LAUNCHING NOVEL ANTIBIOTICS- ACCESS OPPORTUNITIES AND RESISTANCE IN EUROPEAN MARKETS
Author(s)
Hakim P1, Gilbane A2, Schlegel R2
1Navigant Consulting Inc, London, UK, 2Navigant Consulting Inc., London, UK
BACKGROUND: In Europe there is a current issue with bacterial resistance in the community and hospital setting. In France, Italy, and Spain, the rate of macrolide resistance still exceeds 20% of S. pneumoniae isolates. This represents an increase from the 18% average macrolide resistance rate observed among S. pneumoniae isolates across Europe in 2005. In 2014, approximately 12% of S. pneumoniae isolates have been reported to be resistant to macrolides across Europe. Although resistance rates are high, there is consensus towards not paying a premium price for novel antibiotics, driven primarily by a high numbers of generics. However, with a growing need for therapies with low resistance profile, there is a need for manufacturers to effectively launch commercially attractive novel antibiotics. METHODOLOGY: Navigant conducted both the primary and secondary research to analyse the current demand for novel antibiotics. Secondary research was supplemented with qualitative research in EU5 with physicians, regional and national payers. The methodology was used to assess the current unmet needs and the payer’s perception of antibiotics demanding a premium price as well as assessing various key drivers and barriers to launching an antibiotic in Europe. RESULTS: Manufacturers will have to consider a variety of key parameters including trial design, variability in geographical resistance rates and real-world restrictions of antibiotics use as well as identifying key decision makers and ensuring early engagements with payer/regulatory bodies. CONCLUSIONS: There is a perceived low unmet need for novel antibiotics. However, from a political and societal point of view, there are strong concerns with antibiotics resistance driving the need for innovative antibiotics with a low resistance profile. Although such therapies are likely to be held for later line, manufacturers are encouraged to invest early in understanding the pricing and market access implications of launching a novel antibiotics in Europe.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP359
Topic
Health Policy & Regulatory
Disease
Infectious Disease (non-vaccine)