Publications by authors named "Usa Chaikledkaew"

72 Publications

Cost-Utility Analysis of Drug Treatments in Patients with Polypoidal Choroidal Vasculopathy in Thailand.

Clinicoecon Outcomes Res 2021 12;13:917-926. Epub 2021 Nov 12.

Department of Ophthalmology, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.

Purpose: The aim of this study was to estimate the cost-utility and budget impact of pharmacological treatments for the eye with polypoidal choroidal vasculopathy (PCV) in Thailand.

Methods: A Markov model-based cost-utility analysis (CUA) and budget impact analysis were conducted. The lifetime cost and outcomes of PCV treatments were estimated. We discounted costs and outcomes at 3% per annum. Parameters were estimated using data from published literatures, local cost and utility data, and epidemiology data among Thai patients. Univariate and probabilistic sensitivity analyses were performed to account for parameter uncertainty.

Results: Intravitreal bevacizumab (IVB) resulted in the lowest lifetime cost, followed by IVB plus verteporfin photodynamic therapy (IVB+vPDT) and intravitreal aflibercept (IVA). The combination of IVB or intravitreal ranibizumab (IVR) and verteporfin photodynamic therapy (IVB+vPDT or IVR+vPDT) yielded the highest quality-adjusted life-years (QALY). When compared with IVB from a societal perspective, the incremental cost-effectiveness ratio for patients with PCV receiving IVB+vPDT, IVR+vPDT, IVA were 10,304; 54,135; and 82,738 the United States dollar (USD) per QALY gained, respectively. At the Thai societal willingness to pay threshold of 4884 USD, IVB had the highest probability of being cost-effective (99%) followed by IVB+vPDT (1%). IVB+vPDT could be a cost-effective strategy and required a budget of 12.61 million USD over five fiscal years when the price of verteporfin reduced by approximately 45%.

Conclusion: None of the drug treatments for PCV was cost-effective in the Thai context. The decreased price of verteporfin is required to support the inclusion of IVB+vPDT in the Thai National List of Essential Medicines for the treatment of PCV.
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http://dx.doi.org/10.2147/CEOR.S340570DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594557PMC
November 2021

Cost-Utility Analysis of Dapagliflozin Compared to Sulfonylureas for Type 2 Diabetes as Second-Line Treatment in Indian Healthcare Payer's Perspective.

Clinicoecon Outcomes Res 2021 22;13:897-907. Epub 2021 Oct 22.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Background: Type 2 diabetes mellitus (T2DM) is a leading health issue, causing economic burden in India. Pharmacotherapy is a major cost driver in diabetic care usually funded through out of pocket expenditure; however, there has been a very limited economic evaluation evidence to guide the choice of diabetes pharmacotherapy in India. Therefore, this study aims to evaluate the long-term cost-effectiveness of dapagliflozin (sodium glucose transporter 2 inhibitor) compared to commonly used sulfonylureas as second-line drugs in Indian patients with T2DM.

Methods: Cost-utility analysis was employed to estimate the costs and health outcomes using a Markov model with 1-year cycle length during a lifetime horizon based on an Indian payer's perspective. A treatment pathway with dapagliflozin as second-line therapy was compared to sulfonylureas after failure of initial metformin therapy. Clinical and cost data were collected from literature reviews and available secondary data sources. Both costs and outcomes were discounted at a 3% annual discount rate. The results were presented as the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were performed to test parameter uncertainties.

Results: Compared to sulfonylurea, dapagliflozin was estimated to incur an additional cost of ₹182,632 (US$2,446) with an expected 3.49 life years (LY) or 1.72 quality adjusted life years (QALY) gained, resulting in an ICER of ₹52,270 (US$699) per LY gained, or ₹106,133 (US$1,421) per QALY gained. Uncertainty analyses showed that the ICER values were not sensitive to changes in most parameters.

Conclusion: Dapagliflozin would be cost-effective compared to sulfonylureas as the second line added to metformin for T2DM patients based on an Indian payer's perspective.
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http://dx.doi.org/10.2147/CEOR.S328433DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548256PMC
October 2021

The Cost of Locally Advanced Cervical Cancer in Thailand: an Empirical Study for Economic Analysis.

Asian Pac J Cancer Prev 2021 Oct 1;22(10):3171-3179. Epub 2021 Oct 1.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Objective: To evaluate cost of illness of locally advanced cervical cancer patients from societal perspective in three scenarios including completely cured without severe late side effects (S1), completely cured with late grade 3-4 gastrointestinal side effects (S2.1) or genitourinary side effects (S2.2), and disease recurrence and death (S3).

Methods:  The incidence-based approach was conducted. The cost was calculated for 5-year time horizon starting for the treatment initiation. Direct medical costs were extracted from hospital database. Cost of using two-dimensional technique and three-dimensional conformal radiation therapy were calculated separately. Direct non-medical costs and indirect costs in terms of productivity loss were based on actual expenses from the interview of 194 locally advanced cervical cancer patients from two tertiary hospitals in Bangkok, during June to December 2019. All costs were converted to US dollar in 2019 values.

Results: For 5 years, cost of illness per patient for using two-dimensional technique and three-dimensional conformal radiation therapy were US $8,391 and US $10,418 for S1, US $18,018 and US $20,045 for S2.1, US $17,908 and US $19,936 for S2.2, and US $61,076 and US $63,103 for S3, respectively. The economic burden for newly diagnosed locally advanced cervical cancer patients in Thailand in 2018 was approximately US $129 million and US $131 million for using two-dimensional technique and three-dimensional conformal radiation therapy, respectively. Cost from S3 accounted for 70% of all total cost. Premature death was the most important cost driver of cost of illness accounted for 64 % of the total cost estimates.

Conclusions: Cost of illness of locally advanced cervical cancer patients produced significant economic burden from societal perspective. Disease recurrence and early death from cancer was the most influential cause of this burden.
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http://dx.doi.org/10.31557/APJCP.2021.22.10.3171DOI Listing
October 2021

Economic evaluation of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for stroke prevention in patients with atrial fibrillation: a systematic review and meta-analysis.

BMJ Evid Based Med 2021 Oct 11. Epub 2021 Oct 11.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Objectives: To assess cost-effectiveness of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF) by pooling incremental net benefits (INBs).

Design: Systematic review and meta-analysis.

Setting: We searched PubMed, Scopus and Centre for Evaluation of Value and Risks in Health Registry from inception to December 2019.

Participants: Patients with AF.

Main Outcome Measures: The INB was defined as a difference of incremental effectiveness multiplied by willing to pay threshold minus the incremental cost; a positive INB indicated favour treatment. These INBs were pooled (stratified by level of country income, perspective, time-horizon, model types) with a random-effects model if heterogeneity existed, otherwise a fixed effects model was applied. Heterogeneity was assessed using Q test and I statistic. Risk of bias was assessed using the economic evaluations bias (ECOBIAS) checklist.

Results: A total of 100 eligible economic evaluation studies (224 comparisons) were included. For high-income countries (HICs) from a third-party payer (TPP) perspective, the pooled INBs for DOAC versus VKA pairs were significantly cost-effective with INBs (95% CI) of $6632 ($2961.67 to $10 303.72; I=59.9%), $6353.24 ($4076.03 to $8630.45; I=0%), $7664.58 ($2979.79 to $12 349.37; I=0%) and $8573.07 ($1877.05 to $15 269.09; I=0%) for dabigatran, apixaban, rivaroxaban and edoxaban relative to VKA, respectively but only dabigatran was significantly cost-effective from societal perspective (SP) with an INB of $11 746.96 ($2429.34 to $21 064.59; I=52.4%). The pooled INBs of all comparisons for upper-middle income countries (UMICs) were not significantly cost-effective. The ECOBIAS checklist indicated that risk of bias was mostly low for most items with the exception of five items which should be less influenced on pooling INBs.

Conclusions: Our meta-analysis provides comprehensive economic evidence that allows policy makers to generalise cost-effectiveness data to their local context. All DOACs may be cost-effective compared with VKA in HICs with TPP perspective. The pooling results produced moderate to high heterogeneity particularly in UMICs. Further studies are required to inform UMICs with SP.

Prospero Registeration Number: CRD 42019146610.
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http://dx.doi.org/10.1136/bmjebm-2020-111634DOI Listing
October 2021

Cellular senescence in liver fibrosis: Implications for age-related chronic liver diseases.

Expert Opin Ther Targets 2021 Sep 22;25(9):799-813. Epub 2021 Oct 22.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Introduction: New insights indicate a causative link between cellular senescence and liver fibrosis. Senescent hepatic stellate cells (HSCs) facilitate fibrosis resolution, while senescence in hepatocytes and cholangiocytes acts as a potent mechanism driving liver fibrogenesis. In many clinical studies, telomeres and mitochondrial DNA contents, which are both aging biomarkers, were reportedly associated with a degree of liver fibrosis in patients with chronic liver diseases (CLDs); this highlights their potential as biomarkers for liver fibrogenesis. A deeper understanding of mechanisms underlying multi-step progression of senescence may yield new therapeutic strategies for age-related chronic liver pathologies.

Areas Covered: This review examines the recent findings from preclinical and clinical studies on mechanisms of senescence in liver fibrogenesis and its involvement in liver fibrosis. A comprehensive literature search in electronic databases consisting of PubMed and Scopus from inception to 31 August 2021 was performed.

Expert Opinion: Cellular senescence has diagnostic, prognostic, and therapeutic potential in progressive liver complications, especially liver fibrosis. Stimulating or reinforcing the immune response against senescent cells may be a promising and forthright biotherapeutic strategy. This approach will need a deeper understanding of the immune system's ability to eliminate senescent cells and the molecular and cellular mechanisms underlying this process.
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http://dx.doi.org/10.1080/14728222.2021.1992385DOI Listing
September 2021

Pharmacogenetic testing for adverse drug reaction prevention: systematic review of economic evaluations and the appraisal of quality matters for clinical practice and implementation.

BMC Health Serv Res 2021 Oct 2;21(1):1042. Epub 2021 Oct 2.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayuthaya Rd, Payathai, Ratchathewi, Bangkok, 10400, Thailand.

Background: Genetic testing has potential roles in identifying whether an individual would have risk of adverse drug reactions (ADRs) from a particular medicine. Robust cost-effectiveness results on genetic testing would be useful for clinical practice and policy decision-making on allocating resources effectively. This study aimed to update a systematic review on economic evaluations of pharmacogenetic testing to prevent ADRs and critically appraise the quality of reporting and sources of evidence for model input parameters.

Methods: We searched studies through Medline via PubMed, Scopus and CRD's NHS Economic Evaluation up to October 2019. Studies investigating polymorphism-based pharmacogenetic testing, which guided drug therapies to prevent ADRs, using economic evaluation methods were included. Two reviewers independently performed data extraction and assessed the quality of reporting using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines and the quality of data sources using the hierarchy of evidence developed by Cooper et al. RESULTS: Fifty-nine economic evaluations of pharmacogenetic testing to avoid drug-induced ADRs were found between 2002 and 2018. Cost-utility and cost-effectiveness analyses were the most common methods of economic evaluation of pharmacogenetic testing. Most studies complied with the CHEERS checklist, except for single study-based economic evaluations which did not report uncertainty analysis (78%). There was a lack of high-quality evidence not only for estimating the clinical effectiveness of pharmacogenetic testing, but also baseline clinical data. About 14% of the studies obtained clinical effectiveness data of testing from a meta-analysis of case-control studies with direct comparison, which was not listed in the hierarchy of evidence used.

Conclusions: Our review suggested that future single study-based economic evaluations of pharmacogenetic testing should report uncertainty analysis, as this could significantly affect the robustness of economic evaluation results. A specific ranking system for the quality of evidence is needed for the economic evaluation of pharmacogenetic testing of ADRs. Differences in parameters, methods and outcomes across studies, as well as population-level and system-level differences, may lead to the difficulty of comparing cost-effectiveness results across countries.
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http://dx.doi.org/10.1186/s12913-021-07025-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487501PMC
October 2021

A Systematic Review of Demand-Side Methods of Estimating the Societal Monetary Value of Health Gain.

Value Health 2021 Oct 6;24(10):1423-1434. Epub 2021 Aug 6.

Centre for Health Economics, University of York, York, England, UK.

Objectives: Although many reviews of the literature on cost-effectiveness thresholds (CETs) exist, the availability of new studies and the absence of a fully comprehensive analysis warrant a new review. This study systematically reviews demand-side methods for estimating the societal monetary value of health gain.

Methods: Several electronic databases were searched from inception to October 2019. To be included, a study had to be an original article in any language, with a clearly described method for estimating the societal monetary values of health gain and with all estimated values reported. Estimates were converted to US dollars ($), using purchasing power parity (PPP) exchange rates and the gross domestic product (GDP) per capita (2019).

Results: We included 53 studies; 45 used direct approach and 8 used indirect approach. Median estimates from the direct approach were PPP$ 24 942 (range 554-1 301 912) per quality-adjusted life-year (QALY), which were typically 0.53 (range 0.02-24.08) GDP per capita. Median estimates using the indirect approach were PPP$ 310 051 (range 36 402-7 574 870) per QALY, which accounted for 7.87 (range 0.68-116.95) GDP per capita.

Conclusions: Our review found that the societal values of health gain or CETs were less than GDP per capita. The great variety in methods and estimates suggests that a more standardized and internationally agreed methodology for estimating CET is warranted. Multiple CETs may have a role when QALYs are not equally valued from a societal perspective (eg, QALYs accruing to people near death compared with equivalent QALYs to others).
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http://dx.doi.org/10.1016/j.jval.2021.05.018DOI Listing
October 2021

Global DNA hypomethylation of Alu and LINE-1 transposable elements as an epigenetic biomarker of anti-tuberculosis drug-induced liver injury.

Emerg Microbes Infect 2021 Dec;10(1):1862-1872

Division of Genomic Medicine and Innovation Support, Department of Medical Sciences, Ministry of Public Health, Genomic Medicine Centre, Nonthaburi, Thailand.

Despite being highly effective, anti-tuberculosis (TB) drugs often induce adverse liver injury, anti-TB drug-induced liver injury (ATDILI), leading to treatment failure given no sensitive and selective ATDILI markers. Herein, we conducted a case-control association study to determine whether global DNA methylation of Alu and LINE-1 transposable elements responsible for genomic stability and transcriptional regulation was correlated with clinical parameters indicating ATDILI in TB patients and might serve as an ATDILI biomarker. Alu and LINE-1 methylation levels in blood leukocyte of 130 TB patients (80 ATDILI cases and 50 non-ATDILI cases) and 100 healthy controls were quantified using quantitative combined bisulfite restriction analysis. Both TB patients with and without ATDILI had significantly lower methylation levels of Alu and LINE-1 elements than healthy controls. Compared with non-ATDILI patients, Alu methylation levels were significantly decreased in ATDILI patients, commensurate with LINE-1 methylation analysis. Hypomethylation of Alu and LINE-1 measured within 1-7 days of TB treatment was independently associated with raised levels of serum aminotransferases assessed within 8-60 days of TB treatment. Receiver operating characteristic curve analysis uncovered that Alu and LINE-1 methylation levels were both more sensitive and specific for differentiating ATDILI cases from non-ATDILI cases than serum aminotransferases after starting TB treatment within 1-7 days. Kaplan-Meier analysis displayed a significant association between hypomethylation of Alu and LINE-1 elements and an increased rate of ATDILI occurrence in TB patients. Collectively, global DNA hypomethylation of Alu and LINE-1 elements would reflect ATDILI progression and might serve as novel sensitive and specific ATDILI biomarkers.
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http://dx.doi.org/10.1080/22221751.2021.1976079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451674PMC
December 2021

Cartilage oligomeric matrix protein as a marker of progressive liver fibrosis in biliary atresia.

Sci Rep 2021 08 17;11(1):16695. Epub 2021 Aug 17.

Osteoarthritis and Musculoskeleton Research Unit, Department of Biochemistry, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Chulalongkorn University, Bangkok, 10330, Thailand.

This study aimed to determine whether mRNA and protein levels of cartilage oligomeric matrix protein (COMP), a glycoprotein responsible for modulating homeostasis of extracellular matrix, in the systemic and local liver environments were associated with clinical parameters of biliary atresia (BA) patients and might serve as a biomarker for BA severity. COMP protein levels in the circulation of 96 BA patients and 56 healthy controls and its mRNA and protein expressions in the liver of 20 BA patients and 5 non-BA patients were evaluated using enzyme-linked immunosorbent assay, real-time polymerase chain reaction, and immunohistochemistry, respectively. In the circulation of BA patients, COMP levels were significantly higher than those in healthy controls. Compared with early-stage BA patients, those with advanced-stage including jaundice, fibrosis, and hepatic dysfunction had significantly increased circulating COMP levels. Raised circulating COMP levels were found to be independently correlated with degree of liver fibrosis. Survival analysis showed that elevated circulating COMP levels were significantly associated with decreased survival of BA patients. Receiver-operating characteristic curve analysis unveiled a diagnostic value of circulating COMP as a non-invasive biomarker of BA (AUC = 0.99), with a sensitivity of 100.0% and a specificity of 98.2%. In the liver, both COMP mRNA and protein expressions of BA patients with fibrosis were significantly greater than those of BA patients without fibrosis and non-BA patients. Collectively, increased circulating COMP might reflect unfavorable outcome of BA patients and have potential as a novel biomarker for the disease severity following Kasai-operation.
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http://dx.doi.org/10.1038/s41598-021-95805-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8371124PMC
August 2021

Cost-Utility Analysis of Vasoconstrictors Plus Albumin in the Treatment of Thai Patients with Type 1 Hepatorenal Syndrome.

Clinicoecon Outcomes Res 2021 29;13:703-715. Epub 2021 Jul 29.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Purpose: Type 1 hepatorenal syndrome (type 1 HRS) or hepatorenal syndrome-acute renal injury (HRS-AKI) leads to high short-term mortality rates in patients with cirrhosis. Vasoconstrictor therapy effectively improves survival of these patients and has been a bridge to liver transplantation. The aim of this study was to assess the cost-utility of terlipressin plus albumin (T+A) and noradrenaline plus albumin (N+A) compared to best supportive care (BSC) for treating type 1 HRS patients in Thailand.

Methods: A cost-utility analysis using a six-state Markov model was performed from societal and payer perspectives over a lifetime horizon. The clinical outcomes, costs, and utility parameters were obtained from literature, network meta-analyses, and expert opinion. One-way and probabilistic sensitivity analyses were conducted to account for uncertainty.

Results: The T+A yielded the highest cost (848,325 Thai Baht (THB)) and health outcomes (2.82 life-years (LY) and 2.27 quality-adjusted life-years (QALY)). Compared to BSC, incremental cost-effectiveness ratios (ICERs) of the T+A and N+A were 377,566 and 412,979 THB per QALY gained, respectively. If N+A is administered outside the intensive care unit, the ICER was 308,964 THB per QALY. The treatment cost after liver transplantation from year 3 onwards was the most influential factor for ICERs, followed by the cost of terlipressin, duration of noradrenaline treatment, and cost of albumin. At the Thai societal willingness-to-pay threshold of 160,000 THB per QALY gained, the probabilities of being cost-effective for T+A, N+A, and BSC were 11%, 20%, and 69%, respectively.

Conclusion: The T+A and N+A treatments would not be cost-effective compared to BSC in the Thai setting.
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http://dx.doi.org/10.2147/CEOR.S317390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328389PMC
July 2021

, , and genetic polymorphisms and their associations with susceptibility to antituberculosis drug-induced liver injury in Thai tuberculosis patients.

Heliyon 2021 Apr 20;7(4):e06852. Epub 2021 Apr 20.

Department of Biochemistry, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.

Antituberculosis drug-induced liver injury (ATDILI) is the common adverse reaction of antituberculosis drugs. Glutathione S-transferases (GSTs), which are phase II metabolizing enzymes for detoxification, are recognized as potential mediators of hepatotoxicity. However, role of s polymorphisms in ATDILI pathogenesis has never been observed in Thais. This study aimed to investigate associations between s and ATDILI susceptibility. This retrospective case-control multicentered study was conducted by the collaboration from ten secondary and tertiary care hospitals across Thailand, including Northern, Central, and Southern parts of Thailand. We enrolled 80 tuberculosis (TB) patients with ATDILI and 174 those without ATDILI into the study. Polymerase chain reaction (PCR) was used to determine genetic polymorphisms of and genes. genotyping data were derived from microarray data. We illustrated that null and / dual null genotypes were correlated with an increased risk of ATDILI with odds ratio (OR) at 1.83 (95% confidence interval (CI), 1.00 to 3.35; P = 0.049) and 2.12 (95%CI, 1.02 to 4.38; P = 0.044), respectively. Interestingly, null and / dual null genotypes were found to be correlated with an increased risk of ATDILI in Thai TB patients who carried wild type phenotype with OR 2.99 (95%CI, 1.07 to 8.39; P = 0.037) and 3.44 (95%CI, 1.01 to 11.71; P = 0.048), respectively. Collectively, null and / dual null genotypes were associated with a higher risk of ATDILI in Thai TB patients, which may serve as alternative genetic biomarkers for ATDILI.
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http://dx.doi.org/10.1016/j.heliyon.2021.e06852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082558PMC
April 2021

Incremental Net Monetary Benefit of Bariatric Surgery: Systematic Review and Meta-Analysis of Cost-Effectiveness Evidences.

Obes Surg 2021 07 24;31(7):3279-3290. Epub 2021 Apr 24.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Bangkok, Thailand.

This systematic review aimed to comprehensively synthesize cost-effectiveness evidences of bariatric surgery by pooling incremental net monetary benefits (INB). Twenty-eight full economic evaluation studies comparing bariatric surgery with usual care were identified from five databases. In high-income countries (HICs), bariatric surgery was cost-effective among mixed obesity group (i.e., obesity with/without diabetes) over a 10-year time horizon (pooled INB = $53,063.69; 95% CI $42,647.96, $63,479.43) and lifetime horizon (pooled INB = $101,897.96; 95% CI $79,390.93, $124,404.99). All studies conducted among obese with diabetes reported that bariatric surgery was cost-effective. Also, the pooled INB for obesity with diabetes group over lifetime horizon in HICs was $80,826.28 (95% CI $32,500.75, $129,151.81). Nevertheless, no evidence is available in low- and middle-income countries.
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http://dx.doi.org/10.1007/s11695-021-05415-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8175295PMC
July 2021

A comparison of six approaches for measuring utility values among patients with locally advanced cervical cancer.

Expert Rev Pharmacoecon Outcomes Res 2021 Apr 6:1-11. Epub 2021 Apr 6.

Social Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Background: Several instruments are available to measure health utility values. However, limited studies have not yet comprehensively assessed the agreement among these instruments. This study therefore aimed to investigate the performance and agreement of six instruments for utility measures: EQ-5D-3L, EQ-5D-5L (cTTO model), EQ-5D-5L (DCE model), EQ-5D-5L (Hybrid model), TTO, and VAS, among locally advanced cervical cancer (LACC) patients in Thailand.

Methods: We compared utility scores derived from six approaches using Friedman's test. We also assessed the agreement of utility scores between each pairwise comparison by intraclass correlation coefficient (ICC) and Bland-Altman plot.

Results: The mean (SD) utility values derived from six approaches were as follows: 0.755 ± 0.248 (EQ-5D-3L), 0.801 ± 280 (TTO), 0.806 ± 0.156 (VAS), 0.871 ± 0.184 (cTTO model), 0.875 ± 0.168 (Hybrid model), and 0.900 ± 0.142 (DCE model). Significant differences across six approaches were found in Friedman's test. The ICC showed high agreement between EQ-5D-5L and EQ-5D-3L, and very high agreement between all three models of EQ-5D-5L. The Bland-Altman plots showed wide limit of agreement, except the pairwise comparison, between each model of the EQ-5D-5L.

Conclusion: TTO, VAS, EQ-5D-3L and EQ-5D-5L could not be used interchangeably in LACC patients. The impact of using different instruments on economic evaluation findings warrants further investigation.
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http://dx.doi.org/10.1080/14737167.2021.1906224DOI Listing
April 2021

A systematic review and meta-analysis of genotype-based and individualized data analysis of SLCO1B1 gene and statin-induced myopathy.

Pharmacogenomics J 2021 06 19;21(3):296-307. Epub 2021 Feb 19.

Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

This meta-analysis was conducted to determine the genotypic effects of rs4149056 and rs2306283 polymorphism in SLCO1B1 gene on myopathy in patients with statin. Studies were searched using multiple databases and selected following inclusion criteria. Two reviewers independently performed data extraction and assessments for risk of bias. Fixed-or-random-effect was applied to pool allele frequency/effects. Mixed-effect logit model was used to pool genotypic effects using individual patient data. Heterogeneity and publication bias were explored. Fourteen studies were pooled for rs4149056; the minor C allele frequency were 15% in Caucasians and 14% in Asians. Six studies were pooled for rs2306283; the minor G allele frequency was 34% in Caucasian and 75% in Asians. Genotypic effects of rs4149056 polymorphism in Caucasians indicated that statin users who carried CC and TC genotypes had a significantly higher risk of myopathy than those who carried TT genotype, with a pooled odds ratio (OR) of 2.9 (95% confidence interval, 1.59, 5.34) and 1.6 (1.20, 2.16), respectively. For subgroup analysis, CC and TC genotypes also suggested a higher risk of myopathy in simvastatin users [OR = 2.8 (1.17, 6.77) and OR = 1.8 (1.15, 2.77), respectively] and in atorvastatin users [OR = 4.0 (1.23, 12.63) and OR = 2.0 (1.11, 3.52), respectively] than those who carried TT genotype. There was no significant association between rs2306283 polymorphism and myopathy in Caucasians and Asians. There was no evidence of publication bias for both polymorphisms.
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http://dx.doi.org/10.1038/s41397-021-00208-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8159730PMC
June 2021

Economic impact of medical genetic testing on clinical applications in Thailand.

PLoS One 2020 18;15(12):e0243934. Epub 2020 Dec 18.

Social Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

Background: Although the clinical benefits of medical genetic testing have been proven, there has been limited evidence on its economic impact in Thai setting. Thus, this study aimed to evaluate the economic impact of genetic testing services provided by the Center for Medical Genomics (CMG) in Thailand.

Methods: Cost-benefit analysis was conducted from provider and societal perspectives. Cost and output data of genetic testing services provided by the CMG during 2014 to 2018 and published literature reviews were applied to estimate the costs and benefits. Monetary benefits related to genetic testing services were derived through human capital approach.

Results: The total operation cost was 126 million baht over five years with an average annual cost of 21 million baht per year. The net benefit, benefit-to-cost ratio, and return on investment were 5,477 million baht, 43 times, and 42 times, respectively. Productivity gain was the highest proportion (50.57%) of the total benefit.

Conclusions: The provision of genetic testing services at the CMG gained much more benefits than the cost. This study highlighted a good value for money in the establishment of medical genomics settings in Thailand and other developing countries.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243934PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7748141PMC
February 2021

Diagnostic performance of clinic and home blood pressure measurements compared with ambulatory blood pressure: a systematic review and meta-analysis.

BMC Cardiovasc Disord 2020 11 23;20(1):491. Epub 2020 Nov 23.

Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Background: Clinic blood pressure measurement (CBPM) is currently the most commonly used form of screening for hypertension, however it might have a problem detecting white coat hypertension (WCHT) and masked hypertension (MHT). Home blood pressure measurement (HBPM) may be an alternative, but its diagnostic performance is inconclusive relative to CBPM. Therefore, this systematic review aimed to estimate the performance of CBPM and HBPM compared with ambulatory blood pressure measurement(ABPM) and to pool prevalence of WCHT and MHT.

Methods: Medline, Scopus, Cochrane Central Register of Controlled Trials and WHO's International Clinical Trials Registry Platform databases were searched up to 23rd January 2020. Studies having diagnostic tests as CBPM or HBPM with reference standard as ABPM, reporting sensitivity and specificity of both tests and/or proportion of WCHT or MHT were eligible. Diagnostic performance of CBPM and HBPM were pooled using bivariate mixed-effect regression model. Random effect model was applied to pool prevalence of WCHT and MHT.

Results: Fifty-eight studies were eligible. Pooled sensitivity, specificity, and diagnostic odds ratio (DOR) of CBPM, when using 24-h ABPM as the reference standard, were 74% (95% CI: 65-82%), 79% (95% CI: 69%, 87%), and 11.11 (95% CI: 6.82, 14.20), respectively. Pooled prevalence of WCHT and MHT were 0.24 (95% CI 0.19, 0.29) and 0.29 (95% CI 0.20, 0.38). Pooled sensitivity, specificity, and DOR of HBPM were 71% (95% CI 61%, 80%), 82% (95% CI 77%, 87%), and 11.60 (95% CI 8.98, 15.13), respectively.

Conclusions: Diagnostic performances of HBPM were slightly higher than CBPM. However, the prevalence of MHT was high in negative CBPM and some persons with normal HBPM had elevated BP from 24-h ABPM. Therefore, ABPM is still necessary for confirming the diagnosis of HT.
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http://dx.doi.org/10.1186/s12872-020-01736-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7681982PMC
November 2020

Circulating Levels of Interleukin-6 and Interleukin-10, But Not Tumor Necrosis Factor-Alpha, as Potential Biomarkers of Severity and Mortality for COVID-19: Systematic Review with Meta-analysis.

J Clin Immunol 2021 01 31;41(1):11-22. Epub 2020 Oct 31.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, 10400, Thailand.

Purpose: Cytokine storm, an uncontrolled overproduction of inflammatory cytokines contributing to an aberrant systemic inflammatory response, is a major pathological feature of acute respiratory distress syndromes being severe manifestations of COVID-19, thus highlighting its potential as a biomarker and therapeutic target for COVID-19. We aimed to determine associations of circulating levels of inflammatory cytokines with severity and mortality of COVID-19 by systematic review and meta-analysis.

Methods: A comprehensive literature search in electronic databases consisting of PubMed, Scopus, and Cochrane Library and in a hand searching of reference lists from inception to July 31, 2020, was performed using the following search terms: COVID-19, interleukin (IL)-6, IL-10, and tumor necrosis factor-alpha (TNF-α). Mean difference (MD) from individual studies was pooled using a random-effects model. Quality assessment, publication bias, meta-regression, subgroup, and sensitivity analyses were performed.

Results: A total of 6212 COVID-19 patients from 24 eligible studies were included. Compared with non-severe COVID-19 patients, systemic levels of IL-6 and IL-10, but not TNF-α, were significantly elevated in severe COVID-19 patients (MD = 18.63, 95% CI: 10.91, 26.35, P < 0.00001; MD = 2.61, 95% CI: 2.00, 2.32, P < 0.00001; respectively). For COVID-19 mortality, circulating levels of IL-6, IL-10, and TNF-α were found to be significantly increased in non-survivors when compared with survivors (MD = 57.82, 95% CI: 10.04, 105.59, P = 0.02; MD = 4.94, 95% CI: 3.89, 6.00, P < 0.00001; MD = 5.60, 95% CI: 4.03, 7.17, P < 0.00001; respectively).

Conclusion: Circulating levels of IL-6 and IL-10 might have great potential as biomarkers for the disease severity and mortality in COVID-19 patients.
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http://dx.doi.org/10.1007/s10875-020-00899-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7602765PMC
January 2021

Economic evaluation of carbetocin as prophylaxis for postpartum hemorrhage in the Philippines.

BMC Health Serv Res 2020 Oct 26;20(1):975. Epub 2020 Oct 26.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Background: The World Health Organization (WHO) recommends oxytocin as the drug of choice for postpartum hemorrhage (PPH) prevention. However, the WHO has also recently considered carbetocin for PPH prevention, but only if carbetocin were a cost-effective choice in the country. Consequently, we determined the cost-effectiveness and budgetary impact of carbetocin against oxytocin in the Philippines.

Methods: A cost-utility analysis using a decision tree was done to compare the costs and outcomes of carbetocin with oxytocin for PPH prophylaxis among women undergoing either vaginal delivery (VD) or cesarean section (CS) in a six-week time horizon using a societal perspective. One-way and probabilistic sensitivity analyses were applied to investigate parameter uncertainties. Additionally, budget impact analysis was conducted using a governmental perspective. Results were presented as incremental cost-effectiveness ratio (ICER) using a 2895 United States dollar (USD) per quality adjusted life year (QALY) gained as the ceiling threshold in the Philippines.

Results: Carbetocin was not cost-effective given the listed price of carbetocin at 18 USD. Given a societal perspective, the ICER values of 13,187 USD and over 40,000 USD per QALY gained were derived for CS and VD, respectively. Moreover, the ICER values were sensitive to the risk ratio of carbetocin versus oxytocin and carbetocin price. On budget impact, the five-year total budget impact of a drug mix of carbetocin and oxytocin was 25.54 million USD (4.23 million USD for CS and 21.31 million USD for VD) compared with 'only oxytocin' scenario.

Conclusion: Carbetocin is not a cost-effective choice in PPH prevention for both modes of delivery in the Philippines, unless price reduction is made. Our findings can be used for evidence-informed policies to guide coverage decisions on carbetocin not only in the Philippines but also in other low and middle-income countries.
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http://dx.doi.org/10.1186/s12913-020-05834-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7586682PMC
October 2020

Economic evaluation of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer: systematic review and quality assessment.

Expert Rev Pharmacoecon Outcomes Res 2021 Oct 24;21(5):1001-1010. Epub 2020 Sep 24.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Introduction: As the availability of new economic evaluations (EE) on adjuvant trastuzumab therapy for early-stage breast cancer (EBC) with HER2-positive since last search and other EEs missed warrant a more extensive review, this study aimed to systematically review EEs of adjuvant trastuzumab compared with chemotherapy alone for HER2-positive EBC.

Area Covered: The search was performed in February 2019 using MEDLINE and Scopus. Reviewers independently selected studies based on eligibility criteria, extracted data, assessed quality of reporting, and appraised quality of data sources.

Expert Opinion: 22 studies were included which were from high-income (HICs) and upper-middle income countries (UMICs). Incremental cost-effectiveness ratios (ICERs) from HICs were within their cost-effectiveness thresholds and ranged from 6,018 to 78,929 USD per quality-adjusted life year (QALY) gained. ICERs from UMICs mostly exceeded their thresholds ranging from 3,526 to 174,901 USD per QALY gained. Evidence shows cost-effectiveness of trastuzumab for HER2-positive EBC in HICs. There were no methodological variations. The extent and adequacy of reporting were high. The quality of data sources was moderate to high. The quality of future EEs can be improved by enhancing the reporting quality, by using context-based data and real-world efficacy data, which would impact cost-effectiveness.
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http://dx.doi.org/10.1080/14737167.2020.1819795DOI Listing
October 2021

Cost-Utility Analysis of Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Genotype 1 and 6 in Vietnam.

Value Health 2020 09 20;23(9):1180-1190. Epub 2020 Jul 20.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand; Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand. Electronic address:

Objective: Very few cost-utility analyses have either evaluated direct-acting antivirals (DAAs) on hepatitis C virus (HCV) genotype 6 patients or undertaken societal perspective. Recently, DAAs have been introduced into the Vietnamese health insurance drug list for chronic hepatitis C (CHC) treatment without empirical cost-effectiveness evidence. This study was conducted to generate these data on DAAs among CHC patients with genotypes 1 and 6 in Vietnam.

Methods: A hybrid decision-tree and Markov model was employed to compare costs and quality-adjusted life-years (QALYs) of available DAAs, including (1) sofosbuvir/ledipasvir, (2) sofosbuvir/velpatasvir, and (3) sofosbuvir plus daclatasvir, with pegylated-interferon plus ribavirin (PR). Primary data collection was conducted in Vietnam to identify costs and utility values. Incremental cost-effectiveness ratios were estimated from societal and payer perspectives. Uncertainty and scenario analyses and value of information analyses were performed.

Results: All DAAs were cost-saving as compared with PR in CHC patients with genotypes 1 and 6 in Vietnam, and sofosbuvir/velpatasvir was the most cost-saving regimen, from both societal and payer perspectives. From the societal perspective, DAAs were associated with the increment of quality-adjusted life-years by 1.33 to 1.35 and decrement of costs by $6519 to $7246. Uncertainty and scenario analyses confirmed the robustness of base-case results, whereas the value of information analyses suggested the need for further research on relative treatment efficacies among DAA regimens.

Conclusions: Allocating resources for DAA treatment for HCV genotype 1 and 6 is surely a rewarding public health investment in Vietnam. It is recommended that the government rapidly scale up treatment and enable financial accessibility for HCV patients.
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http://dx.doi.org/10.1016/j.jval.2020.03.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7491253PMC
September 2020

Preventive Role of Diet Interventions and Dietary Factors in Type 2 Diabetes Mellitus: An Umbrella Review.

Nutrients 2020 Sep 6;12(9). Epub 2020 Sep 6.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok 10400, Thailand.

Background: Although the body of evidence indicates clear benefits of dietary modifications for prevention of type-2 diabetes mellitus (T2DM), it may be difficult for healthcare providers to recommend which diet interventions or dietary factors are appropriate for patients as there are too many modalities available. Accordingly, we performed an umbrella review to synthesize evidence on diet interventions and dietary factors in prevention of T2DM.

Methods: Medline and Scopus databases were searched for relevant studies. Systematic reviews with meta-analyses of randomized-controlled trial or observational studies were eligible if they measured effects of diet interventions and/or dietary factors including dietary patterns, food groups, and nutrients on risk of T2DM. The effect of each diet intervention/factor was summarized qualitatively.

Results: Sixty systematic reviews and meta-analyses were eligible. Results of the review suggest that healthy dietary patterns such as Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets, and high consumption of whole grains, low-fat dairy products, yogurt, olive oil, chocolate, fiber, magnesium, and flavonoid significantly reduced the risk of T2DM. In contrast, high glycemic index and glycemic load diets, high consumption of red and processed meat, and sugar or artificial sugar-sweetened beverages significantly increased risk of T2DM. Prescribing diet interventions with or without physical activity interventions significantly decreased risk of T2DM in both high-risk and general population.

Conclusion: High consumption of Mediterranean and DASH diet, and interventions that modified the quality of diet intake significantly reduced risk of T2DM especially in the high-risk population. These lifestyle modifications should be promoted in both individual and population levels to prevent and decrease burden from T2DM in the future.
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http://dx.doi.org/10.3390/nu12092722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551929PMC
September 2020

Glucagon-like peptide 1 agonists for treatment of patients with type 2 diabetes who fail metformin monotherapy: systematic review and meta-analysis of economic evaluation studies.

BMJ Open Diabetes Res Care 2020 07;8(1)

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.

Objectives: To conduct a systematic review and meta-analysis and to pool the incremental net benefits (INBs) of glucagon-like peptide 1 (GLP1) compared with other therapies in type 2 diabetes mellitus (T2DM) after metformin monotherapy failure.

Research Design And Methods: The study design is a systematic review and meta-analysis. We searched MEDLINE (via PubMed), Scopus and Tufts Registry for eligible cost-utility studies up to June 2018, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. We conducted a systematic review and pooled the INBs of GLP1s compared with other therapies in T2DM after metformin monotherapy failure. Various monetary units were converted to purchasing power parity, adjusted to 2017 US$. The INBs were calculated and then pooled across studies, stratified by level of country income; a random-effects model was used if heterogeneity was present, and a fixed-effects model if it was absent. Heterogeneity was assessed using Q test and I statistic.

Results: A total of 56 studies were eligible, mainly from high-income countries (HICs). The pooled INBs of GLP1s compared with dipeptidyl peptidase-4 inhibitor (DPP4i) (n=10), sulfonylureas (n=6), thiazolidinedione (TZD) (n=3), and insulin (n=23) from HICs were US$4012.21 (95% CI US$-571.43 to US$8595.84, I=0%), US$3857.34 (95% CI US$-7293.93 to US$15 008.61, I=45.9%), US$37 577.74 (95% CI US$-649.02 to US$75 804.50, I=92.4%) and US$14 062.42 (95% CI US$8168.69 to US$19 956.15, I=86.4%), respectively. GLP1s were statistically significantly cost-effective compared with insulins, but not compared with DPP4i, sulfonylureas, and TZDs. Among GLP1s, liraglutide was more cost-effective compared with lixisenatide, but not compared with exenatide, with corresponding pooled INBs of US$4555.09 (95% CI US$3992.60 to US$5117.59, I=0) and US$728.46 (95% CI US$-1436.14 to US$2893.07, I=0), respectively.

Conclusion: GLP1 agonists are a cost-effective choice compared with insulins, but not compared with DPP4i, sulfonylureas and TZDs.

Prospero Registration Number: CRD42018105193.
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http://dx.doi.org/10.1136/bmjdrc-2019-001020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371226PMC
July 2020

Decreased circulating vitamin D reflects adverse outcomes of hepatitis C virus infection: A systematic review and meta-analysis.

J Infect 2020 10 15;81(4):585-599. Epub 2020 Jun 15.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand; Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Bangkok 10400, Thailand. Electronic address:

Objectives: This study aimed to clarify associations of circulating vitamin D and its status with severity of HCV infection.

Methods: We performed systemic literature search in PubMed, Scopus, and Cochrane library databases from inception until the end of December 2019 with terms related to vitamin D and hepatitis C.

Results: A total of 28 studies consisting of 7736 HCV-infected patients and 14061 control subjects without liver diseases were included. Compared to controls, circulating vitamin D levels were significantly lessened in HCV-infected patients (mean difference, MD=-14.15, 95% CI: -20.51 to -7.80). Remarkably decreased circulating vitamin D was found in the patients with severe fibrosis (MD=-3.38, 95% CI: -4.51 to -2.25), non-achieving SVR (MD=-2.99, 95%CI: -5.55 to -0.42), and advanced inflammation (MD=-4.68, 95% CI: -8.50 to -0.86). Low vitamin D status (<20 ng/mL) was significantly associated with increased odds of HCV infection (pooled OR=2.41, 95% CI: 1.48 to 3.95). Besides, HCV-infected patients with low vitamin D status showed significantly escalated odds of severe fibrosis and non-achieving SVR (pooled OR=1.70, 95% CI: 1.27 to 2.26; pooled OR=2.04, 95% CI: 1.62 to 2.57, respectively).

Conclusion: HCV-infected patients with declined circulating vitamin D levels were associated with severe fibrosis, non-achieving SVR, and advanced inflammation.
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http://dx.doi.org/10.1016/j.jinf.2020.06.025DOI Listing
October 2020

Quality assessment and cost saving of renal dosing recommendation by clinical pharmacists at medical wards in Thailand.

Int J Clin Pharm 2020 Apr 27;42(2):610-616. Epub 2020 Mar 27.

Department of Pharmacy, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, Thailand.

Background Renal dosage adjustment for patients with reduced kidney function is a common function of clinical pharmacy service. Assessment of pharmacist's intervention in the aspect of quality and economic impact should be conducted to evaluate the benefit of this service. Objective This study aimed to assess the quality and cost saving of clinical pharmacists' recommendation on renal dosage adjustment among patients with reduced kidney function. Setting Eight medical wards of the Siriraj Hospital, a tertiary-care hospital in Bangkok, Thailand. Method A retrospective study was conducted using medical records and clinical pharmacist's intervention database. All patients admitted to the study wards whose estimated creatinine clearance were less than 60 mL/min or presented with acute kidney injury on admission during October 2016-December 2017 were included. The targeted medications were antimicrobial agents. Main outcome measure Percentage of the concordance between pharmacists' recommendation compared to standard dosing references and related cost saving. Results Among 158 patients, pharmacists provided 190 recommendations, including 151 (79.1%) dose reduction, 17 (8.9%) dose increase and 22 (11.5%) recommendations to provide supplemental dose after dialysis. These recommendations were 90.5% consistent with standard references. Physician accepted and complied with 89.5% of pharmacists' recommendations. Average direct cost saving was €5,114.11 while cost avoidance was €863.47. Conclusion Trained clinical pharmacists were able to provide high-quality recommendation on dosage adjustment in these patients in accordance to standard dosing guidelines. In addition, dosage adjustment also led to a significant direct cost saving and cost avoidance from prevention of adverse drug reactions.
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http://dx.doi.org/10.1007/s11096-020-01016-1DOI Listing
April 2020

and genetic polymorphisms and their association with antituberculosis drug-induced liver injury.

Biomed Rep 2020 Apr 10;12(4):153-162. Epub 2020 Feb 10.

Department of Biochemistry, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.

Antituberculosis (anti-TB) drugs are the most common cause of drug-induced liver injury (DILI). There are numerous studies revealing the associations between the polymorphisms of pharmacogenes and the risk of anti-TB DILI (ATDILI). In the present study, relevant studies regarding the pharmacogenes associated with ATDILI were systematically searched in PubMed and Scopus. A total of 24 genes associated with ATDILI were reported on and the top five reported genes in terms of frequency were revealed to be N-acetyltransferase 2, cytochrome P450 family 2 subfamily E member 1, glutathione S-transferases [glutathione S-transferase mu 1 () and glutathione S-transferase theta 1 ()] and solute carrier organic anion transporter family member 1B1. As ATDILI may be the result of direct and indirect interactions, the encoded proteins were further analysed using the Search Tool for the Retrieval of Interacting Genes/Proteins (STRING) to observe the protein-protein interactions and the associations amongst these proteins. The results suggested that only and were central proteins associated with all the other analysed proteins. Therefore, the association between or and the risk of developing ATDILI were further analysed. The results revealed that a deletion genotype was significantly associated with risk of ATDILI [odds ratio (OR), 1.28; 95% confidence interval (CI), 1.08-1.51; P=0.004], whereas the deletion genotype and dual-deletion genotype were not significantly associated with risk of ATDILI. Subgroup analysis based on ethnicity was performed and the results demonstrated a significant association between and ATDILI in South Asian individuals (OR, 1.48; 95% CI, 1.12-1.95; P=0.005), which has not been reported previously, to the best of our knowledge. In conclusion, was associated with ATDILI in South Asian individuals.
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http://dx.doi.org/10.3892/br.2020.1275DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7054707PMC
April 2020

Survival analysis of colorectal cancer patients in a Thai hospital-based cancer registry.

Expert Rev Gastroenterol Hepatol 2020 Apr 16;14(4):291-300. Epub 2020 Mar 16.

Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.

: The study aimed to assess the overall and stage-specific colorectal cancer (CRC) survival and to identify the prognostic factors for survival among Thai patients.: The retrospective data of CRC patients from a university hospital-based cancer registry from 2001 to 2014 were used to estimate five-year overall survival (OS). Kaplan-Meier method and log-rank tests were used to assess the differences in five-year OS by age at diagnosis, diagnostic period, tumor site, stage at diagnosis and treatment modalities. A multivariate Cox's proportional hazard model was used to identify independent prognostic factors for the OS.: A total of 1,507 (48%) colon and 1,648 (52%) rectal cancer patients were included. Five-year OS for CRC patients was 44%. It differed significantly by stage, age group, and treatment received. Stage at diagnosis, age group, diagnostic period, receiving surgical and chemotherapy treatments were prognostic factors for OS.: An increasing trend in the number of CRC patients mostly at stage III and IV was found. Our results emphasized that an improvement in CRC survival could be achieved through the adoption of advanced cancer therapies, as well as improved access to quality diagnosis and timely treatment.
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http://dx.doi.org/10.1080/17474124.2020.1740087DOI Listing
April 2020

Systematic Review with Meta-Analysis: Efficacy and Safety of Direct-Acting Antivirals for Chronic Hepatitis C Genotypes 5 and 6.

Biomed Res Int 2019 11;2019:2301291. Epub 2019 Nov 11.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Bangkok, Thailand.

Direct-acting antivirals (DAAs) are modern treatments for chronic hepatitis C infection, but majority of available evidence on its treatment effect covers genotypes 1 to 4. Therefore, the efficacy and safety of DAAs for genotypes 5 and 6 need to be analysed. Studies were identified from Medline, Scopus, and CENTRAL and a Chinese database CNKI, from inception until Dec 4, 2018. Clinical trials were included if they enrolled patients with genotypes 5 and/or 6 infection, any type of second-generation DAAs was studied, and sustained virological response was assessed at the 12 week after treatment (SVR12) as outcome measure. Meta-analysis using statistical program was applied for pooling proportions if data were sufficient (i.e., at least 2 studies). Thirteen studies were included in the analysis. Four studies assessed the efficacy of four DAA regimens in genotype 5 patients, which were mainly sofosbuvir (SOF) plus pegylated-interferon/ribavirin (PR) or other DAAs, with SVR12 ranging from 94.4% to 100%. Twelve studies assessed the efficacy of seven DAA regimens among genotype 6 patients, but only two DAA regimens (i.e., SOF + PR and SOF/ledipasvir) had sufficient data for pooling. The pooled SVR12 rates (95% CI) were 99.6% (92.2 to 100) for SOF + PR and 99.2% (96.5 to 100) for SOF/ledipasvir. No treatment-related serious adverse event was reported, while the nonserious adverse events were comparable to other genotypes. In conclusion, DAAs are effective and may be safe for the treatment of chronic hepatitis C genotypes 5 and 6. However, our evidence is based on noncomparative studies; hence, further larger-scale randomized controlled trials in these genotypes are still required.
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http://dx.doi.org/10.1155/2019/2301291DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6877942PMC
April 2020

Cost Utility of Sodium-Glucose Cotransporter 2 Inhibitors in the Treatment of Metformin Monotherapy Failed Type 2 Diabetes Patients: A Systematic Review and Meta-Analysis.

Value Health 2019 12 18;22(12):1458-1469. Epub 2019 Nov 18.

Mahidol University Health Technology Assessment Graduate Program, Bangkok, Thailand; Section for Clinical Epidemiology and Biostatistics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address:

Objectives: Type 2 diabetes mellitus (T2DM) and associated ailments are leading economic burdens to society. Sodium glucose cotransporter-2 (SGLT2) inhibitors are recent antidiabetic medications with beneficial clinical efficacy. This meta-analysis was conducted to quantitatively pool the incremental net benefit of SGLT2 inhibitors in T2DM patients who failed metformin monotherapy.

Methods: Relevant economic evaluation studies of T2DM patients were identified from PubMed, Scopus, ProQuest, the Cochrane Library, and the Tufts Cost-Effective Analysis Registry until June 2018. Studies were eligible if they studied T2DM patients who failed metformin monotherapy and assessed the cost-effectiveness/utility between SGLT2 inhibitors and other treatments. Details of the study characteristics, economic model inputs, costs, and outcomes were extracted. Risk of bias was assessed using the biases in economic studies (ECOBIAS) checklist. The incremental net benefit was calculated with monetary units adjusting for purchasing power parity for 2017 US dollars. This was then pooled across studies stratified by the country's level of income using a random-effect model if heterogeneity was present and with a fixed-effect model otherwise. Heterogeneity was assessed using the Q test and I statistic.

Results: A total of 13 studies with 22 comparisons, mainly from high-income countries, were eligible. Six and 4 studies compared SGLT2 with dipeptidyl peptidase-4 inhibitors (DPP4i) and sulfonylureas, respectively. The pooled incremental net benefits (95% confidence interval) for these corresponding comparisons were $164.95 (-$534.71 to $864.61; I = 0%) and $3675.09 ($1656.46-$5693.71; I = 85.4%), respectively. These results indicate that SGLT2s were cost-effective in comparison with sulfonylureas but not DPP4i.

Conclusion: SGLT2s were cost-effective as compared with sulfonylureas but not DPP4i. Most of the evidence was from high-income countries with few comparative drug groups, and the results might not be representative of the actual global scenario. Further studies from middle and lower economies and other comparators are still required.
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http://dx.doi.org/10.1016/j.jval.2019.09.2750DOI Listing
December 2019

Cost-utility analysis of adjuvant trastuzumab therapy for HER2-positive early-stage breast cancer in the Philippines.

BMC Health Serv Res 2019 Nov 21;19(1):874. Epub 2019 Nov 21.

Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Bangkok, Thailand.

Background: Breast cancer is the leading malignancy among Filipino women, with about 23.50% of cases characterized by human epidermal growth factor receptor-2 (HER2) overexpression. Trastuzumab, in addition to standard chemotherapy, is currently recommended as primary treatment for HER2-positive early-stage breast cancer (EBC) in the adjuvant settings, and has been listed in the Philippine National Formulary (PNF) since 2008, but with no current evidence yet on its value for money, to date. Hence, despite several policy enablers, its accessibility remains to be limited in the Philippines. We performed an economic evaluation to assess the cost-effectiveness and budget impact of adjuvant trastuzumab therapy for HER2-positive EBC in the Philippines, using healthcare system and societal perspectives, in aid of guiding coverage decisions.

Methods: A Markov model-based cost-utility and budget impact analyses were conducted to estimate the total costs incurred and outcomes gained in using 1 year of adjuvant trastuzumab added to standard chemotherapy versus standard chemotherapy alone, over a lifetime horizon. We discounted both costs and outcomes at 3.5% per annum. Parameters were estimated using country survival data, systematic review and meta-analysis of the relative treatment effect, local and international cost data, and published utility data. Univariate and probabilistic sensitivity analyses were used to account for parameter uncertainty.

Results: Trastuzumab therapy was dominated with an incremental cost-effectiveness ratio (ICER) at PHP 453,505 per QALY gained from a healthcare system perspective or PHP 458,686 per QALY gained from a societal perspective, with 10% cost-effectiveness probability at the country cost-effectiveness threshold of PHP 120,000 per QALY gained. National implementation will cost an additional amount of PHP 13,909 million in year one alone, plus about PHP 2000 to 3000 million annually for the succeeding fiscal years.

Conclusion: At its current cost, 1 year of adjuvant trastuzumab therapy compared to standard chemotherapy alone for HER2-positive EBC does not represent value for money in the Philippines. Its current cost will have to significantly lower down by one-half to achieve cost-effectiveness.
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http://dx.doi.org/10.1186/s12913-019-4715-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6873585PMC
November 2019

Southeast Asian Pharmacogenomics Research Network (SEAPharm): Current Status and Perspectives.

Public Health Genomics 2019 4;22(3-4):132-139. Epub 2019 Oct 4.

Center for Medical Genomics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand,

Pharmacogenomics (PGx) is increasingly being recognized as a potential tool for improving the efficacy and safety of drug therapy. Therefore, several efforts have been undertaken globally to facilitate the implementation process of PGx into routine clinical practice. Part of these efforts include the formation of PGx working groups working on PGx research, synthesis, and dissemination of PGx data and creation of PGx implementation strategies. In Asia, the Southeast Asian Pharmacogenomics Research Network (SEAPharm) is established to enable and strengthen PGx research among the various PGx communities within but not limited to countries in SEA; with the ultimate goal to support PGx implementation in the region. From the perspective of SEAPharm member countries, there are several key elements essential for PGx implementation at the national level. They include pharmacovigilance database, PGx research, health economics research, dedicated laboratory to support PGx testing for both research and clinical use, structured PGx education, and supportive national health policy. The status of these essential elements is presented here to provide a broad picture of the readiness for PGx implementation among the SEAPharm member countries, and to strengthen the PGx research network and practice in this region.
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http://dx.doi.org/10.1159/000502916DOI Listing
May 2020
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