Improving Patient Access Scheme in Malaysia: lessons from Italy

Purpose Medicine prices are increasing globally, including in Malaysia where previous studies show prices higher than international averages. Patient Access Scheme (PAS) is a mechanism adopted by Malaysia in 2018 to facilitate access to expensive medicines, similarly used by Italy since 2005. This study aims to compare the implementation of PAS in Malaysia and Italy. Design/methodology/approach This review systematically searched for peer-reviewed articles in PubMed, Scopus and ScienceDirect on how Italy implemented PAS system from 2012 to 2022 using the related keywords. The systematic review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Findings The search identified 363 articles. A total of eight studies were included. Most of the studies found that PAS is able to control the expenditure on expensive drugs. PAS has also had several challenges, such as high administrative burden, high upfront cost and the need for good data infrastructure. Originality/value This study’s unique focus on Italy’s adoption of managed entry agreements (MEA) can provide valuable insights for Malaysia’s pricing mechanisms and access to expensive drugs. Notably, this research addresses a gap in the literature regarding the practical implications of MEA implementation in developing countries. The findings have the potential to improve access to essential medicines for Malaysian citizens while offering a fresh perspective on MEA utilization in emerging markets.