for Health Economy and in contact with Institute for Quality and Efficiency in Healthcare and Institute for Hospital Reimbursement; Hospital pharmacy director and member of hospital formulary committee; adviser to a group that creates national medical guidelines regarding rebate contracts; national payer who consults national sick funds and authorities as head of the department for generic medicine, adviser to a group that makes national medical guidelines regarding rebate contracts, and previously worked at IKK classic sick fund.
- Italy: Prontuario terapeutico ospedaliero (PTO) and prontuario terapeutico ospedaliero regionale (PTOR) member; hospital pharmacy director and PTO/PTOR member; adviser to Agenzia Italiana del Farmaco (AIFA) and PTO/PTOR member.
- Spain: Adviser to Dirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products), to the Comisión Nacional para el Uso Racional del Medicamento (CNURM; National Commission for the Rational Use of Medicines), and to hospital/regional formulary committee; chief of pharmacy and president of therapeutic committee, member of regional committee of market access, adviser for protocol writing for community, and member of ethical committee for region; hospital pharmacy director and hospital/regional formulary committee member.
- United Kingdom: Clinical commissioning group (CCG) member and chronic disease lead for committee; hospital formulary committee member and CCG pharmaceutical adviser; medicines procurement specialist pharmacist on behalf of CCG and the National Health Service (NHS) trusts, and member of the National Biosimilars group.