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.

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.

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 Único de Saúde (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.

Cost-effectiveness of tamsulosin, doxazosin, and terazosin in the treatment of benign prostatic hyperplasia.

OBJECTIVE: To evaluate the cost-effectiveness of tamsulosin, doxazosin, or terazosin as initial treatments for moderate benign prostatic hyperplasia (BPH) over a 3-year time horizon from a health-system-payer perspective. METHODS: A decision-analytic model is used to project the course of treatment at 6-month intervals over 3 years following initiation of therapy with tamsulosin, doxazosin, or terazosin. Treatment failure is defined as failure to attain and maintain a 25% improvement in the American Urological Association (AUA) symptom score from baseline. In the model, finasteride is added for patients who fail on their initial therapy and, in the event of finasteride treatment failure, patients progress to transurethral resection of the prostate (TURP) and, if needed, a second TURP. The ranges of values for treatment failure rates and clinical event cost parameters used in the decision model are derived from the literature. Only direct medical costs related to BPH and its treatment are included. Since 2 comparators are available generically (doxazosin and terazosin) drug acquisition costs are defined by the list prices at Drugstore.com. All costs are discounted by 3% per year. Effectiveness is measured as successful medical treatment without surgery over 3 years. RESULTS: For base-case model parameters, discounted BPH-related total direct medical costs over 3 years are 4084 dollars, 4323 dollars, and 4695 dollars for generic terazosin, generic doxazosin, and tamsulosin, respectively. The model estimates a medical treatment success rate (no TURP) at 3 years of 72.3% for tamsulosin, compared with 68.2% for both terazosin and doxazosin. The incremental cost for tamsulosin versus terazosin is 610 dollars over 3 years, which yields an incremental cost-effectiveness ratio of 14,609 dollars per success. Generic doxazosin is dominated (higher cost but equal effectiveness compared with terazosin). Higher rates of twice-daily (or 2 units per day) dosing are associated with higher incremental cost-effectiveness ratios. The decision-model results also are sensitive to the estimated costs of TURP and hypotensive adverse events. CONCLUSION: As an initial medical therapy for moderate BPH, tamsulosin is more effective than generic terazosin or doxazosin, with an incremental cost of about 203 dollars per year (or about 17 dollars per month) over 3 years.

An economic evaluation of doxazosin, finasteride and combination therapy in the treatment of benign prostatic hyperplasia.

OBJECTIVE: The Proscar Long-Term Efficacy and Safety Study (PLESS) and the Medical Therapy of Prostatic Symptoms (MTOPS) study provide new evidence regarding the benefits of finasteride in the treatment of benign prostatic hyperplasia (BPH). The objective of this study was to utilize data from the PLESS and MTOPS studies to assess the cost-utility of finasteride and finasteride in combination with doxazosin, compared to doxazosin alone in men with moderate to severe BPH symptoms. METHODS: A semi-Markov decision analytic model was constructed to estimate the clinical consequences, costs and cost-utility of doxazosin, finasteride, and combination therapy. Analyses were conducted for a 15-year time frame from the perspective of the Ontario Ministry of Health and Long Term Care (MOHLTC). Results are reported stratified by baseline serum prostate-specific antigen (PSA) level according to all baseline serum PSA levels, patients with baseline serum PSA > 1.3 ng/ml, and patients with baseline serum PSA > 3.2 ng/ml. RESULTS: Compared to doxazosin alone, combination therapy was more expensive but more effective. Cost-utility ratios ranged from 27,823 dollars/QALY for patients with PSA > 3.2 ng/ml to 34,085 dollars/QALY for all patients. Finasteride, although dominated by doxazosin, may be cost-effective compared to watchful waiting in patients who fail doxazosin and do not choose to proceed to surgery. Compared to watchful waiting, cost-utility ratios for finasteride ranged from 35016 dollars/QALY for patients with PSA > 3.2 ng/ml to 44,336 dollars/QALY for all patients. Results were robust across a wide range of sensitivity analyses. CONCLUSIONS: Combination therapy is cost-effective compared to doxazosin with cost-utility ratios under 40,000 dollars/QALY across a wide range of scenarios. The cost-effectiveness of combination therapy increases as serum PSA level increases.

Impact of clinical trial results on national trends in alpha-blocker prescribing, 1996-2002.

CONTEXT: Research on factors that influence prescribing patterns and the extent of change produced by clinical trial findings is limited. OBJECTIVE: To examine the changes in prescribing of alpha-blockers for hypertension treatment before and after the April 2000 publication of the unfavorable Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) early termination involving the study's doxazosin mesylate arm. Changes in prescribing were considered in the context of other potential concurrent influences on medication use between 1996 and 2002, including changes in alpha-blocker drug prices, generic conversion, drug promotion, and competition. DESIGN, SETTING, AND PATIENTS: Using 2 national pharmaceutical market research reports published by IMS HEALTH, alpha-blocker prescription orders reported in the National Prescription Audit-a random computerized sample of about 20 000 of 29 000 retail, independent, and mail order pharmacies and mass merchandise and discount houses--and office-based physician alpha-blocker prescribing patterns reported in the National Disease and Therapeutic Index--a random stratified sample of about 3500 physician offices--were tracked. OUTCOME MEASURES: Trends in physician-reported use of alpha-blockers and alpha-blocker prescribing and dispensing by US pharmacies. RESULTS: There were steady increases in alpha-blocker new prescriptions, dispensed prescriptions, and physician drug use from 1996 through 1999. There was a moderate reversal in these trends following ALLHAT early termination and subsequent publications in early 2000. Between 1999 and 2002, new annual alpha-blocker prescription orders declined by 26% (from 5.15 million to 3.79 million), dispensed prescriptions by 22% (from 17.2 million to 13.4 million), and physician-reported drug use by 54% (from 2.26 million to 1.03 million). Other potential influences did not appear to have contributed significantly to this decline although cessation of alpha-blocker marketing may have hastened the decline. CONCLUSIONS: Modest yet statistically significant declines in the use of doxazosin and other alpha-blockers coincided with the early termination of the ALLHAT doxazosin arm. Although physicians responded to this new evidence, strategies to augment the impact of clinical trials on clinical practice are warranted.

Evaluación económica del cambio de tratamientode doxazosina estándar a doxazosina deliberación modificada en pacientes conhipertensión leve a moderada en condicioneshabituales de cuidado médico / Economic evaluation of switching from standard doxazosin to doxazosin gastro-intestinal-therapeutic system in patients with mild to moderate hypertension under usual medical care

Objetivo. El objetivo de este estudio ha sido realizar una evaluación económica con costes españoles de un estudio clínico, prospectivo, naturalístico que comparaba la efectividad del cambio de doxazosina estándar, en dosis de 1 a 16 mg/día, a doxazosina de liberación modificada, 4 a 8 mg/día, en el tratamiento de la hipertensión leve a moderada en condiciones de cuidado médico habitual en Atención Primaria. La evaluación económica consistió en una análisis coste-efectividad realizado desde la perspectiva del Sistema Nacional de Salud utilizando los precios de venta al público publicados de especialidad de marca para doxazosina de liberación moderada (DLM) y de genérico para doxazosina estándar, computándose el coste total, coste medio por paciente, coste por paciente tratado con éxito y coste incremental, e incluyó análisis de sensibilidad univariado con el coste de la medicación y la proporción de éxito terapéutico. Ambos tratamientos redujeron significativamente la presión arterial sistólica (PAS), diastólica (PAD) y media (PAM), logrando DLM una reducción adicional en todos los casos. La proporción de pacientes con la presión arterial controlada (PAS <140 mmHg y PAD<90 mmHg) fue significativamente superior con DLM que con estándar; 63,4 por ciento frente a 47,9 por ciento; p < 0,00001. El coste anual medio por paciente con presión arterial controlada fue menor con DLM; 468,12 euros (457,30-479,46 euros) frente a 561,67 euros (543,51-581,07 euros), con un coste incremental por paciente adicional con presión arterial controlada de 179,04 euros (149,20-223,80 euros).El cambio de tratamiento de la formulación estándar de doxazosina a una formulación de liberación modificada se acompaña de un mayor número de pacientes con la presión arterial controlada a un menor coste por paciente que logra el objetivo terapéutico. (AU)

The cost-effectiveness of doxazosin for the treatment of hypertension in type II diabetic patients in the UK and Italy.

The objective of this analysis was to assess the cost-effectiveness of achieving 'tight control' versus 'less tight control' of blood pressure, as defined in the UK Prospective Diabetics Study 38, in type II diabetic patients in the UK and Italy. The effect of including doxazosin in a 'tight control' combination therapy was analysed. Given doxazosin's positive impact on lipid levels in addition to its antihypertensive effect, it is hypothesised that treatment including doxazosin will reduce the incidence of macrovascular complications. For each country, a Markov model was constructed to simulate macrovascular outcomes of patients on various drug combinations. Transitional probabilities were based on the risk rates presented in UKPDS 38. Risk rates were adjusted for the ageing of the cohort and the lipid-lowering properties of doxazosin using Framingham risk equations. Incremental cost-effectiveness ratios ranged from 2224 Pounds to 4867 Pounds (US$3225-7057) per life-year saved for the UK and from L1.8-9.3 million (US$818-4159) per life-year saved for Italy. Doxazosin is a cost-effective agent when included in a combination therapy in the treatment of hypertension in the diabetic populations of the UK and Italy.

Trends in alpha-blocker treatment of patients with benign prostatic hyperplasia and hypertension: dosing regimens and cost comparisons.

Dosing regimen is an important determinant of both drug cost and patient compliance. This retrospective analysis evaluated dosing regimens and drug acquisition costs for 101 patients identified from medical records in a large metropolitan hospital as having hypertension and/or benign prostatic hyperplasia and receiving alpha-blocker therapy with either doxazosin or terazosin. Although once-daily administration is generally recommended for both drugs, 25 (38%) of 66 patients receiving terazosin were treated twice daily compared with 6 (17%) of 35 patients treated twice daily with doxazosin. This difference was statistically significant. The average (mean +/- SD) daily treatment cost per patient for all individuals receiving terazosin during the period of the record review was $1.68 +/- 0.60. For patients treated with doxazosin, the average was $0.96 +/- 0.65-a highly statistically significant result. If all 66 patients receiving terazosin had been converted to doxazosin at the beginning of the study, annual savings would have been $17,345.00. These results demonstrate the importance of reviewing actual dosing regimens. The fact that doxazosin could be administered to a significantly higher percentage of patients once daily rather than twice daily substantially decreased its cost relative to terazosin. A once-daily treatment regimen may also enhance patient compliance, thereby improving the chances of therapeutic success.