OBJECTIVES: The Taiwanese healthcare system has undergone substantial reform, transforming into a sophisticated single payer, universal coverage system that simultaneously strives towards encouraging investment by innovative, multinational pharmaceutical companies. This research aimed to explore how these efforts have led to access and commercial opportunity for multi-indication products, especially in comparison to France and Germany.

METHODS: A review was undertaken to compare policy dynamics for follow-on indications in Taiwan relative to France and Germany, which are also two countries within Taiwan’s international reference pricing (IRP) market sample. Analysis of reimbursement decisions for multi-indication products across each respective market was conducted to understand HTA outcomes and access policies for first-launch indications, and subsequent indications. Supplementary secondary research examined trends in France and Germany, to understand whether Taiwan is converging towards or diverging from these two markets that served as important models for its reforms into a single payer system.

RESULTS: The results suggest that Taiwan shares some similarities with the healthcare systems in France and Germany for access to follow-on indications. In Taiwan and France, it is possible to receive regulatory approval without pursuing public reimbursement; in Germany a manufacturer would be required to pull a product out of the market entirely to avoid assessment by the G-BA. While access restrictions are less commonly observed for follow-on indications in Taiwan, budgetary expenditure is managed through IRP and the establishment of budgetary ceilings. If budgetary-ceilings are exceeded, clawback payments may be required. Uniquely, Taiwan allows abbreviated regulatory approval for follow-on indications for products that have already been approved in the EU or USA.

CONCLUSIONS: Inter-market vulnerability and opportunities abound through the planning process for access in Taiwan. IRP heavily influences pricing opportunity for these multi-indication products in Taiwan, while FDA and EMA regulatory decisions can expedite or hamper access timelines.