• Howard L Kaufman, Michael B Atkins, Prasun Subedi, James Wu, James Chambers, Joseph MattinglyTT2ndUniversity of Maryland, 20 N. Pine St, Baltimore, MD, USA., Jonathan D Campbell, Jeff Allen, Andrea E Ferris, Richard L Schilsky, Daniel Danielson, J Leonard Lichtenfeld, Linda House, and Wendy K D Selig.
• Society for Immunotherapy of Cancer (SITC) Policy Committee, Replimune, Inc, 18 Commerce Way, Woburn, MA, USA.
• J Immunother Cancer. 2019 May 17; 7 (1): 129.

AbstractThe rapid development of immuno-oncology (I-O) therapies for multiple types of cancer has transformed the cancer treatment landscape and brightened the long-term outlook for many patients with advanced cancer. Responding to ongoing efforts to generate value assessments for novel therapies, multiple stakeholders have been considering the question of "What makes I-O transformative?" Evaluating the distinct features and attributes of these therapies, and better characterizing how patients experience them, will inform such assessments. This paper defines ways in which treatment with I-O is different from other therapies. It also proposes key aspects and attributes of I-O therapies that should be considered in any assessment of their value and seeks to address evidence gaps in existing value frameworks given the unique properties of patient outcomes with I-O therapy. The paper concludes with a "data needs catalogue" (DNC) predicated on the belief that multiple key, unique elements that are necessary to fully characterize the value of I-O therapies are not routinely or robustly measured in current clinical practice or reimbursement databases and are infrequently captured in existing research studies. A better characterization of the benefit of I-O treatment will allow a more thorough assessment of its benefits and provide a template for the design and prioritization of future clinical trials and a roadmap for healthcare insurers to optimize coverage for patients with cancers eligible for I-O therapy.

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