Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. This typically sees higher-priced drugs, even in oncology, being sidelined in favor of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. In itself, this also poses risks from international reference pricing and parallel importation.
This, therefore, presents opportunities for the new disruptors to gain access and uptake in markets across Asia, Africa, and South America, either through inclusion in essential medicines lists, or by making themselves more affordable to individual patients that may have to spend out-of-pocket to receive treatment. It also would be in line with emerging markets’ ambitions to grant patients access to the latest, on-patent, innovative medicines. However, even then, challenges could remain.
At present many of the new disruptor PD-1/PD-L1 drugs only have trials conducted in China, which could raise concerns with local regulators that may wish to see more diverse, or locally representative, patient inclusion criteria. This could increase development costs and timelines for new entrants. Indeed, in the US, the FDA has recently declined approval of Lilly’s sintilimab (Tyvyt), driven in part by a vote 14-1 against approval by the Oncologic Drugs Advisory Committee, owing to the availability of China-only data1. It suggested that Lilly and Innovent conduct multiregional clinical trials before reapplication.