OBJECTIVES: Orphan drugs (ODs) benefit from incentives from EMA for their development, but in a context of economical restrictions payers are more and more worried by highly priced medicines. The aim of this research was to evaluate whether the orphan designation has an impact on the reimbursement and pricing for drugs in oncology in European coutries. METHODS: First, a literature review was performed to identify specific methodologies or consideration applied for the evaluations of ODs. Second, a comparative analysis of HTA recommendations for drugs registered for their first indication in oncology between 2006 and 2013 and appraised by four agencies (HAS, G-BA, NICE, SMC) was performed, as well as coverage decisions, treatment cost, and delay between approval and price agreement. RESULTS: In the selected countries, there is no specific methods to assess ODs. However some special considerations are made to accept higher level of uncertainty. 49 drugs were included in the analysis. Significant inter-country variability in the HTA recommendations exists: 20% of drugs received heterogeneous recommendations across countries. The highest concordance scores were obtained between NICE and SMC for ODs (0.9 kappa score), for others concordance was poor. The percentage of rejection for ODs was not higher than the one for non-ODs. Average treatment costs were in favour of orphan oncology drugs, still it was not significant. There was correlation between treatment cost and population size for the non-ODs, but it was not the case for ODs. Delay of appraisal for ODs was slightly shorter, but never significant, except for NICE.  CONCLUSIONS: In this study we did not show a significant advantage or disadvantage in the market access of ODs in oncology. However, as more ODs will obtain regulatory approval on an accelerated or conditional licensing, providing expanded evidence package to show the value for money to payer will become harder.