As healthcare system budgets tighten and payers and regulators continue to focus on the patient’s perspective, health economics and outcomes research (otherwise non-interventional studies) is key to products’ success. Budget impact and cost effectiveness are crucial considerations for formulary acceptance and market access. Moreover, real-world evidence for the clinical effectiveness of products as well as patients’ health-related quality-of-life and other patient-reported outcomes (PROs) are becoming increasingly important for registration, reimbursement and marketing of new treatments. Generating relevant economic and humanistic evidence for a variety of different stakeholders, health authorities and technology assessment agencies requires a multidisciplinary approach to the design, execution and analysis of data.