1313O Assessment of investigational new drugs (INDs) approved in USA and Europe after early phase trials using the ESMO-magnitude of clinical benefit scale (ESMO-MCBS)

Abstract

Increasingly regulatory approval for novel agents is sought following early phase single-arm trials. However, many countries’ governmental agencies require value assessment of new agents to determine reimbursement. The ESMO-MCBS provides an evaluation framework based on treatment efficacy, response duration, adverse events, quality of life, and phase 4 data scored from 1-5 with scores >4 indicating substantial benefit worthy of reimbursement.