OBJECTIVES: The analysis was conducted to compare trends in recommendations for orphan and non-orphan products reviewed by the Scottish Medicines Consortium (SMC), the National Institute of Health and Care Excellence (NICE) and the Gemeinsamer Bundesausschuss (G-BA), and identify disease areas that may be particularly challenging for manufacturers planning European product launches. METHODS: The following were categorised as ‘recommended’: NICE and SMC positive and restricted recommendations, G-BA major, minor and considerable additional benefit decisions; and ‘unable to recommended’: NICE negative recommendations, SMC negative recommendations and non-submissions, G-BA no-benefit or unquantifiable benefit. Analysis of products by disease area was conducted by classification into British National Formulary (BNF) categories. RESULTS: SMC, NICE and G-BA have published 1160, 147 and 100 recommendations since their formation. Positive recommendations from NICE/SMC have increased in 2012-2014 (58% to 74%) but decreased from G-BA (50% to 43%). Treatments for malignant disease and immunosuppression formed the largest category of submissions (SMC 244, NICE 70, G-BA 34) with higher recommendation rates in Germany (65%) than the UK (50%). Significant differences in recommendations between the UK and Germany were found in endocrine treatments (73% vs. 24%, p=0.00003) and eye treatments (74% vs. 20%, p=0.012). In 2011-2014, NICE and G-BA only evaluated 9 and 16 orphan products, respectively. Overall, NICE has recommended more orphan products (67%) than G-BA (63%) or SMC (49%). NICE and SMC recommendations for orphan products have increased in 2014 compared to previous years. CONCLUSIONS: This analysis illustrates that the UK market may be easier to access than the German market but the scale of the challenge depends on the BNF category of the treatment. The next stage of analysis will consider trend analysis when accounting for SMC resubmissions and the re-review of NICE technology appraisals and multiple technology appraisals.