AUTHORS: Giulia Chirico, Theia Kwong, Fatima Chunara
OBJECTIVES
This study explores the role of economic benefit for ATMPs in HTA decisions across different market types: cost-effectiveness driven (UK), budget-impact driven (Italy), and clinical-differentiation driven (France). The aim is to determine whether clinical or economic factors primarily influence these decisions and how this varies across market archetypes.
METHODS
The UK, Italy, and France were chosen as representative market archetypes. ATMPs assessed by HTA bodies within these markets were identified using NICE, AIFA, and HAS databases. Two ATMPs, Yescarta and Alofisel, were selected to illustrate contrasting examples from a P&R perspective. Key payer considerations from HTA reports were categorised as positive, uncertain, or negative, and as clinical or economic. A comparative analysis was conducted between the two ATMPs across the three markets.
RESULTS
Yescarta (first indication) received positive HTA outcomes in the selected markets, often linked to conditions or facilitated by MEAs. Alofisel, however, is only reimbursed in France and only for a sub-group. Key payer considerations for both Yescarta and Alofisel mainly pertain to the clinical domain across all markets. In France and the UK, economic concerns arise from uncertainties in clinical benefit.
CONCLUSION
The level of clinical benefit is the key factor in HTA decisions for ATMPs. ATMPs often lack sufficient evidence to demonstrate clinical and economic benefit at launch. Alternative reimbursement schemes, like coverage with evidence development, and payment methods are used to provide access despite uncertainties. However, if clinical benefit uncertainty is too high, as with Alofisel, these schemes are not considered. This is especially true in markets where clinical benefit assessment precedes economic discussions.
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