The value-for-money assessment and funding arrangements for high-priced drugs in an era of uncertainty: a comparative analysis of national health technology assessment agencies in South Korea, England, Australia, and Canada.

Background: Innovative health technologies have increasingly emerged as a promising solution for patients with untreatable or challenging conditions. However, these technologies often come with expensive costs and limited evidence at the time of launch. This study assessed how these high-priced drugs with limited evidence were appraised and introduced in South Korea, England, Australia, and Canada, where cost-effectiveness analysis (CEA) generally plays a central role in pricing and reimbursement decisions.

Cyclin F-EXO1 axis controls cell cycle-dependent execution of double-strand break repair.

Ubiquitination is a crucial posttranslational modification required for the proper repair of DNA double-strand breaks (DSBs) induced by ionizing radiation (IR). DSBs are mainly repaired through homologous recombination (HR) when template DNA is present and nonhomologous end joining (NHEJ) in its absence. In addition, microhomology-mediated end joining (MMEJ) and single-strand annealing (SSA) provide backup DSBs repair pathways.

Values, challenges, and responses associated with high-priced potential cures: perspectives of diverse stakeholders in South Korea.

Background: The emergence of high-priced potential cures has sparked significant health policy discussions in South Korea, where the healthcare system is funded through a single-payer National Health Insurance model. We conducted focus group interviews (FGIs) and accompanying surveys with diverse stakeholders to comprehensively understand related issues and find better solutions to the challenges brought by these technologies.

Methods: From October to November 2022, 11 FGIs were conducted with stakeholders from various sectors, including government payers, policy and clinical experts, civic and patient organisations, and the pharmaceutical industry, involving a total of 25 participants.

Public preferences in healthcare resource allocation: A discrete choice experiment in South Korea.

Objectives: This study aimed to explore the public view on priority-setting criteria for healthcare resource allocation. Specifically, it investigates how the value of a quality-adjusted life year (QALY) varies depending on patient characteristics.

Methods: A discrete choice experiment was conducted using an online sample of the general South Korean population.

Protective effect of leaf extracts on atopic dermatitis: and studies.

Background/objectives: Atopic dermatitis (AD) is a chronic disease with an increasing incidence globally; therefore, there is a growing demand for natural compounds effective in treating dermatitis. In this study, the protective effects of leaves with and without chlorophyll (LLE and LLE[Ch-]) on AD were investigated in animal models of AD and HaCaT cells. Further, we investigated whether LLE and LLE(Ch-) show any differences in physiological activity.

A Measles Outbreak in a Local Children's Hospital in Korea, 2019.

A measles outbreak with 20 confirmed cases occurred at a local children's hospital in Daejeon from March 28 to April 21, 2019. The index patient was a 7-month-old girl with a recent history of travel to Vietnam. Contact tracing, active surveillance, and post-exposure prophylaxis were conducted by health authorities.

A Comparative Analysis of Anticancer Drug Appraisals Including Managed Entry Agreements in South Korea and England.

Objectives: This study aimed to compare appraisal decisions about anticancer drugs between the health technology assessment (HTA) agencies in Korea and England, and investigate whether the decisions and supporting evidence are comparable.

Methods: This study identified 49 anticancer drugs listed by the Korean Ministry of Health and Welfare between January 2014 and December 2019. Of those, 46 anticancer drugs for 58 indications were included for analysis.

Regulatory Effects of Extract and Isolated Scopoletin on Atopic Dermatitis-Like Skin Inflammation.

and scopoletin are widely used in oriental Eastern medicine and are often consumed as teas. In this study, proinflammatory cytokines expressed in human keratinocytes (HaCaT) were induced by skin diseases caused by 2,4-dinitrochlorobenzene (DNCB) and tumor necrosis factor alpha (TNF-)/interferon gamma (IFN-). The inhibitory activity of EtOH extract (LBE) and scopoletin on proinflammatory cytokines and chemokines was investigated.

Systematic Review and Quality Assessment of Health Economic Evaluation Studies (2007-2019) Conducted in South Korea.

Background: South Korea formally adopted economic evaluation in December 2006 to aid drug reimbursement decision-making. While this policy change is applied only to pharmaceuticals, it has also sparked interest in economic evaluations for non-pharmaceutical interventions and programmes.

Objective: This study aimed to provide a snapshot of the current practice for published health economic evaluation studies and critically assess the quality of these studies.

How Sensitive is Sensitivity Analysis?: Evaluation of Pharmacoeconomic Submissions in Korea.

We aimed to describe the types of uncertainties examined in the economic evaluations submitted for reimbursement in Korea and their impact on the incremental cost-effectiveness ratio (ICER). Fifty dossiers were submitted by pharmaceutical companies to the economic subcommittee of the Pharmaceutical Benefit Coverage Advisory Committee (PBCAC) from January 2014 to December 2018. The types of uncertainties were categorized as structural and parametric, and the frequencies of the sensitivity analysis per variables were analyzed.

Factors associated with the mental health status of isolated COVID-19 patients in Korea.

Background: The COVID-19 pandemic has a substantial impact on the physical and mental health status of patients with COVID-19. This study's objective was to evaluate the factors associated with mental health in patients isolated with COVID-19.

Methods: It is a retrospective, cross-sectional study.

Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version.

The first version of the pharmacoeconomic (PE) guidelines was published in South Korea in 2006. Despite its first revision in 2011, there were still ambiguities in its interpretation. Moreover, methodologies for estimating effectiveness and costs have also evolved since then.

Elevated Plasma Apurinic/Apyrimidinic Endonuclease 1/Redox Effector Factor-1 Levels in Refractory Kawasaki Disease.

Kawasaki disease (KD) refers to systemic vasculitis of medium-sized vessels accompanied by fever. The multifunctional protein apurinic/apyrimidinic endonuclease-1/redox factor-1 (APE1/Ref-1) is a new biomarker for vascular inflammation. Here, we investigated the association between APE1/Ref-1 and KD.

How can we improve patients' access to new drugs under uncertainties? : South Korea's experience with risk sharing arrangements.

Background: New drugs including cancer drugs and orphan drugs are becoming increasingly more expensive. Risk sharing arrangements (RSAs) could manage the risk based on both financial impact and the health outcome of new drugs if reimbursed. To improve patients' access to new drugs under uncertainties, many developed countries have adopted RSAs.

A Review of Utility Measurement Methods Used in Pharmacoeconomic Submissions to HIRA in South Korea: Methodological Consistency and Areas for Improvement.

Pharmacoeconomic (PE) guidelines, first published in 2006 and later updated in 2011, were developed to guide the preparation and submission of PE data to the Health Insurance Review and Assessment Service (HIRA) for drug reimbursement decision making in South Korea. This study, which was conducted as part of a project for revision of the PE guideline, reviewed utility values used in the PE submissions processed at HIRA during 2014-2018 to identify aspects of the current guidelines that may need to be revisited. A total of 50 PE submissions were processed at HIRA over the 5 years.

Public Preferences in Resource Allocation for Insurance Coverage of Dental Implant Service in South Korea: Citizens' Jury.

The Korean government sought to include dental implant services for the elderly in the benefits package of the national health insurance. In 2014, the Citizens' Jury was held to discuss the topic, during which thirty jurors, randomly selected from the 2665 applicants, participated in a day-long deliberation process after having an information session on the topic by a team of experts. There was a substantial shift in opinion during the deliberation session toward a more cost-conscious view.

Who should be given priority for public funding?

Background: This study explored if Koreans consider the type of disease, rarity, and availability of alternative treatments as priority criteria in limited healthcare resource allocation.

Materials And Methods: A web-based survey was conducted with a representative sample of 3,482 Korean adults. Participants were divided into six cohorts, differing in terms of the disease being compared and the cost and benefits of the treatments.

Anti-photoaging effect of skin cream manufactured with ziyuglycoside I isolated from on ultraviolet B-induced hairless mice.

In this study, skin cream containing ziyuglycoside I isolated from was manufactured and examined the protective effects of the skin cream against UVB-induced hairless mice. UVB-induced hairless mice were topically treated with the skin cream once a day for 5 weeks. Application of the skin cream did not exhibit side effect on body growth showing normal body weight and food efficiency in the mice.

Anti-inflammatory effect of Lycium barbarum on polarized human intestinal epithelial cells.

Background/objectives: Inflammatory Bowel Disease (IBD) has rapidly escalated in Asia (including Korea) due to increasing westernized diet patterns subsequent to industrialization. Factors associated with endoplasmic reticulum (ER) stress are demonstrated to be one of the major causes of IBD. This study was conducted to investigate the effect of () on ER stress.

Role of Health Technology Assessment in Drug Policies: Korea.

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee.

Role of economic evidence in coverage decision-making in South Korea.

Objectives: The South Korean government required the submission of economic evidence when it implemented the Positive-List System in December 2006. This study investigates the key factors that influenced actual public insurance reimbursement decisions, including the role of economic evidence, after 10 years of decision practice under compulsory health technology assessment (HTA) for new drugs.

Method: Logistic regression analysis was used to estimate the impact of the variables involved, including cost-effectiveness ratio as a key variable, on reimbursement decisions.

Eliciting preferences for medical devices in South Korea: A discrete choice experiment.

This study aims to identify the attributes that contribute to the value of medical devices and quantify the relative importance of them using a discrete choice experiment. Based on a literature review and expert consultation, seven attributes and their levels were identified-severity of disease (2), availability of substitutes (2), improvement in procedure (3), improvement in clinical outcomes (2), increase in survival (2), improvement in quality of life (3), and cost (4). Among 576 hypothetical profiles, optimal choice sets with 20 choices were developed and experts experienced in health technology assessment and reimbursement decision making in South Korea were surveyed.

Eight-year experience of using HTA in drug reimbursement: South Korea.

This study describes the process and results of drug reimbursement decision-making in South Korea and evaluates its performance from the perspectives of the various stakeholders involved. Data were retrieved from the evaluation report posted on the Health Insurance Review and Assessment Service (HIRA) website. As of 2014, 253 new drugs had been submitted to the HIRA for appraisal.

CHALLENGES FACED IN TRANSFERRING ECONOMIC EVALUATIONS TO MIDDLE INCOME COUNTRIES.

Background: Decision makers in middle-income countries are using economic evaluations (EEs) in pricing and reimbursement decisions for pharmaceuticals. However, whilst many of these jurisdictions have local submission guidelines and local expertise, the studies themselves often use economic models developed elsewhere and elements of data from countries other than the jurisdiction concerned. The objectives of this study were to describe the current situation and to assess the challenges faced by decision makers in transferring data and analyses from other jurisdictions.