Cost-effectiveness analysis of shunt surgery for idiopathic normal pressure hydrocephalus based on the SINPHONI and SINPHONI-2 trials
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We showed that ventriculoperitoneal (VP) shunt and lumboperitoneal (LP) shunt surgeries are beneficial for patients with idiopathic normal pressure hydrocephalus (iNPH) in the Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement (SINPHONI; a multicenter prospective cohort study) and in SINPHONI-2 (a multicenter randomized trial). Although therapeutic efficacy is important, cost-effectiveness analysis is equally valuable.
Using both a set of assumptions and using the data from SINPHONI and SINPHONI-2, we estimated the total cost of treatment for iNPH, which consists of medical expenses (e.g., operation fees) and costs to the long-term care insurance system (LCIS) in Japan. Regarding the natural course of iNPH patients, 10% or 20% of patients on each modified Rankin Scale (mRS) show aggravation (aggravation rate: 10% or 20%) every 3 months if the patients do not undergo shunt surgery, as described in a previous report. We performed cost-effectiveness analyses for the various scenarios, calculating the quality-adjusted life year (QALY) and the incremental cost-effective ratio (ICER). Then, based on the definition provided by a previous report, we assessed the cost-effectiveness of shunt surgery for iNPH.
In the first year after shunt surgery, the ICER of VP shunt varies from 29,934 to 40,742 USD (aggravation rate 10% and 20%, respectively) and the ICER of LP shunt varies from 58,346 to 80,392 USD (aggravation rate 10% and 20%, respectively), which indicates that the shunt surgery for iNPH is a cost-effective treatment.
In the 2nd postoperative year, the cost to the LCIS will continue to decrease because of the lasting improvement of the symptoms due to the surgery. The total cost for iNPH patients will show a positive return on investment in as soon as 18 months (VP) and 21 months (LP), indicating that shunt surgery for iNPH is a cost-effective treatment.
Because the total cost for iNPH patients will show a positive return on investment within 2 years, shunt surgery for iNPH is a cost-effective treatment and therefore recommended.
The SINPHONI-2 study was registered with the University Hospital Medical Information Network Clinical Trials registry: UMIN000002730)
SINPHONI was registered with ClinicalTrials.gov, no. NCT00221091.
KeywordsiNPH Ventriculoperitoneal shunt Lumboperitoneal shunt Cost-effectiveness analysis
This study was a project of the Japanese Society of Normal-Pressure Hydrocephalus. We thank the patients for their participation. We would also like to thank both the people who agreed to participate in this trial and the study contributors.
Conception and design: all authors; acquisition of data: all authors; analysis and interpretation of data: all authors; drafting of the article: Kameda; critically reviewing the article: all authors; revising the manuscript: Kameda; reviewing the submitted version of the manuscript: all authors; statistical analysis: Kameda and Yamada; administrative/technical/material support: all authors; study supervision: Atsuchi, Kimura, Kazui, Miyajima, Mori, Ishikawa, and Date.
Compliance with Ethical Standards
Johnson & Johnson and Nihon Medi-Physics provided financial support to the SINPHONI-2 study , and Johnson & Johnson, Nihon Medi-Physics, and Daiichi Pharmaceuticals Co. provided financial support to the SINPHONI study . These sponsors had no role in the design or conduct of this research.
Conflict of Interest
Dr. Miyajima receives clinical and research support from Johnson & Johnson K.K., Inc. (Japan), and Nihon Medi-Physics Co., Ltd. (Japan). Dr. Ishikawa receives lecture fees from Codman and Shurtleff (Japan) and Medtronic Corp. (Japan). Dr. Mori receives honoraria from Johnson & Johnson K.K., Inc.
Dr. Kazui received donations for the 15th Japan Congress of Normal Pressure Hydrocephalus from Johnson & Johnson K.K., Nihon Medi-Physics Co., Ltd., and Medtronic, Inc. and speaker’s honoraria from Johnson & Johnson K.K., Nihon Medi-Physics Co., Ltd., and Medtronic, Inc.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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