A COMPARISON OF HEALTH TECHNOLOGY ASSESSMENT (HTA) REQUIREMENTS FOR SYSTEMATIC LITERATURE REVIEWS (SLRS)
Author(s)
Sarnes E1, Cadarette SM1, Sawchyn B1, Gittings K1, Kulp W2, Siu EC3, Ruiz K1, Wissinger E1
1Xcenda, L.L.C., Palm Harbor, FL, USA, 2Xcenda GmbH, Hannover, Germany, 3Innomar Strategies, Oakville, ON, Canada
OBJECTIVES: An SLR provides comprehensive, high-quality synthesis of published evidence, and is a fundamental component of regulatory submissions for many HTA agencies. While there is a broad consensus among HTA bodies that an SLR is essential to identify relevant data, specific guidance on data sources, methodology, required outcomes, and reporting of the SLR varies considerably between HTA agencies. This study aimed to review and compare requirements for SLRs from several prominent HTA organizations. METHODS: Searches of 5 leading HTA agency websites were performed to identify guidelines or requirements for the conduct of SLRs used in product submissions. Available relevant guidance was extracted and compared between HTA bodies. RESULTS: All HTA websites included information regarding the type of literature review required to provide evidence for the proposed intervention (Table 1). With the exception of AMCP and CADTH, all other agencies reviewed (AMNOG, NICE, and PBAC) require an SLR evaluating clinical data and explicitly mention inclusion of comparator data and the potential need for indirect treatment comparisons. All 3 of these agencies mandate detailed documentation of SLR methodology. AMNOG restricts the SLR to head-to-head evidence against an agency-specified comparator; AMNOG and PBAC further specify data sources for the review. CADTH does not require an SLR, but requests documentation of search strategies. While all of the included organizations require background information on the intended patient population, none requests an SLR on epidemiological evidence. Economic data are required by AMCP, CADTH, and NICE, although only NICE dictates an SLR of economic evidence. CONCLUSIONS: The most stringent guidelines for SLR methodology were seen in Europe (UK and Germany) and Australia. North American HTAs’ guidance for the conduct and documentation of evidence development varied. Key differences between HTA agency requirements must be considered when developing an SLR to be used for submissions across global markets.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP263
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases