NICE AND SINGLE? RECOMMENDATION RATES OF ONCOLOGY THERAPIES APPROVED ON CLINICAL TRIAL PACKAGES LACKING COMPARATIVE PHASE 3 DATA
Author(s)
Macaulay R1, Anell B2
1PAREXEL International, London, UK, 2PAREXEL International, Stockholm, Sweden
Presentation Documents
The National Institute of Health and Care Excellence (NICE) makes recommendations on the reimbursement of new medicines based upon their clinical and cost-effectiveness (as defined by their incremental cost per additional Quality Adjusted Life Year [QALY]) METHODS: NICE single technology appraisal (STA) guidance for systemic anti-cancer therapies was screened (01/01/2009-31/05/2017) and the recommendation and supportive trial package extracted. RESULTS: CONCLUSIONS: NICE have recommended 5/6 oncology STAs supported by a clinical trial package lacking comparative data. The trend for such appraisals is increasing with most having been conducted in the last 12 months. The clinical benchmark of EMA approval for oncology drugs on such a data package seems sufficient to enable acceptance under NICE’s clinical criteria. Nevertheless, NICE’s recommendations are further conditional on cost-effectiveness being adequately demonstrated. Additional price discounts and/or innovative contracting may frequently be required to offset the inherent uncertainties on conducting economic modelling based on such limited clinical data package.
Conference/Value in Health Info
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN251
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
Oncology