Outpatient parenteral antimicrobial therapy (OPAT) is a convenient mechanism for treating patients with infections that require intravenous (IV) antibiotic drugs but are clinically stable and do not otherwise require hospitalization. In addition to improved convenience, OPAT offers distinct advantages over inpatient treatment, such as the potential to reduce healthcare costs and decrease the risk of complications due to prolonged hospitalization. Nonetheless, in contrast to its widespread use in the United States, the OPAT treatment modality has been slower to gain traction in the EU5. However, given that the reduction of treatment costs associated with inpatient antibiotic therapy can be a key driver of OPAT prescribing, commercial opportunity exists for novel antibiotics that can increase OPAT use via improvements in efficacy, safety, and delivery over currently available parenteral drugs.

Questions Answered in This Report:

  • The most frequently prescribed IV antibiotics in the outpatient setting vary, depending on physician familiarity with each agent, national and regional guidelines and/or HTA parameters, and the cost of treatment for each therapy. What are the most prescribed antibiotics for the treatment of infections due to GNPs and MRSA in the hospital vs. in the outpatient setting? What clinical and nonclinical factors do physicians consider when choosing an antibiotic for OPAT? How do physician choices for OPAT drugs vary by indication? What clinical, logistical, infrastructural, and reimbursement factors limit physician prescribing of OPAT?

  • HTA review of infused parenteral antibiotics are limited in the EU5 and approved agents are often subject to hospital-only distribution controls in EU5 markets; thus, hospital-level policy can impact OPAT prescribing. What are the key OPAT-amenable agents approved for reimbursement in each of the EU5 countries? Which antibiotics have received successful HTA review and which have encountered setbacks? What types of distribution controls and prescribing restrictions are common OPAT drugs subject to, and how do these impact their use in the outpatient setting?

  • Emerging therapies for OPAT must offer notable improvements over currently marketed IV and oral antibiotics to gain formulary inclusion despite their premium pricing, which will drive their uptake in the outpatient setting. How do physicians and payers perceive the competitive potential for long-acting lipoglycopeptides, Allergan’s Xydalba (dalbavancin) and The Medicines Company’s Orbactiv (oritavancin)? What currently available OPAT therapies will be replaced by these two emerging agents? What do EU5 payers believe are the key areas of differentiation between these two emerging therapies and current standards of care?

  • Separate budgets for inpatient and outpatient treatment can create conflict regarding OPAT funding. What funding mechanisms support OPAT in the EU5? What strategies can marketers implement to optimize pricing negotiations with HTA agencies? What role will pharmacoeconomic outcomes play in HTA negotiations, and how will they vary among EU5 countries?

Scope:

The European Physician & Payer Forum report entitled EU5 Market Access Opportunities and Barriers for Outpatient Parenteral Antibiotic Therapy explores the extent of OPAT prescribing in each of the EU5 countries, the opportunity for further growth of this market segment, and the key country-specific market access drivers and constraints. The report evaluates physician prescribing trends for OPAT across key infections, such as complicated skin and skin structure infections, complicated urinary tract infections and complicated intra-abdominal infections, caused by gram-negative pathogens (GNPs) and methicillin-resistant Staphylococcus aureus (MRSA). Further, this study juxtaposes payers’ perspectives on budgetary processes, reimbursement hurdles, and infrastructural factors that limit the broader prescribing of OPAT, as well as actionable recommendations to marketers and developers on overcoming these barriers.

Markets covered: France, Germany, Italy, Spain, and the United Kingdom.

Primary research: Online survey of 252 ID specialists, internal medicine physicians, or general practitioners (France and Germany only). Interviews with 15 EU5 payers and payer-advising KOLs.

Population segments: Our analysis involves patients treated in the outpatient setting with parenteral antibiotics.

Author(s): Maria Ascano, Ph.D.
Tara M. Stewart, Ph.D., M.A.