ASSESSING THE FINANCIAL VALUE OF PATIENT ENGAGEMENT

• Published in: Value in health Vol. 20; no. 5; p. A33
• Main Authors: Levitan, B, Getz, KA, Eisenstein, EL, Goldberg, M, Harker, M, Hesterlee, SE, Patrick-Lake, B, Roberts, J, DiMasi, JA
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01.05.2017
• Subjects: Clinical trials; Investments; Medical treatment; Oncology; Patients; Present value; Return on investment; Risk adjustment; Uncertainty
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs due to uncertainty in the return on investment. The objective of this work was to develop an approach to estimate the financial value of patient engagement. METHODS: Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We describe an approach to assess the impact of patient engagement on ENPV for a medical treatment development program, then apply it to a typical oncology development program entering phase 2 (cost to launch $121MM, NPV $493MM) or phase 3 (cost to launch $114MM, NPV $640MM). RESULTS: For a prephase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $50,000 in patient engagement, the NPV and ENPV increases exceed 1000-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). CONCLUSIONS: Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.