RESUMO
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.
Assuntos
Finasterida/uso terapêutico , Hiperplasia Prostática/terapia , Tansulosina/uso terapêutico , Ressecção Transuretral da Próstata/economia , Agentes Urológicos/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Custos e Análise de Custo , Quimioterapia Combinada , Finasterida/economia , França , Alemanha , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/economia , Espanha , Tansulosina/economia , Reino Unido , Agentes Urológicos/economiaRESUMO
PURPOSE OF REVIEW: To provide an economic context within which to consider treatment options for benign prostatic hyperplasia (BPH). To this end, this review provides a comparison of the costs of combination medical therapy, operative treatment, and office-based therapies for BPH from a payer perspective. RECENT FINDINGS: Analysis of Medicare charges from the authors' institution, as well as local retail costs of medication, demonstrated a wide range in costs of commonly used BPH treatments. In this study, interventions for BPH reached cost equivalence with combination medical therapy within 6 months to 8 years. A myriad of options for managing men with symptomatic BPH exist. It is prudent not only to consider surgeon preference and patient-specific factors when selecting a treatment but also to understand the economic impact different BPH therapies confer.
Assuntos
Hiperplasia Prostática/economia , Hiperplasia Prostática/terapia , Terapia Combinada/economia , Custos e Análise de Custo , Humanos , Masculino , Medicare/economia , Estados Unidos , Procedimentos Cirúrgicos Urológicos Masculinos/economia , Procedimentos Cirúrgicos Urológicos Masculinos/métodos , Agentes Urológicos/economia , Agentes Urológicos/uso terapêuticoRESUMO
BACKGROUND: Despite several new medications being Food and Drug Administration-approved for overactive bladder (OAB) and new prescription drug payment programs, there are limited population-based data regarding OAB medication use among older adults. OBJECTIVES: To examine: (1) impacts of new medications and $4 generic programs on time trends for OAB-related medication dispensing for older adults in the United States; (2) differences by age and sex; and (3) temporal changes in OAB-related medication payments. METHODS: Using Truven Health Analytics' Medicare Supplemental Database (2000-2015), we analyzed OAB-related medication claims for 9,477,061 Medigap beneficiaries age 65-104. We estimated dispensing rates (per 1000 person-months), assessed dispensing trends using interrupted time-series methods, compared dispensing rates by age and sex, and summarized payment trends. RESULTS: From 2000 to 2015, 771,609 individuals filled 13,863,998 OAB-related prescriptions. During 2000-2007, 3 new extended-release medications became available (tolterodine, darifenacin, solifenacin), leading to increases in overall OAB-related dispensing rates by 19.1 (99% confidence interval, 17.0-21.2), a 92% increase since 2000; overall rates remained stable during 2008-2015. By 2015, the most common medications were oxybutynin (38%), solifenacin (20%), tolterodine (19%), and mirabegron (12%). Dispensing rates peaked at age 90 (rate, 53.4; 99% confidence interval, 53.1-53.7). Women had higher rates than men at all ages (average ratewomen-ratemen, 22.0). The gap between upper and lower percentiles of medication payments widened between 2008-2015; by 2015, 25% of reimbursed dispensed prescriptions had total payments exceeding $250. CONCLUSIONS: Medication-specific dispensing rates for OAB changed when new alternatives became available. Recent changes in utilization and cost of OAB medications have implications for clinical guidelines, pharmacoepidemiologic studies, and payment policies.
Assuntos
Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/economia , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico , Idoso , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Medicare/estatística & dados numéricos , Adesão à Medicação , Estados UnidosRESUMO
AIMS: Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril® , IBSA) to dimethyl sulfoxide (DMSO). METHODS: Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses. RESULTS: A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735/quality-adjusted life years (QALY) and 8003/QALY. CONCLUSIONS: Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile.
Assuntos
Sulfatos de Condroitina/administração & dosagem , Cistite Intersticial/tratamento farmacológico , Dimetil Sulfóxido/administração & dosagem , Ácido Hialurônico/administração & dosagem , Agentes Urológicos/administração & dosagem , Administração Intravesical , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Sulfatos de Condroitina/economia , Análise Custo-Benefício , Cistite Intersticial/complicações , Cistite Intersticial/economia , Dimetil Sulfóxido/economia , Feminino , Humanos , Ácido Hialurônico/economia , Pessoa de Meia-Idade , Dor/tratamento farmacológico , Dor/etiologia , Medição da Dor , Qualidade de Vida , Resultado do Tratamento , Bexiga Urinária/efeitos dos fármacos , Agentes Urológicos/economia , Adulto JovemRESUMO
INTRODUCTION: Several recent trials have reported limited benefit for medical expulsive therapy (MET) in terms of stone passage rates, analgesic requirements, or need for intervention. We evaluated patient attitudes regarding MET after explaining these new findings. MATERIALS AND METHODS: Over a 12 week period, an investigator-designed survey was offered to sequential patients during routine appointments in our urologic clinic. A brief summary of the conflicting data for MET was provided. Patients then answered questions about their attitudes toward using MET. RESULTS: Patients (n = 200; 103 M, 97 F) were 56 ± 14 years old (range 20-103 years) and were mostly being seen for management of kidney stones (88%). Forty-nine percent reported they would try tamsulosin despite the new data; 26% said they would not, and 25% were unsure. Of patients indicating they would take tamsulosin, 35% stated they would also be willing to take steroids. Thirty-five percent of patients said they were willing to pay the full price of tamsulosin if needed. Seventy-one percent said they would prefer to try medical therapy prior to pursuing surgical therapy, again, despite new evidence regarding the efficacy of MET. CONCLUSION: In this initial report of patient attitudes about MET after SUSPEND trial results, we found that nearly half of patients would still try MET and that the vast majority of patients prioritize medical over surgical therapy when possible. As new research emerges, ways to translate this information to patients and to assess their attitudes and perceptions should be developed.
Assuntos
Preferência do Paciente/estatística & dados numéricos , Sulfonamidas/uso terapêutico , Cálculos Ureterais/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cólica Renal/etiologia , Sulfonamidas/efeitos adversos , Sulfonamidas/economia , Inquéritos e Questionários , Tansulosina , Cálculos Ureterais/complicações , Cálculos Ureterais/cirurgia , Agentes Urológicos/efeitos adversos , Agentes Urológicos/economia , Adulto JovemRESUMO
OBJECTIVES: Benign prostatic hyperplasia (BPH) can cause lower urinary tract symptoms (LUTS). Medications are first line treatment for mild-moderate BPH. Office-based minimally invasive therapies (MITs) are also acceptable early treatment options but comparisons of MIT to medications are limited. MIT may be equally effective and less costly compared to long-term medical therapy. We compared data from a medication trial to pooled data of high-energy transurethral microwave therapy (HE-TUMT) to evaluate differences in outcomes and costs between the modalities. STUDY DESIGN: Covariate-adjusted comparison of treatments from independent clinical trials. MATERIALS AND METHODS: Data from Medical Therapy of Prostatic Symptoms (MTOPS) study arms were compared to Urologix pooled data from seven HE-TUMT studies at 25 centers. Improvements in voiding symptoms and quality of life (QoL) were determined and a repeated measure logistic regression analysis to control for baseline covariates was performed. Cost data were collected using published outcomes, Medicare 2013 national averages, and discount online pharmacy prices. RESULTS: HE-TUMT provided significant improvement in voiding symptoms and QoL compared to all MTOPS arms through two years. At four years, all therapies maintain similar improvements when adjusting for baseline covariates. Four year cumulative costs of HE-TUMT ($3,620) were less than combination medical therapy ($7,200). CONCLUSIONS: HE-TUMT provides better improvement of LUTS compared to medication for two years. At four years, all therapies provide comparable improvement but HE-TUMT is less expensive with better QoL. This suggests that HE-TUMT is an excellent alternative to medical therapy that should be routinely discussed and offered during detailed management of BPH.
Assuntos
Hiperplasia Prostática/tratamento farmacológico , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/economia , Ressecção Transuretral da Próstata/métodos , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico , Idoso , Assistência Ambulatorial , Humanos , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/epidemiologia , Qualidade de Vida , Estudos Retrospectivos , Resultado do TratamentoRESUMO
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.
Assuntos
Azasteroides/economia , Azasteroides/uso terapêutico , Orçamentos , Hiperplasia Prostática/tratamento farmacológico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico , Análise Custo-Benefício , Quimioterapia Combinada , Dutasterida , Grécia , Humanos , Masculino , Pessoa de Meia-Idade , Visita a Consultório Médico/estatística & dados numéricos , Hiperplasia Prostática/cirurgia , Tansulosina , Ressecção Transuretral da Próstata/estatística & dados numéricos , Retenção Urinária/prevenção & controleRESUMO
OBJECTIVE: To evaluate the impact of treating urge urinary incontinence (UUI), including mixed urinary incontinence (MUI), on healthcare resource utilisation, productivity, activity impairment and associated costs. METHODS: The study used data from the 2011 U.S. National Health and Wellness Survey, an Internet-based questionnaire of a nationwide sample of adults. UUI or MUI respondents were identified via three Incontinence Questions. Respondents with stress urinary incontinence only, prostate cancer or (medication for) benign prostatic hyperplasia were excluded. UUI/MUI respondents were categorised as Rx users for overactive bladder (OAB) and non-Rx users (who never used Rx and whose condition reportedly interfered with life activities or was difficult to manage). Outcome measures included healthcare utilisation and Work Productivity and Activity Impairment questionnaire-based scores. Direct and indirect costs were estimated using 2010 labour and 2008 medical expenditure data sources. Generalised linear models predicted resource use and productivity as a function of treatment status, adjusting for covariates (e.g. sociodemographics, OAB severity, comorbid status) that may also predict impairment. RESULTS: Rx (vs. non-Rx) users were more likely to be female (80.7% vs. 70.0%), older (mean = 62.7 vs. 53.1) and reporting more moderate-to-severe OAB (70.9% vs. 52.6%; all p < 0.05). Adjusting for covariates, Rx (vs. non-Rx) users had significantly lower activity impairment (41.1% vs. 46.8%), more provider visits (7.42 vs. 5.60) and costs ($18,175 vs. $13,679), and higher total direct costs ($27,291 vs. $21,493), all p < 0.01. CONCLUSIONS: Urge urinary incontinence patients using, vs. never using, prescription medication reported lower activity impairment but higher direct costs. These findings may inform the degree to which UUI pharmacotherapy affects health outcomes.
Assuntos
Incontinência Urinária de Urgência/economia , Agentes Urológicos/economia , Adolescente , Adulto , Idoso , Custos e Análise de Custo , Estudos Transversais , Eficiência , Emprego/estatística & dados numéricos , Feminino , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Profissionais/tratamento farmacológico , Doenças Profissionais/economia , Medicamentos sob Prescrição/uso terapêutico , Incontinência Urinária de Urgência/dietoterapia , Agentes Urológicos/uso terapêutico , Adulto JovemRESUMO
Overactive bladder syndrome (OAB), accompanied by incontinence, is a relatively common disease. Currently, in the Russian Federation, unfortunately, management of patients with OAB includes the recommendations for symptomatic use of incontinence pads without pharmacotherapy. Along with this, the market is represented by a number of drugs that can reduce the occurrence of adverse symptoms associated with OAB syndrome. This study presents the pharmacoeconomic analysis of use of solifenacin for the treatment of patients with the OAB syndrome in Russia. Based on previous clinical studies, formal mathematical model for the development of OAB have been suggested, taking into account the concomitant symptoms (urinary incontinence), and complications (urinary tract infections, skin infections, depression and fractures). The model considers the direct medical and non-medical costs, as well as indirect social costs, arising from the traditional management of patients with OAB syndrome (no medication) and the use of solifenacin. As a result, it was found that the use of solifenacin is economically feasible option for the management of patients with OAB within 1 year, the difference in costs between these strategies per patient is 2,385 rubles. The use of solifenacin ceases to be a resource-saving if the cost of incontinence pads will reduced by more than half of the basic price included in the calculations, or if the effectiveness of solifenacin would be 15% lower than the value used in the basic model.
Assuntos
Gastos em Saúde , Modelos Estatísticos , Quinuclidinas/uso terapêutico , Tetra-Hidroisoquinolinas/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Incontinência Urinária de Urgência/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Farmacoeconomia , Humanos , Quinuclidinas/administração & dosagem , Quinuclidinas/efeitos adversos , Quinuclidinas/economia , Succinato de Solifenacina , Tetra-Hidroisoquinolinas/administração & dosagem , Tetra-Hidroisoquinolinas/efeitos adversos , Tetra-Hidroisoquinolinas/economia , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/economia , Incontinência Urinária de Urgência/complicações , Incontinência Urinária de Urgência/economia , Agentes Urológicos/administração & dosagem , Agentes Urológicos/efeitos adversos , Agentes Urológicos/economiaRESUMO
BACKGROUND: Overactive bladder (OAB) is associated with high healthcare costs, which may be partially driven by drug treatment. There is little comparative data on antimuscarinic drugs with respect to resource use and costs. This study was conducted to address this gap and the growing need for naturalistic studies comparing health economics outcomes in adult patients with OAB syndrome initiating treatment with different antimuscarinic drugs in a primary care setting in Spain. METHODS: Medical records from the databases of primary healthcare centres in three locations in Spain were assessed retrospectively. Men and women ≥18 years of age who initiated treatment with fesoterodine, tolterodine or solifenacin for OAB between 2008 and 2010 were followed for 52 weeks. Healthcare resource utilization and related costs in the Spanish National Health System were compared. Comparisons among drugs were made using multivariate general linear models adjusted for location, age, sex, time since diagnosis, Charlson comorbidity index, and medication possession ratio. RESULTS: A total of 1,971 medical records of patients (58.3% women; mean age, 70.1 [SD:10.6] years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952) or tolterodine (n = 717) were examined. Annual mean cost per patient was 1798 (95% CI: 1745; 1848). Adjusted mean (95% bootstrap CI) healthcare costs were significantly lower in patients receiving fesoterodine (1639 [1542; 1725]) compared with solifenacin (1780 [1699; 1854], P = 0.022) or tolterodine (1893 [1815; 1969], P = 0.001). Cost differences occurred because of significantly fewer medical visits, and less use of absorbent products and OAB-related concomitant medication in the fesoterodine group. CONCLUSIONS: Compared with solifenacin and tolterodine, fesoterodine was a cost-saving therapy for treatment of OAB in the primary care setting in Spain.
Assuntos
Colinérgicos/economia , Colinérgicos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Atenção Primária à Saúde/economia , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/economia , Idoso , Compostos Benzidrílicos/economia , Compostos Benzidrílicos/uso terapêutico , Análise Custo-Benefício , Cresóis/economia , Cresóis/uso terapêutico , Feminino , Humanos , Masculino , Fenilpropanolamina/economia , Fenilpropanolamina/uso terapêutico , Prevalência , Atenção Primária à Saúde/estatística & dados numéricos , Quinuclidinas/economia , Quinuclidinas/uso terapêutico , Estudos Retrospectivos , Succinato de Solifenacina , Espanha/epidemiologia , Síndrome , Tetra-Hidroisoquinolinas/economia , Tetra-Hidroisoquinolinas/uso terapêutico , Tartarato de Tolterodina , Resultado do Tratamento , Bexiga Urinária Hiperativa/epidemiologia , Agentes Urológicos/economia , Agentes Urológicos/uso terapêuticoAssuntos
Prescrições de Medicamentos/economia , Controle de Acesso/economia , Acessibilidade aos Serviços de Saúde , Doenças Urológicas/tratamento farmacológico , Agentes Urológicos/economia , Prescrições de Medicamentos/estatística & dados numéricos , Formulários Farmacêuticos como Assunto , Humanos , Patient Protection and Affordable Care Act , Estados Unidos , Doenças Urológicas/enfermagemRESUMO
It is often reported that falsified medicines have harmful effects on patients both Japan and abroad. In this study, we purchased vardenafil tablets on the internet and investigated their quality and authenticity using visual observations, authenticity investigations, non-destructive tests (handheld NIR and Raman spectroscopy), and quality analyses (active ingredient content and tablet dissolution rate). We used genuine 20-mg Levitra tablets that were sold in Japan and tablets from Bayer AG (Germany) as controls. In April 2015, we obtained 28 samples from 15 websites on the internet. Our authenticity investigations revealed that 11 (40%) were genuine products and 17 (60%) were falsified products. Handheld NIR and Raman results revealed that the falsified products had different spectra to the genuine products. Principal component analysis of the NIR and Raman spectra showed variation among the falsified products. The 11 genuine products were of good quality, and the 17 falsified products were of poor quality. The falsified products contained sildenafil (the active ingredient of Viagra) or tadalafil (the active ingredient of Cialis) instead of vardenafil. Our results show that falsified Vardenafil tablets are sold on the internet and that it is important to prevent illegal internet sales and increase consumer awareness of the presence of falsified medicines.
Assuntos
Medicamentos Falsificados/análise , Disponibilidade de Medicamentos Via Internet/normas , Controle de Qualidade , Agentes Urológicos/análise , Dicloridrato de Vardenafila/análise , Medicamentos Falsificados/química , Medicamentos Falsificados/economia , Humanos , Japão , Disponibilidade de Medicamentos Via Internet/economia , Análise de Componente Principal , Citrato de Sildenafila/análise , Análise Espectral Raman , Comprimidos , Tadalafila/análise , Agentes Urológicos/química , Agentes Urológicos/economia , Agentes Urológicos/normas , Dicloridrato de Vardenafila/químicaRESUMO
OBJECTIVES: The Brazilian public health system does not cover pharmacotherapy for urge urinary incontinence (UUI). The aim of this study was to estimate the cost-effectiveness and budget impact of providing tolterodine, solifenacin, oxybutynin (OXY), darifenacin, and mirabegron for the treatment of UUI in Brazilian public health system. METHODS: A cost-effectiveness analysis with budget impact was performed. Six scenarios were assessed: in one scenario, all 5 therapeutic alternatives approved for coverage, and in the remaining 5 scenarios, only 1 alternative is approved for adoption for all patients. Clinical data were derived from a rapid systematic review conducted in several databases. One-way sensitivity analysis was also performed. The time horizon was 12 months. RESULTS: The cost-effectiveness analysis showed that patients treated with OXY had the lowest incremental cost-effectiveness ratio (ICER) per outcomes assessed (change in urinary incontinence episodes (UIE): R$1180.08; change in urge incontinence episodes: R$757.85 and change in micturition frequency: R$907.75), corresponding to a budget impact of R$17.9 billion over 5 years. The change in effectiveness measures was the parameter that most influenced the results of the ICER per patient-year. CONCLUSION: The results of the study have shown that OXY and solifenacin had the lowest ICER per patient-year and the lowest budget impact when compared with other drugs.
Assuntos
Acetanilidas/economia , Antagonistas Muscarínicos/economia , Saúde Pública/tendências , Tiazóis/economia , Incontinência Urinária de Urgência/tratamento farmacológico , Acetanilidas/uso terapêutico , Adulto , Brasil , Análise Custo-Benefício/métodos , Análise Custo-Benefício/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/uso terapêutico , Saúde Pública/economia , Saúde Pública/estatística & dados numéricos , Tiazóis/uso terapêutico , Incontinência Urinária de Urgência/economia , Agentes Urológicos/economia , Agentes Urológicos/uso terapêuticoRESUMO
AIM: To assess the cost-effectiveness of onabotulinumtoxinA (onabotA), implantable sacral nerve stimulation devices, percutaneous tibial nerve stimulation, anticholinergic medications and mirabegron compared with best supportive care (BSC) for management of refractory overactive bladder (OAB). METHODS: A Markov model was developed to compare the cost-effectiveness of treatment options with BSC over a 10-year time horizon. Resource utilization, discontinuation rates and costs were derived from unpublished and published sources. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were reported. RESULTS: Treatment with onabotA 100U produced the largest gain in QALYs (7.179) and lowest estimated incremental cost-effectiveness ratio ($32,680/QALY) of all assessed treatments compared with BSC. CONCLUSION: Compared with BSC, onabotA 100U was the most cost-effective treatment option for patients with refractory OAB.
Assuntos
Análise Custo-Benefício/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Bexiga Urinária Hiperativa/economia , Bexiga Urinária Hiperativa/terapia , Acetanilidas/economia , Acetanilidas/uso terapêutico , Toxinas Botulínicas Tipo A/economia , Toxinas Botulínicas Tipo A/uso terapêutico , Antagonistas Colinérgicos/economia , Antagonistas Colinérgicos/uso terapêutico , Terapia por Estimulação Elétrica/economia , Eletrodos Implantados/economia , Humanos , Pessoa de Meia-Idade , Fármacos Neuromusculares/economia , Fármacos Neuromusculares/uso terapêutico , Tiazóis/economia , Tiazóis/uso terapêutico , Resultado do Tratamento , Estados Unidos , Agentes Urológicos/economia , Agentes Urológicos/uso terapêuticoRESUMO
OBJECTIVE: Overactive bladder syndrome is a condition with high prevalence, which has a negative impact on patients' quality of life. A drug with a novel mechanism of action has been recently approved: mirabegron. The objective of this study is to review the scientific evidence available on mirabegron, with the aim to analyze its efficacy, safety and cost, and thus estimate its role within current pharmacotherapy. Methods: The effectiveness and safety of mirabegron were analyzed through an evaluation of scientific evidence. The cost of different pharmacological alternatives was calculated based on their Defined Daily Dose (DDD) and their manufacturer's sale price. Results: The use of mirabegron in the treatment of overactive bladder syndrome is supported by three randomized clinical trials, controlled with placebo, at 12 weeks. All three share the same primary efficacy variables (number of incontinence episodes per 24 hours and number of micturitions per 24 hours). Long-term efficacy data are based on a 12-month study, where efficacy outcomes were measured as secondary variables. In all studies, mirabegron showed a significant but modest effect. Some of the most frequently detected adverse effects were: hypertension, increase of glucose in blood, headache, urinary tract infections, constipation and tachycardia. Special attention must be paid to cardiovascular events. Conclusions: The clinical efficacy of mirabegron is very modest and comparable to that achieved with the other drugs approved for this indication. Moreover, it is more expensive than other therapeutic options. Cardiac risks and urinary infections only allow to consider it as an alternative option to anticholinergic drugs, when these are contraindicated, show no clinical efficacy, or cause unacceptable adverse effects.
Objetivo: El síndrome de vejiga hiperactiva es una patología con elevada prevalencia y que tiene un impacto negativo sobre la calidad de vida de los pacientes. Recientemente se ha aprobado un fármaco con un novedoso mecanismo de acción: el mirabegrón. El objetivo de este estudio es revisar la evidencia científica disponible sobre el mirabegrón, con el fin de analizar su eficacia, seguridad y coste, y así estimar su papel en la farmacoterapia actual.Metodología: La eficacia y seguridad del mirabegrón se analizó mediante una evaluación de la evidencia científica. El coste de las diferentes alternativas farmacológicas se calculó en base a sus dosis diarias definidas (DDD) y el precio de venta del laboratorio. Resultados: Tres ensayos clínicos aleatorizados, controlados con placebo, de 12 semanas de duración, apoyan el uso del mirabegrón en el tratamiento del síndrome de vejiga hiperactiva. Los tres comparten las mismas variables principales de eficacia (número de episodios de incontinencia/24 h y número de micciones/24 h). Los datos de eficacia a largo plazo se basan en un estudio de seguridad de 12 meses de duración en el que los resultados de eficacia se medían como variables secundarias. En todos los estudios, el mirabegrón mostró un efecto significativo pero modesto. Entre los efectos adversos más frecuentes se detectaron hipertensión, aumento de glucosa en sangre, dolor de cabeza, infecciones del tracto urinario, estreñimiento y taquicardia. Se debe prestar especial atención a los eventos cardiovasculares. Conclusiones: La eficacia clínica del mirabegrón es muy modesta y comparable a la conseguida con el resto de fármacos aprobados para esta indicación. Además, presenta un mayor coste que otras alternativas terapéuticas. Los riesgos cardiacos e infecciones urinarias solo hacen posible considerarlo como una alternativa a los anticolinérgicos cuando estos estén contraindicados, sean clínicamente ineficaces o sus efectos adversos sean inaceptables.
Assuntos
Acetanilidas/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Acetanilidas/economia , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Tiazóis/economia , Resultado do Tratamento , Bexiga Urinária Hiperativa/economia , Agentes Urológicos/economiaRESUMO
OBJECTIVE: To evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. PATIENTS AND METHODS: An observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of P<.05. RESULTS: Of the total of1,277 patients included in the study, 42.9% were on oxybutynin and 57.1% mirabegron. The mean age was 69.3 years and 53.2% were female. Demographic characteristics and morbidity were similar between the drugs and had a similar persistence (35.0% oxybutynin vs. 32.2% mirabegron, P=.294), although their costs were lower (1,151.2 vs. 1,809.6, P<.001). The biggest differences were observed in the price of medication (279.2 vs. 692.3, P<.001; a variation of: -413.1); and adverse events (9.7 vs. 4.9%, P<.001). CONCLUSIONS: Patients treated with oxybutynin vs. mirabegron for overactive bladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates.
Assuntos
Acetanilidas/administração & dosagem , Ácidos Mandélicos/administração & dosagem , Tiazóis/administração & dosagem , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/administração & dosagem , Acetanilidas/efeitos adversos , Acetanilidas/economia , Adolescente , Adulto , Idoso , Feminino , Seguimentos , Custos de Cuidados de Saúde , Humanos , Masculino , Ácidos Mandélicos/efeitos adversos , Ácidos Mandélicos/economia , Adesão à Medicação , Pessoa de Meia-Idade , Estudos Retrospectivos , Espanha , Tiazóis/efeitos adversos , Tiazóis/economia , Bexiga Urinária Hiperativa/economia , Agentes Urológicos/efeitos adversos , Agentes Urológicos/economia , Adulto JovemRESUMO
AIMS: To compare healthcare costs and resource utilization in patients with overactive bladder (OAB) in the US who switch from mirabegron to onabotulinumtoxinA (onabotA) with those who persist on mirabegron. MATERIALS AND METHODS: A retrospective observational claims analysis of the OptumHealth Administrative Claims database conducted between April 1, 2012 and September 30, 2015 used medical and pharmacy claims to identify patients with at least one OAB diagnosis who switched from mirabegron to onabotA (onabotA group) or persisted on mirabegron for at least 180 days (mirabegron persisters). Propensity score weighting was used to balance baseline characteristics that were associated with increased healthcare expenditures across treatment groups. Multivariate analyses assessed the impact of switching and persistence on all-cause and OAB-related healthcare costs and resource utilization in the year following each patient's index date. RESULTS: In total, 449 patients were included in this study: 54 patients were included in the onabotA group, and 395 patients were included in the mirabegron persister group. Compared with the mirabegron persister patients, the onabotA patients observed significantly higher OAB-related total costs ($5,504 vs $1,772, p < .001), OAB-related medical costs ($5,033 vs $351, p < .001), sacral neuromodulation costs ($865 vs $60, p = .017), and outpatient costs ($17,385 vs $9,035, p = .009), and more OAB-related medical visits (6.0 vs 1.9, p < .001). OnabotA patients had lower OAB-related prescription costs ($470 vs $1,421, p < .001) and fewer OAB-related pharmacy claims (1.6 vs 5.0, p <.001). There were no significant differences in all-cause total medical or prescription costs. LIMITATIONS: This study was a retrospective analysis using claims data that only included patients with commercial health coverage or Medicare supplemental coverage. Accuracy of the diagnosis codes and the generalizability of the results to other OAB populations are limited. The study was not designed to determine the impact of OAB treatments on the economic outcomes examined. CONCLUSIONS: OAB patients who persisted on mirabegron treatment for at least 180 days had lower OAB-related healthcare costs and resource utilization compared with those who switched to onabotA.
Assuntos
Acetanilidas/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Gastos em Saúde/estatística & dados numéricos , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Acetanilidas/economia , Adulto , Idoso , Toxinas Botulínicas Tipo A/economia , Feminino , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tiazóis/economia , Estados Unidos , Agentes Urológicos/economiaRESUMO
BACKGROUND: The impact of formulary management strategies on utilization and expenditures in overactive bladder (OAB) treatment has not been extensively investigated. In 2013, step therapy (ST) policies for 2 branded OAB treatments, mirabegron and fesoterodine, were removed from Humana Medicare Advantage Prescription Drug (MAPD) plans and Medicare prescription drug plans (PDP), allowing for an examination of the effect of ST policies on OAB medication use patterns and costs. OBJECTIVE: To assess the impact of removal of formulary restriction policies for mirabegron and fesoterodine on medication utilization patterns and costs associated with OAB treatment in Medicare patients. METHODS: A retrospective cross-sectional study design was utilized. Subjects included individuals enrolled in Humana MAPD plans or PDPs, aged ≥ 65 years, with ≥ 1 prescription for an OAB medication in 2013. Patient demographic characteristics, OAB medication utilization, and pharmacy cost trends in 2013 were described. OAB medication use was calculated as the number of 30-day-supply equivalent medication claims and reported as a percentage of the total number of 30-day-supply equivalent claims across all OAB products. OAB medication expenditures were calculated as a percentage of the sum of pharmacy costs for OAB medications and reported separately for each month and drug during 2013. Temporal trends of OAB medication utilization and expenditures in 2013 were calculated using ordinary least squares regression. RESULTS: Of 194,511 patients, trends in utilization of OAB medications indicated that on average, there was a statistically significant monthly increase in utilization of mirabegron (regression coefficient [B] = 274; P < 0.001; 95% CI: 218, 330), fesoterodine (B = 167; P < 0.001; 95% CI = 129, 205), oxybutynin extended release (ER; B = 357; P = 0.011; 95% CI = 99, 614), and trospium ER (B = 33; P = 0.001; 95% CI = 17, 50) and statistically significant decreases in utilization of solifenacin (B = -202; P = 0.048; 95% CI = -402, -2), tolterodine ER (B = -287; P = 0.002; 95% CI = -437, -137), darifenacin (B = -94; P < 0.001; 95% CI = -128, -61), and trospium immediate release (IR; B = -22; P = 0.001; 95% CI = -32, -12). Total OAB medication expenditures significantly increased an average of 0.12% for each month during the course of 2013 (B = 0.12; P = 0.026; 95% CI = 0.017, -0.223). While monthly oxybutynin IR utilization did not change significantly throughout 2013 (B = 228; P = 0.169; 95% CI = -114, -570), it demonstrated the largest average monthly expenditure increase (B = 0.082; P < 0.001; 95% CI = 0.056, 0.108). When removing oxybutynin IR costs from the total OAB medication costs, the trend in total OAB medication average monthly expenditures was not significant (B = 0.038; P = 0.365; 95% CI = -0.051, -0.126). An over 4-fold per-unit-cost increase for oxybutynin IR was noted. CONCLUSIONS: Utilization of 2 branded OAB products increased in the months after ST removal with minimal cost impact. One of the possible reasons total OAB expenditures increased may have been due to the increased cost of the largest-volume generic product, oxybutynin IR. DISCLOSURES: This research was funded by Astellas Pharma Global Development and was conducted as part of the Astellas-Humana Research Collaboration. Ng, Kristy, Schermer, and Bradt are employees of Astellas. Astellas manufactures mirabegron (Myrbetriq) and solifenacin (VESIcare). Abbass, Caplan, Collins, and Suehs are employees of Comprehensive Health Insights, a subsidiary of Humana, which received funding from Astellas for this study. Suehs owns stock in Humana. Chan is an employee of Humana Pharmacy Solutions. Portions of this study were presented as a poster at Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; Orlando, Florida. Study concept and design were contributed by Ng, Chan, Suehs, and Abbass, along with Collins. Abbass took the lead in data collection, along with Collins and with assistance from Caplan, Chan, and Suehs. Data interpretation was provided by Kristy and Bradt, along with Abbass, Caplan, Ng, Suehs, Collins, and Chan. The manuscript was written primarily by Caplan, along with Schermer, Suehs, and Abbass, and revised by Caplan, Schermer, and Ng, along with the other authors.
Assuntos
Uso de Medicamentos/economia , Gastos em Saúde/estatística & dados numéricos , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/economia , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico , Acetanilidas/economia , Acetanilidas/uso terapêutico , Idoso , Compostos Benzidrílicos/economia , Compostos Benzidrílicos/uso terapêutico , Estudos Transversais , Uso de Medicamentos/estatística & dados numéricos , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Programas de Assistência Gerenciada/economia , Programas de Assistência Gerenciada/estatística & dados numéricos , Medicare/economia , Medicare/estatística & dados numéricos , Antagonistas Muscarínicos/economia , Antagonistas Muscarínicos/uso terapêutico , Estudos Retrospectivos , Tiazóis/economia , Tiazóis/uso terapêutico , Estados UnidosRESUMO
OBJECTIVES: To assess the costs of treating overactive bladder (OAB) with fesoterodine compared to no OAB pharmacotherapy among vulnerable elderly from the US payer perspective. METHODS: A decision analytic cost model was developed to estimate the 52-week costs of a cohort of vulnerable elderly with OAB initiating treatment with fesoterodine or no OAB pharmacotherapy. Vulnerable elderly OAB patients were defined as those aged ≥65 years with self-reported urge urinary incontinence (UUI) symptoms for ≥3 months, 2-15 UUI episodes/day, and at risk of deteriorating health by a score of ≥3 on the Vulnerable Elders Survey (VES)-13. Patients were evaluated for fesoterodine treatment response (defined as no UUI episodes) and persistence at weeks 12, 26, and 52. The model included a hypothetical health plan with 100,000 elderly members. A total of 7096 vulnerable elderly subjects were identified as the model target population based on the percentage of vulnerable elderly and annual prevalence of OAB among vulnerable elderly. OAB-related costs included fesoterodine drug acquisition costs, healthcare resource use (inpatient hospitalization, outpatient visits, and physician office visits), and OAB-related co-morbidities (falls/fractures, urinary tract infections, depression, and nursing home admissions). All costs were inflated to 2013 US$ using the medical care component of the consumer price index (CPI). RESULTS: When 7096 vulnerable elderly OAB patients were treated with fesoterodine, US healthcare payers could save $11,463,981 per year, or $1616 per patient vs no OAB pharmacotherapy. Univariate one-way sensitivity analyses supported the robustness of the findings and showed results were most sensitive to changes in fesoterodine efficacy followed by annual costs of inpatient hospitalization. CONCLUSIONS: From a US payer perspective, treating vulnerable elderly OAB patients with fesoterodine was cost-saving compared to no OAB pharmacotherapy.
Assuntos
Compostos Benzidrílicos/economia , Compostos Benzidrílicos/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/economia , Incontinência Urinária de Urgência/tratamento farmacológico , Incontinência Urinária de Urgência/economia , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico , Idoso , Redução de Custos , Técnicas de Apoio para a Decisão , Feminino , Avaliação Geriátrica , Hospitalização/economia , Humanos , Masculino , Estados Unidos , Populações VulneráveisRESUMO
BACKGROUND AND OBJECTIVE: The first class of oral pharmacologic treatments for overactive bladder (OAB) are antimuscarinics that are associated with poor persistence, anticholinergic adverse events, and increased anticholinergic burden (ACB) with risk of cognitive impairment. Mirabegron, a ß3-adrenoceptor agonist, is an oral treatment that does not contribute to ACB and has early evidence of improved persistence. The objective of the analysis was to assess the cost-effectiveness of mirabegron for OAB vs six antimuscarinics in the US. METHODS: A Markov state-transition model assessed US commercial health-plan and Medicare Advantage perspectives over a 3-year time horizon in an OAB patient population. Transition probabilities between five micturition and five incontinence severity states were derived from a network meta-analysis of 44 trials of oral OAB treatments. Therapy beginning with an oral OAB agent could discontinue or switch to another oral agent and could be followed by tibial nerve stimulation, sacral neuromodulation, or onabotulinumtoxinA. The primary outcome was cost per quality-adjusted life year (QALY). Utilities were mapped from incontinence and micturition frequencies as well as demographics. Based on analysis of data from a large healthcare system, elevated ACB was associated with increased healthcare utilization and probability of cognitive impairment. RESULTS: From both commercial and Medicare Advantage perspectives, mirabegron was the most clinically effective treatment, while oxybutynin was the least expensive. Tolterodine immediate release (IR) was also on the cost-effectiveness frontier. The analysis estimated costs per QALY of $59,690 and $66,347 for mirabegron from commercial health plan and Medicare Advantage perspectives, respectively, compared to tolterodine IR. Other antimuscarinics were dominated. CONCLUSIONS: This analysis estimated that mirabegron is a cost-effective treatment for OAB from US commercial health plan and Medicare Advantage perspectives, due to fewer projected adverse events and comorbidities, and data suggesting better persistence.