The prevalence of difficult-to-treat infections is increasing worldwide, despite regional variations in the etiological pathogens. This report provides an extensive overview of the use of antibiotics in Brazil and Mexico, with a special focus on complicated hospital-treated infections (HTIs) due to methicillin-resistant Staphylococcus aureus (MRSA) and gram-negative pathogens. Such multi-drug resistant pathogens are becoming increasingly life-threatening and burdensome to local healthcare economies, which are overflowing with generics from a broad range of antibiotic classes. However, governments are keen to regulate the use of antibiotics so that forthcoming multi-drug resistance can be restrained. Healthcare providers struggle to employ more effective and costly antibiotics that address complicated infections caused by resistant pathogens in these cost-constrained markets. Thus, novel antibiotics, such as Actavis/AstraZeneca’s Avycaz, The Medicines Company’s Carbavance, Tetraphase’s eravacycline, and Merck’s Zerbaxa, must overcome stringent clinical and reimbursement challenges.

Questions Answered in This Report:

  • Explore current and evolving drug coverage and prescribing trends. How does coverage of approved antibiotics vary between countries? How do national healthcare authorities regulate the prescribing of these drugs? How does coverage compare in the public and private settings? What are the most prescribed and the preferred antibiotics for the treatment of key infections? What are the differences between empiric treatments and treatments for confirmed MRSA and gram-negative infections (GNIs)? What are the key drivers for the prescribing of a specific antibiotic over others? How common is off-label use of antibiotics in these markets? What are the prescribing restrictions for different antibiotics, and how do those vary by indication? How do cost/reimbursement-related constraints outline prescribing patterns? With which pathogens are physicians and payers most concerned? How does perceived multi-drug resistance shape drug coverage and prescribing patterns? What measures have been implemented by national/local governments to track and prevent multi-drug resistance? How have these measures affected the use of antibiotics in local institutions/hospitals? What is the current status of outpatient parenteral antimicrobial therapy (OPAT) for MRSA prescribing in Brazil and Mexico?

  • Explore the outlook for emerging antibiotics for complicated infections. What are payers’ attitudes toward emerging antibiotics? How do payers expect access to antibiotics to evolve in the next 2-3 years? What clinical and economic features of emerging antibiotics would allow for faster formulary inclusion? What market access obstacles will these novel therapies face? Which indications pose most demanding need for new therapies in the future? Which clinical and reimbursement/coverage opportunities can drug developers benefit from to better position their products in these markets? How will prescribing patterns evolve with the availability of novel antibiotics? How will multi-drug resistance rank with other reimbursement/coverage constraints, such as cost, for the use of novel antibiotics? What role will head-to-head and pharmacoeconomic outcomes play in the coverage of novel antibiotics versus current standards of care?

Scope:

This Emerging Markets Physician & Payer Forum surveys 101 infectious disease specialists, internal medicine physicians, and primary care physicians and interviews six payers in Brazil and Mexico, to explore how the antibiotic market space for HTIs is currently shaped and how it will evolve in these countries in the next two to three years. Interviewees were required to be influential in determining patient access to therapies for HTIs at the institutional or regional/national level, and they came from the following backgrounds:

Head of pharmaceutical assistance programs at São Paulo State, consultant for the São Paulo State Department of Health and the MoH; head of the Patient Safety Program at Ebserh for the MoH at several federal hospitals, member of the working group for the Pharmaceutical Assistance Qualification Program of the MoH (QUALIFAR-SUS); head of the nephrology department at a large university hospital at the Paraná State, professor at the same hospital, member of the drug standardization committee of the institution.

Mexico: Head of the Epidemiology and Preventive Medicine Program at ISSSTE, including the Epidemiological Surveillance of Nosocomial Infections Program, member of the Hospital Epidemiological Surveillance network (RHoVE); infectious diseases specialist at a major Ministry of Health hospital, member of the infectious diseases committee and transplant committees, member of the RHoVE, private practitioner; infectious disease specialist, head of department and member of the epidemiological surveillance committee at a major IMSS hospital.

Author(s): Andreia Ribeiro, Ph.D.
Susana Silva, B.S., M.S.