Economic Evaluation of Oral Cancer Screening Programs: Review of Outcomes and Study Designs.

A lack of guidance on economic evaluations for oral cancer screening programs forms a challenge for policymakers and researchers to fill the knowledge gap on their cost-effectiveness. This systematic review thus aims to compare the outcomes and design of such evaluations. A search for economic evaluations of oral cancer screening was performed on Medline, CINAHL, Cochrane, PubMed, health technology assessment databases, and EBSCO Open Dissertations. The quality of studies was appraised using QHES and the Philips Checklist. Data abstraction was based on reported outcomes and study design characteristics. Of the 362 studies identified, 28 were evaluated for eligibility. The final six studies reviewed consisted of modeling approaches (n = 4), a randomized controlled trial (n = 1), and a retrospective observational study (n = 1). Screening initiatives were mostly shown to be cost-effective compared to non-screening. However, inter-study comparisons remained ambiguous due to large variations. The observational and randomized controlled trials provided considerably accurate evidence of implementation costs and outcomes. Modeling approaches, conversely, appeared more feasible for the estimation of long-term consequences and the exploration of strategy options. The current evidence of the cost-effectiveness of oral cancer screening remains heterogeneous and inadequate to support its institutionalization. Nevertheless, evaluations incorporating modeling methods may provide a practical and robust solution.

A Comparison of Self-evaluated Survey and Work Sampling Approach for Estimating Patient-care Unit Cost Multiplier in Genetic Nursing Activities.

PURPOSE: To compare patient care multipliers estimated from subjective evaluation against work sampling (WS) techniques in genetic nursing activities. METHODS: An observational WS technique was conducted from November to December 2019 with nine genetic nurses in a tertiary referral center in Malaysia. The WS activity instrument was devised, validated, and pilot tested. All care- and non-care-related activities were sampled at 10-minute intervals within 8 hours of working over 14 days, followed by a subjective evaluation of activities survey over the same period. Bonferroni correction was undertaken for multiple testing with a p value of 0.0025. RESULTS: The two techniques produced significant differences in genetic nurses' activities categorization. The WS showed that compared with subjective evaluation, direct care (19.3% vs. 45.0%; p < .001) was estimated to be significantly lower, and indirect care (40.4% vs. 25.6%; p < .001) and unit-related activity (28.5% vs. 16.9%; p < .001) were higher. Both techniques produced a similar proportion of time spent in other non-care activities (12.0%) but differed in genetic meetings and information-gathering activities. While the multipliers for patient face-to-face contact were significantly larger between WS (4.57) and the survey (1.94), the multipliers for patient care time were smaller between WS (1.47) and the survey (1.24), indicating that caution should be taken when multiplying for patient contact time compared to patient care activity to determine the cost of care provision. CONCLUSION: A considerable proportion of time spent away from the patient needs to be allocated to patient-related care time. Thus, estimating the paid cost solely based on direct time with patients considerably underestimates the cost per hour of nurses' care. It is recommended to employ 'patient-related activity' instead of the 'face-to-face contact' multiplier because the former did not significantly differ from the one estimated using WS.

Household Catastrophic Health Expenditure from Oral Potentially Malignant Disorders and Oral Cancer in Public Healthcare of Malaysia.

OBJECTIVE: Oral cancer causes a significant disease burden and financial distress, especially among disadvantaged groups. While Malaysia has achieved universal health coverage via its highly subsidized public healthcare, patient and family expenditure for treatment of oral potentially malignant disorders (OPMD) and oral cancer remains a concern in the equitability of care. This study thus aims to estimate household out-of-pocket (OOP) expenditures and the extent of catastrophic healthcare expenditure (CHE) while identifying its predictors. METHODS: This three-part study consists of a cross-sectional survey to collect sociodemographic and health utilization data of patients, a retrospective medical record abstraction to identify resources consumed, and cost modeling to simulate expenditures in two tertiary public hospitals. Loss of productivity was calculated based on absenteeism related to disease management in the hospital. OOP payments for transport, care in public healthcare facilities, and other healthcare expenditures were tallied. A CHE was defined as OOP spendings of more than 10% from total annual household income. Multivariable logistic regression was further applied to identify the association between sociodemographic factors and the incidence of CHE. RESULTS: A total of 52 patients with OPMD and 52 with oral cancer were surveyed and medical records were abstracted. A Kruskal-Wallis test showed a statistically significant difference in OOP share over household income between OPMD, early- and late-stage cancer, χ2(2)=51.05, p<0.001, with the mean percentage of 9%, 22%, and 65% respectively. This study found that the prevalence of CHE in the first year of diagnosis was 86.5% for oral cancer and 19.2% for OPMD. Indian ethnicity (OR=6.24, p=0.046) and monthly income group 'less than USD 2,722' (OR=14.32, p=0.023) were shown as significant predictors for CHE. CONCLUSIONS: Our study demonstrated the provision of subsidies may not be adequate to shield the more vulnerable group from CHE when they are diagnosed with OPMD and oral cancer.

Do health preferences differ among Asian populations? A comparison of EQ-5D-5L discrete choice experiments data from 11 Asian studies.

INTRODUCTION: Many countries have established their own EQ-5D value sets proceeding on the basis that health preferences differ among countries/populations. So far, published studies focused on comparing value set using TTO data. This study aims to compare the health preferences among 11 Asian populations using the DCE data collected in their EQ-5D-5L valuation studies. METHODS: In the EQ-VT protocol, 196 pairs of EQ-5D-5L health states were valued by a general population sample using DCE method for all studies. DCE data were obtained from the study PI. To understand how the health preferences are different/similar with each other, the following analyses were done: (1) the statistical difference between the coefficients; (2) the relative importance of the five EQ-5D dimensions; (3) the relative importance of the response levels. RESULTS: The number of statistically differed coefficients between two studies ranged from 2 to 16 (mean: 9.3), out of 20 main effects coefficients. For the relative importance, there is not a universal preference pattern that fits all studies, but with some common characteristics, e.g. mobility is considered the most important; the relative importance of levels are approximately 20% for level 2, 30% for level 3, 70% for level 4 for all studies. DISCUSSION: Following a standardized study protocol, there are still considerable differences in the modeling and relative importance results in the EQ-5D-5L DCE data among 11 Asian studies. These findings advocate the use of local value set for calculating health state utility.

Cost-Effectiveness and Cost-Utility of Palbociclib versus Ribociclib in Women with Stage IV Breast Cancer: A Real-World Data Evaluation.

Palbociclib and ribociclib are indicated in the first-line treatment of hormonal-receptor-positive HER-2 negative (HR+/HER-2 negative) advanced breast cancer. Despite their clinical benefit, they can increase healthcare expenditure. Yet, there are no comparative pharmacoeconomic evaluations for them in developing countries, the Middle East, or Gulf countries. This study compared the cost-effectiveness of palbociclib and ribociclib in Qatar. A 10-year within-cycle-corrected Markov's model was developed using TreeAge Pro® software. The model consisted of three main health states: progression-free (PFS), progressed-disease (PD), and death. Costs were obtained from the actual hospital settings, transition probabilities were calculated from individual-patient data, and utilities were summarized from the published literature. The incremental cost-effectiveness ratio (ICER) and the incremental cost-utility ratio (ICUR) were calculated and compared to three gross-domestic-products per capita. Deterministic and probabilistic sensitivity analyses were performed. Ribociclib dominated palbociclib in terms of costs, life-years gained, and quality-adjusted life-years gained. The conclusions remained robust in the different cases of the deterministic sensitivity analyses. Taking all combined uncertainties into account, the confidence in the base-case conclusion was approximately 60%. Therefore, in HR+/HER-2 negative stage IV breast cancer patients, the use of ribociclib is considered cost-saving compared to palbociclib.

Provider cost of treating oral potentially malignant disorders and oral cancer in Malaysian public hospitals.

Oral cancer has been recognized as a significant challenge to healthcare. In Malaysia, numerous patients frequently present with later stages of cancers to the highly subsidized public healthcare facilities. Such a trend contributes to a substantial social and economic burden. This study aims to determine the cost of treating oral potentially malignant disorders (OPMD) and oral cancer from a public healthcare provider's perspective. Medical records from two tertiary public hospitals were systematically abstracted to identify events and resources consumed retrospectively from August 2019 to January 2020. The cost accrued was used to estimate annual initial and maintenance costs via two different methods- inverse probability weighting (IPW) and unweighted average. A total of 86 OPMD and 148 oral cancer cases were included. The initial phase mean unadjusted cost was USD 2,861 (SD = 2,548) in OPMD and USD 38,762 (SD = 12,770) for the treatment of cancer. Further annual estimate of initial phase cost based on IPW method for OPMD, early and late-stage cancer was USD 3,561 (SD = 4,154), USD 32,530 (SD = 12,658) and USD 44,304 (SD = 16,240) respectively. Overall cost of late-stage cancer was significantly higher than early-stage by USD 11,740; 95% CI [6,853 to 16,695]; p< 0.001. Higher surgical care and personnel cost predominantly contributed to the larger expenditure. In contrast, no significant difference was identified between both cancer stages in the maintenance phase, USD 700; 95% CI [-1,142 to 2,541]; p = 0.457. A crude comparison of IPW estimate with unweighted average displayed a significant difference in the initial phase, with the latter being continuously higher across all groups. IPW method was shown to be able to use data more efficiently by adjusting cost according to survival and follow-up. While cost is not a primary consideration in treatment recommendations, our analysis demonstrates the potential economic benefit of investing in preventive medicine and early detection.

Mapping PedsQL™ Generic Core Scales to EQ-5D-3L utility scores in transfusion-dependent thalassemia patients.

PURPOSE: To develop a mapping algorithm for generating EQ-5D-3L utility scores from the PedsQL Generic Core Scales (PedsQL GCS) in patients with transfusion-dependent thalassemia (TDT). METHODS: The algorithm was developed using data from 345 TDT patients. Spearman's rank correlation was used to evaluate the conceptual overlap between the instruments. Model specifications were chosen using a stepwise regression. Both direct and response mapping methods were attempted. Six mapping estimation methods ordinary least squares (OLS), a log-transformed response using OLS, generalized linear model (GLM), two-part model (TPM), Tobit and multinomial logistic regression (MLOGIT) were tested to determine the root mean squared error (RMSE) and mean absolute error (MAE). Other criterion used were accuracy of the predicted utility score, proportions of absolute differences that was less than 0.03 and intraclass correlation coefficient. An in-sample, leave-one-out cross validation was conducted to test the generalizability of each model. RESULTS: The best performing model was specified with three out of the four PedsQL GCS scales-the physical, emotional and social functioning score. The best performing estimation method for direct mapping was a GLM with a RMSE of 0.1273 and MAE of 0.1016, while the best estimation method for response mapping was the MLOGIT with a RMSE of 0.1597 and MAE of 0.0826. CONCLUSION: The mapping algorithm developed using the GLM would facilitate the calculation of utility scores to inform economic evaluations for TDT patients when EQ-5D data is not available. However, caution should be exercised when using this algorithm in patients who have poor quality of life.

Economic burden in the management of transfusion-dependent thalassaemia patients in Malaysia from a societal perspective.

BACKGROUND: Transfusion-dependent thalassaemia (TDT) is a hereditary blood disorder in which blood transfusion is the mainstay treatment to prolong survival and improve quality of life. Patients with this disease require blood transfusion at more than 100 ml/kg annually and iron-chelating therapy (ICT) to prevent iron overload (IOL) complications. There are substantial numbers of TDT patients in Malaysia, but limited data are available regarding the economic burden associated with this disease. The purpose of this study was to determine the lifetime cost of TDT from a societal perspective and identify potential factors increasing patient and family expenditures among thalassaemia populations. METHODS: The total lifetime cost per TDT patient (TC1) is the sum of lifetime healthcare cost (TC2) and lifetime patient and family healthcare expenditure (TC3). TC2 was simulated using the Markov model, taking into account all costs subsidized by the government, and TC3 was estimated through a cross-sectional health survey approach. A survey was performed using a two-stage sampling method in 13 thalassaemia centres covering all regions in Malaysia. RESULTS: A TDT patient is expected to incur TC2 of USD 561,208. ICT was the main driver of cost and accounted for 56.9% of the total cost followed by blood transfusion cost at 13.1%. TC3 was estimated to be USD 45,458. Therefore, the estimated TC1 of a TDT patient was USD 606,665. Sensitivity analyses showed that if all patients were prescribed oral ICT deferasirox for their lifetime, the total healthcare cost would increase by approximately 65%. Frequency of visits to health facilities for blood transfusion/routine monitoring and patients who were prescribed desferrioxamine were observed to be factors affecting patient and family monthly expenses. CONCLUSION: The lifetime cost per TDT patient was USD 606,665, and this result may be useful for national health allocation planning. An estimation of the economic burden will provide additional information to decision makers on implementing prevention interventions to reduce the number of new births and medical service reimbursement.

EQ-5D-3L health state utility values in transfusion-dependent thalassemia patients in Malaysia: a cross-sectional assessment.

PURPOSE: There is a gap of information describing the health state utility values (HSUVs) of transfusion-dependent thalassemia (TDT) patients in Malaysia. These values are useful in the assessment of health-related quality of life (HRQoL), economic evaluations and provide guidance to disease management decisions. The objective of this study was to estimate and derive HSUVs associated with the treatment and complications of TDT patients in Malaysia using the EQ-5D-3L instrument. METHODS: A cross-sectional survey using the EQ-5D-3L instrument was conducted between May to September 2018 across various public hospitals in Malaysia. Using a multi-stage sampling, patients diagnosed with TDT and receiving iron chelating therapy were sampled. The findings on the EQ-5D-3L survey were converted into utility values using local tariff values. A two-part model was used to examine and derive the HSUVs associated with the treatment and complications of iron overload in TDT. RESULTS: A total of 585 patients were surveyed. The unadjusted mean (SD) EQ-5D-3L utility value for TDT patients were 0.893 (0.167) while mean (SD) EQ VAS score was 81.22 (16.92). Patients who had more than two iron overload complications had a significant decline in HRQoL. Patients who were on oral monotherapy had a higher utility value of 0.9180 compared to other regimen combinations. CONCLUSION: Lower EQ-5D-3L utility values were associated with patients who developed iron overload complications and were on multiple iron chelating agents. Emphasizing compliance to iron chelating therapy to prevent the development of complications is crucial in the effort to preserve the HRQoL of TDT patients.

Cost-effectiveness analyses of breast cancer medications use in developing countries: a systematic review.

BACKGROUND: Pharmacoeconomic evaluation is important for breast-cancer medications due to their high costs. To our knowledge, no systematic literature reviews of pharmacoeconomic studies for breast-cancer medication use are present in developing-countries. OBJECTIVES: To systematically review the existing cost-effectiveness evaluations of breast-cancer medication in developing-countries. METHODOLOGY: A systematic literature search was performed in PubMed, EMBASE, SCOPUS, and EconLit. Two researchers determined the final articles, extracted data, and evaluated their quality using the Quality of Health-Economic Studies (QHES) tool. The interclass-correlation-coefficient (ICC) was calculated to assess interrater-reliability. Data were summarized descriptively. RESULTS: Fourteen pharmacoeconomic studies published from 2009 to 2019 were included. Thirteen used patient-life-years as their effectiveness unit, of which 10 used quality-adjusted life-years. Most of the evaluations focused on trastuzumab as a single agent or on regimens containing trastuzumab (n = 10). The conclusion of cost-effectiveness analysis varied among the studies. All the studies were of high quality (QHES score >75). Interrater reliability between the two reviewers was high (ICC = 0.76). CONCLUSION: In many studies included in the review, the use of breast-cancer drugs in developing countries was not cost-effective. Yet, more pharmacoeconomic evaluations for the use of recently approved agents in different disease stages are needed in developing countries.

Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward.

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

Cost-Effectiveness of Insulin Glargine and Insulin Detemir in the Basal Regimen for Naïve Insulin Patients with Type 2 Diabetes Mellitus (T2DM) in Malaysia.

OBJECTIVE: To compare the cost-effectiveness of long-acting insulin analogue (LAIA) (insulin Detemir and insulin Glargine) versus NPH insulin in the basal insulin regime for naïve insulin T2DM Malaysian patients. METHODS: The UKPDS-Outcome Model version 2.0 (UKPDS-OM2) was used to evaluate the cost and consequence of diabetes-related complication. The effectiveness of the insulin was derived from the literature review, and the patients' epidemiology characteristics were retrieved from the Malaysian Diabetes Registry. A discount rate of 3% was applied to both costs and health effects. Another simple mathematical model was used to compare the benefit of reducing the hypoglycemia events between LAIA and NPH insulin. The outputs of the models were combined to obtain the final result. One-way sensitivity analyses were performed to assess the uncertainties. RESULTS: The net cost difference (without accounting for hypoglycemia) was RM4868 for insulin Glargine and RM6026 for insulin Detemir. The saving from preventing severe hypoglycemia was RM4377 for insulin Glargine and RM12,753 for insulin Detemir. The total additional QALY gained from insulin Glargine was 0.1317 and from insulin Detemir was 0.8376. The sensitivity analysis shows the discount rate, and drug acquisition cost may affect the incremental cost-effectiveness ratio (ICER) value. CONCLUSION: Both insulin Detemir and Glargine are cost-effective compared to NPH insulin for T2DM patients, especially when the benefit of reducing the hypoglycemia event rate is taken into account.

One-year follow-up of efficacy and cost of repeated doses versus single larger dose of intra-articular hyaluronic acid for knee osteoarthritis.

PURPOSE: A recent 3-month randomized, open-label controlled trial found that the intra-articular hyaluronic acid injection (GO-ON®) given as a single dose of 5 mL is as effective and safe as three repeated doses of 2.5 mL in patients with knee osteoarthritis. However, the information on the long-term efficacy and economic implications of the single-dose regimen is still limited. Hence, this follow-up study was designed to compare the effectiveness and costs of the two regimens 12 months following the treatment. METHODS: All the 127 patients, who received either three repeated doses (n = 64) or a single dose (n = 63) of GO-ON in the previous trial, were followed up in month 12 following the treatment. The effectiveness of both the regimens was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores were compared with those recorded at the baseline and in month 3. Additionally, the total treatment costs of the two regimens, taking account of both direct and indirect costs, were computed and compared. RESULTS: A total of 125 patients (98.4%) completed the assessment. Despite the reduction of the overall mean WOMAC score from 39.24 to 19.93 (p < 0.001) in the first 3 months following the treatment with GO-ON, no further changes were observed up to month 12 (p > 0.95). In the meantime, the two regimens did not differ in the mean WOMAC scores (p = 0.749) and in the subscale scores for pain (p = 0.970), stiffness (p = 0.526), and physical functioning (p = 0.667) in month 12. The cost for single-dose injection was found to be approximately 30% lower compared to the repeated doses. CONCLUSION: These findings indicate that the single larger dose of GO-ON is as effective as the repeated doses over 12 months, and yet the total treatment cost is lowered.

Estimating the population health and economic impacts of introducing a pneumococcal conjugate vaccine in Malaysia- an economic evaluation.

Pneumococcal disease is a potentially fatal bacterial infection that is vaccine-preventable. Malaysia has yet to adopt a pneumococcal conjugate vaccine (PCV) into its national immunization program (NIP). In 2016, pneumonia was the 3rd leading cause of death in children under five in Malaysia, accounting for 3.8% of under-five deaths. Introducing a pneumococcal conjugate vaccine (PCV) is an effective strategy to reduce the disease burden. This study used a decision-analytic model to assess the potential impacts of introducing the available PCVs (13-valent and 10-valent) in Malaysia. Epidemiological and costs inputs were sourced from published literature. For each vaccination program, health outcomes and associated healthcare costs were estimated. The scenarios of initiating PCV13 vs. PCV10 and the status quo (no pneumococcal vaccine) were compared. Serotype trends of Finland and the U.K. were used to model the clinical impacts of PCV10 and PCV13 respectively. The base-case analysis used a societal perspective over a 5-year time horizon. Compared with PCV10, PCV13 was projected to avert an additional 190,628 cases of pneumococcal disease and 1126 cases of death. The acquisition of PCV13 was estimated to cost an incremental US$89,904,777, offset by a cost reduction of -US$250,219,914 on pneumococcal disease-related medical care and lost productivity. PCV13 demonstrated a higher cost-saving potential over PCV10. Compared with no vaccination, PCV13 was estimated as cost-saving. Results were robust across a series of sensitivity analyses. The introduction of PCV13 in a NIP was estimated to reduce a significant burden of disease and to be a cost-saving for the Malaysian health system.

Cost-Effectiveness Analysis of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin Regimen for Patients Infected With Chronic Hepatitis C Virus Genotype 1 in Malaysia.

OBJECTIVES: The combination of pegylated-interferon and ribavirin (PegIFN+RBV) is currently the gold standard in treating chronic hepatitis C virus (HCV) patients in Malaysia and is reimbursed by the Malaysian authorities. This analysis evaluated the cost-effectiveness (CE) of the ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin (OBT/PTV/r+DSB±RBV) regimen as compared with the PegIFN+RBV or no treatment in chronic HCV Genotype 1 (GT1) treatment-naïve and treatment-experienced cirrhotic and noncirrhotic patients in Malaysia. METHODS: A Markov model based on previously published CE models of HCV was adapted for the Malaysian public healthcare payer perspective, based on good modeling practices. Treatment attributes included efficacy, regimen duration, and EQ-5D treatment-related health utility. Transitional probabilities and health state health utilities were derived from previous studies. Costs were derived from Malaysian data sources. Costs and outcomes were discounted at 3.0% per year. Deterministic and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties around key variables. RESULTS: Based on the analysis, patients treated with the OBT/PTV/r+DSB±RBV showed less frequent progression to compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths when compared with standard care (ie, PegIFN+RBV or no treatment). At a price of MYR 1846/day, the OBT/PTV/r+DSB±RBV regimen is cost-effective over PegIFN+RBV and yields better outcomes in terms of life-years (LYs) gained and quality-adjusted life-years (QALYs) at a higher cost, which is still well below the implied willingness to pay threshold of MYR 384 503/QALY. CONCLUSION: The OBT/PTV/r+DSB±RBV regimen is cost-effective for treatment naïve, treatment experienced, cirrhotic, and noncirrhotic GT1 chronic HCV patients in Malaysia.

Landscape analysis of health technology assessment (HTA): systems and practices in Asia.

This paper explores the characteristics of health technology assessment (HTA) systems and practices in Asia. Representatives from nine countries were surveyed to understand each step of the HTA pathway. The analysis finds that although there are similarities in the processes of HTA and its application to inform decision making, there is variation in the number of topics assessed and the stakeholders involved in each step of the process. There is limited availability of resources and technical capacity and countries adopt different means to overcome these challenges by accepting industry submissions or adapting findings from other regions. Inclusion of stakeholders in the process of selecting topics, generating evidence, and making funding recommendations is critical to ensure relevance of HTA to country priorities. Lessons from this analysis may be instructive to other countries implementing HTA processes and inform future research on the feasibility of implementing a harmonized HTA system in the region.

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

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.

Consensus among healthcare stakeholders on a collaborative medication therapy management model for chronic diseases in Malaysia; A Delphi study.

BACKGROUND: The general problem is lack of inter-professional collaboration and the way private primary care responds to manage chronic diseases in Malaysia. Absence of prescription review, inadequate patient education, the highest percentage of prescribing errors and half of the chronic disease patients are nonadherent. Medicines are the most common and life long used interventions in chronic diseases. Hence, the need to manage medicine in chronic diseases becomes obligatory. As both general practitioner and community pharmacist can dispense medications, this has resulted in a business rivalry. There is a need to build consensus among various healthcare stakeholders for a collaborative medication therapy management model (CMTM) where community pharmacist has an active role in chronic care. METHOD: This study utilized modified e-Delphi method to build consensus. A validated e-Delphi survey was administered to a purposive sample of 29 experts. Consensus was pre-defined to be the point where >85% of the experts fall in either agree or strongly agree category for each statement. The inter-expert agreement was computed in both rounds using Intra-class correlation coefficient and Kendall's W. Delphi operates in an iterative fashion till there comes stability in responses. At the end of each round, experts were provided aggregate response, their own response and choice to change their response in the light of aggregate response. RESULTS: Response rate was 70.73% and 100% in 1st and 2nd round, respectively. Consensus was achieved on 119/132 statements which mainly referred to the need, structural and regulatory aspects of CMTM model in Malaysia. However, there were some flashpoints on dispensing separation and means to finance this model. Stability in response of experts was achieved after 2nd round; hence, no next round was executed. CONCLUSION: Overall, the study findings witnessed the expert panel's support for the CMTM model. Study helped to sketch CMTM model and facilitated development of some recommendations to the authorities which may help to formulate a policy to bring CPs under a working relationship with GPs. Hence, this study should be taken as a call for redefining of the roles of CPs and GPs in Malaysia.

Psychometric performance assessment of Malay and Malaysian English version of EQ-5D-5L in the Malaysian population.

PURPOSE: To determine the psychometric properties and performance of Malay and English versions of the EQ-5D-5L descriptive instrument in the general Malaysian population. METHODS: 1137 members of the Malaysian general public were sampled in this national study. Respondents were recruited by quota sampling of urbanicity, gender, age, and ethnicity. In face-to-face interviews, respondents first answered the EQ-5D-5L questionnaire administered using the EQ-Valuation Technology software, and then completed the EQ-5D-3L questionnaire on paper. A subgroup of the respondents were given paper form of EQ-5D-5L for completion within 2 weeks for test-retest reliability. Ceiling effects, response redistribution, informativity, and convergent validity were compared between EQ-5D-5L and ED-5D-3L separately by Malay and English language versions. RESULTS: The proportion of 'full health' responses (11111) drastically decreased by 25.55% and 15.74% in the Malay and English language versions indicating lower ceiling effects in EQ-5D-5L. Inconsistencies from response redistribution was below 6% for all dimensions across languages. The measure of relative informativity was comparatively higher in EQ-5D-5L than in EQ-5D-3L in both language versions, with the exception of dimensions mobility and pain/discomfort in the English version. Convergent validity in terms of correlation with EQ-VAS was relatively better for EQ-5D-5L dimensions, with pain/discomfort of the Malay version having the strongest correlation (|r| = 0.37). Also, reliability testing revealed moderate to poor agreements on all 5L dimensions. CONCLUSIONS: EQ-5D-5L fared better in terms of psychometric performance compared to EQ-5D-3L for both language versions. This encourages the application of the EQ-5D-5L in health-related research in Malaysia.