RESUMEN
PURPOSE: A cost minimisation analysis compares the costs of different interventions' to ascertain the least expensive over time. We compared different prostate targeted drug treatments with TURP to identify the optimal cost saving duration of a medical therapy for symptomatic benign prostatic enlargement (BPE). METHODS: The Evolution registry is a prospective, multicentre registry, conducted by the European Association of Urology Research Foundation (EAUrf) for 24 months in 5 European countries. Evolution was designed to register the management of symptomatic BPE in clinical practice settings in 5 European countries. Direct cost evaluation associated with prostate targeted medical therapies and TURP was also recorded and analysed. RESULTS: In total, 1838 men were enrolled with 1246 evaluable at 24 months. Medical therapies were more cost saving than TURP for treatment durations ranging from 2.9 to 70.4 years. Cost saving depended on both medication class and individual country assessed. Daily tamsulosin monotherapy was more cost saving than TURP for ≤ 13.9 years in Germany compared to ≤ 32.7 years in Italy. Daily finasteride monotherapy was more cost saving for ≤ 5.9 years in France compared to ≤ 36.9 years in Spain. Combination therapy was more cost saving for ≤ 5.9 years for Italian patients versus ≤ 13.8 years in Germany. CONCLUSIONS: BPE medical management was more cost saving than TURP for different specific treatment durations. Information from this study will allow clinicians to convey medical and surgical costs over time, to both patients and payors alike, when considering BPE treatment.
Asunto(s)
Finasterida/uso terapéutico , Hiperplasia Prostática/terapia , Tamsulosina/uso terapéutico , Resección Transuretral de la Próstata/economía , Agentes Urológicos/uso terapéutico , Anciano , Anciano de 80 o más Años , Costos y Análisis de Costo , Quimioterapia Combinada , Finasterida/economía , Francia , Alemania , Humanos , Italia , Masculino , Persona de Mediana Edad , Hiperplasia Prostática/economía , España , Tamsulosina/economía , Reino Unido , Agentes Urológicos/economíaRESUMEN
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 40âml and PSA greater than 1.5âng/ml. Combination therapy is the treatment of choice in these patients, but with prostate volume greater than 58âml 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.
Asunto(s)
Inhibidores de 5-alfa-Reductasa/uso terapéutico , Azaesteroides/uso terapéutico , Finasterida/uso terapéutico , Hiperplasia Prostática/tratamiento farmacológico , Inhibidores de 5-alfa-Reductasa/efectos adversos , Inhibidores de 5-alfa-Reductasa/economía , Azaesteroides/efectos adversos , Azaesteroides/economía , Análisis Costo-Beneficio , Dutasterida , Finasterida/efectos adversos , Finasterida/economía , Hormona Liberadora de Gonadotropina/antagonistas & inhibidores , Hormona Liberadora de Hormona del Crecimiento/antagonistas & inhibidores , Humanos , Masculino , Hiperplasia Prostática/economía , Hiperplasia Prostática/patología , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Costos de la Atención en Salud/estadística & datos numéricos , Programas Nacionales de Salud/economía , Hiperplasia Prostática/terapia , Inhibidores de 5-alfa-Reductasa/economía , Inhibidores de 5-alfa-Reductasa/uso terapéutico , Antagonistas de Receptores Adrenérgicos alfa 1/economía , Antagonistas de Receptores Adrenérgicos alfa 1/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Brasil , Análisis Costo-Beneficio , Doxazosina/economía , Doxazosina/uso terapéutico , Finasterida/economía , Finasterida/uso terapéutico , Humanos , Masculino , Hiperplasia Prostática/economía , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: Improvement in the cost-effectiveness of chemoprevention for prostate cancer could be realized through the identification of patients at higher risk. We estimated the cost-effectiveness of prostate cancer chemoprevention across risk groups defined by family history and number of risk alleles, and the cost-effectiveness of targeting chemoprevention to higher risk groups. MATERIALS AND METHODS: We developed a probabilistic Markov model to estimate costs, survival and quality adjusted survival across risk groups for patients receiving or not receiving chemoprevention with finasteride. The model uses data from national cancer registries, online sources and the medical literature. RESULTS: The incremental cost-effectiveness of 25 years of chemoprevention with finasteride in patients 50 years old was an estimated $89,300 per quality adjusted life-year (95% CI $58,800-$149,800), assuming finasteride decreased all grades of prostate cancer by 24.8%. Among patients with a positive family history (without genetic testing) chemoprevention provided 1 additional quality adjusted life-year at a cost of $64,200. Among patients with a negative family history at $400 per person tested, the cost-effectiveness of genetically targeted chemoprevention ranged from $98,100 per quality adjusted life-year when limiting finasteride to individuals with 14 or more risk alleles, to $103,200 per quality adjusted life-year when including those with 8 or more risk alleles. CONCLUSIONS: Although there are small differences in the cost-effectiveness of genetically targeted chemoprevention strategies in patients with a negative family history, genetic testing could reduce total expenditures if used to target chemoprevention for higher risk groups.
Asunto(s)
Inhibidores de 5-alfa-Reductasa/economía , Inhibidores de 5-alfa-Reductasa/uso terapéutico , Finasterida/economía , Finasterida/uso terapéutico , Polimorfismo Genético , Neoplasias de la Próstata/economía , Neoplasias de la Próstata/prevención & control , Anciano , Análisis Costo-Beneficio , Humanos , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/genéticaRESUMEN
OBJECTIVE: To examine the geographic and pharmacy-type variation in costs for generic benign prostatic hyperplasia (BPH) medications in order to improve drug price transparency and reduce health disparities. Medical therapy for BPH can be expensive, having significant implications for uninsured and underinsured patients. METHODS: We generated a 20% random sample of all pharmacies in Pennsylvania and queried each for the uninsured cash price of a 30-day prescription of tamsulosin 0.4mg daily, finasteride 5mg daily, oxybutynin immediate release 5mg TID and oxybutynin XL 10mg daily. Our primary objectives were to identify price variation based on pharmacy type (i.e., big chain and independent) and between geographic regions (predetermined by the Pennsylvania Health Care Cost Containment Council Database). We fit multivariable quantile regression models to test for an association between drug price and region after controlling for pharmacy type. RESULTS: Among 575 retail pharmacies contacted, 473 responded (82% response rate). The median cash price was significantly higher for big chain pharmacies than for independent pharmacies for tamsulosin ($66 vs. $15), finasteride ($68 vs. $15), oxybutynin immediate release ($49 vs. $35), and oxybutynin XL ($79 vs. $31) (all p < 0.05). When controlling for region, the median and 75th percentile price of all drugs was significantly higher for big chain pharmacies. When controlling for pharmacy type, regional variation was noted in all four drugs at the 75th percentile price and was greater for independent pharmacies. CONCLUSION: Compared to independent pharmacies, big chain pharmacies charged significantly more for generic BPH medications to uninsured patients. However, independent pharmacies demonstrated more regional variation in their pricing.
Asunto(s)
Costos y Análisis de Costo , Medicamentos Genéricos/economía , Finasterida/economía , Ácidos Mandélicos/economía , Hiperplasia Prostática/economía , Tamsulosina/economía , Finasterida/uso terapéutico , Humanos , Masculino , Ácidos Mandélicos/uso terapéutico , Pennsylvania , Hiperplasia Prostática/tratamiento farmacológico , Tamsulosina/uso terapéuticoRESUMEN
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.
Asunto(s)
Inhibidores de 5-alfa-Reductasa/uso terapéutico , Antagonistas de Receptores Adrenérgicos alfa 1/uso terapéutico , Análisis Costo-Beneficio , Doxazosina/uso terapéutico , Quimioterapia Combinada , Dutasterida/uso terapéutico , Finasterida/uso terapéutico , Hiperplasia Prostática/tratamiento farmacológico , Inhibidores de 5-alfa-Reductasa/economía , Antagonistas de Receptores Adrenérgicos alfa 1/economía , Adulto , Colombia , Doxazosina/economía , Dutasterida/economía , Finasterida/economía , Humanos , Masculino , Persona de Mediana Edad , Hiperplasia Prostática/economíaRESUMEN
BACKGROUND: The Prostate Cancer Prevention Trial found reduced prostate cancer prevalence for men treated with finasteride. The public health cost of wide-scale chemoprevention is unclear. We developed a model to help clarify the cost effectiveness of public use of prostate cancer-preventive agents. METHODS: A Markov decision analysis model was designed to determine the lifetime prostate health-related costs, beginning at the age of 50 years, for men treated with finasteride compared with placebo. Model assumptions were based on data from the Prostate Cancer Prevention Trial, a literature review of survival and progression rates for patients treated with radical prostatectomy, and costs associated with prostate cancer disease states. RESULTS: Chemoprevention with finasteride resulted in a gain of 8.7 [corrected] life years per 1,000 men at a cost of $1.107 million [corrected] per life year saved (LYS). However, if finasteride is assumed to not increase the incidence of high-grade tumors, it renders a gain of 16.9 [corrected] life years per 1,000 men at a cost of $578,400 [corrected] per LYS; finasteride must cost $160 per year [corrected] to reach $100,000 [corrected] per LYS. When applied to a population at higher risk (lifetime prevalence >or=40%) [corrected]for developing prostate cancer, the cost of finasteride must be reduced from its current cost ($62/month) to <$15/month [corrected]for the cost effectiveness to fall below $50,000 [corrected] per LYS. CONCLUSIONS: Given the natural history of treated prostate cancer, implementation of chemoprevention would require an inexpensive medication with substantial cancer risk reduction to be cost effective. Targeting populations at higher risk for developing prostate cancer, however, allows for considerable flexibility in the medication cost to make prostate cancer chemoprevention a more attainable goal.
Asunto(s)
Técnicas de Apoyo para la Decisión , Modelos Econométricos , Neoplasias de la Próstata/economía , Neoplasias de la Próstata/prevención & control , Anciano , Quimioprevención , Análisis Costo-Beneficio , Inhibidores Enzimáticos/economía , Inhibidores Enzimáticos/uso terapéutico , Finasterida/economía , Finasterida/uso terapéutico , Costos de la Atención en Salud , Investigación sobre Servicios de Salud/economía , Humanos , Masculino , Cadenas de Markov , Persona de Mediana Edad , Neoplasias de la Próstata/epidemiología , Sensibilidad y EspecificidadRESUMEN
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.
Asunto(s)
Inhibidores de 5-alfa-Reductasa/economía , Análisis Costo-Beneficio , Dutasterida/economía , Finasterida/economía , Cadenas de Markov , Hiperplasia Prostática/economía , Inhibidores de 5-alfa-Reductasa/uso terapéutico , Anciano , Envejecimiento , Presupuestos , Análisis Costo-Beneficio/economía , Dutasterida/uso terapéutico , Finasterida/uso terapéutico , Humanos , Masculino , Montenegro , Hiperplasia Prostática/tratamiento farmacológico , Calidad de Vida , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Inhibidores de 5-alfa-Reductasa/economía , Inhibidores de 5-alfa-Reductasa/uso terapéutico , Antagonistas Adrenérgicos alfa/economía , Antagonistas Adrenérgicos alfa/uso terapéutico , Dutasterida/economía , Dutasterida/uso terapéutico , Finasterida/economía , Finasterida/uso terapéutico , Hiperplasia Prostática/tratamiento farmacológico , Hiperplasia Prostática/economía , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Progresión de la Enfermedad , Costos de la Atención en Salud , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos , Retención Urinaria/economía , Retención Urinaria/etiología , Retención Urinaria/terapiaRESUMEN
PURPOSE: We estimate the lifetime implications of daily treatment with finasteride following the results of the Prostate Cancer Prevention Trial (PCPT). In this trial, prostate cancer prevalence was reduced by 25%; however, an increase in the number of high-grade tumors among the treatment group necessitates the long-term projection of the likely benefits and costs. METHODS: We use a Markov decision analysis model with data from the trial, the SEER program, and published literature. The model measures the cost per life-year and cost per quality-adjusted life-year (QALY) gained for a cohort of men age 55 years who initiate preventive treatment with finasteride. RESULTS: Finasteride is associated with a gain of 6 life-years per 1000 men treated at an incremental cost of 1660000 dollars per life-year gained. The quality-adjusted analysis results in 46 QALYs gained per 1000 men treated at an incremental cost of 200000 dollars per QALY gained, due primarily to the favorable effects of finasteride on benign prostatic hyperplasia. Under the assumption that the increase in high-grade tumors observed among finasteride treated men is a pathologic artifact, the incremental costs are 290000 dollars per life-year gained and 130000 dollars per QALY gained. CONCLUSIONS: The cost burden associated with finasteride is substantial, while its survival benefit is small and only realized many years after initiating treatment. To achieve an incremental cost below 100000 dollars per QALY gained, the price of finasteride must be reduced by 50% from its current average wholesale price and finasteride must be shown to prevent high-grade as well as low-grade disease.
Asunto(s)
Inhibidores Enzimáticos/economía , Finasterida/economía , Cadenas de Markov , Neoplasias de la Próstata/prevención & control , Años de Vida Ajustados por Calidad de Vida , Anciano , Anciano de 80 o más Años , Análisis Costo-Beneficio , Inhibidores Enzimáticos/uso terapéutico , Finasterida/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Modelos Econométricos , Neoplasias de la Próstata/economía , Neoplasias de la Próstata/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Estados Unidos/epidemiologíaRESUMEN
UNLABELLED: Finasteride inhibits type 25alpha-reductase activity, significantly reducing dihydrotestosterone levels. Consequent reductions in prostate volume, increases in urinary flow rates and improvements in symptoms compared with placebo have been observed in trials of up to 4 years' duration and in noncomparative extensions (for up to 6 years). Results from the 4-year placebo-controlled PLESS trial show finasteride to significantly reduce the risk of benign prostatic hypertrophy (BPH)-related acute urinary retention and the requirement for surgical intervention. Finasteride has significantly greater efficacy in patients with a large prostate (> or = 40 ml) than in patients with a small prostate. However, the predictive value of prostate size has been questioned. Results of an earlier comparative 1-year trial show terazosin monotherapy and terazosin plus finasteride therapy to be significantly more effective than both finasteride monotherapy and placebo in reducing symptom scores and improving maximum urinary flow rates. Prostatic volume was significantly reduced by finasteride monotherapy and combination therapy only. The overall efficacy of finasteride in patients with mild to moderate symptomatic BPH tended to be greater than that of serenoa repens (Permixon) in a 6-month trial. A US cost analysis model indicates that finasteride and terazosin are less expensive than transurethral resection of the prostate (TURP) during the first 2 years of initiation. Canadian cost-effectiveness and cost-utility analyses using decision analysis modelling have shown primary intervention with finasteride to provide more quality-adjusted life years (QALYs) at lesser cost than watchful waiting or TURP in patients with moderate symptoms who receive the drug for < or = 3 years and < or = 14 years, respectively, but fewer QALYs at a higher cost in patients with severe symptoms needing therapy for > or = 4 years. Confirmatory prospective economic studies are required. Finasteride appears to improve overall quality of life to a similar extent to serenoa repens; patient satisfaction appears similar with finasteride and TURP. Finasteride is generally well tolerated. Most commonly reported adverse effects are sexually related (1 to 2.1 %). Gynaecomastia has been reported in 0.4% of patients. CONCLUSIONS: Despite modest improvements in maximum urinary flow rates and symptom scores, finasteride is a first-line treatment option in those with moderate uncomplicated BPH, especially in patients with a large prostate (> or = 40 ml). It is also an option in patients with more severe symptoms who are unable or unwilling to undergo surgery and in those awaiting surgery. Importantly, finasteride appears to reduce disease progression, significantly decreasing the incidence of acute urinary retention and the requirement for surgical intervention; to date, no other pharmacological agent has been shown to reduce these outcomes.
Asunto(s)
Finasterida , Hiperplasia Prostática/tratamiento farmacológico , Ensayos Clínicos Controlados como Asunto , Inhibidores Enzimáticos/efectos adversos , Inhibidores Enzimáticos/economía , Inhibidores Enzimáticos/farmacocinética , Inhibidores Enzimáticos/uso terapéutico , Finasterida/efectos adversos , Finasterida/economía , Finasterida/farmacocinética , Finasterida/uso terapéutico , Humanos , Masculino , Hiperplasia Prostática/economía , Hiperplasia Prostática/metabolismo , Calidad de VidaRESUMEN
Benign prostatic hyperplasia (BPH) is one of the most common medical conditions in older men in the United States. BPH is often associated with a reduction in quality of life and may progress to acute urinary retention (AUR), the inability to pass any urine. Recently, a 4-year placebo-controlled clinical trial known as the Proscar Long-Term Efficacy and Safety Study (PLESS) demonstrated that finasteride use reduces the risk of developing AUR by 57% and the need for BPH-related surgery by 55%. The economic implications of these findings were investigated using a model-based decision-analytic approach to compare finasteride with both watchful waiting and alpha-blocker therapy. The modeling used the longest-term published controlled data concerning alpha-blockers, which were for the alpha-blocker terazosin. The base case considered a 64-year-old man (the mean age of a PLESS patient) with prostatic enlargement on digital rectal examination and moderate-to-severe symptoms of BPH. The model suggested savings in surgical and AUR costs with finasteride versus watchful waiting, with an estimated 25% of total finasteride costs recouped in savings on surgical events avoided in the first year. Over 2 years, the expected cost per patient starting finasteride therapy was $2304, whereas the expected cost per patient starting terazosin was $2334. Analyses also explored the variation in economic results by baseline levels of prostate-specific antigen (PSA), a proxy for prostate volume. For patients with PSA levels > or =1.4 ng/mL, expected 2-year costs with finasteride and terazosin were $2342 and $2479, respectively. For patients with PSA levels > or =3.3 ng/mL, expected 2-year costs with finasteride were $373 less than with terazosin ($2347 vs $2720). Results were robust over a range of model assumptions and cost estimates. The analyses illustrate that all medical interventions, including watchful waiting, have associated costs. Finasteride shows cost offsets compared with watchful waiting and cost savings compared with terazosin over 2 years. Finasteride appears to be more economical in men with higher PSA levels.
Asunto(s)
Inhibidores Enzimáticos/economía , Finasterida/economía , Modelos Económicos , Hiperplasia Prostática/tratamiento farmacológico , Hiperplasia Prostática/economía , Antagonistas Adrenérgicos alfa/economía , Antagonistas Adrenérgicos alfa/uso terapéutico , Anciano , Árboles de Decisión , Inhibidores Enzimáticos/efectos adversos , Inhibidores Enzimáticos/uso terapéutico , Finasterida/efectos adversos , Finasterida/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Prazosina/análogos & derivados , Prazosina/economía , Prazosina/uso terapéutico , Antígeno Prostático Específico/sangre , Hiperplasia Prostática/cirugía , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Men with moderate symptoms of benign prostatic hyperplasia (BPH) are the best candidates for medical treatment, while surgery is usually indicated for patients with severe symptoms. Men with mild symptoms do not usually need treatment, but they might be re-evaluated annually if desirable. Finasteride, which produces selective hormonal deprivation, is now established as a well tolerated drug for the long term medical therapy of BPH. Recent studies suggest that finasteride is most effective in men with large prostates (> 40 ml), and the drug should probably be reserved for these patients. alpha-Blockers work in men with small or large prostates, and their rapid onset of action facilitates the identification of responders. alpha-Blockers are more effective than finasteride during the first year of treatment, but only finasteride induces regression of the prostate and offers increased efficacy over time. Even if drug therapy reduces the need for prostate surgery, the total economic cost of BPH treatment is likely to rise because of the increasing application of medical treatment. The magnitude of this increase depends largely on what percentage of the male population embark on long term therapy, at what age treatment is started, and how successful it is. At present, the answers to these questions are largely unknown. The personal economic expenses for men who begin long term medical therapy will probably be an important factor in deciding how common drug treatment for BPH will become in the future. For many men, the main benefit of drug treatment will be the relief of urinary symptoms, but whether this improvement is substantial enough to improve their overall quality of life has not yet been clearly demonstrated in controlled studies.
Asunto(s)
Antagonistas Adrenérgicos alfa/uso terapéutico , Inhibidores Enzimáticos/uso terapéutico , Finasterida/uso terapéutico , Prazosina/análogos & derivados , Prostatectomía/economía , Hiperplasia Prostática/tratamiento farmacológico , Hiperplasia Prostática/economía , Antagonistas Adrenérgicos alfa/efectos adversos , Antagonistas Adrenérgicos alfa/economía , Anciano , Inhibidores Enzimáticos/efectos adversos , Inhibidores Enzimáticos/economía , Finasterida/efectos adversos , Finasterida/economía , Humanos , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Prazosina/efectos adversos , Prazosina/economía , Prazosina/uso terapéutico , Prevalencia , Hiperplasia Prostática/epidemiología , Hiperplasia Prostática/cirugía , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
This evaluation was conducted at the request of a Canadian provincial government considering finasteride for formulary inclusion. The comparator therapies, in accordance with Canadian pharmacoeconomic guidelines, were the most prevalent treatment [transurethral resection of the prostate (TURP)] and the lowest cost treatment (watchful waiting). All costs were measured in 1994 Canadian dollars ($Can), and both costs and outcomes were discounted at 5% per annum. Cost-effectiveness and cost-utility ratios were calculated, and were found to be dependent on initial symptom severity and the anticipated duration of treatment with finasteride. The drug was shown to be the dominant alternative compared with both TURP and watchful waiting for patients with moderate symptoms, when the duration of drug therapy is 3 years or less. However, finasteride is a weak alternative for patients with severe symptoms who are treated for 4 years or more. For other groups of patients (i.e. moderate symptoms and on finasteride for 4 years or more; severe symptoms and on treatment for 3 years or less), the drug can improve health-related quality of life, but at a cost of between $Can3000 and $Can97,000 per incremental quality-adjusted life year (1994 dollars). Our study also indicated that it would cost between $Can2.7 million and $Can5.6 million, depending on the severity mix of the patients, to treat cohort of 10,000 men aged 60 years or older with finasteride.
Asunto(s)
Inhibidores Enzimáticos/economía , Finasterida/economía , Hiperplasia Prostática/terapia , Anciano , Canadá , Análisis Costo-Beneficio , Árboles de Decisión , Inhibidores Enzimáticos/uso terapéutico , Finasterida/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Prostatectomía/economía , Hiperplasia Prostática/economía , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate patients willingness to share the costs of 2 medications (often described as "lifestyle medications"): sildenafil for erectile dysfunction and finasteride for hair loss, which are not routinely covered by the Department of Veterans Affairs (VA) healthcare system. STUDY DESIGN: Self-administered, anonymous survey. PATIENTS AND METHODS: Adult men (n = 339) were recruited from waiting rooms for primary care or erectile dysfunction clinic appointments at 2 Los Angeles VA facilities. RESULTS: Participants with self-reported need were analyzed separately for finasteride (primary care patients only) and sildenafil (both primary care and erectile dysfunction clinic patients). The mean age of the participants was 56 and 60 years for the finasteride and sildenafil groups, respectively. Mean annual household income for both groups was under $10,000. Respondents reported a mean willingness to cost-share $4.20 for a 30-day prescription of daily finasteride (VA wholesale cost = $27) and $5.40 for 4 sildenafil pills (VA wholesale cost = $20). In the multivariate analysis, higher income (P = .002) and increasing self-reported need for medication (P = .04) were associated with increased willingness to cost-share for finasteride after controlling for age, race/ethnicity, insured status, comorbid conditions, and type of clinic. In addition, younger age (P = .01) was associated with greater willingness to cost-share for sildenafil. CONCLUSIONS: In this low-income veteran population, patients with a self-reported need for sildenafil and finasteride would be willing to make a higher copayment than the current VA maximum copayment of $2.00 per 30-day prescription, if these medicines were made available.
Asunto(s)
Alopecia/economía , Actitud Frente a la Salud , Seguro de Costos Compartidos/estadística & datos numéricos , Costos de los Medicamentos , Inhibidores Enzimáticos/economía , Disfunción Eréctil/economía , Finasterida/economía , Piperazinas/economía , Adulto , Anciano , Alopecia/tratamiento farmacológico , Inhibidores Enzimáticos/uso terapéutico , Disfunción Eréctil/tratamiento farmacológico , Finasterida/uso terapéutico , Encuestas de Atención de la Salud , Hospitales de Veteranos/economía , Hospitales de Veteranos/estadística & datos numéricos , Humanos , Los Angeles , Masculino , Persona de Mediana Edad , Piperazinas/uso terapéutico , Purinas , Citrato de Sildenafil , SulfonasRESUMEN
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.
Asunto(s)
Antagonistas Adrenérgicos alfa/economía , Doxazosina/economía , Inhibidores Enzimáticos/economía , Finasterida/economía , Hiperplasia Prostática/tratamiento farmacológico , Antagonistas Adrenérgicos alfa/uso terapéutico , Análisis Costo-Beneficio , Doxazosina/uso terapéutico , Quimioterapia Combinada , Inhibidores Enzimáticos/uso terapéutico , Finasterida/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Modelos Económicos , Hiperplasia Prostática/economíaRESUMEN
Benign prostatic hyperplasia (BPH) has an important impact on the national health economics and can be managed in a large spectrum of modalities from simple follow-up to surgery. In this study, we aimed to compare different treatment options of BPH in terms of cost effectiveness in Turkey. The first evaluation of a BPH patient has a cost of $200. The cost of TURP or open prostatectomy (OP) in our hospital including all the expenses is $740. Finasteride has an annual cost nearly equal to TURP and OP. Considering the expenses of the close follow-up studies and regular visits, one-year lasting Finasteride treatment is two times more expensive than surgery. In comparison with medical treatment options, TURP as the gold standard of treatment of BPH is cost effective when long-term expenses are considered.