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

Myung, Jae-Eun; Tanaka, Yuji; Choi, Hyunsook; Strachan, Liesl; Watanuki, Tomohiro; Lee, Ji‐Hyun; Hwang, Hyojung; Lee, Sang-Soo

doi:10.31662/jmaj.2021-0011

Cited by 2 publications

(4 citation statements)

References 20 publications

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“…In Australia, CED schemes are referred to as ‘interim funding schemes’, however they are not currently utilised for medical device technologies [ 60 ]. CED schemes assist in addressing uncertainties around costs and outcomes by generating evidence on the effectiveness and efficiency of new medical technologies [ 61 ]. Japan and South Korea recommended the use of CED to overcome the challenge of a lack of robust clinical data in the early phases of the adoption of a new medical technology [ 61 ].…”

Section: Discussionmentioning

confidence: 99%

“…CED schemes assist in addressing uncertainties around costs and outcomes by generating evidence on the effectiveness and efficiency of new medical technologies [ 61 ]. Japan and South Korea recommended the use of CED to overcome the challenge of a lack of robust clinical data in the early phases of the adoption of a new medical technology [ 61 ]. The use of CED data from countries in Asia-Pacific can support reimbursement applications in Australia.…”

Section: Discussionmentioning

confidence: 99%

“…The Australian Department of Health and Aged Care (DoHAC) can actively engage and participate in collaboratively designing and implementing CED schemes with multiple stakeholders to enable patients to benefit by improved access to innovative medical technologies [ 61 ].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

Gumbie

Costa

Erb

et al. 2022

Journal of Market Access & Health Policy

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Purpose The success of reverse total shoulder arthroplasty (RTSA) has expanded its use for a broader range of shoulder indications worldwide. Evidence regarding the relative efficacy and long-term safety of medical technologies used in RTSA is subjected to rigorous assessment. Nonetheless, substantial challenges impede market access for innovative shoulder implant technologies for RTSA in Australia, resulting in delayed patient access. Approach This paper addresses the key challenges associated with generating evidence for the health technology assessments of innovative medical technologies for RTSA that are required for access to the Australian market. The transition to value-based care requires establishing a benchmarking reference that incorporates patient-reported outcome measures (PROMs) and combines revision outcomes with additional clinical outcomes to increase patient cohort sizes. Establishing the benchmark would require agreement on the outcome measures to be collected for each indication, and investment in reporting patient-reported outcomes for RTSA to the national orthopaedic registry. Implications for practice The need for increased flexibility in developing evidence for health technology assessment of RTSA medical technologies is required. Optimised approaches for benchmarking RTSA require extensive stakeholder discussions, including the agreement on evidence requirements and follow-up periods, selection of clinical outcomes, as well as pre-operative and post-operative PROMs as a value assessment.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

Gumbie

Costa

Erb

et al. 2022

Journal of Market Access & Health Policy

View full text Add to dashboard Cite

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“… 19 When the clinical effectiveness of rATP was approved by the Japanese regulatory authority in the challenge application programme, novel functional categories with higher reimbursement prices than CIEDs without rATP were established for pacemakers (PMs) and CRT-D devices with rATP. 20 However, to the best of our knowledge, no studies have examined the cost-effectiveness of rATP. Therefore, the aim of this study was to assess the cost-effectiveness of rATP in PMs and CRT-D devices and the functional categories of these devices in the Japanese public health insurance system.…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing

Noda

Ueda

Tanaka³

et al. 2023

EP Europace

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Aims Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. Methods and results We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. Conclusion According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

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

Cited by 2 publications

References 20 publications

Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing

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