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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]

Background: One major challenge in prioritizing health care using cost-effectiveness (CE) information is when alternatives are more expensive but more effective than existing technology. In such a situation, an external criterion in the form of a CE threshold that reflects the willingness to pay (WTP) per quality-adjusted life-year is necessary.Objectives: To determine a CE threshold for health care interventions in Malaysia.Methods: A cross-sectional, contingent valuation study was conducted using a stratified multistage cluster random sampling technique in four states in Malaysia. One thousand thirteen respondents were interviewed in person for their socioeconomic background, quality of life, and WTP for a hypothetical scenario.Results: The CE thresholds established using the nonparametric Turnbull method ranged from MYR12,810 to MYR22,840 (~US $4,000-US $7,000), whereas those estimated with the parametric interval regression model were between MYR19,929 and MYR28,470 (~US $6,200-US $8,900). Key factors that affected the CE thresholds were education level, estimated monthly household income, and the description of health state scenarios.Conclusions: These findings suggest that there is no single WTP value for a quality-adjusted life-year. The CE threshold estimated for Malaysia was found to be lower than the threshold value recommended by the World Health Organization. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To describe the health-related quality of life (HRQOL) among nonprescription medicine customers in Malaysia and the factors that affect it. Methods: A nationwide cross-sectional survey was conducted among pharmacy customers in 59 randomly selected community pharmacies in Malaysia. The self-administered questionnaire included the EuroQoL five-dimensional (EQ-5D) questionnaire, the EuroQol visual analogue scale (EQ-VAS), nonprescription medicines purchase, and demographic questions. Data were analyzed by using the multivariate analysis of variance and multiple logistic regressions. Results: A total of 2729 customers enrolled in this study, with a mean EQ-5D questionnaire score of 0.92±0.15 and a mean EQ-VAS score of 69.92±24.80. Compared with the Malaysian adult population, nonprescription medicine customers have a lower mean EQ-5D questionnaire score (t =−4.49, P<0.01) and EQ-VAS score (t =−25.87, P<0.01). We found that pain/discomfort (25.6%) and anxiety/depression (13.7%) were the major HRQOL problems. Locality, age, ethnicity, household income per month, type of occupation, and type of nonprescription medicine purchased were associated with health status of nonprescription medicine customers (F 22,5286 = 2.555; Wilks’ lambda = 0.979; P< 0.01). Conclusions: The HRQOL of nonprescription medicine customers is lower than that of the general Malaysian population. Lower health status was independently associated with older age, living in rural areas, having low income and education level, and purchasing blood and blood-forming medicines from community pharmacy. [Copyright &y& Elsevier]

Abstract: Purpose: Aims of this study were to estimate the first-year medical care costs of newly diagnosed children with structural-metabolic epilepsy and to determine the cost-driving factors in the selected population. Method: This was a prevalence-based retrospective chart review that included patients who attended a pediatric neurology clinic in a tertiary referral center in Malaysia. The total first-year medical care costs were estimated from the provider (i.e., hospital) perspective, using a bottom-up, microcosting analysis. Medical chart/billing data (i.e., case reports) obtained from the hospital (i.e., provider) were collected to determine the resources used. Prices or cost data were standardized for the year 2010 (One Malaysian Ringgit MYR is equivalent to 0.26 Euro or 0.32 USD). Results: The most expensive item in the costs list was antiepileptic drugs, whereas ultrasound examination represented the cheapest item. Hospitalization and the use of non-antiepileptic drugs were the second and third most costly items, respectively. The cost of therapeutic drug monitoring comprised only a small proportion of the total annual expenditure. None of the demographic variables (i.e., gender, race, and age) significantly impacted the first-year medical care costs. Similarly, child development, seizure type, therapy type (i.e., polytherapy versus monotherapy), and therapeutic drug monitoring utilization were also not associated with the cost of management. The first-year medical care costs positively correlated with seizure frequency (r s =0.294, p =0.001). However, the only variable that significantly predict the first-year medical care costs was the type of antiepileptic drugs (R 2 =0.292, F =7.772, p <0.001). Conclusion: This investigation was the first cost analysis study of epilepsy in Malaysia. The total first-year medical care costs for 120 patients with structural-metabolic epilepsy were MYR 202,816 (i.e., MYR 1690.13 per patient per year). The study findings highlight the importance of optimizing seizure control in reducing the cost of management. [Copyright &y& Elsevier]

Summary: The role of pharmacists has transformed significantly because of changes in pharmacists'' training and population health demands. Within this context, community pharmacists are recognized as important health personnel for the provision of extended health services. Similarly, in Malaysia, the need to transform community pharmacy practice has been discussed by all interested parties; however, the transition has been slow due in part to the nonexistence of a dispensing separation policy between pharmacists and medical doctors in private community practices. For decades, medical doctors in private community practices have had the right to prescribe and dispense, thus diluting the role of community pharmacists because of overlapping roles. This article explores dispensing separation in Malaysia and, by taking into account the needs of health professionals and health care consumers, suggests a mechanism for how dispensing separation practice can be implemented. [Copyright &y& Elsevier]

Summary: Treatment with antiepileptic drugs is commonly guided by serum level monitoring. Such monitoring requires expensive laboratory equipment and products. However, well-conducted studies on the cost-effectiveness of therapeutic drug monitoring for antiepileptic drugs are lacking particularly in patients with structural-metabolic epilepsy. The study aims to assess the cost-effectiveness of serum level monitoring services in the management of children with structural-metabolic epilepsy during the first year of diagnosis. A retrospective cost-effectiveness analysis was conducted from the provider perspective. It included patients attended a paediatric neurology clinic. The effectiveness measures used in this analysis were the number of patients that achieved ≥50% reduction in seizure frequency, and the number of patients with 3-month seizure free. Medical records of the patients were reviewed for the required information. Medical chart/billing data obtained from the hospital were collected to estimate the resources used (One Malaysian Ringgit MYR is equivalent to 0.31 USD). The recruited children were followed for one year following their first visit. The average cost effectiveness ratio for the monitored patients (MYR 2735 per patient that achieved a ≥50% reduction in seizure frequency) was lower than that for non-monitored patients (MYR 2921 per patients that achieved a ≥50% reduction in seizure frequency), with incremental cost-effectiveness ratio of MYR 2357 per one additional patient that achieved a ≥50% reduction in seizure frequency. The average cost effectiveness ratios for monitored and non-monitored group were MYR 8279 and MYR 6433 per patient with a 3-month seizure-free period, respectively, with incremental cost-effectiveness ratio of MYR 29,666 per one additional patient with a 3-month seizure-free period. In terms of the effectiveness measures used, serum level monitoring of antiepileptic drugs was found to be cost-effective. However, the incremental cost-effectiveness ratio was found to be sensitive to the cost of management. [Copyright &y& Elsevier]