EXPLORING THE FLAWS IN CLINICAL DATA THAT LEAD TO REJECTION OF NICE SUBMISSIONS
Author(s)
Hendrich J, Griffiths EA
PAREXEL, London, UK
Presentation Documents
OBJECTIVES New health technologies are required to demonstrate clinical- and cost-effectiveness before being recommended by NICE for use in the National Health Service. A large proportion of submissions are rejected, at least in part, due to poor trial design or flaws in the presented clinical data. Published NICE guidance includes a comprehensive critique of submitted clinical evidence. Therefore, the flaws in clinical data leading to rejection by NICE were examined, as a means of providing guidance for future submissions. METHODS All single technology appraisals from January 2006 to May 2014 from NICE were included in the analysis. Multiple technology appraisals, resubmissions, vaccination programmes, and requests for advice were excluded. The recommendation and reasoning behind each decision were assessed, focusing on the critique of the clinical evidence. RESULTS
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
NI1
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Multiple Diseases