Health Technology Assessment and Its Use in Drug Policy in Malaysia.

To describe the process and role of health technology assessment (HTA) in the context of drug policy in Malaysia. We summarized the HTA process through review of documents and reports available in the public domain combined with the authors' experience. Health technology assessment plays an integral part in prioritizing treatment in public health facilities in Malaysia, particularly for the Ministry of Health Medicines Formulary (MOHMF). The MOHMF is the reference list of drugs allowed to be prescribed in the Ministry of Health (MOH) facilities. There are 2 organizations within the MOH that conduct HTA as their core activities, namely the Malaysian Health Technology Assessment Section and the Formulary Management Branch of Pharmacy Practice & Development Division. The assessment of pharmaceuticals for the purpose of listing medicines into the MOHMF is under the purview of the Formulary Management Branch. The evidence-based assessment focuses on safety, efficacy, effectiveness, and budget impact of the drug. Cost-effectiveness evidence is currently not mandatory but is of interest to the decision makers. The assessment outcomes are considered by the MOH Medicines List Review Panel for formulary decisions. Health technology assessment has supported formulary decisions in MOH. Evidence generation needs to progress beyond efficacy or effectiveness, safety, and budget impact to incorporate cost-effectiveness. Nevertheless, there are challenges to be met to achieve this. The impact of the HTA process is currently unknown and is yet to be evaluated formally. • There are 2 organizations conducting health technology assessment (HTA) activities in the Ministry of Health Malaysia with different scopes of activities. • Health technology assessment use for drug policy in the public sector is evident in the formulary decision-making process at the national level. • Though HTA is used as part of the Ministry of Health Formulary decision making process, there is still an avenue to improve the HTA process and expand its use in drug policy decisions. [ABSTRACT FROM AUTHOR]