DO HEALTH TECHNOLOGY AGENCIES ACCEPT METHODS FOR DEALING WITH TREATMENT SWITCHING AND IMMATURE OS DATA?
Author(s)
Zhang Y1, Wright J2, Luke S3, Ryan J4, van Engen A5
1Astrazeneca, Gaithersburg, MD, USA, 2Quintiles, Reading, UK, 3AstraZeneca, Macclesfield, UK, 4AstraZeneca, Cambridge, UK, 5Quintiles Advisory Services, Hoofddorp, The Netherlands
OBJECTIVES: Upon disease progression or early termination of a trial, cancer patients in the control arm of clinical studies commonly switch to the experimental drug or receive other post-study treatments. In many oncology studies survival data is far from being complete with many patients still alive by the end of follow-up. There is no universally accepted definition of the cut-off for immature overall survival (OS).The objective of this study was to assess the methods agencies accept to adjust for treatment switching and for extrapolation of immature OS data. METHODS: An in-depth review was performed on assessments for 5 products with immature overall survival data and where treatment switching occurred (pembrolizumab, dabrafenib, crizotinib, enzalutamide and vemurafenib) by 7 agencies (NICE, HAS, G-BA, IQWiG, pCODR, PBAC and TLV) from January 2011 to December 2015. RESULTS: CONCLUSIONS: Payers highlighted the uncertainty of immature data results and that extrapolation results are questionable, invalid or overestimate potential benefits. NICE will review complex treatment switching methodologies while at other agencies it is not common practice as yet.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PRM120
Topic
Methodological & Statistical Research
Topic Subcategory
Modeling and simulation
Disease
Oncology