Generically available IV antibiotics commonly used as outpatient parenteral antibiotic therapy (OPAT) (e.g., IV vancomycin, daptomycin) have extensive clinical histories, benefit from strong physician familiarity, and garner the majority of the OPAT market for the treatment of methicillin-resistant Staphylococcus aureus (MRSA). Furthermore, oral antibiotics (e.g., Merck & Co.’s Sivextro, generic oral linezolid) experience uptake in the outpatient setting and are competition for established OPAT drugs and follow-on long-acting agents, including Allergan’s Dalvance and the Medicines Company’s Orbactiv. New and older brands will need to offer improvements in key areas of differentiation to gain uptake in this crowded market.

Questions Answered:

Generic IV  vancomycin and daptomycin dominate the OPAT market for the treatment of MRSA infections. What is the current uptake of branded IV agents in first-, second-, and third-line treatment of outpatients diagnosed with skin infections, diabetic foot infections, or bone and joint infections caused by MRSA?

Inpatients are the most important patient population for OPAT drugs as the majority of MRSA patients initiate OPAT following hospitalization. What are the most important factors that influence OPAT initiation and drug selection? What are the top reasons why outpatients discontinue their initial OPAT protocol prematurely (by product)?

Convenience, safety, and stronger efficacy in difficult-to-treat MRSA infections are the key areas of product differentiation for branded IV antibiotics. How do prescribers anticipate changing their use of branded products for OPAT in the next 12 months? What are the most frequently encountered clinical obstacles that limit brand prescribing as OPAT? How do reimbursement and access hurdles affect the prescribing of brands?

Branded products for OPAT have limited use as first-line therapies. Which therapies are MRSA outpatients usually administered before they are initiated on branded products such as Allergan’s Teflaro? How have the long-acting agents Allergan’s Dalvance and the Medicines Company’s Orbactiv influenced the management of MRSA infections in the outpatient setting? How will the availability of generic oral linezolid and daptomycin affect the uptake of OPAT drugs and the prescribing of Sivextro?

Scope:·

Markets covered: United States

Methodology: Surveys of 103 infectious disease (ID) specialists, completed in March 2017.

Indication coverage: MRSA infections, including skin infections, diabetic foot infections, and bone and joint infections caused by MRSA.

Key drugs covered: Dalvance, Orbactiv, Sivextro, Teflaro, Tygacil, Vibativ, daptomycin, linezolid, vancomycin.

Key companies mentioned: Allergan, Clinigen, the Medicines Company, Theravance, Novartis, Merck, Pfizer.

Table of contents

  • Methicillin-Resistant Staphylococcus Aureus Infections - Current Treatment - Detailed, Expanded Analysis Of Outpatient Parenteral Antibiotic Therapy (OPAT) For MRSA Infections (US)
    • Key Updates
      • December 2017
      • September 2017
    • Introduction to Current Treatment for MRSA OPAT
      • Key Findings
      • Summary Figures
        • Patient Share of Different Antibiotics as the First-, Second-, or Third-Line OPAT for BJIs (Including PJIs and Osteomyelitis) in the Past 12 Months
        • Clinical Drivers for Using Select Branded Antibiotics as OPAT for MRSA Infections: ID Specialists
        • Nonclinical Drivers for Using Select Branded Antibiotics as OPAT for MRSA Infections: ID Specialists
      • Introduction to Current Treatment and Medical Practice for MRSA OPAT
      • Drugs Included in This Study of Current Treatment of MRSA OPAT
    • Physician Prescribing Practices
      • Key Findings
      • Patient Characteristics
        • BJIs, BSIs, and cSSSIs/ABSSSIs Are the Most Common Infections Managed with Anti-MRSA OPAT
        • Common Types of Infection Among MRSA Patients Treated with OPAT in the Past 12 Months
        • Common Discharge Antibiotics Prescribed to MRSA Patients in the Past 12 Months
        • Situations for Initiating OPAT in MRSA Patients in the Past 12 Months
        • Percentage of MRSA Patients Who Received OPAT in Different Treatment Settings in the Past 12 Months
        • Type of Physician to Manage MRSA OPAT Patients Following Hospital Discharge in the Past 12 Months
        • Percentage of MRSA OPAT Patients with Laboratory Confirmation of MRSA as the Causative Pathogen in the Past 12 Months
      • Physician Treatment Practices
        • Branded OPAT Drugs Are Reserved for Later-Line Treatment and for Severe or Difficult-to-Treat MRSA Infections
        • It Takes About Four to Five Days Between Diagnosis and OPAT Initiation Among MRSA Patients
        • Interval Between Diagnosis and OPAT Initiation Among MRSA Patients in the Outpatient Setting in the Past 12 Months
        • More than Half of MRSA Patients with a BSI, Endocarditis, BJI, or Medical or Prosthetic Device Infection Are Treated with OPAT
        • Percentage of Patients with Different Types of MRSA Infections Who Were Treated with OPAT in the Past 12 Months
        • Vancomycin and Daptomycin Are the Most Commonly Prescribed IV Antibiotics for OPAT
        • Percentage of MRSA OPAT Patients Who Received Different IV Antibiotics in the Outpatient Setting in the Past 12 Months
        • MRSA Infections for Which Select Antibiotic Was Most Frequently Prescribed as OPAT in the Past 12 Months (Part 1)
        • MRSA Infections for Which Select Antibiotic Was Most Frequently Prescribed as OPAT in the Past 12 Months (Part 2)
        • Average Duration of OPAT Is Determined by the Type of Infection and the Features of the IV Antibiotic Used
        • Days of Therapy by OPAT Drug for cSSSIs/ABSSSIs (Excluding DFIs) due to MRSA in the Past 12 Months
        • Days of Therapy by OPAT Drug for DFIs (Excluding BJIs) due to MRSA in the Past 12 Months
        • Days of Therapy by OPAT Drug for BJIs (Including PJIs and Osteomyelitis) due to MRSA in the Past 12 Months
        • Average Number of Doses of Dalbavancin and Oritavancin as OPAT for MRSA Infections in the Past 12 Months
        • Vancomycin Is the Preferred First-Line OPAT; Branded IV Antibiotics Are Reserved for Later-Line Treatment
        • Only a Small Proportion of MRSA OPAT Patients Require Second- and Third-Line Treatment with OPAT
        • Percentage of OPAT Patients Receiving the Next Line of OPAT for Different MRSA Infections in the Past 12 Months
        • Chances of Progressing to Second- or Third-Line OPAT Are Not High
        • Percentage of MRSA OPAT Patients Who Progressed to Second-Line and Third-Line OPAT in the Past 12 Months
        • Branded IV Antibiotics Are Used More Often as a Second- or Third-Line OPAT
        • Patient Share of Different Antibiotics as the First-, Second-, or Third-Line OPAT for cSSSIs/ABSSSIs (Excluding DFIs) in the Past 12 Months
        • Patient Share of Different Antibiotics as the First-, Second-, or Third-Line OPAT for DFIs (Excluding BJIs) in the Past 12 Months
        • Patient Share of Different Antibiotics as the First-, Second-, or Third-Line OPAT for BJIs (Including PJIs and Osteomyelitis) in the Past 12 Months
        • Most OPAT Patients with MRSA Infections Are Prescribed Monotherapy
        • Percentage of OPAT Patients Receiving Combination Therapy by MRSA Infection
      • Physician Insight on Compliance and Persistency
        • Compliance and Persistency Are High Among OPAT Patients
        • Percentage of OPAT Patients Who Discontinued or Modified Initial OPAT Protocol Prematurely
        • Percentage of OPAT Patients Who Discontinued or Modified Initial OPAT Protocol due to Reimbursement Limitations
        • Next-Step Strategies for OPAT Patients Who Discontinued or Modified Initial OPAT Protocol Prematurely
      • Sequencing of Treatment
        • Oral Linezolid, Oral Tedizolid, and Daptomycin Are Top Switch Therapies at Discharge or in the Outpatient Setting for MRSA Inpatients
        • Antibiotics to Which MRSA Patients Were Most Commonly Switched at Discharge or in the Outpatient Setting in the Past 12 Months
      • Recent and Anticipated Changes in Treatment Practices
        • Ceftaroline, Dalbavancin, and Oritavancin Will Be Prescribed More as OPAT for MRSA Patients
        • Recent Changes in Prescribing of Select Antibiotic as OPAT for MRSA Patients in the Past 12 Months
        • Expected Changes in Prescribing of Select Antibiotics as OPAT for MRSA Patients in the Next 12 Months
        • Physicians' Level of Agreement on Anticipated Changes in MRSA Patients Receiving OPAT due to the Availability of Generic Linezolid in the Next 12 Months
        • Physicians' Level of Agreement on Anticipated Changes in MRSA Patients Receiving OPAT due to the Availability of Generic Daptomycin
    • Physician Insight on Medical Practice
      • Key Findings
      • Factors Influencing Treatment Practice
        • OPAT Drug Selection Is Heavily Influenced by the Overall Cost Savings
        • Reimbursement Hurdles Are Key Prescribing Obstacles for OPAT Drugs
        • Important Drivers for Initiating OPAT Among Patients with MRSA Infections
        • Frequently Encountered Obstacles When Prescribing OPAT Drugs to Patients with MRSA Infections
        • Convenient Administration, Good Safety Profiles, and Inclusion in the Hospital Formulary Are Key Drivers of Branded OPAT Drugs' Uptake for MRSA
        • Inclusion of Select Antibiotics in Hospital/OPAT Clinic Treatment Guidelines for MRSA Infections
        • Clinical Drivers for Using Select Branded Antibiotics as OPAT Among Patients with MRSA Infections: All ID Specialists
        • Nonclinical Drivers for Using Select Branded Antibiotics as OPAT Among Patients with MRSA Infections: All ID Specialists
        • Use of Branded Antibiotics as OPAT Is Largely Constrained by Their Premium Prices
        • Clinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: All ID Specialists
        • Nonclinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: All ID Specialists
        • ID Specialists' Preference for Generic Linezolid vs. Branded Tedizolid
        • Adverse Effects, Burdensome Out-of-Pocket Costs, Treatment Failure, and Clinical Cure Are Top Causes of OPAT Discontinuation
        • Top Causes of OPAT Discontinuation in MRSA Patients Receiving Select Antibiotics
    • Methodology
      • Primary Market Research Methodology
      • Years in Practice Postresidency
      • Percentage of Hospital-Based Practice Among Surveyed ID Specialists
      • Primary Practice Setting Among Surveyed ID Specialists
      • Regional Distribution of Surveyed ID Specialists
      • Number of MRSA Patients to Whom Surveyed ID Specialists Prescribed Parental Antibiotic Therapy in a 30-Day Period in the Past 12 Months
      • MRSA Indications for Which ID Specialists Have Prescribed OPAT in the Past 12 Months
      • Parenteral Antibiotics Prescribed by Surveyed ID Specialists in the Past 12 Months
      • Size of Hospital Among Surveyed ID Specialists
      • Type of Hospital Among Surveyed ID Specialists
      • Percentage of Surveyed ID Specialists Whose Hospitals Provide OPAT Services or Have Outpatient Infusion Centers
    • Appendix
      • Key Abbreviations
      • Primary Market Research
        • Clinical Drivers for Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Inpatient-Based ID Specialists
        • Clinical Drivers for Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Outpatient-Based ID Specialists
        • Nonclinical Drivers for Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Inpatient-Based ID Specialists
        • Nonclinical Drivers for Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Outpatient-Based ID Specialists
        • Clinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Inpatient-Based ID Specialists
        • Clinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Outpatient-Based ID Specialists
        • Nonclinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Inpatient-Based ID Specialists
        • Nonclinical Obstacles to Using Select Branded Antibiotics as OPAT in Patients with MRSA Infections: Outpatient-Based ID Specialists

Author(s): Jiamin Zhuo, PhD

Jiamin Zhuo, Ph.D., is a business insights analyst on the infectious, niche, and rare diseases team at Decision Resources Group. He provides expert insight into the commercial aspects of drug development and market dynamics in bacterial infections, including gram-negative infections and Methicillin-resistant Staphylococcus aureus.

He attained his Ph.D. at the Mayo Graduate School, Mayo Clinic, in Minnesota and his B.Sc. in physiology from Peking University in China. Prior to joining DRG, Dr. Zhuo was a postdoctoral fellow at Boston University and MIT, where he gained extensive experience in quantitative research methods.