Procedures for Pricing Medication and the Impact of Management Entry Agreement on the Pricing and Negotiation

Abstract Background: Drug prices and the pharmaceutical spending constitute a significant proportion of the healthcare expenditures. Regulating the prices of pharmaceuticals for cancers and rare diseases can especially help in reducing this enormous burden. Managed entry agreements (MEAs) are financial agreements between payers and manufacturers or regulators that improve access to high-cost therapies. The impact of these agreements on drug pricing and the negotiation process is still debated. Aim: The aim of the study was to systematically review pricing procedures for pharmaceuticals and to assess how MEAs influence pricing policies, negotiation processes, and market access for innovative therapies, with particular attention to high-income country contexts. Materials and Methods: The present study provides a narrative review of the literature to analyze the impact of MEAs on the drug pricing and negotiation processes. Results and Conclusions: MEAs enable access to health technology based on certain criteria, including compensation or coverage. To ensure the effective and sustained coverage of expensive innovative drugs, payers may negotiate a mix of various MEAs with the producer. However, currently, a structured framework is lacking to guide the negotiation process.