OBJECTIVES: There has been concern that new oncology medicines may not be accessible to patients due to the requirement to demonstrate cost-effectiveness in order to gain public reimbursement.  In Australia, Public Summary Documents (PSDs) reporting on the Pharmaceutical Benefits Advisory Committee’s (PBAC) decision making relating to government reimbursement of medicines have been published since July 2005. A review of PSDs reporting on oncology drugs which presented cost-effectiveness analyses was undertaken to identify the success factors for achieving a positive recommendation. METHODS: Data related to history, clinical outcomes, cost-effectiveness and recommendations for oncology drugs from published PSDs between July 2005 and November 2011 were extracted and reviewed. RESULTS: Eighty-one PSDs were reviewed of which 51 were first, 18 second and 12 subsequent submissions.  The PBAC recommended 26 for listing on the Australian Pharmaceutical Benefits Scheme (PBS).  Of the first, second and subsequent submissions, 29%, 33% and 42% received a positive recommendation respectively.  Of those that reported a AU$/QALY, the range was: below $15k; 0% of instances, 15-45k; 67%, 45-75k; 33%, 75-105k; 0% and above 105k; 0%.  The findings were generally similar when AU$/LYG was reported, however one product was approved with AU$/LYG greater than $105k under the “rule of rescue”.  Of the products approved with AU$/QALY or LYG greater than $45k factors that were noted included high clinical need, risk sharing agreement and further price negotiation.  CONCLUSIONS: Cost per QALY above $45k is acceptable in conjunction with factors such as clinical need and robust evidence. Nevertheless, further price negotiation may be required to gain reimbursement on the Australian PBS.