DecisionBase

April 2013

Hospital-Acquired Pneumonia

Introduction:

With Growing Rates of Antimicrobial Resistance, Are Physicians and Hospital Pharmacy Directors Receptive to Premium-Priced Treatments Targeting Multidrug-Resistant Pathogens?

Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), is a serious hospital-treated infection associated with high rates of multidrug-resistant (MDR) pathogens (e.g., methicillin-resistant S. aureus [MRSA], MDR P. aeruginosa, extended-spectrum beta-lactamase-producing and K. pneumoniae carbapenemase-producing Enterobacteriaceae), as well as significant morbidity and mortality. Although several therapies in late-stage clinical development retain activity against these MDR pathogens, drug developers have largely been deterred from conducting trials in HAP/VAP as a result of recent changes to the FDA’s clinical trial guidelines for this indication. Despite these challenges, significant opportunity remains for additional therapies that are active against MDR pathogens. Such therapies are poised to command premium prices relative to currently marketed treatments.

Questions Answered in This Report:

  *   Clinical cure rate in clinically evaluable patients at test-of-cure visit and 28-day all-cause mortality rate are key goals in the treatment of HAP. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European infectious disease (ID) specialists weight specific efficacy end points and other drug attributes in their prescribing decisions for HAP?

  *   Increased clinical cure rate, reduction in 28-day all-cause mortality rate, increased eradication of P. aeruginosa, and more therapies available in interchangeable intravenous (IV) and oral formulations are key areas of unmet need in HAP, according to the insights of surveyed U.S. and European ID specialists. Which therapies in development for HAP are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. hospital pharmacy directors (PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   Drug price per day and activity against MDR P. aeruginosa are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new HAP therapies. What trade-offs across these and other clinical attributes are U.S. ID specialists willing to make when considering the use of emerging therapies for the treatment of HAP? Based on the trade-offs in price and performance across key drug attributes that U.S. ID specialists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for HAP?

  *   Based on its clinical profile, meropenem (AstraZeneca’s Merrem/Meronem) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge meropenem as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint-analysis-based assessment of target product profiles for HAP:

- Cure rate in HAP due to MRSA

- Cure rate in HAP due to P. aeruginosa

- Activity against MDR P. aeruginosa

- Activity against ESBL-producing Enterobacteriaceae

- Activity against KPC-producing Enterobacteriaceae

- Drug formulation

- Price per day

Attributes included in assessment of U.S. payers’ receptivity to new therapies for HAP:

- Activity against MDR P. aeruginosa

- Activity against ESBL-producing Enterobacteriaceae

- Activity against KPC-producing Enterobacteriaceae

- Drug formulation

Physicians surveyed: 60 U.S. and 30 European ID specialists

Payers surveyed: 22 U.S. hospital PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Linezolid (Pfizer’s Zyvox)

- Piperacillin/tazobactam (Pfizer’s Zosyn, generics)

- Vancomycin (generics)

- Meropenem (AstraZeneca’s Merrem/Meronem, generics)

- Levofloxacin (Johnson & Johnson’s Levaquin, Sanofi’s Tavanic, Daiichi Sankyo’s Cravit, generics)

Emerging Therapies

- Tedizolid (Trius Therapeutics)

- CAZ-AVI (Forest/AstraZeneca, ceftazidime/avibactam)

- CXA-201 (Cubist, ceftolozane/tazobactam)

- Eravacycline (Tetraphase Pharmaceuticals)

- CEF-AVI (Forest/AstraZeneca, ceftaroline/avibactam)


Search Reports

Mentioned in this report:

  • - AstraZeneca
  • - Bayer
  • - Calixa
  • - Covis Pharma
  • - Cubist
  • - Daiichi Sankyo
  • - Dainippon Sumitomo
  • - Dong-A Pharmaceutical
  • - Forest
  • - GlaxoSmithKline
  • - Hospira
  • - Janssen
  • - Johnson & Johnson
  • - Merck
  • - Novexel
  • - Pfizer
  • - Sanofi
  • - Shionogi
  • - Tetraphase Pharmaceuticals
  • - Trius Therapeutics
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