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

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.

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References

  1. 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 61:37–49

    PubMed  Article  Google Scholar 

  2. 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 97:96–100

    PubMed  Article  Google Scholar 

  3. 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 108:1132–1138

    PubMed  Article  Google Scholar 

  4. Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on assessment and nonsurgical management of urinary incontinence. EurUrol 62:1130–1142

    Google Scholar 

  5. Lucas MG, Bosch RJ, Burkhard FC et al (2012) EAU guidelines on surgical treatment of urinary incontinence. EurUrol 62:1118–1129

    Google Scholar 

  6. 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 14:219–228

    PubMed  Article  Google Scholar 

  7. 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 108:558–564

    CAS  PubMed  Article  Google Scholar 

  8. 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–A355

    Article  Google Scholar 

  9. 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

    Google Scholar 

  10. 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

    Google Scholar 

  11. 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

    CAS  Google Scholar 

  12. 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 186:954–959

    PubMed  Article  Google Scholar 

  13. 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 184:2416–2422

    CAS  PubMed  Article  Google Scholar 

  14. 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. 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. 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

    CAS  Google Scholar 

  17. 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 111:106–113

    PubMed  Article  Google Scholar 

  18. 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. 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 97:1267–1272

    PubMed  Article  Google Scholar 

  20. L’informatore farmaceutico – Medicinali 2011. Elsevier, Milano, 2011

  21. Age.Na.S. Prestazioni specialistiche ambulatoriali. Confronto tariffe nazionali ex DM1996 e le tariffe regionali vigenti nel 2009, 2009

  22. Servizio Infermieristico 537. Costituzione della Commissione per il monitoraggio e la prevenzione dell’incontinenza. ASL Trieste. 2006

  23. 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. 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

    Google Scholar 

  25. 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. 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 182:2799–2804

    PubMed  Article  Google Scholar 

  27. 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

    Google Scholar 

  28. 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 178:2029–2034

    PubMed  Article  Google Scholar 

  29. 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

    Google Scholar 

  30. Sahai A, Dowson C, Khan MS et al (2010) Repeated injections of Botulinum toxin-A for idiopathic detrusor overactivity. Urology 75:552–558

    PubMed  Article  Google Scholar 

  31. 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):835–840

    PubMed  Article  Google Scholar 

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Acknowledgments

The authors thank Medtronic for the permission of adaptation of the model used to perform the study. The economic evaluation was conducted by a Private Company, MSc, Creativ-Ceutical, Milan, Italy, supported by a grant by Medtronic, which never interfered with the evaluation of data and the results of the study. The authors thank Medtronic also for the propriety demonstrated in order to guarantee the intellectual autonomy of the Authors.

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Correspondence to Maria Paola Bertapelle.

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Bertapelle, M.P., Vottero, M., Popolo, G.D. et al. Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System. World J Urol 33, 1109–1117 (2015). https://doi.org/10.1007/s00345-014-1401-7

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  • DOI: https://doi.org/10.1007/s00345-014-1401-7

Keywords

  • Botulinum toxin A
  • Cost-utility analysis
  • Overactive bladder
  • Sacral neuromodulation