Pricing of innovative medicines and advanced therapies worldwide: an scoping review.

Pricing policies may contribute to improving patient access to medicines. Innovative Medicines and Advanced Therapies represent promising treatment options; however, their high costs and limited clinical evidence pose both clinical and financial risks. In many cases, prices do not reflect the actual benefit or degree of innovation, highlighting the need to better understand and refine pricing approaches. The objective of this scoping review is to assess the application of pricing policies for these products worldwide. The methodology followed the JBI Manual for Evidence Synthesis and the PRISMA Extension for Scoping Reviews guidelines. Publications describing pricing policies applied to the definition of prices for Innovative Medicines and Advanced Therapies were included. A comprehensive literature search was conducted. Study selection was performed in two stages by independent reviewers, who also carried out data extraction. Fifty-five publications describing pricing policies for these products across different countries were included. A wide range of policies and methodologies for price determination were identified. The review assessed value-based pricing, external reference pricing, tendering and/or negotiation, internal reference pricing, cost-plus approaches, and initiatives promoting price transparency. Pricing policies play an essential role in regulating the costs of Innovative Medicines and Advanced Therapies. Although such policies may facilitate access to these technologies, challenges such as lack of transparency and heterogeneous methodologies remain. It is crucial that policymakers establish fair and transparent pricing frameworks that balance access, incentives for innovation, and the sustainability of health systems.