In Hong Kong, the Drug Advisory Committee (DAC) has had the role of evaluating and advising new drugs to be included in the listing of the Hospital Authority Drug Formulary since July 2005. The drug review process was subject to challenge due to a lack of transparency to members of the public and documentation of the scientific basis for decision making. The purpose of this review was to describe the process, evaluation criteria and possible outcomes of decision making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to Health Technology Assessment (HTA) policies in overseas countries.

Details of the decision-making processes including new drug listing submissions, the DAC meeting, procedures before and after the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly available information related to new drug decision making processes for four HTA agencies (National Institute for Health and Clinical Excellence (NICE), Scottish Medicines Consortium (SMC), Australian Pharmaceutical Benefits Advisory Committee (PBAC), and Canadian Agency for Drugs and Technologies in Health (CADTH)) were reviewed and retrieved from official documents on their public domains.

The DAC is in charge of the systematical and critical appraisal of new drugs for listing on the formulary, reviewing submitted applications, and making decisions of drug listing based on scientific evidence in which safety, efficacy and cost-effectiveness are primary considerations. When compared to other HTA agencies, transparency of decision-making processes of the DAC, relevance of clinical and health economic evidence, and lack of health economic and methodological input to submissions were major challenges of the new drug listing policy in Hong Kong.

Despite the challenges identifed, this review provided suggestions for establishing a more transparent, credible, evidence-based decision-making process for the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority in healthcare reform.