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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. [ABSTRACT FROM AUTHOR]

Aim: This systematic review compares European HTA-agencies (Health Technology Assessment-agencies) for the evaluation of submitted reimbursement dossiers and the acceptance of the by regulatory authorities proven indications (slicing procedure). Subjects and methods: A Europe-wide literature search and Internet survey from 2000 to 2012 was applied. For 10 market leaders and 4 drugs which were approved in 2009 or 2010, the approved indications were compared to the indications which were eligible for reimbursement in Germany, the United Kingdom (UK) and France. Results: A slicing procedure could be found for 5 applications (drugs) in UK and France and for 6 applications (out of 14) in Germany. Three drugs out of 16 were referred to a fixed price group. The position of the regulatory authorities remained unchanged for eight compounds. As a final result, it is obvious that indications will be cut off (slicing), market authorizations modified and comparators changed. Scientific reasons are not published. Conclusion: Slicing (cutting off indications and populations) is well known in European HTA bodies but is applied only in a minority of submissions, which has resulted in a decrease of the population and reimbursement rate. A harmonization process between HTA agencies and regulatory authorities should be initiated. [ABSTRACT FROM AUTHOR]

Aims: To explore health technology assessment (HTA) outcomes of matched drug pairs by national agencies in Germany (Gemeinsamer Bundesausschuss, GBA), France (Haute Autorité de Santé, HAS) and England and Wales (NICE). Methods: We considered published GBA decisions, HAS reports and NICE guidance from January 2011 to June 2018. HTAs of matched pairs were compared overall, and for non-cancer and cancer drugs separately. We further analyzed the role of additional attributes related to cancer therapies. Results: Matched pairs show higher concordance for GBA/HAS than for GBA/NICE and HAS/NICE. Overall, NICE evaluated technologies more favorably than GBA and HAS. GBA appraisals of cancer drugs, however, tended to be more positive than cancer-related recommendations by NICE and HAS. Conclusion: The findings indicate substantial variations in HTAs, although cancer-related outcomes seem to diverge less than non-cancer results.