Outpatient parenteral antimicrobial therapy (OPAT) allows patients with clinically stable infections (e.g., skin and soft tissue infections, bone and joint infections, osteomyelitis, intra-abdominal infections, urinary tract infections) requiring intravenous (IV) antibiotics to be treated outside the hospital. OPAT has become a widespread practice in the United States due to its potential to reduce healthcare costs, improve convenience, and decrease the risk of complications. Given the push for cost containment and development of efficacious IV antimicrobial agents that offer advantages in safety, tolerability, and/or delivery, commercial opportunities in the OPAT market exist for novel branded agents. However, emerging therapies must compete against, and demonstrate significant benefits over, entrenched generic products in a highly cost-sensitive healthcare climate.
The U.S. Physician & Payer Forum report entitled Outpatient Parenteral Antimicrobial Therapy: What Opportunities and Barriers Will Shape the OPAT Market Access Landscape in the United States? examines the prescribing and reimbursement environment for current and emerging IV antibiotics for use as OPAT among surveyed infectious disease (ID) specialists and surveyed managed care organization (MCO) pharmacy directors and medical directors. This report explores stakeholder perspectives that affect prescribing and reimbursement of key branded antibiotics for OPAT-suitable infections due to Gram-negative pathogens (GNPs) and methicillin-resistant Staphylococcus aureus (MRSA), and dynamics that will promote or restrict market access and uptake of emerging therapies to treat these infections. The report examines the range of IV antibiotics used to treat infections due to GNPs or MRSA in the outpatient setting; however, the report has a particular focus on the market access dynamics for Merck’s Invanz (ertapenem), Merck’s Cubicin (daptomycin), Allergan’s Dalvance (dalbavancin), and The Medicines Company’s Orbactiv (oritavancin). The report evaluates current prescribing patterns, the fit of emerging therapies in the outpatient treatment paradigm, formulary status of current and emerging therapies, and areas of unmet need.
Questions Answered in This Report:
- OPAT prescribing and reimbursement: What are the most prescribed and the preferred IV antibiotics for the treatment of infections due to GNPs and MRSA? What are the key drivers and obstacles for prescribers in the OPAT market?
- Formulary status and drivers of reimbursement in the OPAT market: Which marketed antibiotics have the most favorable positioning within hospital formularies? What are the key drivers, beyond efficacy, for formulary inclusion of antibiotics? What attributes of emerging antibiotics will be most convincing and influential to key stakeholders in formulary decision-making? How do P&T committee members expect to include novel agents on hospital formularies, and how is the formulary status of current and emerging therapies expected to change in 2016? What value drivers are important to MCOs when making formulary and reimbursement decisions for OPAT drugs? Which therapies do physicians and payers believe have the advantage in terms of various clinical and cost-related attributes?
- Restrictions on OPAT (drugs and treatment settings) and impact of payer policy on prescribing in OPAT: What types of restrictions are commercial and Medicare Advantage placing on OPAT drugs to control costs? How frequently do prescribers encounter payer restrictions when prescribing OPAT for their commercial and Medicare Advantage patients, and what kinds of restrictions do they encounter? How do those restrictions impact prescribing of these agents? Which agents would physicians prescribe if commercial and Medicare Advantage access restrictions were not a factor?
- Outlook for emerging agents in the OPAT market: What is the current and potential prescribing of Dalvance and Orbactiv for OPAT? What are the top prescribing drivers for these novel, long-acting agents in the outpatient setting? What is the likely impact of Dalvance and Orbactiv in 2016 and how might health plan tier positioning affect their uptake?
Markets covered: United States.
Primary research: Online survey of 102 ID specialists and 30 MCOs (15 medical directors and 15 pharmacy directors).
Population segments: Our analysis involves patients covered under commercial and Medicare Advantage health plans.
Brenda Perez-Cheeks, Ph.D.