OBJECTIVES: Data published by the Office for Health Economics in 2011 showed rejection from the SMC was more likely for orphan than for non-orphan products. Following a review of the SMC in 2012, the process for appraising end-of-life, orphan and ultra-orphan drugs was modified to facilitate greater access for patients in Scotland. We analyse if the revised SMC process has been successful in providing more positive recommendations for orphan products and which factors may influence the decision. METHODS: Analyses were based on a validated, longitudinal database of all recommendations from 2002 to 2014. Products with a European Orphan designation were analysed. SMC recommendations following full submission, resubmission or abbreviated submission were reviewed and sub divided into British National Formulary (BNF) category. RESULTS: In 2002-2014, there were 8 abbreviated submissions to the SMC for orphan products, 68 full submissions and 25 resubmissions. The positive recommendations rate (with or without restriction) from 2002-2013 was 53% (n=92); in 2014 this recommendation rate increased to 89% (n=9). Up to 2013, malignant disease and immunosuppressive treatments accounted for 43% of the published guidance of orphan products with a recommendation rate of 50% (n=40); in 2014 this improved to 80% (n=5). Cardiovascular treatments have a high recommendation rate of 92% (n=13) but treatments for musculoskeletal and joint diseases have the lowest success with all three submissions receiving negative recommendation. In 2013, evidence for 7 orphan products was not submitted to the SMC within the required 3 months of license thus received automatic negative recommendation, however, this reduced to only one non-submission in 2014. CONCLUSIONS: The SMC recommendation rate for orphan products, particularly malignant disease and immunosuppressive drugs, has improved from 2013 to 2014 suggesting the revised SMC appraisal process may be more effective in enabling the SMC to provide positive recommendations for orphan products.