Psychedelic Therapies and HTA Methods
A wave of psychedelic-based therapies is in late-stage clinical trials and may seek entry into European health systems within the next few years. HTA is a cornerstone for evaluating new medicinal therapies and informing reimbursement and patient access decisions, but how suitable are current HTA methods for evaluating psychedelic therapies and determining their value for the conditions they might treat? The meeting will provide perspectives related to unmet need for mental health treatment today, the clinical promise of psychedelics in early study results in mental health, and the rationale for why developers and researchers have implemented novel study approaches to manage issues such as blinding and reporting bias. Key characteristics will be discussed to determine if these present issues for HTA, such as novel study approaches to manage blinding, combination drug + talking therapy, and infrastructure needs. The issue of including/not including indirect value will also be discussed. The debate will review if these therapy characteristics are novel and if HTA methods need adaptation.