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      A cost effective analysis of fixed-dose combination of dutasteride and tamsulosin compared with dutasteride monotherapy for benign prostatic hyperplasia in Nigeria: a middle income perspective; using an interactive Markov model

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          Abstract

          Background

          The number of Nigerian men presenting with benign prostatic hyperplasia is on the rise because of increase awareness about the ailment. With the renewed effort by the national health insurance scheme to cover the informal sector, it becomes imperative to determine the cost implication for managing Benign Prostatic Hyperplasia (BPH) and the cost effective drug combination to be adopted. The objective of this study is to estimate cost effective analysis (CEA) of fixed -dose combination of dutasteride and tamsulosin compared with dutasteride monotherapy from the health service provider perspective design.

          Methods

          An interactive Markov’s model was used to generate incremental cost per QALY and incremental cost per life years gained. 2.9 million Men who were 50 years of age were fed into the model. The outcome measures included: costs of drug treatment, consultation, acute urinary retention (AUR), transurethral resection of prostate (TURP), hospitalisation post TURP, and quality adjusted life years (QALYs), incremental cost per life years gained, and incremental cost per QALY gained.

          Results

          Fixed-dose combination of dutasteride and tamsulosin (FDCT) produced an Incremental cost-effectiveness ratios of US$1481.92 per Quality adjusted for life-years saved.

          Conclusion

          Universal FDCT provision for Nigeria has major economic implications. This study in the context of its limitations has demonstrated the cost effectiveness of FDCT for the long term treatment of patients with moderate to severe BPH from the perspective of a developing country. Currently, there are few studies available to give economic data evidence to policy makers in Nigeria which is applicable to developing countries with similar economies. As such, the findings in this study will be relevant to policy makers in these countries.

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          Most cited references23

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          The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

          John McConnell, Claus Roehrborn, Oliver M Bautista … (2003)
          Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy. Copyright 2003 Massachusetts Medical Society
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            Update on AUA guideline on the management of benign prostatic hyperplasia.

            Kevin T. McVary, Claus Roehrborn, Andrew Avins … (2011)
            To revise the 2003 version of the American Urological Association's (AUA) Guideline on the management of benign prostatic hyperplasia (BPH). From MEDLINE® searches of English language publications (January 1999 through February 2008) using relevant MeSH terms, articles concerning the management of the index patient, a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms (LUTS) were identified. Qualitative analysis of the evidence was performed. Selected studies were stratified by design, comparator, follow-up interval, and intensity of intervention, and meta-analyses (quantitative synthesis) of outcomes of randomized controlled trials were planned. Guideline statements were drafted by an appointed expert Panel based on the evidence. The studies varied as to patient selection; randomization; blinding mechanism; run-in periods; patient demographics, comorbidities, prostate characteristics and symptoms; drug doses; other intervention characteristics; comparators; rigor and intervals of follow-up; trial duration and timing; suspected lack of applicability to current US practice; and techniques of outcomes measurement. These variations affected the quality of the evidence reviewed making formal meta-analysis impractical or futile. Instead, the Panel and extractors reviewed the data in a systematic fashion and without statistical rigor. Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases. Guideline statements concerning pharmacotherapies, watchful waiting, surgical options and minimally invasive procedures were either updated or newly drafted, peer reviewed and approved by AUA Board of Directors. New pharmacotherapies and technologies have emerged which have impacted treatment algorithms. The management of LUTS/BPH continues to evolve. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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              The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study.

              Claus Roehrborn, Paul Siami, Jack Barkin … (2010)
              Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. The Combination of Avodart and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men > or =50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score > or =12, prostate volume > or =30 cm(3), prostate-specific antigen 1.5-10 ng/ml, and maximum urinary flow rate (Q(max)) >5 and or =125 ml. Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Q(max), prostate volume, safety, and tolerability. Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. CLINICALTRIALS.GOV IDENTIFIER: NCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).
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                Author and article information

                Contributors
                Emeka I. Udeh: emeka.udeh@unn.edu.ng
                Chimaobi G. Ofoha: drchimao@yahoo.com
                David A. Adewole: ayodadewole@yahoo.com
                Ikenna I. Nnabugwu: ikenna.nnabugwu@unn.edu.ng
                Journal
                Journal ID (nlm-ta): BMC Cancer
                Journal ID (iso-abbrev): BMC Cancer
                Title: BMC Cancer
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2407
                Publication date (Electronic): 7 July 2016
                Publication date PMC-release: 7 July 2016
                Publication date Collection: 2016
                Volume: 16
                Electronic Location Identifier: 405
                Affiliations
                [ ]Department of Surgery, Faculty of medicine, College of Medicine, University of Nigeria Enugu campus, Enugu, Nigeria
                [ ]Department of Surgery, University of Nigeria Teaching Hospital Ituku-Ozalla Enugu, Enugu, Nigeria
                [ ]Department of Community Medicine, Bowen University/Bowen University Teaching Hospital, Iwo/Ogbomoso, Nigeria
                [ ]Division of Urology, Department of Surgery, Jos University Teaching Hospital, Jos, Nigeria
                Article
                Publisher ID: 2431
                DOI: 10.1186/s12885-016-2431-x
                PMC ID: 4936011
                PubMed ID: 27388750
                SO-VID: a2b0f314-77c4-4ac0-b11b-542d0bc0d5ac
                Copyright © © The Author(s). 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 8 July 2015
                Date accepted : 27 June 2016
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: cost effectiveness analysis,dutasteride monotherapy,fixed dose combination of dutasteride- tamsulosin,nigerian men,benign prostatic hyperplasia
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: cost effectiveness analysis, dutasteride monotherapy, fixed dose combination of dutasteride- tamsulosin, nigerian men, benign prostatic hyperplasia

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