Generating scientific and commercial evidence to elevate product value and reimbursement potential
ICON's health economics and outcomes services span the entire product lifecycle to generate scientifically rigorous and commercially relevant evidence, and ensure that the patient voice is captured to elevate the client’s product value proposition and reimbursement potential.
In 2021, methods for capturing the patient voice and payer perspective changed drastically. But despite the continuing global pandemic, ICON's global HEOR team delivered over 400 projects to125 clients.
Services through all stages of development and commercialisation
Our experts use established methods and innovative tailored solutions to help pharma, biotech and medical device clients generate HEOR evidence, meet specific HTA challenges with early advice and submissions, support market access and bolster arguments for product reimbursement.
- Development of global HEOR strategy, including strategic roadmaps and evidence generation for early product planning; Advisory boards to externally validate the strategy; and regulatory support for FDA and EMA activities
- Systematic and targeted literature reviews on efficacy and safety, costs, economic evaluations, clinical outcome assessments, HrQoL utilities
- Selection, design, development, and validation of clinical outcome assessments (COAs) and refinement of endpoint selections, preparation of COA dossiers for regulatory submissions; Cognitive debriefing & usability testing (CDUT) and analysis of data for equivalent testing of COAs migrated to electronic platforms
- De novo development of global economic models for HTA/reimbursement submissions, including survival analysis modelling and local country adaptations
Patient preference studies and utility measurement
- Discrete choice experiments; design & evaluation of patient support and adherence programs; data generation for utility measurement data used in economic modelling and HTA submissions
HTA submissions and early advice
- Formal and informal scientific advice to understand evidence generation plans to support HTA / reimbursement, including briefing book preparation, and scientific advice meeting preparation and support; and development of HTA dossiers
- Development of global value dossiers and payer engagement slide decks, objection handlers, and toolkits