Key Recommendations from the MedtecHTA Project

Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

doi:10.1002/hec.3468

Cited by 49 publications

(55 citation statements)

References 8 publications

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“…As is often pointed out, the HTA of a medical device has many difficulties due to insufficient clinical evidence, which is based on methods such as randomized control trials, the influence of the learning curve, frequent product improvement, and others. If such difficulties are to be properly solved, it will be important to introduce the HTA concept appropriately …”

Section: Discussionmentioning

confidence: 99%

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Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate?

Tamura

Nakano

2018

Health Planning & Management

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Summary Objectives In Japan, strong reimbursement pricing control measures for existing medical device products have rendered new medical device reimbursement pricing critical for manufacturers. Few studies have been conducted on this aspect; therefore, this paper (1) clarifies whether evaluation of innovation is appropriate or not and (2), if not, investigates its background. Methods In this research, 319 C1/C2 government decisions for new medical devices in the 10 years from April 2008 to March 2018 were analyzed. Evaluation of innovation was considered in terms of the reimbursement price, as well as the foreign average price ratio. Results Considering the degree of evaluation of innovation, the average premium rate for the similar function category comparison method was 10.2% during 2008 to 2010 (this means the newly set reimbursement price was 10.2% higher than that of corresponded exiting categories); it declined consistently thereafter, to 3.2% during 2016 to 2018. Moreover, evaluation of innovation by the foreign average price (FAP) ratio was 1.04 in 2008 to 2010, consistently decreasing to 0.88 in 2016 to 2018. The period from product approval to the non‐Special Designated Treatment Material (non‐STM) (a part of technical fee) price listing is much longer than that of the STM (own reimbursement price) listing. Conclusion Several reasons were considered for the decline in innovation evaluation: (1) the lowering of the FAP upper limit ratio, (2) the possibility that there was not enough evidence at the time of price listing, (3) and the more rigorous standards to create a new separate functional category. However, some aspects were attributable to reimbursement system reform.

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Section: Discussionmentioning

confidence: 99%

“…If such difficulties are to be properly solved, it will be important to introduce the HTA concept appropriately. 11…”

Section: Sufficiency Of the Reimbursement Pricementioning

confidence: 99%

Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate?

Tamura

Nakano

2018

Health Planning & Management

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“…In addition, recommendations on developments in methodology were made for the scientific community. These recommendations are summarized in the final paper in this supplement (Tarricone et al , ). These are divided into recommendations for policy, recommendations for methods and recommendations for further research.…”

Section: Dissemination Of Project Findingsmentioning

confidence: 99%

Challenges in the Assessment of Medical Devices: The MedtecHTA Project

2017

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Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing.The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs.This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project.

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“…The recent European Union MedtecHTA Project made further recommendations concerning the design of registries to facilitate the assessment of comparative effectiveness. Ideally, registries should include more than one device, routinely collect information on possible confounding factors in order to facilitate the analysis of observational data, collect data on treatment patterns and resource use over time in order to monitor learning effects and stratify patients by level of risk [12].…”

Section: Strengthening the Arrangements For Post-market Researchmentioning

confidence: 99%