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1.
Clin Genitourin Cancer ; 17(2): e258-e262, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30545674

RESUMO

PURPOSE: To assess the pharmacologic costs of second-line treatments for metastatic renal-cell cancer (mRCC). METHODS: The present evaluation was restricted to pivotal phase 3 randomized controlled trials in second-line for mRCC. We calculated the pharmacologic costs necessary to get the benefit in progression-free survival and overall survival (OS) for each trial. The costs of drugs are at the pharmacy of our hospital and are expressed in euros. RESULTS: Our analysis evaluated 5 phase 3 randomized controlled trials including 3112 patients. The lowest cost per month of progression-free survival and OS gained was associated with the use of cabozantinib (€2006 and €1473, respectively), while everolimus had the highest cost per month of OS gained (€28,590). CONCLUSION: Combining pharmacologic costs of drugs with the measure of efficacy represented by OS, cabozantinib is a cost-effective second-line treatments for patients with mRCC.


Assuntos
Anilidas/economia , Carcinoma de Células Renais/tratamento farmacológico , Everolimo/economia , Neoplasias Renais/tratamento farmacológico , Piridinas/economia , Anilidas/uso terapêutico , Análise Custo-Benefício , Everolimo/uso terapêutico , Humanos , Piridinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida , Resultado do Tratamento
2.
J Manag Care Spec Pharm ; 24(4): 335-343, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29578848

RESUMO

BACKGROUND: When considering optimal second-line treatments for metastatic renal cell carcinoma (mRCC), clinicians and payers seek to understand the relative clinical benefits and costs of treatment. OBJECTIVE: To use an economic model to compare the additional cost per month of overall survival (OS) and of progression-free survival (PFS) for cabozantinib, nivolumab, and axitinib with everolimus for the second-line treatment of mRCC from a third-party U.S. payer perspective. METHODS: The model evaluated mean OS and PFS and costs associated with drug acquisition/administration; adverse event (AE) treatment; monitoring; and postprogression (third-line treatment, monitoring, and end-of-life costs) over 1- and 2-year horizons. Efficacy, safety, and treatment duration inputs were estimated from regimens' pivotal clinical trials; for everolimus, results were weighted across trials. Mean 1- and 2-year OS and mean 1-year PFS were estimated using regimens' reported OS and PFS Kaplan-Meier curves. Dosing and administration inputs were consistent with approved prescribing information and the clinical trials used to estimate efficacy and safety inputs. Cost inputs came from published literature and public data. Additional cost per additional month of OS or PFS was calculated using the ratio of the cost difference per treated patient and the corresponding difference in mean OS or PFS between everolimus and each comparator. One-way sensitivity analyses were conducted by varying efficacy and cost inputs. RESULTS: Compared with everolimus, cabozantinib, nivolumab, and axitinib were associated with 1.6, 0.3, and 0.5 additional months of PFS, respectively, over 1 year. Cabozantinib and nivolumab were associated with additional months of OS compared with everolimus (1 year: 0.7 and 0.8 months; 2 years: 1.6 and 2.3 months; respectively); axitinib was associated with fewer months (1 year: -0.2 months; 2 years: -0.7 months). The additional costs of treatment with cabozantinib, nivolumab, or axitinib versus everolimus over 1 year were $34,141, $19,371, and $17,506 higher, respectively. Everolimus had similar OS and lower costs compared with axitinib. The additional cost per month of OS was $48,773 for cabozantinib and $24,214 for nivolumab versus everolimus. The additional treatment cost with cabozantinib, nivolumab, or axitinib versus everolimus for each additional month of PFS was estimated at $21,338, $64,570, and $35,012, respectively. Over 2 years, the additional costs per additional month of OS for nivolumab and axitinib versus everolimus were similar to the 1-year analysis; for cabozantinib, the cost was lower. Results were sensitive to changes in mean OS, mean PFS, therapy duration, and drug costs estimates. CONCLUSIONS: Everolimus for second-line mRCC was associated with similar OS and lower costs compared with axitinib over 1- and 2-year horizons. The additional cost per additional month of OS and PFS associated with cabozantinib or nivolumab versus everolimus creates a metric for evaluating the cost of second-line therapies in relation to their respective treatment effects. DISCLOSURES: Funding for this research was provided by Novartis, which was involved in all stages of study research and manuscript preparation. Ghate and Perez are employees of Novartis and own stock/stock options. Swallow, Messali, McDonald, and Duchesneau are employees of Analysis Group, which has received consultancy fees from Novartis. Study concept and design were contributed by Swallow, Messali, Ghate, and Perez, along with McDonald and Duchesneau. Swallow, Messali, McDonald, and Duchesneau collected the data, and all authors participated in data interpretation. The manuscript was written by Swallow, Messali, and Ghate, along with the other authors, and revised by Swallow, Messali, Ghate, and Perez. A synopsis of the current research was presented in poster format at the 15th International Kidney Cancer Symposium on November 4-5, 2016, in Miami, Florida.


Assuntos
Antineoplásicos/economia , Carcinoma de Células Renais/tratamento farmacológico , Custos de Medicamentos , Neoplasias Renais/tratamento farmacológico , Modelos Econômicos , Anilidas/economia , Anilidas/uso terapêutico , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Antineoplásicos/uso terapêutico , Axitinibe , Carcinoma de Células Renais/economia , Carcinoma de Células Renais/mortalidade , Análise Custo-Benefício/métodos , Intervalo Livre de Doença , Everolimo/economia , Everolimo/uso terapêutico , Feminino , Humanos , Imidazóis/economia , Imidazóis/uso terapêutico , Indazóis/economia , Indazóis/uso terapêutico , Neoplasias Renais/economia , Neoplasias Renais/mortalidade , Masculino , Pessoa de Meia-Idade , Nivolumabe , Piridinas/economia , Piridinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
4.
J Med Econ ; 19(12): 1144-1156, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27348464

RESUMO

OBJECTIVE: This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir + asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis. Cost-effectiveness analyses (CEAs) that compared OBV/PTV/r against DCV/ASV and sofosbuvir/ledipasvir (SOF/LDV) in Y93H mutation-negative, GT1b patients with and without cirrhosis were also included. METHODS: A health state transition model was developed to capture the natural history of HCV. A CEA over a lifetime horizon was performed from the perspective of the public healthcare payer in Japan. Costs, health utilities, and rates of disease progression were derived from published studies. Sustained virologic response (SVR) rates of OBV/PTV/r and DCV/ASV were extracted from Japanese clinical trials. Analyses were performed for treatment-naïve and -experienced patients. Alternative scenarios and input parameter uncertainty on the results were tested. RESULTS: OBV/PTV/r exhibited superior clinical outcomes vs comparators. For OBV/PTV/r, DCV/ASV, and no treatment, the lifetime risk of decompensated cirrhosis in treatment-naïve patients without cirrhosis was 0.4%, 1.4%, and 9.2%, and hepatocellular carcinoma was 6.5%, 11.4%, and 49.9%, respectively. Quality-adjusted life years (QALYs) were higher in treatment-naïve and -experienced patients without cirrhosis treated with OBV/PTV/r (16.41 and 16.22) vs DCV/ASV (15.83 and 15.66) or no treatment (11.34 and 11.23). In treatment-naïve and -experienced patients without cirrhosis, the incremental cost-effectiveness ratios (ICERs) of OBV/PTV/r vs DCV/ASV were JPY 1,684,751/QALY and JPY 1,836,596/QALY, respectively; OBV/PTV/r was dominant compared with no treatment. In scenario analysis, including GT1b patients with and without cirrhosis who were Y93H mutation-negative, the ICER of OBV/PTV/r vs DCV/ASV was below the Japanese willingness-to-pay threshold of JPY 5 million/QALY, while the ICER of SOF/LDV vs OBV/PTV/r was above this threshold; thus, OBV/PTV/r was cost-effective. CONCLUSION: OBV/PTV/r appears to be a cost-effective treatment for chronic HCV GT1b infection against DCV/ASV. OBV/PTV/r dominates no treatment in patients without cirrhosis.


Assuntos
Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Genótipo , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Quimioterapia Combinada , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Modelos Econômicos
5.
Adv Ther ; 33(8): 1316-30, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27342742

RESUMO

INTRODUCTION: New treatments for chronic hepatitis C virus (HCV) are highly effective in patients coinfected with human immunodeficiency virus (HIV). This study estimated the cost-effectiveness of treatments for genotype 1 (GT1) HCV in HIV-coinfected patients. METHODS: A Markov model based on HCV natural history was used. The base-case analysis included both treatment-naïve and -experienced patients. Alternatives were ombitasvir/paritaprevir/ritonavir, dasabuvir with or without ribavirin (3D ± R) for 12 or 24 weeks, sofosbuvir plus peginterferon and R (SOF + PR) for 12 weeks, SOF + R for 24 weeks, and no treatment (NT). A subgroup analysis restricted to treatment-naïve, non-cirrhotic patients compared 3D ± R for 12 weeks to SOF plus ledipasvir (LDV) for 12 weeks and NT. Transition probabilities, utilities, and costs were obtained from the published literature. Outcomes were measured over a lifetime horizon and included rates of compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma and liver-related death, total costs, life-years, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). RESULTS: In the base-case, SOF + R was dominated by both SOF + PR and 3D ± R. Compared to SOF + PR, 3D ± R had an ICER of $45,581. The lifetime rates of liver morbidity and mortality were lower among those treated with 3D ± R compared to SOF + PR, SOF + R, or NT. In the subgroup analysis, 3D ± R was cost-effective compared to NT at a threshold of $50,000 per QALY (ICER $27,496). SOF/LDV had an ICER of $104,489 per QALY gained compared to 3D ± R. CONCLUSION: In the GT1 HCV population coinfected with HIV, 3D ± R was cost-effective compared to NT, SOF + R, and SOF + PR. In the treatment-naïve sub-population, 3D ± R was cost-effective compared to NT and SOF/LDV.


Assuntos
Antivirais/economia , Antivirais/uso terapêutico , Infecções por HIV/epidemiologia , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , Adulto , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/administração & dosagem , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Carcinoma Hepatocelular/epidemiologia , Análise Custo-Benefício , Progressão da Doença , Quimioterapia Combinada , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Hepacivirus/genética , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , Cirrose Hepática/epidemiologia , Neoplasias Hepáticas/epidemiologia , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Cadeias de Markov , Pessoa de Meia-Idade , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Ribavirina/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Estados Unidos , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico
6.
Value Health ; 19(4): 326-34, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27325324

RESUMO

BACKGROUND: Interferon-free hepatitis C treatment regimens are effective but very costly. The cost-effectiveness, budget, and public health impacts of current Medicaid treatment policies restricting treatment to patients with advanced disease remain unknown. OBJECTIVES: To evaluate the cost-effectiveness of current Medicaid policies restricting hepatitis C treatment to patients with advanced disease compared with a strategy providing unrestricted access to hepatitis C treatment, assess the budget and public health impact of each strategy, and estimate the feasibility and long-term effects of increased access to treatment for patients with hepatitis C. METHODS: Using a Markov model, we compared two strategies for 45- to 55-year-old Medicaid beneficiaries: 1) Current Practice-only advanced disease is treated before Medicare eligibility and 2) Full Access-both early-stage and advanced disease are treated before Medicare eligibility. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die each year. Morbidity was reduced after successful treatment. We calculated the incremental cost-effectiveness ratio and compared the costs and public health effects of each strategy from the perspective of Medicare alone as well as the Centers for Medicare & Medicaid Services perspective. We varied model inputs in one-way and probabilistic sensitivity analyses. RESULTS: Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost ranging from $5,369 to $11,960 and in effectiveness from 0.82 to 3.01 quality-adjusted life-years. In a probabilistic sensitivity analysis, Full Access was cost saving in 93% of model iterations. Compared with Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients. CONCLUSIONS: Current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full-access strategies. Collaboration between state and federal payers may be needed to realize the full public health impact of recent innovations in hepatitis C treatment.


Assuntos
Antivirais/economia , Acesso aos Serviços de Saúde/economia , Hepatite C/economia , Medicaid/economia , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/uso terapêutico , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Fluorenos/economia , Fluorenos/uso terapêutico , Inibidores da Protease de HIV/economia , Inibidores da Protease de HIV/uso terapêutico , Hepacivirus/genética , Hepatite C/tratamento farmacológico , Humanos , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Ritonavir/economia , Ritonavir/uso terapêutico , Índice de Gravidade de Doença , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Estados Unidos , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico , Uridina Monofosfato/análogos & derivados , Uridina Monofosfato/economia , Uridina Monofosfato/uso terapêutico
7.
J Med Econ ; 19(10): 983-94, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27172133

RESUMO

OBJECTIVES: To estimate clinical outcomes and cost-effectiveness of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (OMB/PTV/r + DSV ± RBV) compared with treatment regimens including pegylated interferon (PegIFN) for patients with chronic genotype 1 hepatitis C virus (HCV) infection. METHODS: An Excel spreadsheet Markov model tracking progression through stages of liver disease was developed. Costs and patient utilities for liver disease stages were taken from published studies. Rates of disease progression were based on studies of untreated HCV infection and long-term follow-up of those achieving sustained virologic response (SVR) after drug treatment. Impact of OMB/PTV/r + DSV ± RBV and other drug regimens on progression was estimated through SVR rates from clinical trials. Analyses were performed for treatment-naive and treatment-experienced patients. Impact of alternative scenarios and input parameter uncertainty on the results were tested. RESULTS: For genotype 1 treatment-naive HCV patients, for OMB/PTV/r + DSV ± RBV, PegIFN + ribavirin (PegIFN/RBV), sofosbuvir + PegIFN/RBV, telaprevir + PegIFN/RBV, boceprevir + PegIFN/RBV, lifetime risk of decompensated liver disease was 5.6%, 18.9%, 7.4%, 11.7%, and 14.9%; hepatocellular carcinoma was 5.4%, 9.2%, 5.7%, 7.0%, and 7.4%; and death from liver disease was 8.7%, 22.2%, 10.4%, 14.8%, and 17.6%, respectively. Estimates of the cost-effectiveness of OMB/PTV/r + DSV ± RBV for treatment-naive and treatment-experienced patients indicated that it dominated all other regimens except PegIFN/RBV. Compared with PegIFN/RBV, the incremental cost-effectiveness ratios were £13,864 and £10,258 per quality-adjusted life-year (QALY) for treatment-naive and treatment-experienced patients, respectively. The results were similar for alternative scenarios and uncertainty analyses. LIMITATIONS: A mixed-treatment comparison for SVR rates for the different treatment regimens was not feasible, because many regimens did not have comparator arms; instead SVR rates were based on those from recent trials. CONCLUSIONS: OMB/PTV/r + DSV ± RBV is a cost-effective oral treatment regimen for chronic genotype 1 HCV infection compared with standard treatment regimens and is estimated to reduce the lifetime risks of advanced liver disease.


Assuntos
Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Uracila/análogos & derivados , Adulto , Quimioterapia Combinada , Feminino , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Ritonavir , Uracila/economia , Uracila/uso terapêutico
8.
J Med Econ ; 19(8): 795-805, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27063573

RESUMO

OBJECTIVE: This study compared the cost-effectiveness of direct-acting antiviral therapies currently recommended for treating genotypes (GT) 1 and 4 chronic hepatitis C (CHC) patients in the US. METHODS: A cost-effectiveness analysis of treatments for CHC from a US payer's perspective over a lifelong time horizon was performed. A Markov model based on the natural history of CHC was used for a population that included treatment-naïve and -experienced patients. Treatment alternatives considered for GT1 included ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± R), sofosbuvir + ledipasvir (SOF/LDV), sofosbuvir + simeprevir (SOF + SMV), simeprevir + pegylated interferon/ribavirin (SMV + PR) and no treatment (NT). For GT4 treatments, ombitasvir/paritaprevir/ritonavir + ribavirin (2D + R), SOF/LDV and NT were compared. Transition probabilities, utilities and costs were obtained from published literature. Outcomes included rates of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver-related death (LrD), total costs, life-years and quality-adjusted life-years (QALYs). Costs and QALYs were used to calculate incremental cost-effectiveness ratios. RESULTS: In GT1 patients, 3D ± R and SOF-containing regimens have similar long-term outcomes; 3D ± R had the lowest lifetime risks of all liver disease outcomes: CC = 30.2%, DCC = 5.0 %, HCC = 6.8%, LT = 1.9% and LrD = 9.2%. In GT1 patients, 3D ± R had the lowest cost and the highest QALYs. As a result, 3D ± R dominated these treatment options. In GT4 patients, 2D + R had lower rates of liver morbidity and mortality, lower cost and more QALYs than SOF/LDV and NT. LIMITATIONS: While the results are based on input values, which were obtained from a variety of heterogeneous sources-including clinical trials, the findings were robust across a plausible range of input values, as demonstrated in probabilistic sensitivity analyses. CONCLUSIONS: Among currently recommended treatments for GT1 and GT4 in the US, 3D ± R (for GT1) and 2D + R (for GT4) have a favorable cost-effectiveness profile.


Assuntos
Antivirais/economia , Antivirais/uso terapêutico , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/administração & dosagem , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Carcinoma Hepatocelular/economia , Carcinoma Hepatocelular/epidemiologia , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Fibrose/economia , Fibrose/epidemiologia , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Humanos , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/epidemiologia , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econométricos , Anos de Vida Ajustados por Qualidade de Vida , Ribavirina/economia , Ribavirina/uso terapêutico , Simeprevir , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Uracila/análogos & derivados , Uracila/economia , Uracila/uso terapêutico
9.
Liver Int ; 36(4): 515-21, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26610059

RESUMO

BACKGROUND & AIMS: Orthotopic liver transplant patients with recurrent hepatitis C (HCV) historically have had limited treatment options. Ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin (3D+R) was approved by the FDA in December 2014 for liver transplant recipients with recurrent genotype 1 HCV, in whom it is effective and well-tolerated. METHODS: Using a two-phase Markov model, we analysed the cost-effectiveness of 3D+R in liver transplant recipients, the only HCV treatment with FDA approval in this population. As a sensitivity analysis, we also considered the cost-effectiveness of pegylated interferon plus ribavirin, the only other therapy with data from Phase III trials in this population. Patients were given one of three options: 3D+R for 24 weeks, pegylated interferon and ribavirin for 48 weeks (PR48) or no treatment (NT). Patients were then followed through subsequent disease progression until death. Outcome measures analysed were: lifetime risks of liver morbidity and mortality, treatment costs, non-treatment medical expenditures, and quality-adjusted life years. RESULTS: Treatment with 3D+R was associated with a significantly lower lifetime risk of liver-related morbidity and mortality than treatment with PR48 or NT. 3D+R also was associated with a higher gain in quality-adjusted life years (11.3 compared to 8.25 with NT) and lower discounted overall costs ($423,585 compared to $724,757 with NT). CONCLUSIONS: The use of 3D+R for liver transplant recipients with recurrent HCV is an outcome-improving and cost-effective regimen for this population with limited treatment options and large unmet need.


Assuntos
Anilidas , Antivirais , Carbamatos , Custos de Medicamentos , Hepacivirus/efeitos dos fármacos , Hepatite C/tratamento farmacológico , Hepatite C/economia , Transplante de Fígado/efeitos adversos , Transplante de Fígado/economia , Compostos Macrocíclicos , Ribavirina , Ritonavir , Sulfonamidas , Uracila/análogos & derivados , Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Antivirais/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Hepatite C/diagnóstico , Hepatite C/mortalidade , Humanos , Transplante de Fígado/mortalidade , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Modelos Econômicos , Fenótipo , Recidiva , Ribavirina/economia , Ribavirina/uso terapêutico , Fatores de Risco , Ritonavir/economia , Ritonavir/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Uracila/economia , Uracila/uso terapêutico , Carga Viral , Ativação Viral/efeitos dos fármacos
10.
Am J Health Syst Pharm ; 70(12): 1033-8, 2013 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-23719880

RESUMO

PURPOSE: The pharmacology, clinical efficacy, adverse effects, cost, and place in therapy of vismodegib are reviewed. SUMMARY: Vismodegib, the first oral treatment for basal cell carcinoma (BCC), was recently approved for the treatment of patients with locally advanced or metastatic BCC whose cancer is refractory to standard treatments or who are not candidates for surgery or radiation. Vismodegib is a small molecule that potently inhibits signal transduction in the hedgehog signaling pathway, demonstrates nonlinear pharmacokinetics, and has a half-life of 13 days. Agents that increase gastrointestinal pH may reduce the solubility and bioavailability of vismodegib. It is effective in both locally advanced and metastatic BCCs, with response rates ranging from 30% to 60% in two clinical trials. Vismodegib is available as a 150-mg capsule, and the approved dosage is 150 mg orally once daily. The most common adverse effects of vismodegib include mild-to-moderate hair loss, muscle cramps, taste disturbance, and weight loss. The estimated cost of one month of treatment with vismodegib is $7500. CONCLUSION: Vismodegib was recently approved for the treatment of locally advanced or metastatic BCC that is refractory to standard treatments or if patients are not candidates for surgery or radiation. Vismodegib may have little effect on the treatment of BCC, given its high cost, the high cure rates achieved with standard therapies, and its unacceptable toxicity profile in patients with a non-life-threatening disease. However, vismodegib's novel mechanism of action, oral dosage form, preliminary efficacy, and tolerability compared with cytotoxic chemotherapy may make it an attractive candidate for the treatment of other cancers.


Assuntos
Anilidas , Neoplasia de Células Basais/tratamento farmacológico , Piridinas , Neoplasias Cutâneas/tratamento farmacológico , Administração Oral , Anilidas/efeitos adversos , Anilidas/economia , Anilidas/farmacologia , Anilidas/uso terapêutico , Antineoplásicos/efeitos adversos , Antineoplásicos/economia , Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Humanos , Neoplasia de Células Basais/economia , Neoplasia de Células Basais/patologia , Piridinas/efeitos adversos , Piridinas/economia , Piridinas/farmacologia , Piridinas/uso terapêutico , Terapia de Salvação , Neoplasias Cutâneas/economia , Neoplasias Cutâneas/patologia
11.
Prostate Cancer Prostatic Dis ; 11(2): 153-9, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-17637761

RESUMO

Treatment choices for metastatic prostate cancer are complex and can involve men balancing survival versus quality of life. The present study aims to elicit patient preferences with respect to the attributes of treatments for metastatic prostate cancer through a discrete choice experiment (DCE) questionnaire. Men with recently diagnosed localized prostate cancer were asked to envisage that they had metastatic disease when completing a survey. As expected, men with prostate cancer placed considerable importance on gains in survival; however, avoiding side effects of treatment was also clearly important. Survival gains should be considered alongside side effects when discussing treatment options in metastatic disease.


Assuntos
Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/secundário , Antagonistas de Androgênios/uso terapêutico , Anilidas/uso terapêutico , Antineoplásicos Hormonais/uso terapêutico , Flutamida/uso terapêutico , Nitrilos/uso terapêutico , Satisfação do Paciente , Neoplasias da Próstata/tratamento farmacológico , Compostos de Tosil/uso terapêutico , Adenocarcinoma/economia , Adenocarcinoma/psicologia , Idoso , Antagonistas de Androgênios/administração & dosagem , Antagonistas de Androgênios/efeitos adversos , Antagonistas de Androgênios/economia , Anilidas/administração & dosagem , Anilidas/efeitos adversos , Anilidas/economia , Antineoplásicos Hormonais/administração & dosagem , Antineoplásicos Hormonais/efeitos adversos , Antineoplásicos Hormonais/economia , Comportamento de Escolha , Estudos Transversais , Diarreia/induzido quimicamente , Diarreia/psicologia , Esquema de Medicação , Custos de Medicamentos , Tratamento Farmacológico/psicologia , Disfunção Erétil/induzido quimicamente , Disfunção Erétil/psicologia , Flutamida/administração & dosagem , Flutamida/efeitos adversos , Flutamida/economia , Ginecomastia/induzido quimicamente , Ginecomastia/psicologia , Inquéritos Epidemiológicos , Hematúria/induzido quimicamente , Hematúria/psicologia , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Nitrilos/administração & dosagem , Nitrilos/efeitos adversos , Nitrilos/economia , Aceitação pelo Paciente de Cuidados de Saúde , Neoplasias da Próstata/economia , Neoplasias da Próstata/psicologia , Compostos de Tosil/administração & dosagem , Compostos de Tosil/efeitos adversos , Compostos de Tosil/economia
12.
Urology ; 66(4): 835-9, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16230148

RESUMO

OBJECTIVES: To determine the cost-effectiveness of combined androgen blockade (CAB) with bicalutamide versus CAB with flutamide in men with Stage D2 prostate cancer. Both bicalutamide and flutamide are commonly used in CAB for prostate cancer. Although the cost of bicalutamide is more than that of flutamide, it is important that the efficacy, quality of life, and side effects are also considered when determining whether CAB with bicalutamide is a cost-effective option. METHODS: A decision model was created to compare treatment strategies. Survival and side-effect information was based on a randomized trial that directly compared bicalutamide and flutamide. The costs and quality-of-life effects related to therapy were determined from published sources. RESULTS: The incremental cost per quality-adjusted life year gained for bicalutamide versus flutamide was 22,000 dollars and 16,000 dollars at 5 and 10 years, respectively. If a quality adjustment was not included, the incremental cost-effectiveness ratio for CAB with bicalutamide compared with CAB with flutamide was even more favorable (20,000 dollars/life year gained at 5 years). One-way sensitivity analysis demonstrated that the cost-effectiveness estimates were most sensitive to drug costs and survival (baseline survival was not significantly different between therapies). Multi-way uncertainty analysis revealed that the median value of the incremental cost-effectiveness ratio at 5 years was 13,637 dollars/quality-adjusted life year when all the parameters were varied over a clinically reasonable range. CONCLUSIONS: Bicalutamide is cost-effective compared with flutamide when used for androgen blockade as part of CAB for men with advanced prostate cancer.


Assuntos
Antagonistas de Androgênios/economia , Antagonistas de Androgênios/uso terapêutico , Anilidas/economia , Anilidas/uso terapêutico , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Flutamida/economia , Flutamida/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/economia , Análise Custo-Benefício , Quimioterapia Combinada , Humanos , Masculino , Nitrilos , Compostos de Tosil
13.
J Urol ; 174(2): 547-52; discussion 552, 2005 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16006889

RESUMO

PURPOSE: Combined androgen blockade therapy (CAB) has been shown to have a small survival advantage over luteinizing hormone releasing hormone LH-RH agonists (LH-RHa) alone in men with metastatic prostate cancer. The goal of this study was to assess the cost-effectiveness of CAB with bicalutamide and LH-RH agonist therapy to LH-RH agonist therapy alone. MATERIALS AND METHODS: A macro-simulation model was developed to compare the cost-effectiveness of 2 interventions for stage D2 prostate cancer, 1) CAB with bicalutamide 50 mg per day and monthly dosing of an LH-RHa or 2) monthly LH-RH agonist therapy. Cost and outcomes are tabulated in 5 and 10-year time horizons. Model assumptions were taken from the published literature. Appropriate 1-way and multi-way sensitivity analyses were performed. RESULTS: At 5 years, the incremental cost-effectiveness ratio (ICER) for CAB, when compared with LH-RHa monotherapy, was US dollars 33,677 per quality-adjusted life-year. In other words, for every additional quality-adjusted life year that a patient lived because he received CAB, it cost US dollars 33,677. At 10 years the ICER for CAB was US dollars 20,053 (well within the accepted cost-effectiveness threshold). If quality adjustment was not included, the ICER for CAB was even more favorable (US dollars 20,489 at 5 years and US dollars 13,313 at 10 years). The model was most sensitive to the estimates of effectiveness (survival) of LH-RHa therapy alone and CAB therapy. The model was also fairly sensitive to the quality of life effect of having late stage prostate cancer and the cost of bicalutamide. CONCLUSIONS: CAB with bicalutamide is cost-effective when compared with LH-RH monotherapy in men with stage D2 prostate cancer.


Assuntos
Antagonistas de Androgênios/uso terapêutico , Anilidas/uso terapêutico , Hormônio Liberador de Gonadotropina/agonistas , Neoplasias da Próstata/tratamento farmacológico , Antagonistas de Androgênios/economia , Anilidas/economia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Quimioterapia Combinada , Hormônio Liberador de Gonadotropina/economia , Humanos , Masculino , Nitrilos , Neoplasias da Próstata/economia , Neoplasias da Próstata/patologia , Qualidade de Vida , Sensibilidade e Especificidade , Compostos de Tosil
14.
Value Health ; 7(4): 472-81, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15449639

RESUMO

OBJECTIVES: To assess the cost-effectiveness of bicalutamide (Casodex) as adjuvant treatment in early prostate cancer (EPC). METHODS: A Markov state transition model was developed, using disease progression rates from a large (N = 8113) clinical trial program comparing bicalutamide in addition to standard care with standard care alone. Utility scores for different disease stages were obtained from published reports. Costs of disease progression were obtained from a retrospective patient chart analysis in six Belgian centers (n = 60). The time horizon was 15 years and the analysis was conducted from the public payer perspective. RESULTS: The model showed good validity in predicting clinical outcomes. At a time horizon of 15 years, an incremental cost-effectiveness of 27,059 euros/QALY was obtained. The main factors influencing conclusions included the time horizon, the duration of bicalutamide treatment, which was set at a maximum (5 years) in the base case, and possible differences in prognosis of metastatic cancer between comparators. Also the discounting of health effects significantly altered cost-effectiveness ratios. Many of these influences are inherently associated with any cost-effectiveness analysis related to treatment of early, slowly progressing malignancies because such an analysis requires a sufficient time horizon to include not only the treatment costs but its benefits as well. CONCLUSION: Based on the current data, bicalutamide appears to be a cost-effective option for adjuvant treatment of EPC.


Assuntos
Anilidas/economia , Anilidas/uso terapêutico , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Análise Custo-Benefício , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/economia , Idoso , Anilidas/administração & dosagem , Antineoplásicos/administração & dosagem , Quimioterapia Adjuvante , Ensaios Clínicos como Assunto , Progressão da Doença , Seguimentos , Humanos , Masculino , Cadeias de Markov , Metástase Neoplásica , Nitrilos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/mortalidade , Fatores de Tempo , Compostos de Tosil
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