• The health technology assessment (HTA) bar is rising across the EU5 (France, Germany, Italy, Spain, UK) as payers come under increasing pressure to balance clinical need with tight budgets. Robustly demonstrating added benefit over currently available standard of care (SOC) therapies is, therefore, an essential requirement for new agents seeking to enter the high-cost oncology markets.
• Manufacturers must ensure flawless pivotal trial design for their emerging agents in order to satisfy the stringent HTA and reimbursement demands of cost-constrained payers, and to ensure uptake among oncologists who require compelling clinical data and who are, to some extent, restricted in their prescribing by payer policy.
• Focusing on key oncology indications, this study examined payer and physician perspectives on the importance of clinical trial design in HTA, reimbursement and prescribing.
Authors: Niamh Buckley, Ph.D.; Laura Vinuesa, D.V.M., M.Sc.; Yulia Privolnev, M.A.; Janie Cox, Ph.D.