Advertisement

A cost-utility analysis of phosphodiesterase type 5 inhibitors in the treatment of erectile dysfunction

  • Svenn Alexander Hansen
  • Eline AasEmail author
  • Oddvar Solli
Original Paper

Abstract

Introduction

Patent expiration for erectile dysfunction (ED) treatments like sildenafil means loss of exclusivity (LOE), and other manufacturers may bring generics to the market. This has resulted in price reductions, which influences the cost-effectiveness. In Norway, this development has led to a discussion on whether reimbursement should be granted. Cost-effectiveness analysis in this treatment area is scarce and more research is demanded.

Objective

The objective of this study was to assess the cost-effectiveness of three separate phosphodiesterase type 5 (PDE5) inhibitors in ED therapy in a Norwegian setting.

Methods

The cost-effectiveness was analyzed using two patient populations: (1) 55-year-old patients diagnosed with ED and with no specific underlying illness, and (2) 55-year-old patients diagnosed with ED and with diabetes as an underlying illness. Using a state-transition Markov model with a 10-year time horizon, a “no-treatment” option was compared with three treatment strategies: (1) treatment using 50/100 mg sildenafil; (2) treatment using 10/20 mg tadalafil; (3) treatment using 10 mg vardenafil. A societal perspective was applied.

Results

All PDE5 inhibitor treatment strategies were cost-effective compared to a “no-treatment” option, with cost per additional quality-adjusted life-year of less than €15,000. With a willingness-to-pay threshold greater than €13,500, sildenafil was estimated as the dominant treatment strategy. The probabilistic sensitivity analysis indicated robust results. However, as the expected value of information was considerable, the cost-effectiveness of conducting further research to reduce uncertainty should be considered. Treating a diabetic population was less cost-effective for all PDE5 inhibitors and was associated with greater uncertainty with regard to choosing the optimal strategy.

Conclusions

Sildenafil treatment of erectile dysfunction was a cost-effective alternative compared to tadalafil and vardenafil, as well as compared to a “no-treatment” option. Treating a diabetic population is less cost-effective for all PDE5 inhibitors and was associated with greater uncertainty.

Keywords

Erectile dysfunction Diabetes Cost-effectiveness analysis Cost-utility analysis Phosphodiesterase type 5 inhibitors CEAC EVPI 

JEL Classification

I1 D61 C1 

Notes

Supplementary material

10198_2019_1112_MOESM1_ESM.docx (240 kb)
Supplementary material 1 (DOCX 241 kb)

References

  1. 1.
    NIH Conference: NIH Consensus Conference. Impotence. NIH Consensus development panel on impotence. JAMA 270(1), 83–90 (1993)CrossRefGoogle Scholar
  2. 2.
    Althof, S.E.: Quality of life and erectile dysfunction. Urology 59(6), 803–810 (2002)CrossRefGoogle Scholar
  3. 3.
    Vaaler, S. et al.: Erectile dysfunction among Norwegian men over 40 years of age. Tidsskr. Nor. Legeforen 121, 28–32. https://www.tidsskriftet.no/2001/01/klinikk-og-forskning/erektil-dysfunksjon-hos-norske-menn-over-40-ar (2001). Accessed 4 Aug 2017
  4. 4.
    Tsertsvadze, A.: University of Ottawa evidence-based practice C, United States agency for healthcare R, quality. Diagnosis and treatment of erectile dysfunction: US dept of health and human services agency for healthcare research and quality-AHRQ Publication (2009)Google Scholar
  5. 5.
    Chen, L., et al.: Phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction: a trade-off network meta-analysis. Eur. Urol. 68(4), 674–680 (2015)CrossRefGoogle Scholar
  6. 6.
    Tsertsvadze, A., et al.: Oral sildenafil citrate (Viagra) for erectile dysfunction: a systematic review and meta-analysis of harms. Urology 74(4), 831–836 (2009). (e8) CrossRefGoogle Scholar
  7. 7.
    Yuan, J., et al.: Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur. Urol. 63(5), 902–912 (2013)CrossRefGoogle Scholar
  8. 8.
    Hatzimouratidis, K., et al.: Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur. Urol. 57(5), 804–814 (2010)CrossRefGoogle Scholar
  9. 9.
    Taylor, J., et al.: Differences in side effect duration and related bother levels between phosphodiesterase type 5 inhibitors. BJU Int. 103(10), 1392–1395 (2009)CrossRefGoogle Scholar
  10. 10.
    The European Medicines Agency. ANNEX 1—summary of product characteristics—CIALIS. https://www.ema.europa.eu/en/documents/product-information/cialis-epar-product-information_en.pdf (2017). Accessed 4 Aug 2017
  11. 11.
    The European Medicines Agency. ANNEX 1—Summary of product characteristics—VARDENAFIL. https://www.ema.europa.eu/en/documents/product-information/levitra-epar-product-information_en.pdf (2017). Accessed 4 Aug 2017
  12. 12.
    The European Medicines Agency. ANNEX 1.Summary of product characteristics—VIAGRA. https://www.ema.europa.eu/en/documents/product-information/viagra-epar-product-information_en.pdf (2017). Accessed 4 Aug 2017
  13. 13.
    Hearing – forslag til endringer i legemiddelforskriften § 14-14: Hearing before the ministry of health and care services – Norway: Document number (L)(982698) Sess. (17.02.2016)Google Scholar
  14. 14.
    Smith, K.J., Roberts, M.S.: The cost-effectiveness of sildenafil. Ann. Intern. Med. 132(12), 933–937 (2000)CrossRefGoogle Scholar
  15. 15.
    Stolk, E.A., et al.: Cost utility analysis of sildenafil compared with papaverine-phentolamine injections. BMJ 320(7243), 1165–1168 (2000)CrossRefGoogle Scholar
  16. 16.
    Mittmann, N., et al.: Erectile dysfunction in spinal cord injury: a cost-utility analysis. J. Rehabil. Med. 37(6), 358–364 (2005)CrossRefGoogle Scholar
  17. 17.
    Dansinger, M. Erectile dysfunction and diabetes. https://www.webmd.com/erectile-dysfunction/guide/ed-diabetes (2017). Accessed 6 May 2017
  18. 18.
    Briggs, A., Claxton, K., Sculpher, M.J.: Decision modelling for health economic evaluation. Handbooks in health economic evaluation series. Oxford University Press, Oxford (2006). (Reprint 2011) Google Scholar
  19. 19.
    Drummond, M.F., et al.: Methods for the economic evaluation of health care programmes. Oxford University Press, Oxford (2015)Google Scholar
  20. 20.
    Neumann, P.J., et al.: Cost-effectiveness in health and medicine. Oxford University Press, Oxford (2016)CrossRefGoogle Scholar
  21. 21.
    Naimark, D.M.J., Bott, M., Krahn, M.: The half-cycle correction explained: two alternative pedagogical approaches. Med. Decision Mak. 28(5), 706 (2008)CrossRefGoogle Scholar
  22. 22.
    Statens legemiddelverk, Helsedirektoratet, (eds.): Retningslinjer for legemiddeløkonomiske analyser. Statens legemiddelverk, Oslo (2012)Google Scholar
  23. 23.
    Waaler Bjornelv, G.M., et al.: Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial. Osteoporos. Int. 23(6), 1711–1719 (2012)CrossRefGoogle Scholar
  24. 24.
    Statens legemiddelverk. Trinnpris. https://legemiddelverket.no/refusjon-og-pris/pris-pa-legemidler/trinnpris (2016). Accessed 4 Mar 2017
  25. 25.
    Tsertsvadze, A., et al.: Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile dysfunction: a systematic review and meta-analysis. Ann. Intern. Med. 151(9), 650–661 (2009)CrossRefGoogle Scholar
  26. 26.
    Corona, G., et al.: First-generation phosphodiesterase type 5 inhibitors dropout: a comprehensive review and meta-analysis. Andrology 4(6), 1002–1009 (2016)CrossRefGoogle Scholar
  27. 27.
    Eardley, I., et al.: Factors associated with preference for sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy: post hoc analysis of data from a multicentre, randomized, open-label, crossover study. BJU International 100(1), 122–129 (2007)CrossRefGoogle Scholar
  28. 28.
    Mohee, A., Bretsztajn, L., Storey, A., Eardley, I.: Management of ED under the “Severe Distress” Criteria in the NHS: A Real-Life Study. J. Sex. Med. 11(4), 1056–1062 (2014)CrossRefGoogle Scholar
  29. 29.
    Smith, K., Roberts, M.: Quality-of-life utility values for erectile function and sildenafil treatment. Clin. Drug Investig. 25(2), 99–105 (2005)CrossRefGoogle Scholar
  30. 30.
    Zhang, P., et al.: Health utility scores for people with type 2 diabetes in US managed care health plans: results from Translating Research Into Action for Diabetes (TRIAD). Diabetes Care 35(11), 2250 (2012)CrossRefGoogle Scholar
  31. 31.
    Xu, R., et al.: EuroQol (EQ-5D) health utility scores for patients with migraine. An international journal of quality of life aspects of treatment, care and rehabilitation—official journal of the international society of quality of life research 20(4), 601–608 (2011)Google Scholar
  32. 32.
    Groeneveld, P.W., et al.: Quality of life measurement clarifies the cost-effectiveness of Helicobacter pylori eradication in peptic ulcer disease and uninvestigated dyspepsia 1 1. Am. J. Gastroenterol. 96(2), 338–347 (2001)Google Scholar
  33. 33.
    Smith, D., et al.: Lower visual acuity predicts worse utility values among patients with type 2 diabetes. Int. J. Quality Life Aspects Treat. Care Rehabil. 17(10), 1277–1284 (2008)CrossRefGoogle Scholar
  34. 34.
    Lai, K.C., et al.: Assessing patient utilities for varying degrees of low back pain. Acad. Radiol. 12(4), 467–474 (2005)CrossRefGoogle Scholar
  35. 35.
    Mittmann, N., et al.: Utility scores for chronic conditions in a community-dwelling population. PharmacoEconomics 15(4), 369–376 (1999)CrossRefGoogle Scholar
  36. 36.
    Statens legemiddelverk. Legemiddelsøk. https://www.legemiddelsok.no/ (2017). Accessed 1 June 2017
  37. 37.
    Statens Legemiddelverk. Single Technology Assessment - Dabigatran (Pradaxa) til forebygging av slag og systemisk emboli. legemiddelverket.no: 2012: Report Number 22-05-2012Google Scholar
  38. 38.
    The Norwegian Institute of Public Health. Norwegian prescription database. http://www.norpd.no/
  39. 39.
    The Norwegian Medicines Agency. Apotekavanse. https://legemiddelverket.no/refusjon-og-pris/pris-pa-legemidler/apotekavanse (2017). Accessed 4 Aug 2017
  40. 40.
    Eddy, D.M., Hollingworth, W., Caro, J.J., Tsevat, J., McDonald, K.M., Wong, J.B., et al.: Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force–7. Value Health 15(6), 843–850 (2012)CrossRefGoogle Scholar
  41. 41.
    Padma-Nathan, H., et al.: Treatment of men with erectile dysfunction with transurethral alprostadil. N. Engl. J. Med. 336(1), 1–7 (1997)CrossRefGoogle Scholar
  42. 42.
    Drummond, M.F., et al.: Methods for the economic evaluation of health care programmes, 4th edn. Oxford University Press, Oxford (2015)Google Scholar
  43. 43.
    Statistics Norway. Table 10325—deaths by sex and one year age groups. https://www.ssb.no/en/statbank/table/10325/ (2016). Accessed 4 Aug 2017
  44. 44.
    Den Norske legeforening. Normaltariff for fastleger og legevakt. https://normaltariffen.legeforeningen.no/pdf/Fastlegetariff_2016.pdf (2016). Accessed 4 Aug 2017

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Svenn Alexander Hansen
    • 1
  • Eline Aas
    • 2
    Email author
  • Oddvar Solli
    • 3
  1. 1.University of OsloOsloNorway
  2. 2.Department of Health Management and Health Economics, Institute for Health and SocietyUniversity of OsloOsloNorway
  3. 3.Pfizer ASOsloNorway

Personalised recommendations