Exploring pharmacological interventions in benign prostate hyperplasia: the role of cost-effectiveness analysis in daily practice and future directions.

INTRODUCTION: Benign Prostate Hyperplasia (BPH) significantly impacts men's health and quality of life, with its prevalence rising with age. This review critically examines the cost-effectiveness of pharmacological interventions for BPH to optimize patient outcomes and healthcare resource utilization. AREAS COVERED: This review explores the integration of cost-effectiveness analysis (CEA) into clinical practice, balancing clinical efficacy with economic efficiency in BPH management. We performed a critical literature search, including recent studies on the economic evaluation of BPH treatments, focusing on pharmacotherapies such as alpha-blockers and 5-alpha reductase inhibitors. Additionally, we discussed the concept of CEA and evaluated the role of medicinal reconciliation and the avoidance of polypharmacy in favor of optimal BPH treatment. EXPERT OPINION: Cost-effectiveness analysis is crucial for evaluating BPH treatments, with evidence suggesting a shift towards surgical interventions may offer greater long-term economic benefits. However, these models must be applied cautiously, considering clinical evidence and patient preferences to ensure equitable and patient-centric healthcare.

[Economic aspects of treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia].

A review of the literature dedicated to the economic aspects of drug and surgical treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is presented in the article. Currently, symptomatic therapy, which usually leads to an increase in the financial costs associated with the complications and surgical treatment, is most commonly used. The pathogenetic treatment of BPH (5-alpha reductase inhibitors), including combination therapy, requires an increase in costs, but it is also considered the most cost-effective approach. Despite the continuous growing of therapeutic armamentarium, the surgical treatment is still relevant and holds an important place. A lot of studies have shown that open procedures are inferior to endoscopic and minimally invasive interventions by both clinical and cost-effective results. At the same time, transurethral interventions on the prostate does not exclude economic losses due to the necessity of expensive laser technologies and the development of complications in the early postoperative period. Thus, currently, the best treatment option should be chosen not only on individual basis, but also depending on economic aspects based on a balanced medical and economic analysis of each treatment method.

Long-term cost comparison between surgical and medical therapy for benign prostatic hyperplasia: a study using hospital billing data.

OBJECTIVES: To analyse actual long-term medical treatment of benign prostatic hyperplasia (BPH) and compare the incurred cost with that of patients with BPH who underwent early surgery. PATIENTS AND METHODS: Patients who were first diagnosed with BPH from 1 January 2008 to 31 December 2010 were identified using the Clinical Data Warehouse. Hospital billing data generated by the electronic hospital management system were collected until December 2015. For outpatient care, only procedures, materials and drugs directly related to the management of BPH were selected for the analysis. For inpatient care, all procedures, materials and drugs ordered on dates with continuity with BPH surgery date were included. The primary endpoint of the study was the total treatment-related direct costs of patients undergoing a long-term curative medical therapy for BPH (Group 1), which was arbitrarily defined as any medical therapy including a 5α-reductase inhibitor with a minimum medication possession ratio of 0.5 during ≥5 consecutive years, or ≥1 year until BPH surgery due to medical therapy failure. In all, 70 patients who underwent BPH surgery at <1 year of initial visit served as controls (Group 2). RESULTS: Amongst 137 patients in the Group 1, four patients underwent BPH surgery at a median of 57.8 months after the initial visit (2.9%). At a median follow-up of 76 months, the mean total treatment cost was significantly higher in Group 1 than in Group 2 ($3987 vs $3036 [USA dollars], P < 0.001). Similarly, the mean 'out-of-pocket' cost was significantly higher in Group 1 than in Group 2 ($1742 vs $1436, P = 0.005). When a linear increment of annual BPH treatment cost is assumed for Group 1 and all costs are assumed to be produced within the first year for Group 2, the total and out-of-pocket costs became equal at the end of the fifth year of medical treatment. For both total and out-of-pocket costs, medication-related costs occupied the largest proportion, exceeding half of the costs. CONCLUSIONS: We suggest patient counselling at the beginning of BPH treatment should include the likelihood that the cumulative out-of-pocket cost at 5 years of continuous medication will exceed that of early surgery. Our cost study using hospital billing data extractable from the electronic hospital management system may be a good model for cost studies that could provide valuable information to health providers and payers.

Cost-Effectiveness of Combination Therapy Versus Monotherapy in Benign Prostatic Hyperplasia: A Colombian Experience.

OBJECTIVES: To estimate the incremental cost-effectiveness ratio of pharmacological treatment for benign prostatic hyperplasia from the payer's perspective. METHODS: The cost-effectiveness of 5 mg finasteride, 0.5 mg dutasteride, 10 mg alfuzosin, 10 mg terazosin, 0.4 mg tamsulosin, 4 mg doxazosin, and the combination therapy of 5 mg finasteride and 8 mg doxazosin was evaluated using a Markov model over a 30-year period. The costs were estimated using national tariffs and were reported in US dollars. Cost and effectiveness outcomes were discounted at a rate of 5% per year. Men (aged ≥40 years) with moderate to severe lower urinary tract symptoms and uncomplicated benign prostatic hyperplasia were included in the analysis. Outcomes included costs and quality-adjusted life-years. A probabilistic sensitivity analysis was performed on important parameters with Monte-Carlo simulation. RESULTS: Finasteride alone or in combination with doxazosin dominated all α-blockers. After excluding dominated alternatives, the incremental cost-utility ratio for combination therapy was $377 per quality-adjusted life-year, being a cost-effective alternative using the threshold of $15 000. Model results were robust to changes in costs, utility weights, and probabilities. Acceptability curves consistently demonstrated that the combination therapy was most likely cost-effective. CONCLUSIONS: The combination of finasteride and doxazosin is cost-effective compared with dutasteride, tamsulosin, terazosin, and alfuzosin in patients with benign prostatic hyperplasia with moderate or severe symptoms who are older than 40 years.

Pharmacotherapy vs surgery as initial therapy for patients with moderate-to-severe benign prostate hyperplasia: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of using a surgery, such as transurethral resection of the prostate (TURP) or photoselective vaporisation of the prostate using greenlight laser (GL-PVP), as initial treatment for men with moderate-to-severe benign prostate hyperplasia (BPH) compared to the standard practice of using pharmacotherapy as initial treatment followed by surgery if symptoms do not resolve. PATIENTS AND METHODS: We compared a combination of eight strategies involving upfront pharmacotherapy (i.e., α-blocker, 5α-reductase inhibitor, or combination) followed by surgery (e.g. TURP or GL-PVP) upon failure vs TURP or GL-PVP as initial treatment, for a target population of men with moderate-to-severe BPH symptoms, with a mean age of 65 years and no contraindications for treatment. A microsimulation decision-analytic model was developed to project the costs and quality-adjusted life years (QALYs) of the target population over the lifetime. The model was populated and validated using published literature. Incremental cost-effectiveness ratios (ICERs) were determined. Cost-effectiveness was evaluated using a public payer perspective, a lifetime horizon, a discount rate of 1.5%, and a cost-effectiveness threshold of $50 000 (Canadian dollars)/QALY. Sensitivity and probabilistic analyses were performed. RESULTS: All options involving an upfront pharmacotherapy followed by TURP for those who fail were economically unattractive compared to strategies involving a GL-PVP for those who fail, and compared to using either BPH surgery as initial treatment. Overall, upfront TURP was the most costly and effective option, followed closely by upfront GL-PVP. On average, upfront TURP costs $1015 more and resulted in a small gain of 0.03 QALYs compared to upfront GL-PVP, translating to an incremental cost per QALY gained of $29 066. Results were robust to probabilistic analysis. CONCLUSIONS: Surgery is cost-effective as initial therapy for BPH. However, the health and economic evidence should be considered concurrently with patient preferences and risk attitudes towards different therapy options.

Comparing Clinical and Economic Outcomes Associated with Early Initiation of Combination Therapy of an Alpha Blocker and Dutasteride or Finasteride in Men with Benign Prostatic Hyperplasia in the United States.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a common disease in men that is characterized by lower urinary tract symptoms. Pharmacologic treatment with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) is recommended to alleviate symptoms, prevent disease progression that can lead to complications, and reduce health care costs. OBJECTIVE: To compare clinical, economic, and health care resource utilization outcomes among BPH patients treated with early continuous combination AB and 5ARI therapy (dutasteride vs. finasteride) using administrative claims data from the United States. METHODS: A retrospective analysis of administrative claims data from 2003-2013 was conducted to compare outcomes between patients with claims for early combination therapy with dutasteride + AB and patients with claims for early finasteride + AB. The study population included males aged older than 50 years with at least 1 medical claim with a diagnosis of BPH and pharmacy dispensing for AB and 5ARI therapies. Outcomes included acute urinary retention (AUR), prostate-related surgery, clinical progression, medical and pharmacy costs, and health care resource utilization. Inverse probability of treatment (IPT) weighted Cox proportional hazards, linear, and Poisson regression models were used to assess the association between outcomes and early combination therapy as appropriate. RESULTS: A total of 2,778 patients were included in the early finasteride + AB treatment cohort, and 4,125 patients were included in the early dutasteride + AB cohort. Dutasteride users were younger than finasteride users (mean age: 64.8 vs. 67.5 years, P < 0.001) and had a greater mean number of urologist visits (10.7 vs. 7.9, P < 0.001) during baseline. After adjusting for confounding using IPT weighting, no statistically significant difference was observed between dutasteride and finasteride for AUR (hazard ratio [HR] = 0.845, 95% CI = 0.660-1.070, P = 0.1643), prostate-related surgery (HR = 0.806, 95% CI = 0.568-1.171, P = 0.2525), and clinical progression (HR = 0.834, 95% CI = 0.663-1.043, P = 0.1122). While dutasteride was associated with higher pharmacy costs per month (adjusted monthly cost difference = $79, 95% CI = $45-$105), total all-cause medical costs were not significantly different between the 2 cohorts (adjusted monthly cost difference = -$44, 95% CI = -$110-$22). CONCLUSIONS: Clinical and economic outcomes were similar between the early dutasteride + AB and early finasteride + AB cohorts, with no statistically significant differences detected. DISCLOSURES: Funding for this study was provided by GlaxoSmithKline (HO-14-15325 and AVO110072). Bell and Swensen are employees of GlaxoSmithKline. DerSarkissian, Xiao, Duh, and Lefebvre are employed by Analysis Group, a consulting company that received research grants from GlaxoSmithKline to conduct this study. Study concept and design were contributed by Bell, Swensen, Lefebvre, and Duh. Bell and Duh acquired the data. DerSarkissian and Xiao performed the statistical analysis and interpreted the data along with Lefebvre, Duh, and Bell. DerSarkissian and Bell drafted the manuscript. All authors contributed equally to critically revising the manuscript and providing final approval of the submitted manuscript.

Cost effectiveness comparison of dutasteride and finasteride in patients with benign prostatic hyperplasia--The Markov model based on data from Montenegro.

BACKGROUND/AIM: Benign prostatic hyperplasia (BPH) is one of the most common disease among males aging 50 years and more. The rise of the prevalence of BPH is related to aging, and since duration of life time period has the tendency of rising the prevalence of BPH will rise as costs of BPH treatment will and its influence on health economic budget. Dutasteride is a new drug similar to finasteride, inhibits enzyme testosterone 5-alpha reductase, diminish symptoms of BPH, reduce risk of the complications and increases quality of life in patients with BPH. But, the use of dutasteride is limited by its high costs. The aim of this study was to compare cost effectiveness of dutasteride and finasteride from the perspective of a purchaser of health care service (Republic Institute for Health Insuranse, Montenegro). METHODS: We constructed a Markov model to compare cost effectivenss of dutasteride and finasteride using data from the available pharmacoeconomic literature and data about socioeconomic sphere actual in Montenegro. A time horizon was estimated to be 20 years, with the duration of 1 year per one cycle. The discount rate was 3%. We performed Monte Carlo simulation for virtual cohort of 1,000 patients with BPH. RESULTS: The total costs for one year treatment of BPH with dutasteride were estimated to be 6,458.00 € which was higher comparing with finasteride which were 6,088.56 €. The gain in quality adjusted life years (QALY) were higher with dutasteride (11.97 QALY) than with finasteride (11.19 QALY). The results of our study indicate that treating BPH with dutasteride comparing to finasteride is a cost effective option since the value of incremental cost-effectiveness ratio (ICER) is 1,245.68 €/QALY which is below estimated threshold (1,350.00 € per one gained year of life). CONCLUSION: Dutasteride is a cost effective option for treating BPH comparing to finasteride. The results of this study provide new information for health care decision makers about treatment of BPH in socioeconomic environment which is actual both in Montenegro and other countries with a recent history of socioeconomic transition.

Benign Prostatic Hyperplasia - An economic assessment of fixed combination therapy based on a literature review.

FederAnziani Senior Italia and SIU - Italian Society of Urology - have decided to work together to draft a document focussing on Benign Prostatic Hyperplasia (BPH), and to stress the importance of adherence with pharmacological treatment in this setting, from both a scientific and a patient standpoint. Starting from a literature search, the two associations analysed to what extent an increase in treatment adherence amongst these patients influences hospital savings and to what extent therapy persistence levels are affected by monotherapy rather than free drug combinations. These estimates were performed only on patients taking medicinal products belonging to the 5 α-reductase inhibitors (5ARI) class that, although not indispensable, are the compounds that bring the greatest benefits, especially in the elderly and for which we know that every additional 30 days of therapy reduced the likelihood of acute urinary retention (AUR) and surgery by 14% and 11% respectively *. The results show that the use of fixed combination therapy would involve an increase in persistence due to the lower rate of patients abandoning treatment over time. Each 30 day-increment of 5ARI therapy, i.e. for an expenditure of 10.6 million euros extra per year for 5ARI medication, savings of approximately 24.3 million euros in hospital costs could be achieved.

Actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia: temporal trends of prescription and hospitalization rates over 5 years in a large population of Italian men.

PURPOSE: The purpose of the study is to estimate the trends in drug prescriptions and the hospitalization rates for lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in real-life clinical practice, using information deriving from administrative databases of the Italian health care system. METHODS: Prescription data on approximately 1,500,000 men over 40 were examined, and prescribed boxes of alpha-blockers (ABs) and/or 5 alpha reductase inhibitors (5ARI) were calculated for 5 consecutive years, from 2004 to 2008. Annual use prevalence and incidence rates for each drug class and for the combination therapy (CT) were calculated according to age for the entire study period. Hospitalization rates for reasons related to LUTS/BPH were also evaluated for the same time period. RESULTS: The overall distribution of drugs for LUTS/BPH, in terms of number of boxes prescribed, increased by 43 %. This increase was accounted for by both classes of drugs although it was greater for 5ARI than for AB (+49 vs +41 %). The prevalence of CT showed a substantial increase to almost 25 % in patients aged ≥75. Hospitalization rate for BPH/LUTS-related reasons decreased during the study period (8 and 3 % per year for non-surgical and surgical reasons, respectively). CONCLUSIONS: The prevalence of the use of drugs prescribed for LUTS/BPH has steadily increased. An increase in terms of prescribed boxes was observed for both classes of drugs, even though the increase was greater for 5ARIs. The reduction in the hospitalization rates needs additional researches.

Model-based cost-effectiveness analyses for prostate cancer chemoprevention : a review and summary of challenges.

BACKGROUND AND PURPOSE: Decision-analytic modelling is often used to examine the economics associated with using a specific treatment. As a result, it is important to understand structural and methodological approaches used in published decision-analytic models for examining the cost effectiveness of 5α-reductase inhibitors (5ARIs) for prostate cancer (PCa) chemoprevention. This understanding allows us to provide recommendations for using decision modelling in future economic evaluations of chemoprevention for PCa. METHODS: A review of the published literature was performed using MEDLINE and the Cochrane Library to identify studies involving mathematical decision models that evaluated 5ARIs for PCa chemoprevention. Published articles were reviewed and key modelling components were extracted and summarized. Recommendations for developing future decision models to examine the economic consequences of PCa chemoprevention were presented. RESULTS: We identified seven published models of PCa chemoprevention. All the models identified used a Markov framework with time horizons ranging from 4 years to lifetime. Due to the wide range of patient risk groups examined, PCa risk data were taken from the Surveillance, Epidemiology, and End Results (SEER) and other databases or estimates published in relevant clinical trials. Treatment effects included change in the incidence of high- and low-grade PCa and impacts on benign prostate hyperplasia. Adverse events were considered to affect compliance, discontinuation and quality of life. Quality-of-life impacts were similar among studies. Examination of modelling parameter sensitivities was comprehensive. CONCLUSIONS: Published models have examined the cost effectiveness of PCa chemoprevention; however, limitations exist. Decision models should take into account the full PCa clinical pathway when compiling health states. The time horizon should be long enough to consider the full benefit of chemoprevention while allowing actual time receiving the drug to occur from the start of the model until a man's life expectancy is less than 10 years. Baseline PCa risk should be specific to the population of concern. Models should examine the impact on both low- and high-grade tumours and account for the impact of 5ARIs on benign prostatic hyperplasia. Because chemoprevention has an upfront effect, the structure of the model should be constructed so that the downstream effect of avoiding or delaying recurrence can be considered. Adverse events due to chemoprevention should be considered through compliance, discontinuation or quality-of-life impact, and understanding the impact of avoiding PCa and benign prostatic hyperplasia events are important model properties.

Cost-effectiveness of single-dose tamsulosin and dutasteride combination therapy compared with tamsulosin monotherapy in patients with benign prostatic hyperplasia in the UK.

OBJECTIVE: To estimate the long-term cost-effectiveness of single-dose dutasteride/tamsulosin combination therapy as a first-line treatment for benign prostatic hyperplasia (BPH) from the perspective of the UK National Health Service (NHS). METHODS: A Markov state transition model was developed to estimate healthcare costs and patient outcomes, measured by quality-adjusted life years (QALYs), for patients aged ≥50 years with diagnosed BPH and moderate to severe symptoms. Costs and outcomes were estimated for two treatment comparators: oral, daily, single-dose combination therapy (dutasteride 0.5 mg + tamsulosin 0.4 mg), and oral daily tamsulosin (0.4 mg) over a period up to 25 years. The efficacy of comparators was taken from results of the Combination of Avodart and Tamsulosin (CombAT) trial. RESULTS: Cumulative discounted costs per patient were higher with combination therapy than with tamsulosin, but QALYs were also higher. After 25 years, the incremental cost-effectiveness ratio for combination therapy was £12,219, well within the threshold range (£20,000-£30,000 per QALY) typically applied in the NHS. Probabilistic sensitivity analysis showed that the probability of combination therapy being cost-effective given the threshold range is between 78% and 88%. CONCLUSION: Single-dose combination dutasteride/tamsulosin therapy has a high probability of being cost-effective in comparison to tamsulosin monotherapy in the UK's NHS.

Hormonal manipulation of benign prostatic hyperplasia.

PURPOSE OF REVIEW: We provide new viewpoints of hormonal control of benign prostatic hyperplasia (BPH). The latest treatment findings with 5-alpha reductase inhibitors (5-ARIs) finasteride and dutasteride, refined indications, efficacy, and safety are discussed and compared. We also discuss potential new 5-ARIs and other hormonal treatments. RECENT FINDINGS: Finasteride and dutasteride have equal efficacy and safety for the treatment and prevention of progression of BPH. 5-ARIs are especially recommended for prostates greater than 40 ml and PSA greater than 1.5 ng/ml. Combination therapy is the treatment of choice in these patients, but with prostate volume greater than 58 ml or International Prostate Symptom Score of at least 20, combinations have no advantage over 5-ARI monotherapy. Updates on the recent developments on BPH therapy with luteinizing hormone-releasing hormone (LHRH) antagonist are also reviewed and analyzed. Preclinical studies suggest that growth hormone-releasing hormone (GHRH) antagonists effectively shrink experimentally enlarged prostates alone or in combination with LHRH antagonists. SUMMARY: New 5-ARIs seem to be the promising agents that need further study. Preclinical studies revealed that GHRH and LHRH antagonists both can cause a reduction in prostate volume. Recent data indicate that prostate shrinkage is induced by the direct inhibitory action of GHRH and of LHRH antagonists exerted through prostatic receptors. The adverse effects of 5ARIs encourage alternative therapy.

Establishing the clinical and economic benefits of adherence to 5-alpha reductase inhibitors in benign prostatic hyperplasia: an assessment of Medicare and Medicaid patients.

OBJECTIVE: The primary objective of this study was to evaluate the length of 5-alpha reductase inhibitor (5ARI) therapy on the likelihood of acute urinary retention (AUR) and prostate surgery in patients diagnosed with benign prostatic hyperplasia (BPH). Additionally, this study attempted to quantify the relationship between length of 5ARI therapy and monthly BPH-related medical costs. STUDY DESIGN: This study used MarketScan® claims data from January 1, 2003, to December 31, 2008. Male Medicare patients ≥ 65 years and Medicaid patients ≥ 50 years who received a diagnosis of BPH and at least one claim for a 5ARI during the study period were included. Cox proportional hazards models were used to evaluate the effect of length of therapy on AUR and surgery, whereas generalized linear models were used to assess the effect on costs. RESULTS: In 28,903 patients, every additional 30 days of 5ARI therapy reduced the likelihood of AUR and prostate surgery by 14 and 11%, respectively, while each 30-day increment of 5ARI therapy reduced BPH-related costs by 15%. CONCLUSION: For patients remaining on 5ARI therapy, significant clinical and economic benefits may be realized, including reductions in AUR and prostate surgery rates and reduced medical costs for these clinical events.

Cost-effectiveness analysis of medical treatment of benign prostatic hyperplasia in the Brazilian public health system.

OBJECTIVE: To perform a cost-effectiveness analysis of medical treatment of benign prostatic hyperplasia (BPH) under Brazilian public health system perspective (Unified Health System--"Sistema Unico de Saude (SUS)"). MATERIAL AND METHODS: A revision of the literature of the medical treatment of BPH using alpha-blockers, 5-alpha-reductase inhibitors and combinations was carried out. A panel of specialists defined the use of public health resources during episodes of acute urinary retention (AUR), the treatment and the evolution of these patients in public hospitals. A model of economic analysis (Markov) predicted the number of episodes of AUR and surgeries (open prostatectomy and transurethral resection of the prostate) related to BPH according to stages of evolution of the disease. Brazilian currency was converted to American dollars according to the theory of Purchasing Power Parity (PPP 2010: US$ 1 = R$ 1.70). RESULTS: The use of finasteride reduced 59.6% of AUR episodes and 57.9% the need of surgery compared to placebo, in a period of six years and taking into account a treatment discontinuity rate of 34%. The mean cost of treatment was R$ 764.11 (US$ 449.78) and R$ 579.57 (US$ 340.92) per patient in the finasteride and placebo groups, respectively. The incremental cost-effectiveness ratio (ICERs) was R$ 4.130 (US$ 2.429) per episode of AUR avoided and R$ 2.735 (US$ 1.609) per episode of surgery avoided. The comparison of finasteride + doxazosine to placebo showed a reduction of 75.7% of AUR episodes and 66.8% of surgeries in a 4 year time horizon, with a ICERs of R$ 21.191 (US$ 12.918) per AUR episodes avoided and R$ 11.980 (US$ 7.047) per surgery avoided. In the sensitivity analysis the adhesion rate to treatment and the cost of finasteride were the main variables that influenced the results. CONCLUSIONS: These findings suggest that the treatment of BPH with finasteride is cost-effective compared to placebo in the Brazilian public health system perspective.

[Pharmacoeconomic evaluation of combination therapy with dutasteride and α1 blocker for treatment of benign prostatic hyperplasia in Japan].

The cost-effectiveness of combination therapy with an α1 blocker and dutasteride in benign prostatic hyperplasia (BPH) was analyzed in comparison with α1 blocker monotherapy. A Markov model with seven health states related to BPH was constructed with 4-year and 10-year time horizons and from the entire payers perspective. The transition probabilities among different health states input into the model were mainly derived from CombAT Study data, while cost parameters were estimated from a clinical database including DPC claims. Effectiveness was defined as quality adjusted life year (QALY). The cost-effectiveness of combination therapy was assessed by the incremental cost-effectiveness ratio (ICER) threshold (6 to 7 million Japanese yen (JPY)/QALY gained). For a base-case analysis, combination therapy produced an incremental effectiveness versus monotherapy of 0.050 and 0.097 QALYs at 4 years and 10 years, respectively, while the concomitant incremental costs were estimated to be 257,172 and 579,908 JPY, respectively. The ICERs for combination therapy versus monotherapy calculated at 4 years and 10 years were 5,119,007 and 5,974,495 JPY/QALY gained, respectively, both below the acceptable ICER threshold. Sensitivity analyses revealed that the ICER tended to decrease with greater BPH severity. These findings suggest that combination therapy with an α1 blocker and dutasteride would be more cost-effective in BPH than α1 blocker monotherapy and more efficient in moderate-to-severe BPH.

Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial.

OBJECTIVE: • To evaluate the cost-effectiveness of combination therapy for benign prostatic hyperplasia (BPH) compared with alpha-blocker (AB), 5-alpha reductase inhibitor (5ARI) monotherapy or watchful waiting (WW) in male patients enrolled in the Combination of Avodart and Tamsulosin (CombAT) trial using a Norwegian economic model. PATIENTS AND METHODS: • A decision analytic model was constructed to evaluate the BPH treatment regimens using point estimate base-case analyses, one-way sensitivity testing and probabilistic sensitivity analyses. • Symptom severity and acute urinary retention/transurethral resection of the prostate (AUR/TURP) event data came from the 4-year evaluation of the CombAT trial with additional data from the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The model makes use of Norwegian practice pattern data and unit cost and utility estimates were taken from the published literature. • The model calculates treatment costs and utility outcomes at two time horizons: 4 years and lifetime. Incremental cost-effectiveness ratios (ICERs) were calculated using WW as the basis of comparison. Costs and health state utilities were discounted after the first year. RESULTS: • At 4 years, ICER results for combination therapy are higher than AB monotherapy as a result of the higher drug cost, but the overall cost and quality-adjusted life-year (QALY) differences are small. • At the lifetime evaluation, the ICER results decrease from those at the 4-year horizon, although AB monotherapy remains less expensive than combination therapy. However, the incremental QALYs gained for combination therapy are twice those of AB monotherapy. CONCLUSIONS: • The model is sensitive to variability in estimates of health state utility assigned on the basis of symptom severity, indicating that both monotherapy and combination therapy have an advantage in maintaining patients in less severe symptom states. • Overall, combination therapy for BPH is expected to provide the greatest net monetary benefit at willingness-to-pay thresholds at or above ≈€6000 (£5400).

[Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. / Coste-efectividad de la combinación dutasterida y tamsulosina en el tratamiento de la hiperplasia benigna de próstata en España.

OBJECTIVES: to evaluate the incremental cost-effectiveness ratio (ICER) of the combination therapy with dutasteride and tamsulosin (DUT+TAM) as initiation treatment versus the most used drug in Spain, tamsulosin (TAM), in the treatment of moderate to severe benign prostatic hyperplasia (BPH) with risk of progression. METHODS: a semi-Markov model was developed using 4-year and 35-year time horizons and from the Spanish National Healthcare Service perspective. Data were obtained from the CombAT trial. Effectiveness was measured in terms of quality adjusted life years (QALYs). Health care resources were defined by an experts' panel, and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in PTP(WAT); in the case of TAM, the generic price is used, in the case of DUT+TAM the price of a fixed dose combination is used. Costs are expressed in 2010 Euros. RESULTS: combination therapy with DUT+TAM produces an incremental effectiveness of 0.06QALY at year 4 and 0.4QALY at year 35. DUT+TAM represents an incremental cost of € 810.53 at 4 years and € 3,443.62 at 35 years. Therefore, the ICER for DUT+TAM versus TAM is € 14,023.32/QALY at year 4 and € 8,750.15/QALY at year 35. CONCLUSIONS: initiation treatment with DUT+TAM represents a cost-effective treatment versus TAM, the most used treatment in Spain, due to the fact the ICER is below the threshold that usually allows a technology to be considered as cost-effective.