Patient-reported outcome (PRO) data are increasingly being included in Health Technology Assessment (HTA) submissions for oncology drugs. This study aims to provide differences in PRO evidence requirements in oncology across key HTA bodies and calls for its harmonization. Method guidance provided by HTA bodies in Germany, France and the UK, and analysis of HTA reports of 20 oncology case studies were evaluated in this review. Differences exist between HTA bodies regarding guidance on how PRO data should be collected, reported and analyzed as well as how the data are reviewed and considered in oncology HTAs. HTA bodies can play a key role to harmonize PRO method guidance in collaboration with regulators and sponsors.
Keywords: G-BA; HAS; IQWiG; NICE; PRO; PRO evidence; health technology assessment; oncology HTAs; patient-reported outcomes.
Patient-reported outcomes (PRO) are information provided directly by the person who is experiencing a disease or undergoing a treatment, without additional interpretation by a clinician or caregiver. Along with other outcome measures, PROs may be included in the body of evidence used by health technology assessment bodies in their review. In this article, the authors summarize the guidance documents published by key health technology assessment agencies and reviewed 20 past cancer drug case studies to understand how different agencies use PROs when deciding on recommendations for new cancer treatments.