Presentation (CTI)

OBJECTIVES: Traditionally, the value of pharmaceutical products is assessed based on direct health outcomes and healthcare costs. However, there is an increasing recognition on the importance of including broader impacts and a societal perspective. Value frameworks help to conceptualise value comprehensively, including benefits for patients, their families and carers, and society. We aimed to establish a comprehensive value framework that can help to consistently determine and communicate the value of pharmaceutical interventions reflecting the perspectives of patients, payers, healthcare systems, and society, in early stages of product development.
METHODS: A targeted review of value frameworks and novel value elements was conducted to collate an inventory of value elements, to assess progress in their measurement and incorporation into payer decision-making, and to identify valuation methods that can translate them into monetary benefit where relevant. Subsequently, we created a process to operationalise this framework in the context of evidence generation and holistic value assessment at early stage of development.
RESULTS: We created a comprehensive value framework that reflects the latest literature on value and perspectives. It includes 19 value elements and five value modifiers across the following domains: ensuring access, unique outcomes for patients and populations, patient experience, health condition and treated population, and societal effects. The proposed framework can be applied to existing and new interventions, and adapted iteratively as new evidence or methodologies evolve.
CONCLUSIONS: Our value framework allows the systematic and holistic assessment of value elements relevant for all stakeholders. Such comprehensive assessment can inform clinical and evidence development from an early stage and help communicating value to all stakeholders including payers for their decision making.