LAUSR

95 Background: Ensuring that effective innovations are accessible in a timely and affordable manner to all cancer patients is a challenge that stakeholders face today. Several oncology frameworks (ASCO, ESMO, ICER, NCCN) have been developed to define and quantify the value of oncological therapies to support clinicians and patients at the time of selection and as a basis for decision-making. However, current frameworks only define treatment value in terms of clinical benefit, creating a need for one that allows holistic evaluation of treatments and supports decision-making in clinical practice. The ECO Foundation led this study to develop a reflective multi-criteria decision analysis (MCDA) based framework for evaluation and positioning of new oncological drugs from the clinical oncology perspective. Methods: The framework was developed following EVIDEM methodology. Systematic literature review was performed to identify most relevant criteria used for evaluation of innovative treatments to complement the EVIDEM V4.0 framework. The criteria compendium was presented to a group of clinical oncologists from ECO. The Expert Group assessed each criterion for its inclusion in the framework and suggested modifications in their definition and/or response scale. This framework was then tested with two case studies (Abemaciclib for metastatic HER-/HR+ breast cancer and TAS for metastatic colorectal cancer). The objective was to validate the criteria selected alongside their definitions and response scale with practical examples. A reflective discussion based on the score assigned to each criterion was also carried out. Results: Out of 15 criteria presented to the Expert Group, 8 were included in the final framework, and definition and/or response scale of 7 of these criteria were modified: Disease severity, Unmet needs, Efficacy comparison, Safety/tolerability comparison, Treatment intention, Treatment cost comparison, Comparison of other medical costs and Quality of evidence. Conclusions: A reflective MCDA framework has been developed and validated, based on the value of the treatment, for assessment and positioning of oncological therapies in the context of clinical practice in Spain.