Evidence requirements and funding of a long-acting intravenous antibiotic in major European markets
Our client was the Director of Health Economics and Reimbursement for a small US-based company. The company had conducted phase 3 trials for a ‘one shot’ intravenous antibiotic entirely in the US and the value proposition revolved around being able to shift care to the ambulatory setting. It was uncertain whether the value proposition would resonate in European countries given differences in settings of care and funding mechanisms.
The client challenge
Our client needed to understand whether the US clinical trials data were sufficient to support market access in EU markets at the target price, and whether the value proposition and supportive evidence needed to be different in Europe compared to the US.
How we helped
We conducted in-depth qualitative research with payers and payer-advising KOLs in infectious diseases in 5 major EU markets (UK, G, F, I, Sp) to understand the setting of care in which patients receiving IV antibiotics are managed, the drivers of use of IV antibiotics, the funding of drugs according to setting of care, and reactions to the product profile. This enabled us to identify the situations and patient types in which the product was seen to be of greatest value and the evidence that would be required to support that value. We were also able to identify the achievable price level in each market.
Our client was delighted to gain a full understanding of how the product would be used and funded in each European market. He used the results of our work to help plan further evidence development activities in Europe. He was able to reduce the scope of a specific pricing study that was being planned.