Cost-Effectiveness Analysis of Tapentadol Versus Oxycodone/Naloxone in both Branded and Generic Formulations in Patients with Musculoskeletal Pain.
Journal
Clinical drug investigation
ISSN: 1179-1918
Titre abrégé: Clin Drug Investig
Pays: New Zealand
ID NLM: 9504817
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
accepted:
08
08
2021
pubmed:
16
9
2021
medline:
2
10
2021
entrez:
15
9
2021
Statut:
ppublish
Résumé
Current evidence shows that tapentadol hydrochloride prolonged-release is more cost effective than other opioids. However, the introduction into the market of generic formulations of traditional comparators, leading to potential savings due to their lower price, creates space for further research. The objective of this study is to evaluate and compare the efficacy of tapentadol versus oxycodone/naloxone and the economic impact of the two alternatives in both branded and generic formulations. A cost-effectiveness analysis was performed using the third-payer perspective (TPP), with specific reference to the Italian National Health Service. A Markov model was implemented to simulate transitions between states, comparing two arms: The first arm simulated the administration of tapentadol, while the second simulated the administration of oxycodone/naloxone, both branded and generic. The results were reported in terms of net monetary benefit (NMB). The willingness to pay (WPT) was estimated at €35,000/quality-adjusted life year. Tapentadol was dominant in all scenarios, assuming a population of 1000 individuals over a 1-year time horizon. In all cases, although the prices of oxycodone/naloxone generic formulations were lower, the costs associated with treatment discontinuation were always higher than those associated with tapentadol. The comparison with the branded formulation of oxycodone/naloxone was associated with the highest savings of €431.77 per patient, and with the highest NMB of €1943.77 per patient. The results of this pharmacoeconomic evaluation promote the use of tapentadol in comparison with oxycodone/naloxone, confirming the results obtained in previous studies with reference to the generic formulations.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
Current evidence shows that tapentadol hydrochloride prolonged-release is more cost effective than other opioids. However, the introduction into the market of generic formulations of traditional comparators, leading to potential savings due to their lower price, creates space for further research. The objective of this study is to evaluate and compare the efficacy of tapentadol versus oxycodone/naloxone and the economic impact of the two alternatives in both branded and generic formulations.
METHODS
METHODS
A cost-effectiveness analysis was performed using the third-payer perspective (TPP), with specific reference to the Italian National Health Service. A Markov model was implemented to simulate transitions between states, comparing two arms: The first arm simulated the administration of tapentadol, while the second simulated the administration of oxycodone/naloxone, both branded and generic. The results were reported in terms of net monetary benefit (NMB). The willingness to pay (WPT) was estimated at €35,000/quality-adjusted life year.
RESULTS
RESULTS
Tapentadol was dominant in all scenarios, assuming a population of 1000 individuals over a 1-year time horizon. In all cases, although the prices of oxycodone/naloxone generic formulations were lower, the costs associated with treatment discontinuation were always higher than those associated with tapentadol. The comparison with the branded formulation of oxycodone/naloxone was associated with the highest savings of €431.77 per patient, and with the highest NMB of €1943.77 per patient.
CONCLUSION
CONCLUSIONS
The results of this pharmacoeconomic evaluation promote the use of tapentadol in comparison with oxycodone/naloxone, confirming the results obtained in previous studies with reference to the generic formulations.
Identifiants
pubmed: 34524651
doi: 10.1007/s40261-021-01074-x
pii: 10.1007/s40261-021-01074-x
doi:
Substances chimiques
Analgesics, Opioid
0
Delayed-Action Preparations
0
Phenols
0
Naloxone
36B82AMQ7N
Oxycodone
CD35PMG570
Tapentadol
H8A007M585
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
875-883Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Coluzzi F, Polati E, Freo U, Grilli M. Tapentadol: an effective option for the treatment of back pain. J Pain Res. 2019;12:1521–8.
doi: 10.2147/JPR.S190176
Raja NS, et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;161(9):1976–82.
doi: 10.1097/j.pain.0000000000001939
Picavet HSJ, Shouten JSAG. Musculoskeletal pain in the Netherlands: prevalences, consequences and risk groups, the DMC (3)-study. Pain. 2003;102(1–2):167–78.
doi: 10.1016/s0304-3959(02)00372-x
Monti S, Caporali R. Chronic Pain: the burden of disease and treatment innovation. Reumatismo. 2015;67(2):35–44.
doi: 10.4081/reumatismo.2015.840
Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011;25(2):173–83.
doi: 10.1016/j.berh.2010.01.012
Sprangers MA, de Regt EB, Andries F, et al. Which chronic conditions are associated with better or poorer quality of life? J Clin Epidemiol. 2000;53(9):895–907.
doi: 10.1016/S0895-4356(00)00204-3
The European Musculoskeletal Conditions Surveillance and Information Network [Internet] Musculoskeletal Health status in Europe v5 2012. http://www.eumusc.net/workpackages_wp4.cfm . Accessed 11 Mar 2021
Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017;31(2):160–8. https://doi.org/10.1016/j.berh.2017.10.004 .
doi: 10.1016/j.berh.2017.10.004
pubmed: 29224694
Hagen KB, Kvien TK, Bjorndal A. Musculoskeletal pain and quality of life in patients with noninflammatory joint pain compared to rheumatoid arthritis: a population survey. J Rheumatol. 1997;24(9):1703–9.
pubmed: 9292791
European Commission. [Internet] Health in the European Union. Special Eurobarometer 272. 2007. http://ec.europa.eu/health/ph_publication/eb_health_en.pdf . Accessed 15 Jan 2021
Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021;396(10267):2006–17. https://doi.org/10.1016/S0140-6736(20)32340-0 (Erratum in: Lancet. 2020 Dec).
doi: 10.1016/S0140-6736(20)32340-0
pubmed: 33275908
Del Giorno R, Frumento P, Varrassi G, Paladini A, Coaccioli S. Assessment of chronic pain and access to pain therapy: a cross-sectional population-based study. J Pain Res. 2017;6(10):2577–84.
doi: 10.2147/JPR.S136292
Ambrosio F, Finco G, Mattia C, et al. SIAARTI recommendations for chronic non-cancer pain. Minerva Anestesiol. 2006;72(11):859–80.
pubmed: 17095986
Hartvigsen J, Hancock MJ, Kongsted A, et al. What low back pain is and why we need to pay attention. Lancet. 2018;391(10137):2356–67.
doi: 10.1016/S0140-6736(18)30480-X
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22 (Erratum in: Lancet. 2020 Nov 14;396(10262):1562).
doi: 10.1016/S0140-6736(20)30925-9
Baron R, Likar R, Martin-Mola E, et al. Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone PR for the management of severe chronic low back pain with a neuropathic component: a randomized, controlled, open-label, phase 3b/4 study. Pain Pract. 2016;16(5):580–99.
doi: 10.1111/papr.12308
Buynak R, Rappaport AS, et al. Long-term safety and efficacy of tapentadol extended release following up to 2 years of treatment in patients with moderate to severe, chronic pain: results of an open-label extension trial. Clin Ther. 2015;37(11):2420–38.
doi: 10.1016/j.clinthera.2015.08.014
Schröder W, Tzschentke TM, Terlinden R, et al. Synergistic interaction between the two mechanisms of action of tapentadol in analgesia. J Pharmacol Exp Ther. 2011;337(1):312–20.
doi: 10.1124/jpet.110.175042
Kent M. The Oxford dictionary of sports science and medicine (3rd ed.). Oxford University Press, Oxford, UK, 2006.
Leppert W, Zajaczkowska R, Wordliczek J. The role of oxycodone/naloxone in the management of patients with pain and opioid-induced constipation. Expert Opin Pharmacother. 2019;20(5):511–22.
doi: 10.1080/14656566.2018.1561863
Coluzzi F, Ruggeri M. Clinical and economic evaluation of tapentadol extended release and oxycodone/naloxone extended release in comparison with controlled release oxycodone in musculoskeletal pain. Curr Med Res Opin. 2014;30(6):1139–51.
doi: 10.1185/03007995.2014.894501
Löwenstein O, Leyendecker P, Hopp M, et al. Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: a randomised controlled trial. Expert Opin Pharmacother. 2009;10(4):531–43.
doi: 10.1517/14656560902796798
Meissner W, Leyendecker P, Mueller-Lissner S, et al. A randomised controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. Eur J Pain. 2009;13(1):56–64.
doi: 10.1016/j.ejpain.2008.06.012
Ikenberg R, Hertel N, Moore RA, et al. Cost-effectiveness of tapentadol prolonged release compared with oxycodone controlled release in the UK in patients with severe non-malignant chronic pain who failed 1st line treatment with morphine. J Med Econ. 2012;15(4):724–36.
doi: 10.3111/13696998.2012.670174
Obradovic M, Ikenberg R, Hertel N, et al. Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs. Clin Ther. 2012;34(4):926–43.
doi: 10.1016/j.clinthera.2012.02.011
Italian Medicine Agency [Internet] Transparency Lists. https://www.aifa.gov.it/liste-di-trasparenza . Accessed 15 Jan 2021.
The Merck Manual Home Edition. Musculoskeletal Pain. Accessed 15 Jan 2021.
Bruusgaard D. International monitoring of musculoskeletal complaints: a need for consensus. Eur J Public Health. 2003;13(3 Suppl):20–3.
doi: 10.1093/eurpub/13.suppl_1.20
Marinangeli F, Evangelista M, Finco G. Tapentadol prolonged release in the treatment of musculoskeletal pain: an innovative pharmacological option. Eur Rev med Pharmacol Sci. 2019;23(4 Suppl):5–13.
pubmed: 31755079
Buchbinder R, van Tulder M, Öberg B, et al. Lancet low back pain series working group. Low back pain: a call for action. Lancet. 2018;6736(18):30488–30484.
Kaplan W, Wirtz VJ, Mantel-Teeuwisse A, Stolk P, Duthey B, Laing R. Priority Medicines for Europe and the World: 2013 update. Geneva, Switzerland: World Health Organization; 2013. http://www.who.int/medicines/areas/priority_medicines/MasterDocJune28_FINAL_Web.pdf?ua=1 . Accessed 17 Jan 2021.
Hartvigsen J, Hancock MJ, Kongsted A, et al. Lancet low back pain series working group. What low back pain is and why we need to pay attention. Lancet. 2018;6736(18):30480.
Itz CJ, Geurts JW, van Kleef M, Nelemans P. Clinical course of non-specific low back pain: a systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17(1):5–15.
doi: 10.1002/j.1532-2149.2012.00170.x
Wild JE, Grond S, Kuperwasser B, et al. Long term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010;10:416–27.
doi: 10.1111/j.1533-2500.2010.00397.x