HTA AGENCIES PERSPECTIVE ON PROGRESSION-FREE-SURVIVAL (PFS)
Author(s)
Schmitter S1, Holzerny P2, Brock E2, Günzel C3, Ruckdäschel S2
1Pfizer Deutschland GmbH, Berlin, Germany, 2HealthEcon AG, Basel, Switzerland, 3Pfizer Pharma GmbH, Berlin, Germany
OBJECTIVES: To systematically review how HTA agencies in Germany (IQWiG, GBA), England (NICE), France (HAS), Spain (AETS) and Italy (AIFA) evaluate PFS and its importance compared to overall survival (OS). METHODS: The agencies’ websites were systematically searched to identify formal and methodological standards as well as assessments of cancer. Only standards affecting cancer drugs and specifically relating to endpoints were considered.RESULTS: GBA does not provide guidance on endpoints besides the requirement of patientrelevance. Hence, no specific statements on PFS and OS can be derived. IQWiG considers outcomes measuring survival and what patients feel and how daily activities are affected by treatment. Surrogates are only accepted when validated according to IQWiG’s methodological requirements. PFS is not accepted as morbidity criterion due to its insufficient relation to symptoms experienced by patients. Based on NICE`s assessments, OS and PFS represent the core parameters, however individual assessments may also consider a variety of other factors, e.g. quality of life (QoL) and unmet medical need. However the essential part of NICE’s assessment is the cost-effectiveness analysis. HAS includes OS, PFS, QoL and adverse events in its assessments. PFS is not explicitly called a surrogate for OS and even in the absence of an improved OS an additional benefit can be granted. None of AETS’ guidelines explicitly mention PFS and it was stated more generally, that an improved health status of the population should be measured. Overall PFS is considered for assessments, although decisions do not solely depend on this parameter. No documents fulfilling the inclusion criteria could be identified on AIFA’swebsite. CONCLUSIONS:
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
HT7
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology
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