Long-acting beta2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) have the potential to be first-line chronic obstructive pulmonary disorder (COPD) therapies, offering the synergistic effects of both bronchodilators in a convenient, single inhaler. Key competition, however, will come from the LABA/inhaled corticosteroid (ICS) FDCs, including the first once-daily combination, Relvar (GlaxoSmithKline/Theravance). Changes in prescribing habits to accommodate these newly launching therapies will depend on how restrictive payers will be in this increasingly competitive market, as pricing and reimbursement negotiations in each EU5 country become ever-more complex and the availability of generic LABA/ICS combinations and Spiriva becomes a reality. This report surveys 250 pulmonologists and interviews 15 European payers to explore international, national, and local market access factors that will impact the treatment of COPD across the EU5 (France, Germany, Italy, Spain, the United Kingdom) in the next 2-3 years as governments in all countries strive to tighten their healthcare belt.

Questions Answered in This Report:

  • Impact of reimbursement and payer policy on use of current COPD maintenance therapies: How do European product labeling and/or local, regional, or institutional prescribing restrictions differentially impact use of key brands in COPD, and how do prescribing patterns vary by country? How does reimbursement of approved COPD therapies vary between countries? How do national, regional, and local healthcare authorities regulate the prescribing of these agents? How are recently approved COPD agents faring in increasingly convoluted health technology assessments and P&R negotiations?

  • Payer and physician perspectives on emerging agents for COPD: 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? How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel agents, and to what degree will prescribing constraints present a future hurdle for novel LABA/LAMAs? What market access levers can drug developers take advantage of to better position new COPD 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? 


Decision Resources’ European Physician & Payer Forum report “COPD in the EU5: How Will Prescribers and Payers Integrate Additional LABA- and LAMA-Containing Products Within Increasingly Constrained Budgets?” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of LABA- and LAMA-containing therapies for COPD. It draws 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; advisor to a group that makes national medical guidelines regarding rebate contracts; national payer who consults national sick funds and authorities as head of the department for generic medicine, advisor 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; advisor to Agenzia Italiana del Farmaco (AIFA) and PTO/PTOR member.

- Spain: Advisor 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, advisor 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 advisor; Medicines procurement specialist pharmacist on behalf of CCG and the National Health Service (NHS) trusts and member of the National Biosimilars group.

Author(s): Colleen E. Albacker, Ph.D.