2025.3.21

Medical Device HTA Decisions in Japan (as of March 2025)

On March 12 the Central Social Insurance Medical Council, or Chuikyo, which is Japan's advisory group on healthcare reimbursement announced a decision on the healthcare technology assessment (HTA) of W.L. Gore & Associates' GORE TAG Conformable Thoracic Stent Graft system (hereafter, GORE TAG). This is the 3rd HTA decision for a reimbursed medical device in Japan since the launch of Japan's HTA system in April 2019. In Japan, HTA is considered after the listing of a new reimbursed medical device, drug, or regenerative medicine product and only products that meet specific criteria are selected for HTA. Hasegawa et al. (2021) provide an detailed overview the HTA process in Japan.

When products are selected for a formal HTA in Japan, the manufacturer must submit a cost-effectiveness analysis (CEA) within 9 months of the listing decision of the product or they will lose their reimbursement premium and/or face a reduction in their operating profit ratio. Please see our publication here for a detailed overview of the HTA process in Japan and other CEAs conducted for reimbursed medical devices in Japan - as well as an overview of the two previous HTA decisions for reimbursed medical devices in Japan, namely Medtronic's Micra Transcatheter Pacing System (hereafter, Micra AV) and Johnson and Johnson's Expedium Verse Fenestrated Screw System (hereafter, Expedium).

The table below provides overview of the HTA evaluation for the GORE TAG and the analysis framework used - as well as the evaluation and framework for the other two medical device HTA decisions (Micra AV and Expedium). GORE TAG was selected for HTA review in Japan based on having received a premium of 5% for its reimbursement price relative to the comparator (i.e. conventional stent grafts) due to its improvement in function and having projected peak annual sales of 8.13 billion JPY (approx. 54.4 million USD), assuming 9-year peak sales. The premium for GORE TAG was awarded because it was said to provide a safer treatment due to an improvement function - namely a lower incidence of post-operative leakage. (Note: GORE TAG is actually an example of one of a few products that was re-evaluated for reimbursement based on the "challenge submission" process introduced in Japan in April 2020, which allows devices with limited data at initial approval to be re-evaluated for reimbursement after listing. We will share more info on that system in a future update).

The manufacturer of GORE TAG conducted a cost-utility analysis (CUA) from the payer perspective as recommended by the pharmacoeconomic guidelines for Japan. A Markov model with four health states (initial surgery, postoperative follow-up, re-intervention, and death) was used. However, the analysis model assumed that the quality-of-life scores did not vary by health status, so ultimately a cost-minimization analysis (CMA) was conducted. The manufacturer analysis found a cost savings of -615,824 JPY per thoracic aortic aneurysm (TAA) case and -664,428 JPY per Stanford type B aortic dissection (TBAD) case. The public analysis group also conducted a CMA and found a cost savings of -615,824 JPY per TAA case and -138,594 JPY per TBAD case. (The reason for the lower cost savings for TBAD for the public analysis is not entirely clear, but the manufacturer assumed slightly higher follow-up costs for the comparator group than the public analysis group.) Based on these results, no change (reduction) in the reimbursement price for GORE TAG was required.

Some points raised during discussions with y the Chuikyo expert committee were as follows:

(1) Concerning the analysis framework:
- The expert committee felt that the indication for patients with traumatic thoracic aortic injury is very important due to the high need, but it was allowed to be excluded from the analysis due to the limited proportion of patients that had that indication.

(2) Concerning the additional benefit:
- The manufacturer wanted to use (1) the number of devices initially implanted, (2) the rapid pacing implementation rate, (3) overall survival rate, and (4) the reoperation rate as outcome measures for the CUA, but the expert committee said it would be inappropriate to use (1) and (2) as outcome measures because it is not clear whether they contribute to improved long-term outcomes.
- The manufacturer wanted to use a specific registry, the GREAT registry, which is a registry for the previous generation of the GORE TAG product, due to the short follow-up period for an alternative registry (the SURPASS registry). But the expert committee said that the alternative registry should be used since the previous generation of the product is a comparator technology for analysis.

Lastly, it seems that the manufacturer was hoping for a price increase due to the cost savings, but since no additional benefit was demonstrated (i.e., it was not shown to be "dominant" or substantially cost-effective) and the stent graft itself is the same product for this product and the comparative control technology an increase was not allowed. (It seems that the manufacturer appealed this decision, but Chuikyo expert committee again concluded that the results of the assessment did not meet the requirements for a price increase and that the results of the public analysis group were appropriate.)

Closing thoughts:

Although about 63 devices, drugs, and regenerative medicine products have been selected for HTA review since the system was introduced in April 2019, only 3 of those products have been devices. So the selection of reimbursed medical devices for HTA in Japan is somewhat rare. This is primarily due to the fact that most devices do not meet the peak annual sales threshold of 5 billion JPY (approximately 33.5 million USD) per year for HTA selection. However, if selected, a manufacturer must show cost-effectiveness based on a threshold of 5 million JPY (approximately 33,500 JPY) per quality-adjusted life year (QALY) or a cost-savings AND that analysis must be upheld based on a review (or re-analysis) by a public analysis group - also referred to as the Academic Technology Assessment Group (ATAG) - or face a reduction in their reimbursement price. The assessment of Micra and Expedium led to a reduction in their reimbursement price of 8.56% and 3.07%, respectively. In both of those cases, the results of the public analysis group were substantially worse that the results of of the manufacturer analysis and the public analysis group's results were prioritized (as is almost always the case!). GORE TAG was able to avoid a reduction in their reimbursement price because the public analysis groups results also showed a cost savings for the both of the indications, but it could have easily gone less smoothly. Please contact us if you would like support with the development of economic evidence for a new device in Japan, including evidence to support an HTA for Japan.

HTA Evaluations for Reimbursed Medical Devices in Japan (as of March 2025)

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