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Survey: Emerging Therapies Expected to Take Lead in Treatment of Infections Due to Multidrug-Resistant Enterobacteriaceae

Formularies look for interchangeable IV and oral formulations

Decision Resources Group, a health-care research firm located in Burlington, Mass., finds that two emerging therapies in late-stage clinical development — ceftazidime/avibactam (AstraZeneca/Forest Laboratories) and eravacycline (Tetraphase) — will replace generic carbapenems as preferred therapies for the treatment of gram-negative infections (GNIs) due to multidrug-resistant Enterobacteriaceae following their launches in 2015 and 2017, respectively.

Surveyed infectious disease specialists and hospital pharmacy directors reported a high unmet need for new therapies that are active against carbapenemase-producing Enterobacteriaceae. Both ceftazidime/avibactam and eravacycline offer notable improvements over carbapenems and will likely see uptake on hospital formularies and clinical use despite the availability of generic competitors, the report predicts.

More than half of surveyed U.S. and European infectious disease specialists cited clinical cure rates as being among the top most persuasive clinical trial endpoints when prescribing a new drug for GNIs due to Enterobacteriaceae.

Most of the surveyed hospital pharmacy directors indicated that they would include new GNI therapies offering improvements in both efficacy and delivery (i.e., available in interchangeable intravenous and oral formulations) on hospital formularies. According to the survey results, these therapies could command an estimated 30% price premium over current branded drugs.

“There are few therapies available in both IV and oral formulations that retain activity against MDR [multidrug-resistant] gram-negative pathogens,” said analyst Hannah E. Cummings, PhD. “The availability of interchangeable formulations is convenient because it allows patients to be discharged earlier, thereby reducing hospitalization costs and minimizing the risk of hospital-associated complications. Eravacycline’s activity against MDR pathogens and its interchangeable IV and oral formulations will make this agent an attractive option for treatment of clinically stable patients with GNIs by facilitating discharge and use in the outpatient setting.”

In the survey, nearly half of the infectious disease specialists indicated a willingness to prescribe premium-priced therapies costing up to $15,000 for a 10- to 14-day course if these agents offered significant improvements in 28-day all-cause mortality rates in patients with hospital-acquired pneumonia due to multidrug-resistant Enterobacteriaceae.

“Physicians are desperate for additional therapies active against MDR gram-negative pathogens, particularly in patients with nosocomial pneumonia,” Cummings remarked. “Mortality rates in these patients are high, and treatment options are extremely limited.”

Source: Decision Resources; April 23, 2014.

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