Center for Health Economics Research Paper. (2011). Uncertainty, evidence and irrecoverable costs: informing approval, pricing and research decisions for health technologies. York, UK: Claxton, K., Palmer, S., Longworth, L., Bojke, L., Griffin, S., McKenna, C., Soares, M., Spackman, E., & Youn, J. Retrieved from http://www.york.ac.uk/media/che/documents/papers/researchpapers/CHERP69_Informing_approval_pricing_and_research_decisions_for_health_technologies.pdf
“The general issue of balancing the value of evidence about the performance of a technology and the value of access to a technology can be seen as central to a number of policy questions. Establishing the key principles of what assessments are needed, as well as how they should be made, will enable them to be addressed in an explicit and transparent manner. This report presents the key finding from MRC and NHIR funded research which aimed to: i) Establish the key principles of what assessments are needed to inform an only in research (OIR) or Approval with Research (AWR) recommendation. ii) Evaluate previous NICE guidance where OIR or AWR recommendations were made or considered. iii) Evaluate a range of alternative options to establish the criteria, additional information and/or analysis which could be made available to help the assessment needed to inform an OIR or AWR recommendation. iv) Provide a series of final recommendations, with the involvement of key stakeholders, establishing both the key principles and associated criteria that might guide OIR and AWR recommendations, identifying what, if any, additional information or analysis might be included in the Technology Appraisal process and how such recommendations might be more likely to be implemented through publicly funded and sponsored research.”