OBJECTIVES : Various oncology drugs using novel pathways have received regulatory approval in recent history, however, the path to global patient access is relatively more fragmented as numerous payers in different regions have unique submission processes and requirements. We sought to elucidate the relative difficulty of obtaining market access across four HTA agencies by identifying trends based on publicly available data.

METHODS : Drugs with oncology indications mutually reviewed by CADTH (Canada), NICE (England), SMC (Scotland) and PBAC (Australia) from 2016-2019 were identified. A clinical expert reviewed the wording of each individual indication across four HTA agencies to ensure that they were comparable. The reimbursement statuses and published reports were reviewed and conditions for reimbursement or reasons for rejection were extracted. Descriptive statistics were performed.

RESULTS : A total of 49 oncology drugs with indications that matched across four HTA agencies underwent reimbursement consideration. Positive recommendations for CADTH, NICE, SMC and PBAC occurred in 86%, 92%, 88% and 71% of oncology drugs, respectively. With CADTH, NICE and SMC, 84%, 57% and 47% of positive recommendations were conditional on improving the cost-effectiveness of the treatment. Positive recommendations without conditions were published for 2%, 4% and 4% of assessments, respectively. A total of 59% of oncology treatments received positive recommendations across all four HTA agencies. Negative recommendations occurred in 14%, 8%, 12% and 29% of assessments, respectively. The most frequently reported reasons included uncertain/immature clinical data and high drug costs resulting in excessive incremental cost-effectiveness ratios. With heterogeneous phrasing of indications across HTA agencies, the matching of indications is partly subjective and remains a limitation of this analysis.

CONCLUSIONS : Patient access to oncology drugs is inconsistent across different regions. The findings suggest that researchers and drug manufacturers could benefit from earlier HTA considerations to address unique submission requirements and establish the economic viability of commercialization.