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Published in: World Journal of Urology 8/2015

01-08-2015 | Original Article

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System

Authors: Maria Paola Bertapelle, Mario Vottero, Giulio Del Popolo, Marco Mencarini, Edoardo Ostardo, Michele Spinelli, Antonella Giannantoni, Anna D’Ausilio

Published in: World Journal of Urology | Issue 8/2015

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Abstract

Objectives

To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS).

Methods

Direct medical costs (€2011) and benefits (quality-adjusted life years—QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model.

Results

Starting with SNM appears to be cost effective (i.e. under €40.000/QALY) from year three (€21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were €32,975 for early SNM and €33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold.

Conclusions

A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.
Literature
1.
go back to reference Abrams P, Cardozo L, Fall M et al (2003) The standardization of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Urology 61:37–49PubMedCrossRef Abrams P, Cardozo L, Fall M et al (2003) The standardization of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Urology 61:37–49PubMedCrossRef
2.
go back to reference Irwin DE, Milsom I, Kopp Z et al (2006) Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int 97:96–100PubMedCrossRef Irwin DE, Milsom I, Kopp Z et al (2006) Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int 97:96–100PubMedCrossRef
3.
go back to reference Irwin DE, Kopp ZS, Aqatep B et al (2011) Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int 108:1132–1138PubMedCrossRef Irwin DE, Kopp ZS, Aqatep B et al (2011) Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int 108:1132–1138PubMedCrossRef
4.
go back to reference Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on assessment and nonsurgical management of urinary incontinence. EurUrol 62:1130–1142 Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on assessment and nonsurgical management of urinary incontinence. EurUrol 62:1130–1142
5.
go back to reference Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on surgical treatment of urinary incontinence. EurUrol 62:1118–1129 Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on surgical treatment of urinary incontinence. EurUrol 62:1118–1129
6.
go back to reference Arlandis S, Castro D, Errando C et al (2011) Cost-effectiveness of sacral neuromodulation compared to Botulinum neurotoxin A or continued medical management in refractory overactive bladder. Value Health 14:219–228PubMedCrossRef Arlandis S, Castro D, Errando C et al (2011) Cost-effectiveness of sacral neuromodulation compared to Botulinum neurotoxin A or continued medical management in refractory overactive bladder. Value Health 14:219–228PubMedCrossRef
7.
go back to reference Leong RK, de Wachter SG, Joore MA et al (2011) Cost-effectiveness analysis of sacral neuromodulation and Botulinum toxin A treatment for patients with idiopathic overactive bladder. BJU Int 108:558–564PubMedCrossRef Leong RK, de Wachter SG, Joore MA et al (2011) Cost-effectiveness analysis of sacral neuromodulation and Botulinum toxin A treatment for patients with idiopathic overactive bladder. BJU Int 108:558–564PubMedCrossRef
8.
go back to reference Walleser S, Betts C, Hallas N et al (2012) Sacral nerve modulation (SNM) for the treatment of idiopathic refractory overactive bladder: cost-effective in the UK compared to optimal medical therapy, Botulinum toxin A (BoNT-A) and percutaneous tibial nerve stimulation (PTNS). Value Health 15:A354–A355CrossRef Walleser S, Betts C, Hallas N et al (2012) Sacral nerve modulation (SNM) for the treatment of idiopathic refractory overactive bladder: cost-effective in the UK compared to optimal medical therapy, Botulinum toxin A (BoNT-A) and percutaneous tibial nerve stimulation (PTNS). Value Health 15:A354–A355CrossRef
9.
go back to reference Gruppo di lavoro AIES coordinato da Giovanni Fattore (2009) Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia. Politiche Sanitarie 10:91–99 Gruppo di lavoro AIES coordinato da Giovanni Fattore (2009) Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia. Politiche Sanitarie 10:91–99
10.
go back to reference Leong RK, De Wachter SG, Nieman FH et al (2011) PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. NeurourolUrodyn 30:1249–1252 Leong RK, De Wachter SG, Nieman FH et al (2011) PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. NeurourolUrodyn 30:1249–1252
11.
go back to reference Chartier-Kastler E, Ballanger P, Belas M et al (2011) Sacral neuromodulation with InterStim system: results from the French national register. ProgUrol 21:209–217 Chartier-Kastler E, Ballanger P, Belas M et al (2011) Sacral neuromodulation with InterStim system: results from the French national register. ProgUrol 21:209–217
12.
go back to reference Groen J, Blok BF, Bosch JL (2011) Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol 186:954–959PubMedCrossRef Groen J, Blok BF, Bosch JL (2011) Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol 186:954–959PubMedCrossRef
13.
go back to reference Dmochowski R, Chapple C, Nitti VW et al (2010) Efficacy and safety of onabotulinumtoxin A for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol 184:2416–2422PubMedCrossRef Dmochowski R, Chapple C, Nitti VW et al (2010) Efficacy and safety of onabotulinumtoxin A for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol 184:2416–2422PubMedCrossRef
14.
go back to reference Nitti VW, Dmochowsky R, Herschorn S et al (2013) OnabotulinumtoxinA for the treatment of patients with Overactive Bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol 189(6):2186–2193 Nitti VW, Dmochowsky R, Herschorn S et al (2013) OnabotulinumtoxinA for the treatment of patients with Overactive Bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol 189(6):2186–2193
15.
go back to reference Chapple C, Sievert KD, MacDiarmid S et al (2013) OnabotulinumtoxinA 100U significantly improves all idiopathic Overactive Bladder symptoms and quality of life in patients with Overactive Bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol 64(2):249–256 Chapple C, Sievert KD, MacDiarmid S et al (2013) OnabotulinumtoxinA 100U significantly improves all idiopathic Overactive Bladder symptoms and quality of life in patients with Overactive Bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol 64(2):249–256
16.
go back to reference Dowson C, Watkins J, Khan MS et al (2012) Repeated Botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. EurUrol 61:834–839 Dowson C, Watkins J, Khan MS et al (2012) Repeated Botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. EurUrol 61:834–839
17.
go back to reference Mohee A, Khan A, Harris N et al (2012) Long-term outcome of the use of intravesical Botulinum toxin for the treatment of overactive bladder. BJU Int 111:106–113PubMedCrossRef Mohee A, Khan A, Harris N et al (2012) Long-term outcome of the use of intravesical Botulinum toxin for the treatment of overactive bladder. BJU Int 111:106–113PubMedCrossRef
18.
go back to reference Paletta T, Lucioni C, Volpe M (2010) L’EuroQoL (EQ-5D) per la misura dell’utilità negli studi di farmacoeconomia. Considerazioni metodologiche applicate al caso del paziente in dimissione dopo infarto miocardico. Pharmacoecon Ital Res Artic 12:51–59 Paletta T, Lucioni C, Volpe M (2010) L’EuroQoL (EQ-5D) per la misura dell’utilità negli studi di farmacoeconomia. Considerazioni metodologiche applicate al caso del paziente in dimissione dopo infarto miocardico. Pharmacoecon Ital Res Artic 12:51–59
19.
go back to reference Currie CJ, McEwan P, Poole CD et al (2006) The impact of the overactive bladder on health-related utility and quality of life. BJU Int 97:1267–1272PubMedCrossRef Currie CJ, McEwan P, Poole CD et al (2006) The impact of the overactive bladder on health-related utility and quality of life. BJU Int 97:1267–1272PubMedCrossRef
20.
go back to reference L’informatore farmaceutico – Medicinali 2011. Elsevier, Milano, 2011 L’informatore farmaceutico – Medicinali 2011. Elsevier, Milano, 2011
21.
go back to reference Age.Na.S. Prestazioni specialistiche ambulatoriali. Confronto tariffe nazionali ex DM1996 e le tariffe regionali vigenti nel 2009, 2009 Age.Na.S. Prestazioni specialistiche ambulatoriali. Confronto tariffe nazionali ex DM1996 e le tariffe regionali vigenti nel 2009, 2009
22.
go back to reference Servizio Infermieristico 537. Costituzione della Commissione per il monitoraggio e la prevenzione dell’incontinenza. ASL Trieste. 2006 Servizio Infermieristico 537. Costituzione della Commissione per il monitoraggio e la prevenzione dell’incontinenza. ASL Trieste. 2006
23.
go back to reference Scroccaro G, Steffenino G, Marini P et al (2005) La valutazione dei benefici e dei costi dei dispositivi medici. Il caso degli stent medicati. Pharmacoecon Ital Res Artic 7:195–206 Scroccaro G, Steffenino G, Marini P et al (2005) La valutazione dei benefici e dei costi dei dispositivi medici. Il caso degli stent medicati. Pharmacoecon Ital Res Artic 7:195–206
24.
go back to reference Ganz M, Clemens JQ, Anger J et al (2011) A Markov model comparing sacral neuromodulation and Botulinum toxin-A for medicare patients with idiopathic overactive bladder refractory to conservative care. Value Health 14:A211–A214 Ganz M, Clemens JQ, Anger J et al (2011) A Markov model comparing sacral neuromodulation and Botulinum toxin-A for medicare patients with idiopathic overactive bladder refractory to conservative care. Value Health 14:A211–A214
25.
go back to reference Hassouna M, Corcos J, Dwyer N et al (2012) Cost-effectiveness of sacral neuromodulation in refractory overactive bladder: a Canadian perspective. J Urol 187(4S):e117 Hassouna M, Corcos J, Dwyer N et al (2012) Cost-effectiveness of sacral neuromodulation in refractory overactive bladder: a Canadian perspective. J Urol 187(4S):e117
26.
go back to reference Siddiqui NY, Amundsen CL, Visco AG et al (2009) Cost-effectiveness of sacral neuromodulation versus intravesical Botulinum A toxin for treatment of refractory urge incontinence. J Urol 182:2799–2804PubMedCrossRef Siddiqui NY, Amundsen CL, Visco AG et al (2009) Cost-effectiveness of sacral neuromodulation versus intravesical Botulinum A toxin for treatment of refractory urge incontinence. J Urol 182:2799–2804PubMedCrossRef
27.
go back to reference Borawski KM, Foster RT, Webster GD et al (2007) Predicting implantation with a neuromodulator using two different test stimulation techniques: a prospective randomized study in urge incontinent women. NeurourolUrodyn 26:14–18 Borawski KM, Foster RT, Webster GD et al (2007) Predicting implantation with a neuromodulator using two different test stimulation techniques: a prospective randomized study in urge incontinent women. NeurourolUrodyn 26:14–18
28.
go back to reference van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP et al (2007) Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol 178:2029–2034PubMedCrossRef van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP et al (2007) Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol 178:2029–2034PubMedCrossRef
29.
go back to reference Kessler TM, La FD, Trelle S et al (2010) Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. EurUrol 58:865–874 Kessler TM, La FD, Trelle S et al (2010) Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. EurUrol 58:865–874
30.
go back to reference Sahai A, Dowson C, Khan MS et al (2010) Repeated injections of Botulinum toxin-A for idiopathic detrusor overactivity. Urology 75:552–558PubMedCrossRef Sahai A, Dowson C, Khan MS et al (2010) Repeated injections of Botulinum toxin-A for idiopathic detrusor overactivity. Urology 75:552–558PubMedCrossRef
31.
go back to reference Watanabe JH, Campbell JD, Ravelo A, Chancellor MB, Kowalski J, Sullivan SD (2010) Cost analysis of interventions for antimuscarinic refractory patients with overactive bladder. Urology 76(4):835–840PubMedCrossRef Watanabe JH, Campbell JD, Ravelo A, Chancellor MB, Kowalski J, Sullivan SD (2010) Cost analysis of interventions for antimuscarinic refractory patients with overactive bladder. Urology 76(4):835–840PubMedCrossRef
Metadata
Title
Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System
Authors
Maria Paola Bertapelle
Mario Vottero
Giulio Del Popolo
Marco Mencarini
Edoardo Ostardo
Michele Spinelli
Antonella Giannantoni
Anna D’Ausilio
Publication date
01-08-2015
Publisher
Springer Berlin Heidelberg
Published in
World Journal of Urology / Issue 8/2015
Print ISSN: 0724-4983
Electronic ISSN: 1433-8726
DOI
https://doi.org/10.1007/s00345-014-1401-7

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