Dutasteride plus tamsulosin fixed-dose combination first-line therapy versus tamsulosin monotherapy in the treatment of benign prostatic hyperplasia: a budget impact analysis in the Greek healthcare setting.

BACKGROUND: The purpose of this study was to explore the budget impact of dutasteride plus tamsulosin fixed-dose combination (DUT + TAM FDC) versus tamsulosin monotherapy, in the treatment of patients with benign prostatic hyperplasia (BPH) from the perspective of the Greek healthcare insurance system. METHODS: A Microsoft Excel-based model was developed to estimate the financial consequences of adopting DUT + TAM FDC within the Greek healthcare setting. The model, compared six mutually exclusive health states in two alternative treatment options: current standard of care and the introduction of DUT + TAM FDC in the market. The model used clinical inputs from the CombAT study; data on resource use associated with the management of BPH in Greece were derived from expert panel, and unit cost data were derived from official reimbursement tariffs. A payer perspective was taken into account. As patient distribution data between public and private sectors are not available in Greece two scenarios were investigated, considering the whole eligible population in each scenario. A 4 year time horizon was taken into account and included treatment costs, number of transurethral resections of the prostate (TURPs) and acute urinary retention (AUR) episodes avoided. RESULTS: The clinical benefit from the market adoption of DUT + TAM FDC in Greece was 1,758 TURPs and 972 episodes of AUR avoided cumulatively in a four year period. The increase in total costs from the gradual introduction of DUT + TAM FDC to the Greek healthcare system ranges from €1.3 million in the first year to €5.8 million in the fourth year, for the public sector, and €1.2 million to €4.0 million, for the private sector. This represents an increase of 1.91% to 7.94% for the public sector and 1.10% 3.29% in the private sector, during the 4-year time horizon. CONCLUSIONS: Budget impact analysis (BIA) results indicated that the gradual introduction of DUT + TAM FDC, would increase the overall budget of the disease, however providing better clinical outcomes. DUT + TAM FDC drug acquisition cost is partly offset by the reduction in the costs associated with the treatment of the disease.

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.

[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 chemoprevention for prostate cancer with dutasteride in a high-risk population based on results from the REDUCE clinical trial.

BACKGROUND: The REDUCE trial examined whether chemoprevention with the dual 5-alpha reductase inhibitor, dutasteride, reduced risk of prostate cancer (PCa) detection on biopsy. OBJECTIVE: We examined the cost effectiveness of dutasteride compared with placebo in preventing PCa in men at increased risk as seen in REDUCE, from a US payer perspective. METHODS: A Markov model was developed to compare costs and outcomes of chemoprevention with dutasteride 0.5 mg/day or placebo with usual care in men aged 50-75 years, with serum prostate-specific antigen (PSA) of 2.5-10 ng/mL (men aged <60 years) or 3.0-10 ng/mL (men aged ≥60 years), and with a single negative prostate biopsy in the prior 6 months. The model simulated the REDUCE cohort annually through different health states over 4-, 10-year and lifetime time horizons. Risks of PCa for men receiving placebo and dutasteride were obtained from REDUCE. Rates of acute urinary retention events and benign prostate hyperplasia-related surgeries also came from REDUCE. Costs and utilities were obtained from published literature. All costs are reported in $US, year 2009 values. RESULTS: The model indicated that, over 10 years, dutasteride patients would experience fewer PCas (251 vs 312 per 1000 patients) at increased cost ($US15 341 vs $US12 316) than placebo patients. Although life-years were not substantially affected, the model calculated an increase in QALYs of 0.14 for dutasteride patients. Chemoprevention with dutasteride appeared to be cost effective, with an incremental cost per QALY of $US21 781 and cost per PCa avoided of $US50 254. The 4-year and lifetime incremental costs per QALY were $US18 409 and $US22 498, respectively. CONCLUSIONS: Despite increased cost due to taking a drug for prevention, dutasteride 0.5 mg/day may be cost effective in men at increased risk for PCa.

[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.

Dutasteride vs finasteride: assessment of differences in acute urinary retention rates and surgical risk outcomes in an elderly population aged > or =65 years.

OBJECTIVE: To determine comparative differences on rates of acute urinary retention (AUR) and prostate-related surgeries among patients aged > or =65 years treated with dutasteride or finasteride. METHODS: For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for enlarged prostate patients aged > or =65 years treated with 5-alpha reductase inhibitors (5ARIs) regardless of alpha-blocker use. Charlson Comorbidity Index, Thomson Medstat Disease Staging, and propensity score matching techniques were used for comparative analysis. RESULTS: A total of 5090 patients met selection criteria. After 1 year of 5ARI therapy, the AUR rate was lower for dutasteride (12%) when compared with finasteride (14.7%) (odds ratio [OR], 0.79; P = .0042). Risks for prostate-related surgeries were also lower among dutasteride-treated patients (3.9% vs 5.1%, respectively; OR, 0.77; P = .03). CONCLUSION: Important therapeutic outcome differences exist between dutasteride and finasteride. Patients treated with dutasteride were significantly less likely to experience AUR and prostate-related surgeries than finasteride patients.

Cost comparison of finasteride and dutasteride for enlarged prostate in a managed care setting among Medicare-aged men.

OBJECTIVE: To assess cost differences between dutasteride and finasteride use within the first year of initiating treatment for enlarged prostate (EP) among men aged > or =65 years in a managed care setting. METHODS: For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for EP patients aged > or =65 years who were treated with dutasteride or finasteride. Analysis of average monthly costs over each patient's 1-year follow-up period incorporated total charges for EP-related medical care, including physician, inpatient and outpatient hospital care, emergency department, and other ancillary services. RESULTS: A total of 4498 patients met selection criteria, with comparable demographics between treatment cohorts. Patients taking dutasteride incurred $51 less per month in medical expenses than finasteride-treated patients ($122 vs $173; P <.001), attributable to lower monthly inpatient hospitalization costs ($55.84 vs $70.34), outpatient costs ($22.07 vs $44.25), and physician office visit costs ($40.69 vs $51.10). CONCLUSION: Medicare-aged patients treated with dutasteride incurred $51 less per month in medical costs than those treated with generic finasteride, suggesting that the higher price of dutasteride may be offset by decreased medical resource consumption.

Finasteride versus dutasteride: a real-world economic evaluation.

OBJECTIVE: The objective of this study was to assess the economic differences between dutasteride and finasteride patients within the first year of initiating treatment. METHODS: A retrospective analysis using the PharMetrics Integrated Medical and Pharmaceutical Database (Watertown, Mass) was conducted to assess economic differences in patients who were initiated on dutasteride or finasteride. The database is nationally representative, encompassing administrative claims from more than 45 million patients within 85 managed healthcare plans. Male patients aged >50 years with a diagnosis of benign prostatic hyperplasia who began 5-alpha reductase inhibitor (5ARI) treatment (dutasteride or finasteride) between January 1, 1999, and March 1, 2005, were identified. Patients eligible for study inclusion were matched (1 dutasteride: 3 finasteride) on 4 variables (measured during the 6-month period before their first 5ARI prescription): age, presence of acute urinary retention, total amount of enlarged prostate (EP)-specific charges (+/- $1), and the duration of follow-up (measured in months). EP-specific charges were defined as the total amount charged for EP-specific physician visits, inpatient hospitalizations, outpatient hospital care, emergency department visits, and other ancillary services during the follow-up period for each patient, expressed as average monthly costs. RESULTS: Overall, patients incurred $121.04 in EP-specific charges per month, with inpatient hospitalizations making up 39.1% ($47.29) of the total costs of care. Physician office visits constituted 33.6% ($40.66) of monthly charges. When comparing differences among patients taking the two 5ARIs, patients taking dutasteride incurred $20.50 less per month in EP-specific charges than patients taking finasteride ($105.67 vs $126.17, P = .0007). This reduction in overall medical utilization resulted from a lower amount of inpatient hospitalization charges for dutasteride patients. CONCLUSION: Patients treated with dutasteride incurred $20.50 less per month in medical costs than patients treated with finasteride. Healthcare plans should consider the incremental differences in medical costs along with the difference in pharmaceutical expenditures when evaluating these two 5ARIs.