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Background Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators.Methods The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/RWE.Results All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled.Conclusion The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.

Since government-provided annual cervical cytology testing for all Taiwanese women aged 30 years or older became available in 1995, both cervical cancer incidence and death have decreased significantly. However, with the 2018 introduction of the national immunization program for human papillomavirus (HPV) vaccination in all schoolgirls aged 13–15 years old, the positive predictive value of cytology testing is expected to decrease with rising vaccination rates, and therefore a transition to more sensitive HPV-based testing may be needed. This position paper, derived from discussions by a panel of experts in cervical cancer screening, provides short-, medium-, and long-term policy recommendations to manage the transition between cervical screening methods for Taiwan. The recommendations include concrete suggestions regarding testing procedures, standards, accreditation, monitoring, promotion, and implementation. It is hoped that comprehensive preparation and management of this transition will enable Taiwan to repeat the previous successes of the cervical cytology testing program.

Efforts to advance health technology assessment (HTA) in Taiwan have aimed to optimize the allocation of National Health Insurance (NHI) resources. This study documents and analyzes the historical timeline of Taiwan’s efforts in HTA, identifying areas to advance the HTA system, such as gaining broad stakeholder acceptance. We document ambitious plans to establish a larger, independent HTA center and how these plans did not materialize. The historical timeline also describes the primary focus of HTA shifting to serve the needs of decision-making authorities and committees. We argue that these changes resulted in growth of the HTA system, but also led to significant external criticism and potential compromise of its foundational principles. The inability to create a national HTA center can be attributed to several factors, including an immature ecosystem of HTA-Policy-Patient-Provider-Academic collaboration, a lack of a supportive culture, and challenging political and economic conditions. Nevertheless, if effectively managed, Taiwan’s current HTA system could play a crucial role in rational decision-making, informed choices, and efficient NHI resource management. We argue that greater autonomy is crucial for enhancing financial sustainability and protecting against external influences to ensure objective and credible assessments. Additionally, we emphasize the importance of fostering a conducive learning environment to improve methodological expertise.

Abstract Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.

Objectives: Budgetary constraints force healthcare authorities to set priorities for optimal vaccine interventions. A comprehensive decision-making tool would help inform the best combination and sequence of introduction of vaccines within constrained budgets. Methods: Looking at available vaccines against pneumococcal infections in Taiwan (10/13-valent pneumococcal conjugate vaccines [PCV10, PCV13] and 23-valent pneumococcal polysaccharide vaccine [PPV23]), a constrained optimization (CO) model was used to assess the optimal combination of vaccines in children and older adults that would maximize the quality-adjusted life years under predefined budget constraints. Scenario analyses were carried out to evaluate the impact of vaccine efficacy (VE) on the optimized solution. Results: The CO model demonstrated that the optimal sequence of vaccine introduction was PPV23 in older adults and PCV10 in children. The optimal solution was mostly driven by the potential to reduce disease burden in the older adult population. The VE of PPV23 in older adults and the VE of PCV vaccines against serotype 19A invasive pneumococcal disease had little impact on the optimal solution. Conclusions: The CO approach can be used to set priorities for introducing new vaccines while maximizing health gains per age group within the constrained National Vaccine Fund for the prevention of pneumococcal disease in Taiwan.

Background/Purpose: This study aims at investigating the epidemiological profile of chronic hepatitis C (CHC) regarding hepatitis C virus (HCV) genotype in Taiwan. Methods: A total of 29,087 CHC patients with advanced fibrosis who received direct-acting antivirals (DAAs) therapy under Taiwan's National Health Insurance (NHI) during 2017–2018 were recruited. The HCV genotype distribution and its association with patients' demographic factors including age, gender, and geographical areas were examined. Results: The most common genotypes were 1b (59.5%) and 2 (30.1%) with characteristics of older age (mean ± standard deviation (SD): 66.5 ± 10.7 years and 67.3 ± 10.9 years) and female gender predominant (57.1% and 59.4%), which were associated with iatrogenic infection decades ago. Most of patients with genotype 1a (5.9%) and 6 (3.7%) infection were relatively younger (59.2 ± 12.0 years and 60.0 ± 13.8 years) and male gender predominant (59.1% and 61.1%), except Liujia and Liuying districts in southern Taiwan. The youngest group (53.2 ± 11.8 years) and most male gender predominant (74.3%) was genotype 3 (0.37%). These genotypes with characteristics of being younger and male gender predominant were highly related to injection drug use in recent years. The number of genotype 4 patients were extremely rare (n = 25) and efficacy of genotype-4-specific-DAA was significantly poorer than non-genotype-4-specific DAA (P value = 0.0411). Conclusion: The significant differences in demographic characteristics among CHC patients with different HCV genotypes found in this study suggest HCV genotype was highly associated with transmission pattern and may be used as a reference for HCV control.

Abstract Background Patients with symptoms of both asthma and chronic obstructive pulmonary disease (COPD) may be classified with the term asthma-COPD overlap (ACO). ACO is of considerable interest as it is currently poorly characterised and has been associated with worse health outcomes and higher healthcare costs compared with COPD or asthma alone. Patients with ACO in Asia remain poorly described, and there is limited information regarding their resource utilisation compared with patients with asthma or COPD only. This study investigated the characteristics, disease burden and medical resource utilisation of patients with ACO in Taiwan. Methods This was a retrospective cohort study of patients identified from National Health Insurance (NHI) claims data in Taiwan in 2009–2011. Patients were classified into incident ACO, COPD or asthma cohorts according to International Classification of Disease, ninth revision, clinical modification codes in claims. Eligible patients were ≥40 years of age with 12 months’ continuous enrolment in the NHI programme pre- and post-index date (date of the first relevant medical claim). Results Patients with ACO (N = 22,328) and COPD (N = 69,648) were older and more likely to be male than those with asthma (N = 50,293). Patients with ACO had more comorbidities and exacerbations, with higher medication use: short-acting β2-agonist prescriptions ranged from 30.4% of patients (asthma cohort) to 43.6% (ACO cohort), and inhaled corticosteroid/long-acting β2-agonist combination prescriptions ranged from 11.1% (COPD cohort) to 35.0% (ACO cohort) in the 12 months following index. Patients with ACO generally had the highest medication costs of any cohort (long-acting muscarinic antagonist costs ranged from $227/patient [asthma cohort] to $349/patient [ACO cohort]); they also experienced more respiratory-related hospital visits than patients with asthma or COPD (mean outpatient/inpatient visits per patient post-index: 9.1/1.9 [ACO cohort] vs 5.7/1.4 [asthma cohort] and 6.4/1.7 [COPD cohort]). Conclusions Patients with ACO in Taiwan experience a greater disease burden with greater healthcare resource utilisation, and higher costs, than patients with asthma or COPD alone.

Early diagnosis and early treatment of rare diseases can prevent severe disabilities and reduce social and medical costs. However, patients face a significant hardship due to the slow and challenging process for obtaining National Health Insurance (NHI) coverage for orphan drugs, as it delays access to lifesaving medications and creates financial burdens. This article outlines the process for listing in the NHI Pharmaceutical Benefits and presents two cases that illustrate the issues with the existing procedures. It concludes by proposing seven reform suggestions for the National Health Insurance Administration to consider. [ABSTRACT FROM AUTHOR]

Background: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. Methods: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/RWE. Results: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. Conclusion: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia. [ABSTRACT FROM AUTHOR]

Although cervical cancer is the most frequent cancer for women in Taiwan, no examination of its treatment costs has yet been undertaken. This study aimed to investigate the costs of cervical cancer and precancerous lesion treatment in Taiwan. A total of 7,398 cases of cervical intraepithelial neoplasia (CIN) lesions were identified from the Taiwan Cervical Cancer Screening Registration System in 2003. A further 1,469 cases of invasive cervical cancer (ICC) were also identified from a survey on cervical cancer staging information conducted by the Taiwan Cancer Registration Task Force. Resource usage covering the first 6 months after CIN diagnosis and the 5 years after ICC diagnosis were extracted from the National Health Insurance claims database. The duration of each visit and the transportation costs were collected by means of personal interviews with CIN/ICC patients. The mean and standard deviation of the treatment and indirect costs were estimated. The average total costs for CIN patients were NT$4,201 for CIN1, NT$8,623 for CIN2 and NT$14,406 for CIN3, with the indirect costs accounting for 25–33% of the total. The total costs for ICC patients were NT$210,230 for Stage 1, NT$392,387 for Stage 2, NT$433,969 for Stage 3 and NT$464,701 for Stage 4, with the indirect costs accounting for about 14–17% of the total. CIN and ICC treatment resulted in considerable costs to the healthcare system in Taiwan. Indirect costs associated with such treatment were also substantial and cannot be ignored. [ABSTRACT FROM AUTHOR]

Background The transition probability of Alzheimer's disease (AD) is defined as the likelihood that the disease progresses from one stage to another in a given time period. Objective To estimate the separate stage-to-stage and stage-to-death transition probabilities for Taiwanese patients with AD and to evaluate the hazard ratios of age, sex, behavioral symptoms, and medications on disease progression. Method We examined data (severity of dementia, hallucinations or delusions, use of cholinesterase inhibitors [CEIs], survival) in 365 patients with probable AD at baseline and at follow-Gup (mean ± SD 29 ± 17 months, range 3–109 months). Results Modified survival analysis revealed that transition probabilities of Taiwanese patients were similar to those of Western patients. The probability of dementia remaining at the same stage was higher in patients taking CEIs than in other. Men had a higher probability of dying in the mild stage. Conclusion Transition probabilities can be used to measure AD progression. CEIs used to treat AD might alter the disease course. Copyright © 2004 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objectives: The study aims to apply the contingent valuation method to elicit the willingness-to-pay (WTP), and measure the value of a statistic life (VSL), for human papillomavirus (HPV) vaccine in Taiwan. Methods: A total of 512 questionnaires were completed on women aged 20 to 55 years with at least one daughter, during March through May 2007. The respondents' WTP for the vaccines was elicited by double-bounded binary-choice questions under two scenarios: one was to protect themselves from cervical cancer (CC) and the other was for their daughter(s). The WTP was modeled as a function of the respondents' knowledge score, attitudes toward CC and HPV vaccine, the vaccination outcome scenarios, and individual characteristics. A log-normal survival model was constructed and the maximum-likelihood method was used for estimation. Results: The median regression-adjusted WTP was estimated at US$1098 to US$1233 (US$913–1004) for vaccinating the daughter (mother); and the VSL was estimated at approximately US$0.65 to US$4.09 (US$0.56–3.16) million for vaccinating the daughter (mother). Conclusions: The study results provided important evidences on the monetary value women placed on a HPV vaccine, and the differential benefits between vaccinating the women and their daughters. [ABSTRACT FROM AUTHOR]