Case Study:
Defining the clinical patient cohort for a new antibiotic treatment in a conservative and cost-restrictive market
The Client
Our client is a world-leader in the development and supply of antibiotic medicines, with a strong heritage and ambition. A novel anti-infective brand was deemed too expensive by EU payers vs older standard of care and the disease state where it worked best was not recognised.
European guidelines provided no opportunity for the uptake of the brand. Unlike payers, clinicians (especially KOLs) recognised the disease states addressed by the new brand & the utility of it here.
Therapy Area
Clostridium difficile (CDI) is the leading cause of infectious nosocomial bacterial diarrhoea in industrialized countries. The incidence and severity of C. difficile infection is increasing in most countries and is associated with significant morbidity and mortality. This represents a large clinical burden and potential complications, including pseudomembranous colitis, toxic megacolon, colonic perforation and sepsis.
The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has highlighted recurrence as the most important issue in the management of CDI. Up to 25% of patients suffer a recurrence of infection within 30 days following treatment. This has patient, clinical, resourcing and health economic implications.
Opportunity
The clinical burden of managing primary cases and recurrences, together with associated management such as cleaning and decontamination, contribute to significant economic costs. US studies estimate the economic burden of CDI to vary between $2,450 and $40,000 per episode. A substantial element of the additional cost relates to the accommodation costs resulting from a prolonged hospital stay.
Overall the cost of CDI is estimated at €3billion per year in the EU and there is concern that this will rise as the population aged >65 years increases. It is important for appropriate and available treatment to be used as early as possible.
- Clinical and health economic considerations are important in the EU
- Antibiotic stewardship varies across the EU
- Appropriate medicines should be accessible based on clinical need
Approach
