| アブストラクト | BACKGROUND: Collagenase Clostridium histolyticum (CCH) injection, an effective enzymatic fasciotomy treatment for Dupuytren disease (DD), was abruptly withdrawn from the healthcare market outside the United States in 2020. The impact on patients, physicians and hospitals of this helpful surgical alternative no longer being available has been little studied. METHODS: To investigate the impact of the withdrawal of CCH in Japan, we used the National Database Open Data Japan from 2014 to 2020. Published by the government, it contains summary data of the National Database of Health Insurance Claims and Specific Health Checkups of Japan. We extracted the numbers of CCH injections with Xiaflex, the product name in Japan, and surgeries identified by "Dupuytren contracture surgery codes." Each treatment was further parsed into one of 12 predefined regions in which it had taken place and by whether it had been delivered on an inpatient or outpatient basis. RESULTS: From its introduction in 2015, the number of DD patients treated with CCH increased in each successive year, reaching a peak in 2019, while the number of surgeries decreased with time. After the withdrawal in 2020, the number of surgeries increased to 1.5 times the 2019 number notwithstanding the impact of COVID-19, but the total number of patients treated decreased by 43%. In the initial regional analysis, CCH accounted for approximately 40% of all DD treatments in the less populous areas, with the exception of the Tohoku region, and more than 50% in the other regions. By 2019, the share of CCH treatment had increased in all regions. There was no significant correlation between the number of hand surgeons authorized to use CCH and the number of CCH cases within each region. CONCLUSIONS: CCH increased treatment options for patients and surgeons. The withdrawal of this valuable pharmaceutical resulted in an increase in the number of surgeries amidst a decrease in the total number of treatments and lost opportunities for patients. |
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