BURLINGTON, Mass., Nov. 24, 2015 /PRNewswire/ -- Decision Resources Group finds that variations in market access schemes across the EU5 countries (France, Germany, Italy, Spain and United Kingdom) pose significant challenges for marketers looking to position their emerging antibiotics in the hospital Gram-negative infections (GNI) market. Despite being dominated by generics, the hospital GNI market represents a high-opportunity segment due to the growing multi-drug-resistance (MDR) rates among Gram-negative pathogens (GNPs). However, given the cost constraints that prevail across European national healthcare systems and hospital reimbursement challenges, marketers will need to navigate through country-specific health technology assessment (HTA) hurdles in order to gain hospital formulary inclusion and favorable pricing. In particular, interviewed European payers emphasize that marketers seeking premium pricing for new antibiotics will need to demonstrate activity against key MDR GNPs, such as carbapenem-resistant Enterobacteriaceae or MDR Pseudomonas spp.
Other key findings from the EU Physician and Payer Forum report entitled "Gram-Negative Infections in the Cost-Constrained EU5: Market Access Opportunities for Novel Therapies Targeting Multi-Drug Resistant Pathogens":
- Although European payers value superiority trials for antibiotics, interviewed experts indicate that developers can still use data from trials designed to test for noninferiority to demonstrate additional benefits (e.g. MDR coverage) offered by their drugs over the standard of care.
- Aside from price, hospital Pharmacy and Therapeutics (P&T) committees also consider physician preferences, the available antibiotic armamentarium, and local epidemiology when making formulary decisions.
- Up to 33 percent of surveyed physicians in the EU5 countries use carbapenem-containing regimens, albeit in high doses, to treat complicated urinary tract infections due to carbapenem-resistant Enterobacteriaceae, which is a clear indication of the lack of treatment options for these MDR pathogens.
- Both interviewed payers and surveyed physicians are enthusiastic about the emerging cephalosporin/beta-lactamase inhibitor combinations, Allergan/AstraZeneca's ceftazidime/avibactam and Merck's ceftolozane/tazobactam. At least 80 percent of surveyed physicians across the EU5 countries anticipate prescribing one or both of these agents.
Comments from Decision Resources Group Analyst Jia-Min Zhuo, Ph.D.:
- "Novel GNI drugs should be able to obtain innovative status and command significant price premiums if they can demonstrate significant improvements over current agents. Considering the high unmet need for new drugs for infections caused by multi-drug resistant Gram-negative pathogens, clinical data demonstrating a new agent's superior efficacy over standard of care in these difficult to treat infections will be a key market access lever across all EU5 countries."
- "Marketers need to understand the regional variations in drug access across the EU5 countries, and implement country-specific strategies to optimize market access for their novel antibiotic brands. In particular, marketers should carefully consider their choice of comparator in clinical trials, given that a favorable HTA review is highly dependent on the demonstrated improvement over country-specific standard of care."
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