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Objectives. The current health technology assessment used to evaluate respiratory inhalers is associated with limitations that have necessitated the development of an explicit formulary decision-making framework to ensure balance between the accessibility, value, and affordability of medicines. This study aimed to develop a multiple-criteria decision analysis (MCDA) framework, apply the framework to potential and currently listed respiratory inhalers in the Ministry of Health Medicines Formulary (MOHMF), and analyze the impacts of applying the outputs, from the perspective of listing and delisting medicines in the formulary. Methods. The overall methodology of the framework development adhered to the recommendations of the ISPOR MCDA Emerging Good Practices Task Force. The MCDA framework was developed using Microsoft Excel 2010 and involved all relevant stakeholders. The framework was then applied to 27 medicines, based on data gathered from the highest levels of available published evidence, pharmaceutical companies, and professional opinions. The performance scores were analyzed using the additive model. The end values were then deliberated by an expert committee. Results. A total of eight main criteria and seven subcriteria were determined by the stakeholders. The economic criterion was weighted at 30%. Among the noneconomic criteria, "patient suitability" was weighted the highest. Based on the MCDA outputs, the expert committee recommended one potential medicine (out of three; 33%) be added to the MOHMF and one existing medicine (out of 24; 4%) be removed/delisted from the MOHMF. The other existing medicines remained unchanged. Conclusions. Although this framework was useful for deciding to add new medicines to the formulary, it appears to be less functional and impactful for the removal/delisting existing medicines from the MOHMF. The generalizability of this conclusion to other formulations remains to be confirmed., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors are employees of the Ministry of Health Malaysia., (© The Author(s) 2021.)

Objective: To describe the process and role of health technology assessment (HTA) in the context of drug policy in Malaysia., Methods: We summarized the HTA process through review of documents and reports available in the public domain combined with the authors' experience., Results: 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., Conclusions: 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., (Copyright © 2019 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Background: Respiratory Medication Therapy Adherence Clinic (RMTAC) is an initiative by the Ministry of Health (MOH) Malaysia to improve patients' medication adherence, as an adjunct to the usual physician care (UC). This study aimed to evaluate the cost-effectiveness of combined strategy of RMTAC and UC (RMTAC + UC) vs. UC alone in asthma patients, from the MOH Malaysia perspective., Methods: A lifetime horizon dynamic adherence Markov model with monthly cycle was developed, for quality-adjusted life year (QALY) gained and hospitalization averted outcomes. Transition probabilities of composite asthma control and medication adherence, utilities, costs, and mortality rates due to all causes were measured from local data sources. Effectiveness, exacerbation rates, and asthma mortality rates were taken from non-local data sources. One-way sensitivity analysis (SA) was conducted for assessing parameter uncertainties, whereas probabilistic SA (PSA) was conducted on a different set of utilities and effectiveness data. Costs were adjusted to 2014 US dollars ($). Both costs and benefits were discounted at a 3% rate annually., Results: RMTAC + UC was found to be a dominant alternative compared to UC alone; $- 13,639.40 ($- 109,556.90 to $104,445.54) per QALY gained and $- 428.93 ($- 521.27 to ($- 328.69)) per hospitalization averted. These results were found to be robust against changes in all parameters except utilities in the one-way SA, and for both scenarios in PSA., Conclusions: RMTAC + UC is more effective and yet cheaper than UC alone, from the MOH perspective. For the benefit of both MOH and patients, RMTAC is thus recommended to be remained, and expanded to more healthcare settings where possible.

Background: Patients with asthma need long-term management to maintain optimal control. In addition to routine maintenance, urgent visits and hospitalizations may be required, as these patients are prone to acute exacerbations. The aim of this study was to estimate the costs of maintenance and acute exacerbation managements in patients with asthma in a suburban public hospital in Malaysia., Methods: An activity-based microcosting approach was applied to estimate the unit cost of events from the hospital's perspective. First, activities and resources that were involved in each cost center were identified and valued against a suitable form of unit. Thereafter, the mean cost of each resource per event was calculated by dividing the product of the quantity of the resource used and the unit cost of the resource by the number of events. The mean cost per event was the sum of the cost of resources for all cost centers involved. The costs were expressed in 2014 US dollars ($) and Malaysian Ringgit (RM)., Results: Data were collected from 15 maintenance, 20 acute exacerbation, and 50 hospitalization events. The mean (±SD) cost of maintenance management was $48.04 (±10.10); RM154.68 (±32.52). The cost of acute exacerbation management in the Emergency Department was $13.50 (±2.21), RM43.46 (±7.10); and in the medical ward, the cost was $552.13 (±303.41), RM1777.86 (±976.98), per hospitalization event., Conclusion: The microcosting of management of asthma-related events provides more accurate estimates that could be used in local economic studies. However, its possible limited generalizability to other types of health care settings in Malaysia needs to be kept in mind., (Copyright © 2018. Published by Elsevier Inc.)

REALISE Asia-an online questionnaire-based study of Asian asthma patients-identified five patient clusters defined in terms of their control status and attitude towards their asthma (categorised as: 'Well-adjusted and at least partly controlled'; 'In denial about symptoms'; 'Tolerating with poor control'; 'Adrift and poorly controlled'; 'Worried with multiple symptoms'). We developed consensus recommendations for tailoring management of these attitudinal-control clusters. An expert panel undertook a three-round electronic Delphi (e-Delphi): Round 1: panellists received descriptions of the attitudinal-control clusters and provided free text recommendations for their assessment and management. Round 2: panellists prioritised Round 1 recommendations and met (or joined a teleconference) to consolidate the recommendations. Round 3: panellists voted and prioritised the remaining recommendations. Consensus was defined as Round 3 recommendations endorsed by >50% of panellists. Highest priority recommendations were those receiving the highest score. The multidisciplinary panellists (9 clinicians, 1 pharmacist and 1 health social scientist; 7 from Asia) identified consensus recommendations for all clusters. Recommended pharmacological (e.g., step-up/down; self-management; simplified regimen) and non-pharmacological approaches (e.g., trigger management, education, social support; inhaler technique) varied substantially according to each cluster's attitude to asthma and associated psychosocial drivers of behaviour. The attitudinal-control clusters defined by REALISE Asia resonated with the international panel. Consensus was reached on appropriate tailored management approaches for all clusters. Summarised and incorporated into a structured management pathway, these recommendations could facilitate personalised care. Generalisability of these patient clusters should be assessed in other socio-economic, cultural and literacy groups and nationalities in Asia., Competing Interests: ADW has received honoraria from Mundipharma for my participation in the REALISE Asia Working Group meetings and discussions, is a member of Mundipharma’s Asia-Pacific Advisory Board and has received speaker fees from Mundipharma, but has no competing interests to disclose in relation to this paper. NCC has received payments for lectures/speaking from Mundipharma Asia Pte and payment for travel/accommodations/meeting expenses from Mundipharma Asia Pte. TvdM has been a member of advisory boards for Almiral, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis and Teva; TvdM offered consultancy to Almiral, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Mundipharma, Novartis, Nycomed, Certe and Teva; TvdM received grants from the University of Groningen, the Lung Foundation Netherlands, Stichting bestrijding Astma, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Mundipharma, Novartis, Nycomed; TvdM received payments for lectures/speaking from Almiral, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Merck, Mundipharma,and Teva; TvdM received payment for the development of educational materials from Mundipharma, Teva; TvdM received payment for travel/accommodations/meeting expenses from Boehringer Ingelheim, Astrazeneca, Novartis, Mundipharma and Teva and has the following patents (planned, pending or issued): CCQ copyrights ICQ copyrights BHQ copyrights. DBP has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, Respiratory Effectiveness Group, Takeda, Teva Pharmaceuticals, Zentiva, and Theravance; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Novartis and Mundipharma; payment for travel/accommodation/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis, Teva Pharmaceuticals, and AstraZeneca; funding for patient enrolment or completion of research from Chiesi, Teva Pharmaceuticals, Zentiva, and Novartis; stock/stock options from AKL Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd, UK and 74% of Observational and Pragmatic Research Institute Pte Ltd, Singapore; and is peer reviewer for grant committees of the Medical Research Council, Efficacy and Mechanism Evaluation programme, and HTA; and received unrestricted funding for investigator-initiated studies from Aerocrine, AKL Ltd, Almirall, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Orion, Takeda, Teva, and Zentiva. The remaining authors declare no conflict of interest.

Objectives: To develop and test the feasibility and validity of a computer-based utility assessment tool that used standard gamble (SG) method for measuring asthma-specific health utilities., Methods: A computer-based SG (CBSG) tool was developed using Microsoft® PowerPoint 2007 to value asthma-specific health states in Malaysia. Eight hypothetical health states were considered, including two anchor states (healthy and dead), three chronic (C) states and three temporary (T) states (each numbered 1 through 3, with increasing severity) in addition to the subject's current health state. Twenty adult asthma patients completed the CBSG tool in addition to paper-based Asthma Control Test, three health status measures (EQ-5D, EQ-VAS, and Mini Asthma Quality of Life Questionnaire (MiniAQLQ)), and VAS utility assessment tool. Patients and interviewers rated the difficulty of the VAS and CBSG tools. Correlations between current health state values derived from the various measures were determined., Results: The SG and the VAS received similar difficulty ratings. 17 patients completed the CBSG tool within 30 minutes. The mean utilities determined by the CBSG tool for the T1-T3 asthma health states met the expected logical order of 1>2>3, but those for the C1-C3 states did not. Correlation between current health state values derived from the CBSG tool and other measurement tools was poor., Conclusion: The CBSG tool developed for measuring utilities of asthma health states showed acceptable feasibility and overall validity.