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Onwipa Rochanathimoke,1 Pramote Tragulpiankit,2 Saowalak Turongkaravee,1 Jiraphun Jittikoon,3 Wanvisa Udomsinprasert,3 Usa Chaikledkeaw1,4 1Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 2Clinical Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 3Department of Biochemistry, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 4Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, ThailandCorrespondence: Usa Chaikledkeaw, Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayudhaya Road, Ratchathewi, Bangkok, 10400, Thailand, Email usa.chi@mahidol.ac.thPurpose: To assess the direct and indirect costs associated with adverse drug reactions (ADRs) in patients receiving treatment regimens for human immunodeficiency virus (HIV) infection and tuberculosis (TB) in selected Thai hospitals.Patients and Methods: This was a retrospective study conducted between October 2014 and September 2019 at three public hospitals in Thailand. Data were obtained from a medical database and spontaneous ADR reporting system of each study site. The out-of-pocket health payments and indirect costs were determined via interviewing. All costs were updated to 2021.Results: A total of 432 eligible patients who experienced ADRs due to HIV and TB treatment, and 93 patients were interviewed to determine direct non-medical and indirect costs. The average direct medical cost for ADR was USD 5.65 for mild cases, USD 156.54 for moderate cases, and USD 1,242.45 for severe cases. For direct non-medical costs, the average cost per episode was USD 27.29 in mild ADR, USD 70.86 in moderate ADR and USD 270.66 in severe ADR. The indirect cost incurred in each mild, moderate and severe ADR was USD 41.86, USD 89.34, and USD 552.60, respectively. The Stevens-Johnson syndrome (SJS) had the highest management costs.Conclusion: ADRs associated with anti-tuberculosis drugs and antiretroviral drugs seem to have a substantial economic impact from a societal perspective. These findings would be useful for increasing awareness and encouraging early avoidance of ADRs.Keywords: cost, adverse drug reaction, HIV, TB, Thai

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., (© 2021. The Author(s).)

Introduction: World Health Organization recommends rotavirus vaccine for all national immunization programs (NIPs). To provide country-specific evidence, we conducted economic evaluation of a monovalent rotavirus vaccination using specific data of the pilot phase in Thailand., Method: A Markov model was adopted to compare the 2020 birth cohort once receiving rotavirus vaccination versus no vaccination from healthcare and societal perspective over five years. Data on disease burden, vaccine effectiveness, costs, and utilities were taken from a cohort study in two provinces of Thailand.  Sensitivity analyses were performed to test the robustness of the results., Results: Rotavirus vaccination would reduce rotavirus diarrhea and costs of illness by 48% and 71%, respectively, over the first five years of life. At USD 13 per dose, vaccine was cost-effective with the ICERs of USD 4,114 and USD 1,571per QALY gained from healthcare and societal perspective, respectively. Results were sensitive to incidence and vaccine cost.  The budget for vaccine purchasing was estimated at USD13 million per year., Conclusion: Incorporating rotavirus vaccination into the NIP substantially reduced health and cost outcomes and was cost-effective for both perspectives. However, the government needs to negotiate vaccine price prior to program implementation to achieve favorable budget impact.

Background: Rotavirus diarrhea is the leading cause of morbidity and mortality in young children in both developed and developing countries. Hospitalization costs are a significant burden of both governments and households. The objective of this study was to estimate the economic burden associated with the hospitalization of children with non-rotavirus and rotavirus diarrhea in two provinces in Thailand., Method: A prospective incidence-based cost-of-illness study was conducted on children under five years old with acute diarrhea who had been admitted to public hospitals in two provinces during October 2012 and June 2013. Caregivers were interviewed to estimate costs from a societal perspective at 2014 values. Stool samples were examined for rotavirus antigens. Multivariate regression analysis was used to assess the relationship of predictor variables to costs. Annual economic burden of rotavirus hospitalization was estimated by multiplying the number of hospitalized children and the hospitalization cost per episode. The costs were converted to international dollars (I$) using purchasing power parity (PPP) (1 USD = 12.36 baht for the year 2014)., Results: Seven hundred and eighty-eight cases of acute diarrhea were included in the analysis. Of the total, one hundred and ninety-seven (25%) were detected as being rotavirus positive. Total societal costs of inpatient care per episode were 822.68 USD (10,165 Baht). The average costs of children with and without rotavirus were 903.39 USD (11,162 Baht) and 795.40 USD (9,827 Baht), respectively. Based on the multiple regression analysis, rotavirus infection, severity, and younger age were significantly associated with the higher costs., Conclusion: Diarrhea, rotavirus diarrhea in particular, represents of a substantial economic burden in the society in Thailand. The accurate estimates that societal costs of the rotavirus diarrhea hospitalizations provide valuable input for considering a preventive program., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Rotavirus diarrhea is a major health problem among young children worldwide with potential negative impacts on health-related quality of life (HRQoL). This study assessed the impact of rotavirus diarrhea on HRQoL of children and their caregivers., Methods: We performed a cross-sectional study among 460 hospitalized children with diarrhea aged under 5 years and their family caregivers at three hospitals in Phetchabun province, Thailand during May 2013 and February 2014. The severity of diarrhea was assessed using the Vesikari severity scoring system while the HRQoL was assessed using the EQ-5D-3L., Results: The mean EQ-5D utility of children with all-causes diarrhea was 0.604. The utility of the rotavirus diarrhea group was significantly lower than that of the non-rotavirus diarrhea group (0.593 vs. 0.612; p-value = 0.040). The family caregiver's utility was 0.964 at baseline and significantly decreased to 0.620 (p-value = 0.041) when their children were hospitalized with diarrhea. In multiple regression analyses, severity but not rotavirus infection had significant negative impacts on the utility of both the children and their caregivers., Conclusion: Diarrhea, either caused by rotavirus or non-rotavirus infection, resulted in substantial negative impacts on the quality of life of both the children and their caregivers.

Background: We assessed the effectiveness and possible impact of introducing rotavirus vaccine into the routine immunization program., Methods: Two provinces were selected for an observational study, one where vaccine was introduced and another where vaccine was not available. In these areas, two sub-studies were linked. The prospective cohort study enrolled children 2month old and followed them to the age of 18months to detect all diarrhea episodes. The hospital surveillance study enrolled all children up to age 5 hospitalized with diarrhea whose fecal samples were tested for rotavirus. Rates of rotavirus hospitalizations in older children who had not been vaccinated in both settings provided data to determine whether immunization had an indirect herd effect. The key endpoints for the study were both vaccine effectiveness (VE) based upon hospitalized rotavirus diarrhea and herd protection., Findings: From the cohort study, the overall VE for hospitalized rotavirus diarrhea was 88% (95%CI 76-94). Data from hospital surveillance indicated that for 2 consecutive years, the seasonal peak of rotavirus admissions was no longer present in the vaccinated area. Herd protection was observed among older children born before the rotavirus vaccine program was introduced, who experienced a 40-69% reduction in admission for rotavirus., Conclusions: Rotavirus vaccine was highly effective in preventing diarrheal hospitalizations and in conferring herd protection among older children who had not been vaccinated., (Copyright © 2016 Elsevier Ltd. All rights reserved.)