OBJECTIVES : Combinations of existing therapies are increasingly being developed and marketed across many indications. Whilst they promise substantial clinical benefits, dual-branded therapies may have substantial financial impacts. Obtaining positive HTA approvals and public reimbursement may be a major challenge, which may be amplified if each monotherapy is marketed by a different company. We evaluated whether combination therapies developed by two manufacturers had slower and/or worse outcomes than those where each constituent was developed by a single manufacturer in HTA bodies that use cost-effectiveness as a key decision-making criterion and whether this varied by based on region.

METHODS : EC-approved combination products, comprising at least one on-patent therapy marketed under a separate brand were identified (01/01/2015–5/6/2019) and the number of manufacturers identified. Corresponding HTA reports were identified from CADTH, NCPE, NICE, PBAC, and SMC websites and relevant data extracted.

RESULTS : 169 HTA assessments across 35 combination products:indications were identified (same manufacturer: 91 assessments, two manufacturers: 78 assessments). For both EU and ex-EU HTA bodies, the rate of positive recommendations was higher for combination therapies developed by one vs. two manufacturers (EU: 82% vs. 57%; ex-EU: 83% vs. 63%), with corresponding shorter median time from regulatory approval to positive recommendation for one vs. two manufacturers (EU: 5.0 vs. 6.5 months; ex-EU: 3.0 vs. 5.0 months).

CONCLUSIONS : HTA bodies assessing cost-effectiveness were more likely to issue positive recommendations, with shorter time to positive recommendations, for combination therapies if each constituent monotherapy was marketed by one company vs. two companies, which was consistent between EU and ex-EU. However, the time to positive recommendation was numerically faster across the board ex-EU vs. EU which may reflect the parallel regulatory and HTA processes in Australia and Canada.