Demonstrating Value: Overcoming the HTA Hurdle
Successful translation of research “from bench to bedside” requires strategic management of the complete development process, guided by a clear understanding of key stakeholder groups and their expectations. Objectives (including positioning, target product profile, and risk assessment) need to be converted into a development and market access plan with precisely defined milestones, each representing a decision point on the design of the next development phase. At the core of the process, strategic value assessments need to inform about potential sources of value, evidence gaps and how to close them, and ways to meet the evaluation criteria of regulatory and HTA agencies.
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Caro JJ, Brazier JE, Karnon J, Kolominsky-Rabas P, McGuire AJ, Nord E, Schlander M. Determining Value in Health Technology Assessment: Stay the Course or Tack Away?. PharmacoEconomics 2019; 37(3):293–299.