for new drugs and new indications for existing drugs were identified from the European Medicines Agency (EMA) website. The decision to undertake an appraisal was obtained from the NICE website and NIHR Horizon Scanning Centre records, and the associations between this and characteristics of the drug and intended patient population were then determined. Results: For 2005-2011, we identified 134 MAs granted by the EMA (116 new drugs and 18 new indications) of which 72 (54%) were selected for appraisal. The decision to undertake an appraisal was significantly associated with an MA granted 2009-2011 (OR= 2.3, p< 0.01), the drug being a biological agent (OR= 3.9, p< 0.01), administered on a long-term basis (OR= 1.8, p< 0.05), indicated for a patient population < 1 in 1,000 (OR= 2.1, p< 0.05), or for malignant disease (OR= 5.1, p< 0.01). It was not associated with an indication for more severe disease (OR= 2.0, p= 0.06), an MA issued for a new indication (OR= 1.4, p= 0.50), or whether a drug was first-of-kind (OR= 1.8, p= 0.10). ConClusions: We identified several characteristics associated with the decision to undertake an appraisal relating to both the drug and intended patient population that do not completely match published topic selection criteria (e.g. severity). Further analyses are required to determine which are the most relevant factors in this decision.
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