TY - JOUR
T1 - Cost-effectiveness of percutaneous closure of a patent foramen ovale compared with medical management in patients with a cryptogenic stroke
T2 - from the US payer perspective
AU - Volpi, John J.
AU - Ridge, John R.
AU - Nakum, Mitesh
AU - Rhodes, John F.
AU - Søndergaard, Lars
AU - Kasner, Scott E.
N1 - Funding Information:
J.V.V. is a consultant and speaker for W.L. Gore & Associates, and a speaker for Amgen and Janssen. M.N. is an employee of Envision Pharma Group Ltd and was commissioned by the sponsor to provide economic modeling and scientific support for the manuscript. J.R.R. is an employee of W.L. Gore & Associates and may hold corporate stock. J.F.R. is a REDUCE study clinical investigator and has received financial support from W.L. Gore & Associates. L.S. is a national principal investigator for the REDUCE study and is compensated for his time by W.L. Gore & Associates. S.E.K. is a national principal investigator for the REDUCE study and is supported by a research grant from W.L. Gore & Associates. Peer reviewers on this manuscript have received an honorarium from J.M.E. for their review work. In addition, one reviewer on this manuscript discloses their role as a member of the RESPECT Trial Steering Committee (Abbott), while another reviewer discloses receiving speaker fees from Abbott. The reviewers have no other relevant financial relationships or otherwise to disclose.
Funding Information:
The study was supported by W.L. Gore & Associates, Inc.
Publisher Copyright:
© 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019
Y1 - 2019
N2 - Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60 years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability. Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%. Results: At 5 years, overall costs and quality-adjusted life-years (QALYs) obtained from PFO closure compared with medical management were $16,323 vs $7,670 and 4.18 vs 3.77, respectively. At 5 years, PFO closure achieved an ICER of $21,049, beneficially lower than the conventional threshold of $50,000. PFO closure reached cost-effectiveness at 2.3 years (ICER = $47,145). Applying discount rates of 0% and 6% had a negligible impact on base-case model findings. Furthermore, PFO closure was 95.4% likely to be cost-effective, with a willingness-to-pay (WTP) threshold of $50,000 and a 5-year time horizon. Limitations: From a cost perspective, our economic model employed a US patient sub-population, so cost data may not extrapolate to other non-US stroke populations. Conclusion: Percutaneous PFO closure plus medical management represents a cost-effective approach for lowering the risk of recurrent stroke compared with medical management alone.
AB - Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60 years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability. Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%. Results: At 5 years, overall costs and quality-adjusted life-years (QALYs) obtained from PFO closure compared with medical management were $16,323 vs $7,670 and 4.18 vs 3.77, respectively. At 5 years, PFO closure achieved an ICER of $21,049, beneficially lower than the conventional threshold of $50,000. PFO closure reached cost-effectiveness at 2.3 years (ICER = $47,145). Applying discount rates of 0% and 6% had a negligible impact on base-case model findings. Furthermore, PFO closure was 95.4% likely to be cost-effective, with a willingness-to-pay (WTP) threshold of $50,000 and a 5-year time horizon. Limitations: From a cost perspective, our economic model employed a US patient sub-population, so cost data may not extrapolate to other non-US stroke populations. Conclusion: Percutaneous PFO closure plus medical management represents a cost-effective approach for lowering the risk of recurrent stroke compared with medical management alone.
KW - Ischemic stroke
KW - cost-effectiveness
KW - cryptogenic stroke
KW - patent foramen ovale
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U2 - 10.1080/13696998.2019.1611587
DO - 10.1080/13696998.2019.1611587
M3 - Article
C2 - 31025589
AN - SCOPUS:85066088258
VL - 22
SP - 883
EP - 890
JO - Journal of Medical Economics
JF - Journal of Medical Economics
SN - 1369-6998
IS - 9
ER -