Analiza odnosa troškova i efekata finasterida i dutasterida u terapiji benigne hiperplazije prostate – Markovljev model baziran na podacima iz Crne Gore
Sažetak
Uvod/Cilj. Benigna hiperplazija prostate (BHP) jedno je od najčešćih oboljenja kod muškaraca starijih od 50 godina i tesno je povezano sa procesom starenja. S obzirom na to da životni vek ima tendenciju produženja, može se očekivati da će povećanje učestalosti ove bolesti dovesti do povećanja troškova zdravstvene zaštite. Ukoliko se ne leči, BHP ima progresivan tok i dovodi do teških komplikacija. Inhibitori testosterona 5-alfa reduktaze, finasterid i dutasterid, ublažavaju simptome bolesti, povećavaju kvalitet života i snižavaju rizik od komplikacija. Dutasterid u odnosu na finosterid značajno usporava progresiju bolesti i komplikacije, kao što su akutna retencija urina i hirurške intervencije, ali je skuplji od finasterida 2,3 puta. Cilj ove studije bio je da pokaže da li je sa stanovišta odnosa troškova i efikasnosti opravdano finansiranje upotrebe dutasterida od strane Fonda za zdravstveno osiguranje Crne Gore. Меtode. Studija je sprovedena prema Markovljevom modelu, koji je razvijen na osnovu podataka iz literature o efektivnosti i na osnovu troškova lečenja u Crnoj Gori. Trajanje jednog ciklusa u modelu je jedna godina a vremenski horizont praćenja iznosio je 20 godina. Za troškove i ishode korišćena je perspektiva društva i oni su diskontovani po stopi od 3% godišnje. Urađena je Monte Karlo mikrosimulacija modela sa 1 000 virtuelnih bolesnika. Rezultati. Primena dutasterida imala je nešto bolji odnos troškova i kliničke efikasnosti od finasterida (539,51 €/QALY u odnosu 544,11 €/QALY). Jedna dobijena godina života prilagođena za kvalitet upotrebom dutasterida košta Fond za zdravstveno osiguranje Crne Gore 1 245,68 €, što ukazuje na to da je terapija sa dutasteridom farmakoekonomski isplativa. Zaključak. Ova studija pokazala je da u terapiji BHP dutasterid ima bolji odnos troškova i kliničke efikasnosti u odnosu na finasterid, pa je finansiranje dutasterida od strane Fonda za zdravstveno osiguranje Crne Gore farmakoekonomski opravdano.
Reference
McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF,et al. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). Linthi-cum, MD: American Urological Association Education and Research, Inc.; 2010.
Chute CG, Panser LA, Girman CJ, Oesterling JE, Guess HA, Jacob-sen SJ, et al. The prevalence of prostatism: a population-based survey of urinary symptoms. J Urol 1993; 150(1): 85−9.
Arrighi HM, Metter EJ, Guess HA, Fozzard JL. Natural History of benign prostatic hyperplasia and risk of prostatectomy. The Baltimore Longitudinal Study of Aging. Urology 1991; 38(1 Suppl): 4−8.
Jakovljević M, Jovanović M, Lazić Z, Jakovljević V, Đukić A, Vel-icković R, et al. Current efforts and proposals to reduce healthcare costs in Serbia. Ser J Exp Clin Res 2011; 12(4): 161−3.
Parsons KJ. Benign Prostatic Hyperplasia and Male Lower Uri-nary Tract Symptoms: Epidemiology and Risk Factors. Curr Bladder Dysfunct Rep 2010; 5(4): 212−8.
Statistical Office of Montenegro - Monstat. Available from: http://www.monstat.org/cg/page.php?id=57&pageid=57 [accessed 2014 February 8].
Issa MM, Fenter TC, Black L, Grogg AL, Kruep EJ. An assess-ment of the diagnosed prevalence of diseases in men 50 years of age or older. Am J Manag Care 2006; 12(4 Suppl): S83−9.
Donovan JL, Kay HE, Peters TJ, Abrams P, Coast J, Matos-Ferreira A, et al. Using the ICSOoL to measure the impact of lower urinary tract symptoms on quality of life: evidence from the ICS-'BPH' Study. International Continence Society--Benign Prostatic Hyperplasia. Br J Urol 1997; 80(5): 712−21.
Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, et al. Guidelines on the Management of Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO). Arnhem: European Association of Urolo-gy; 2012.
McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finas-teride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 2003; 349(25): 2387−98.
Toren P, Margel D, Kulkarni G, Finelli A, Zlotta A, Fleshner N. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ 2013; 346: f2109.
Issa MM, Runken MC, Grogg AL, Shah MB. A large retrospective analysis of acute urinary retention and prostate-related surgery in BPH patients treated with 5-alpha reductase inhibitors: dutasteride versus finasteride. Am J Manag Care 2007; 13(1): 10−6.
The decision on the List of drugs that are prescribed and dis-pensed at the expense of the Health Insurance Fund. Official Gazette of Montenegro. No. 14/2012.
Ismaila A, Walker A, Sayani A, Laroche B, Nickel JC, Posnett J, et al. Cost-effectiveness of dutasteride-tamsulosin combination therapy for the treatment of symptomatic benign prostatic hy-perplasia: A Canadian model based on the CombAT trial. Can Urol Assoc J. 2013 May-Jun;7(5-6):E393-401.nadian model based on the CombAT trial. Can Urol Assoc J 2013; 7(5−6): 393−401.
Fourcade R, Lacoin F, Rouprêt M, Slama A, le Fur C, Michel E, et al. Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia. World J Urol 2012; 30(3): 419−26.
Nickel JC. Comparison of Clinical Trials With Finasteride and Dutasteride. J Rev Urol 2004; 6(Suppl 9): 31−9.
Yang SJ, Ji YS, Song PH, Kim HT, Moon KH. Factors Causing Acute Urinary Retention after Transurethral Resection of the Prostate in Patients with Benign Prostate Hyperplasia. Korean J Androl 2011; 29(2): 168−73.
Chalise PR, Agrawal CS. Change in urinary symptoms and quali-ty of life in men with benign prostatic hyperplasia after tran-surethral resection of prostate. Nepal Med Coll J 2007; 9(4): 255−8.
Lee EH, Chun KH, Lee Y. Benign prostatic hyperplasia in community-dwelling elderly in Korea. J Korean Acad Nurs 2005; 35(8): 1508−13.
Lepor H, Machi G. Comparison of AUA symptom index in unselected males and females between fifty-five and seventy-nine years of age. Urology 1993; 42(1): 36−40.
Taylor BC, Wilt TJ, Fink HA, Lambert LC, Marshall LM, Hoffman AR, et al. Osteoporotic Fractures in Men (MrOS) Study Research Group. Prevalence, severity, and health correlates of lower urinary tract symptoms among older men: the MrOS study. Urology 2006; 68(4): 804−9.
Kaplan SA, Olsson CA, Te AE. The American Urological Asso-ciation symptom score in the evaluation of men with lower urinary tract symptoms: at 2 years of followup, does it work. J Urol 1996; 155(6): 1971−4.
Barry MJ, Fowler FJ, Bin L, Pitts JC, Harris CJ, Mulley AG. The natural history of patients with benign prostatic hyperplasia as diagnosed by North American urologists. J Urol 1997; 157(1): 10−5.
Trueman P, Hood SC, Nayak US, Mrazek MF. Prevalence of lower urinary tract symptoms and self-reported diagnosed 'be-nign prostatic hyperplasia', and their effect on quality of life in a community-based survey of men in the UK. BJU Int 1999; 83(4): 410−5.
Desgrandchamps F, Droupy S, Irani J, Saussine C, Comenducci A. Ef-fect of dutasteride on the symptoms of benign prostatic hy-perplasia, and patient quality of life and discomfort, in clinical practice. BJU Int 2006; 98(1): 83−8.
Kaplan S, Garvin D, Gilhooly P, Koppel M, Labasky R, Milsten R, et al. Impact of baseline symptom severity on future risk of be-nign prostatic hyperplasia-related outcomes and long-term re-sponse to finasteride. The Pless Study Group. Urology 2000; 56(4): 610−6.
Roehrborn CG. Acute urinary retention: risks and management. Rev Urol 2005; 7(Suppl 4): S31−41.
Wong MY, Lim YL, Foo KT. Transurethral resection of the prostate for benign prostatic hyperplasia--a local review. Sin-gapore Med J 1994; 35(4): 357−9.
Armitage JN, Sibanda N, Cathcart PJ, Emberton M, van der Meulen JH. Mortality in men admitted to hospital with acute urinary retention: database analysis. BMJ 2007; 335(7631): 1199−202.
Zorn KC, Liberman D. GreenLight 180W XPS photovaporiza-tion of the prostate: how I do it. Can J Urol 2011; 18(5): 5918−26.
Hargreave TB, Heynes CF, Kendrick SW, Whyte B, Clarke JA. Mor-tality after transurethral and open prostatectomy in Scotland. Br J Urol 1996; 77(4): 547−53.
Ranković A, Rančić N, Jovanović M, Ivanović M, Gajović O, Lazić Z, et al. Impact of imaging diagnostics on the budget: Are we spending too much. Vojnosanit Pregl 2013; 70(7): 709−11.
Jakovljević M, Ranković A, Rančić N, Jovanović M, Ivanović M, Gajović O, et al. Radiology Services Costs and Utilization Patterns Estimates in Southeastern Europe-A Retrospective Analysis from Serbia. Value Health Reg Issues 2013; 2(2): 218−25.
Government of Republic of Serbia. The decision on the max-imum drug prices. Official Gazette of Republic of Serbia 2013; 46:13. (Serbian) Available from: http://www.zdravlje.gov.rs/downloads/2013/Jun/Jun2013SpisakCenaLekova.pdf
Anonymus. Tariff Book of Health Care Services in Health Fa-cilities of Republic of Serbia. Belgrade: Republic Institute for Health Insurance; 2014. (Serbian)
WHO Commission on Macroeconomics and Health. Macroe-conomics and health: Investing in health for economic devel-opment. Report of the Commission on Macroeconomics and Health. Geneva: World Health Organization; 2001.
Kaczor M, Pawlik D, Becla L, Dardzinski W, Jasinska S, Wojcik R, et al. PIH5 Cost-effectiveness of dutasteride in the treatment of benign prostatic hyperplasia. Value Health 2006; 9(6): A253−4.
Jakovljevic MB. Resource allocation strategies in Southeastern European health policy. Eur J Health Econ 2013; 14(2): 153−9.
World Health Organization Statistical Information System (WHOSIS). Global Health Expenditure Database. Available from: http://apps.who.int/nha/database/Country_Profile/Index/en [accessed 2014 November 7].
Spire Harpenden Hospital [cited 2014 May 13]. Available from: http://www.spirehealthcare.com/harpenden/our-facilities-treatments-and-consultants/our-treatments/prostate-surgery-turp/
Joint Formulary Committe. British National Formulary 66, September 2013-March 2014. London: British Medical Association, 2013.
Arznei-telegramm. Available from: http://www.arznei- tele-gramm.de/html/2003_05/0305043_01.html
Codra Medical. Available from: http://www.codrahospital.com/
Dardzinski W, Pawlik D, Walczak J, Wojcik R, Kaczor M, Nogas G, et al. PIH1Budge impact analysis of Avodart (dutasteride) in the treatment of benign prostatic hyperplasia in Poland. Value Health 2006; 9: A252.
Jakovljević MB, Janković SM. Bioequivalence studies. Acta Medica Medianae 2006; 45(4): 50−5.
Savić DM, Jakovljević M. Significance of clinical output evaluation from the point of view of a patient in clinical decision making. Racionalna terapija 2012; 4(1): 47−9. (Serbian