The challenge
Our client was preparing to seek regulatory approval for their asset in a new indication, and wished to understand:
> How HTA bodies in France, Germany, Italy and the UK would evaluate their asset in the new indication
> Payer perceptions of trial design and available evidence for their asset versus known competitors
> Key data requirements for HTA submission and optimal reimbursement in each market.
The solution
We conducted and moderated four virtual advisory boards within France, Germany, Italy and the UK with two national payers and one key opinion leader focusing on the following topics:
> Disease background and current management
> Payer perception of trial design and outcomes and potential historical control arms
> Likely HTA outcome based on evidence available and implications for labelling options
> Payer perception of novel therapy versus emerging comparator evidence.
Key results
Our client received four country-level overviews highlighting HTA insights from key stakeholders with regards to how HTA bodies would evaluate their therapy in a novel indication. Key insights were obtained per market and a global summary of recommendations for our client’s market access strategy was shared, highlighting:
> Key areas of focus for research to highlight the need for a novel therapy within the new indication
> Payer insights with regards to their trial design and outcomes used
> Likely reimbursement outcomes per market and implications for labelling options
> HTA insights of the novel therapy versus existing competitors, and recommendations for key points of focus within their regional submissions.
Value to the client
Our client received a range of insights from key stakeholders that they were able to communicate internally to build their market access strategy for a novel therapy in a new indication.
Our client was entering the highly dynamic clinical treatment landscape for lung cancer, with a focus on precision medicine targeting specific genetic mutations. This reinforced the need to better understand the patient pathway and the proportion of patients in each clinical segment to support research and patient care decision making across the EU5, China and Japan.
