Malaysia’s Ministry of Health (MOH) has recently announced that it will factor real-world evidence (RWE) in its decision-making for the inclusion of drugs into its national formulary – the “Blue Book.” This change signals a shift toward moving beyond reliance on clinical trial data alone and toward a closer alignment with value-based healthcare. The use of RWE will involve collecting treatment outcomes from hospitals and clinics, complementing the existing health technology assessment (HTA) framework, and ensuring that drug listings demonstrate both clinical effectiveness and cost-effectiveness. This ensures that public resources are allocated to therapies that demonstrate a proven value for patients.
Under the current system, in which RWE is not considered, decision-making depends solely on clinical data that may not demonstrate the actual value for patients. The inclusion of RWE is intended to resolve this issue and encourage evidence-based prescribing.
However, challenges persist, including underutilisation of generics, the fragmented nature of data collection systems, and the need for stronger nationwide infrastructure to track patient outcomes.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.