OBJECTIVES: The objective of this study is to verify if the clinical efficacy is the main reason on which negative recommendations issued by AHTAPol (Agency for Health Technology Assessment in Poland) for orphan oncology drugs  are based. The role of AHTAPol is to prepare for the Minister of Health recommendations on financing all medical technologies from public funds. Orphan oncology drugs undergo pharmacoeconomic evaluations and coverage decision processes similar to other molecules. AHTAPol’s reimbursement recommendations  are based on evidence of clinical benefit and efficacy/safety ratio, cost-effectiveness, costs and their impact on the payer’s budget. METHODS: Among recommendations of AHTAPol published until the end of May 2011, we identified all related to orphan oncology drugs. Having categorized into types of recommendations then we analyzed rational for granted decision. RESULTS: Among 420 AHTAPol decisions analyzed, 32 (21,7%) applied to non-drugs technologies, 91 (21,7%) to health care programs and 297 (70,7%)  to drugs technologies. Among 297 drugs recommendations only 15 (5%) was related to oncology orphan molecules. Granted were 10 (out of 15) positive recommendations. For 3 out of 15 drugs AHTAPol issued conditional recommendations (with restriction related to reducing the cost- effectiveness outcomes).  Only two orphan oncology drugs were assessed negatively. In both cases main criteria on which recommendations were based refer to low clinical efficacy and safety. CONCLUSIONS: Neither cost-effectiveness nor costs and budget impact were significant arguments in negative recommendations of AHTAPol. As a matter of fact, lack of clinical efficacy and insufficient safety profile were the key issues for  orphan oncology drugs negatively assessed by AHTAPol.