OBJECTIVES: With rising pressures on healthcare budgets, health technology assessment (HTA) agencies are increasingly scrutinizing medical devices (MDs) for economic benefits in addition to clinical benefits. This level of scrutiny has resulted in many unfavorable recommendations from agencies and only a small proportion of unconditionally favorable reviews. As an extension of our work reported at 2013 ISPOR Annual Congress (Dublin, IR) this study aims to: 1) Identify key criteria cited by HTA agencies as major decision drivers, 2) Note common criteria among reviews that were positive, negative, or positive with reservations, and 3) Analyze temporal or geographic trends among decision drivers. METHODS: A review of 68 HTAs and reimbursement decisions of implantable MD with a variety of indications was conducted, focusing on decisions published from 2008-2013 identified by Quintiles’ HTA Watch from North America, Europe, and Australia.  Clinical, economic, and other factors noted as pivotal to HTA and reimbursement decisions were registered and compared. Importantly, care was exercised to note only the criteria that triggered a HTA to make a favorable or unfavorable decision, as opposed to criteria that were only correlative.    RESULTS: Key product attributes affecting HTA decisions include 1) sufficiency and quality of evidence, 2) cost offsets and budget impact, 3) adverse event profiles, and 4) comparison to existing alternatives where available. Notab ly, 33% of HTA decisions were negative, with many decisions citing insufficient evidence. Additionally, a majority of favorable HTA decisions were reserved in their recommendations, citing a need for additional evidence to uphold the initially favorable recommendation. The relative importance of economic considerations varied across countries. CONCLUSIONS: HTA agencies’ scrutiny of sufficiency of evidence, among others, may significantly impact market access of medical devices. As such, manufacturers need careful planning to align evidence development, pricing and access plans with HTA agency, payer and pricing authority requirements.