Consequences and Enablers of the Selection of High-Cost Medicines to the National List of Essential Medicines Category E(2)

Abstract

The National List of Essential Medicines (NLEM) category E(2) was first announced in 2007 to be the drug list for specific groups of patients to provide equitable access to high-cost medicines regardless of health benefit schemes. The selection of medicines to the category E(2) was managed by the NLEM subcommittee under the National Drug System Development Committee. Since 2007, the selection process has been evolved leading to an increase number of medicines to the E(2) list. This study aimed to describe the selection process of medicine to the NLEM category E(2), including responsible organization, process, definition/selection criteria, outcomes, as well as barriers and enablers. A qualitative approach was employed comprising document review and semi-structured interviews with policymakers and stakeholders of the selection process. Data were analyzed using a content analysis approach. The results revealed that the number of medicines in the NLEM category E(2) increased every 3 years according to the serving term of the committees, resulting in 32 medicines approved for treating 40 indications in 2018. Barriers to efficient work procedures were addressed as follows: 1) limited budget and skilled workforces; 2) limited frequency of call for drug submission to the NLEM; and 3) different interpretation of the definition and enlistment criteria of NLEM on category E(2). In addition, the present study found that giving high priority to the selection of medicines to the category E(2) and reviewing barriers, enablers of the selection processes of the subcommittee would lead to a more efficient selection process. The present study recommends performance improvement plans through organizational structure including recruiting highly skilled staff, improving work processes, and a monitoring and evaluation system to achieve the efficient selection process.