Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review.

It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken.

Factors associated with cardiac implantable electronic device-related infections, New South Wales, 2016-21: a retrospective cohort study.

Objectives: To quantify the rate of cardiac implantable electronic device (CIED)-related infections and to identify risk factors for such infections.

Design: Retrospective cohort study; analysis of linked hospital admissions and mortality data.

Setting, Participants: All adults who underwent CIED procedures in New South Wales between 1 January 2016 and 30 June 2021 (public hospitals) or 30 June 2020 (private hospitals).

Real-world evidence on the association between cardiac implantable electronic device infection and all-cause mortality.

Aims: An infection following cardiac implantable electronic device (CIED) procedure is a serious complication, but its association with all-cause mortality is inconsistent across observational studies. To quantify the association between CIED infection and all-cause mortality in a large, contemporary cohort from New South Wales, Australia.

Methods And Results: This retrospective cohort study used linked hospital and mortality data and included all patients aged >18 years who underwent a CIED procedure between July 2017 and September 2022.

Reimbursement Coverage Decision Making for Digital Health Technologies in South Korea: Does It Fit the Value Framework Used in Traditional Medical Technologies?

Objectives: The introduction of digital health technologies (DHTs) that have the potential to improve health outcomes and lower the costs of healthcare services has seen an explosion in recent years. Indeed, the expectation that these innovative technologies can ultimately fill a gap in the patient-healthcare provider model of care with the hope of bending the continuously increasing healthcare expenditure curve has not yet been realized in many countries including South Korea (from herein referred to as Korea). We examine reimbursement coverage decision making status for DHTs in South Korea.

Current Medical Technology Reimbursement System in Japan.

Objectives: The process for reimbursement of medical technologies in Japan is complex, and to date, it has not been well described overall. This article aims to provide an overview of the reimbursement system for medical technologies in Japan, including the reimbursement application process and the payment decision making.

Methods: Conduct review for relevant health policy and regulation and gather opinion from the key stakeholders.

Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea.

In this article, the operational characteristics of coverage with evidence development (CED) programs in Asia-Pacific regions, focusing on two countries-Japan and South Korea-are reviewed. Both countries recommended the introduction of CED to overcome the barrier of lack of robust clinical evidence in the early stages of the introduction of a medical technology. However, each country has a unique approach to CED implementation that reflects the differences in establishment and healthcare and policy environments.

Delayed Patient Access to Innovative Medical Technologies in South Korea: A Lead-Time Analysis of Reimbursement Coverage Determinations.

Unlabelled: Background and ObjectivesTimely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health outcomes of patients who often have few therapeutic alternatives. We analyzed lead-times for the medical procedure reimbursement coverage process undertaken in South Korea from 2014 to 2017, which is considered one of the most important factors contributing to delays in patient access to new medical technologies.

Methods: This analysis was performed using the open datasets source of "Medical Procedure Expert Evaluation Committee (MPEEC)" meeting results and medical procedure coverage application information published on the Health Insurance Review and Assessment Service Web site.