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1.
Value Health ; 22(6): 693-703, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31198187

RESUMO

BACKGROUND: Direct-acting antivirals are successful in curing hepatitis C virus infection in more than 95% of patients treated for 12 weeks, but they are expensive. Shortened treatment durations, which may have lower cure rates, have been proposed to reduce costs. OBJECTIVES: To evaluate the lifetime cost-effectiveness of different shortened treatment durations for genotype 1 noncirrhotic treatment-naive patients. METHODS: Assuming a UK National Health Service perspective, we used a probabilistic decision tree and Markov model to compare 3 unstratified shortened treatment durations (8, 6, and 4 weeks) against a standard 12-week treatment duration. Patients failing shortened first-line treatment were re-treated with a 12-week treatment regimen. Parameter inputs were taken from published studies. RESULTS: The 8-week treatment duration had an expected incremental net monetary benefit of £7737 (95% confidence interval £3242-£11 819) versus the standard 12-week treatment, per 1000 patients. The 6-week treatment had a positive incremental net monetary benefit, although some uncertainty was observed. The probability that the 8- and 6-week treatments were the most cost-effective was 56% and 25%, respectively, whereas that for the 4-week treatment was 17%. Results were generally robust to sensitivity analyses, including a threshold analysis that showed that the 8-week treatment was the most cost-effective at all drug prices lower than £40 000 per 12-week course. CONCLUSIONS: Shortening treatments licensed for 12 weeks to 8 weeks is cost-effective in genotype 1 noncirrhotic treatment-naive patients. There was considerable uncertainty in the estimates for 6- and 4-week treatments, with some indication that the 6-week treatment may be cost-effective.


Assuntos
Antivirais/economia , Hepatite C Crônica/tratamento farmacológico , Antivirais/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Árvores de Decisões , Hepacivirus/efeitos dos fármacos , Hepacivirus/patogenicidade , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Humanos , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Cadeias de Markov , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Medicina Estatal/organização & administração , Medicina Estatal/estatística & dados numéricos , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Reino Unido
3.
Appl Health Econ Health Policy ; 16(5): 711-722, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30039348

RESUMO

BACKGROUND: Chronic Hepatitis C virus (cHCV) is a major health issue worldwide. New effective direct-acting anti-viral (DAA) drugs such as the combination sofosbuvir/velpatasvir, represent an important turning point, given the high sustained virologic response (SVR) rates associated with their use. OBJECTIVES: To estimate the cost and effects of two different treatment strategies based on sofosbuvir/velpatasvir. Strategy 1: treating all patients, including those in the early stages of fibrosis; Strategy 2: reserving treatments for patients at more advanced stages of disease (≥ F3). The analysis compares the incremental cost-effectiveness ratio (ICER) of Strategy 1 versus Strategy 2 in a cohort of HCV-infected patients and a cohort of hepatitis C virus (HCV)-human immunodeficiency virus (HIV) patients. METHODS: A Markov model simulating the natural history of the disease was built considering a 60-year time horizon and two cohorts of 1000 patients aged ≥ 35 years. Disease morbidity was classified according to the METAVIR classification. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses (PSA). RESULTS: In both cohorts, Strategy 1 results in higher resource consumption and a greater number of quality-adjusted life-years (QALYs) compared with Strategy 2. The ICERs for the cohort of HCV patients and the cohort of co-infected HCV/HIV patients ranged between €15,555-74,804/QALY and €10,708-55,138/QALY, respectively, depending on the assumed cost of the treatment. In the PSA, the ICER distribution remained below the threshold of €30,000/QALY in 96 and 97% of the scenarios in the cohorts of HCV and HCV/HIV patients, respectively. CONCLUSIONS: Extending the treatment of HCV to patients at an early stage of HCV infection is estimated to be cost effective from the perspective of the Italian Healthcare System.


Assuntos
Antivirais/economia , Carbamatos/economia , Hepatite C Crônica/economia , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Sofosbuvir/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antivirais/administração & dosagem , Antivirais/uso terapêutico , Carbamatos/administração & dosagem , Carbamatos/uso terapêutico , Análise Custo-Benefício , Custos de Medicamentos/estatística & dados numéricos , Quimioterapia Combinada , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Hepatite C Crônica/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/administração & dosagem , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Humanos , Itália , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Sofosbuvir/administração & dosagem , Sofosbuvir/uso terapêutico , Adulto Jovem
4.
J Gastroenterol Hepatol ; 33(12): 2029-2036, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29864213

RESUMO

BACKGROUND AND AIM: Treatment of hepatitis C virus (HCV) infection with low-cost generic direct-acting antivirals (DAAs) available in India and other developing countries needs determination of HCV genotype ("genotype-dependent" regimens). Generic velpatasvir, a DAA that obviates the need for genotype determination ("pan-genotypic" regimen), recently became available but is costlier. The aim of this study was to evaluate the cost-effectiveness of genotype-dependent versus pan-genotypic DAA treatments in India. METHODS: A previously validated microsimulation model, adapted to Indian population, was used to compare the costs and long-term outcomes of three scenarios: no treatment, treatment with genotype-dependent regimens, and treatment with pan-genotypic regimen. Input parameters were derived from literature. Using a payer's perspective and lifetime time horizon, quality-adjusted life-years (QALYs), total costs, and incremental cost-effectiveness ratio were calculated. Both deterministic and probabilistic sensitivity analyses were also conducted. RESULTS: At the current price ($US223 for 4 weeks), pan-genotypic regimen was cost-saving compared with no treatment. Compared with genotype-dependent regimens, it increased QALYs by 0.92 and increased costs by $US107 but was deemed cost-effective with an incremental cost-effectiveness ratio of $US242 per QALY gained. Probabilistic sensitivity analysis also supported the cost-effectiveness of pan-genotypic regimen. At the reduced price of $US188 for 4 weeks, the pan-genotypic regimen will become cost-neutral to genotype-dependent regimens (current price: $US100 for 4 weeks). CONCLUSIONS: At current prices, velpatasvir-based pan-genotypic regimen is cost-effective for HCV treatment in India where generic drugs are available. A reduction in the prices of pan-genotypic regimen has the potential to make its use cost-saving while simplifying treatment in community-level programs aimed at HCV elimination.


Assuntos
Antivirais/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Custos de Medicamentos , Medicamentos Genéricos/uso terapêutico , Hepacivirus/efeitos dos fármacos , Hepatite C/tratamento farmacológico , Hepatite C/economia , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Adulto , Antivirais/efeitos adversos , Antivirais/economia , Carbamatos/efeitos adversos , Simulação por Computador , Análise Custo-Benefício , Combinação de Medicamentos , Medicamentos Genéricos/efeitos adversos , Medicamentos Genéricos/economia , Feminino , Genótipo , Hepacivirus/genética , Hepatite C/diagnóstico , Hepatite C/virologia , Compostos Heterocíclicos de 4 ou mais Anéis/efeitos adversos , Humanos , Índia , Masculino , Modelos Econômicos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Sofosbuvir/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
5.
J Manag Care Spec Pharm ; 24(1): 20-22, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29290175

RESUMO

Given the recent approval of the first pan-genotypic chronic hepatitis C virus (HCV) therapy, managed care, health systems, and clinicians will need to evaluate current practices related to essential laboratory assessments used to select therapy. Historically, clinicians and payers required a battery of tests to determine HCV genotype, viral load, degree of fibrosis, and organ function. In light of current and forthcoming approvals of pan-genotypic therapy, clinicians and payers can expect a more competitive marketplace and a downward curve in the price of therapy. Ultimately, this development will lead to the cost of screenings and assessments having an increased role in selecting an optimal HCV therapy. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. All authors contributed to study concept and design. Calabrese took the lead in data collection, along with Shaya. Data interpretation was performed by Calabrese and Hynicka, along with Rodriguez de Bittner and Shaya. The manuscript was written and revised by Calabrese and Hynicka, along with Rodriguez de Bittner and Shaya.


Assuntos
Antivirais/uso terapêutico , Carbamatos/uso terapêutico , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Programas de Assistência Gerenciada/economia , Sofosbuvir/uso terapêutico , Antivirais/economia , Antivirais/normas , Carbamatos/economia , Combinação de Medicamentos , Testes Genéticos/economia , Genótipo , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/virologia , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Humanos , Testes de Sensibilidade Microbiana/economia , Testes de Sensibilidade Microbiana/métodos , Guias de Prática Clínica como Assunto , Sofosbuvir/economia , Estados Unidos , United States Food and Drug Administration
6.
Cad Saude Publica ; 33(8): e00206516, 2017 Aug 21.
Artigo em Português | MEDLINE | ID: mdl-28832788

RESUMO

The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.


Assuntos
Indústria Farmacêutica/economia , Medicamentos Genéricos/economia , Patentes como Assunto , Antirretrovirais/economia , Brasil , Carbamatos/economia , Indústria Farmacêutica/legislação & jurisprudência , Acesso aos Serviços de Saúde , Humanos , Organofosfatos/economia , Patentes como Assunto/legislação & jurisprudência , Sulfonamidas/economia
8.
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
9.
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
10.
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
11.
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
12.
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
14.
Surg Infect (Larchmt) ; 17(4): 427-35, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26891115

RESUMO

BACKGROUND: Surgical site infections (SSI) occur in 1.8%-9.2% of women undergoing cesarean section (CS) and lead to greater morbidity rates and increased treatment costs. The aim of the study was to evaluate the efficacy and cost-effectiveness of dialkylcarbamoyl chloride (DACC) impregnated dressings to prevent SSI in women subject to CS. METHODS: Randomized, controlled trial was conducted at the Mazovian Bródno Hospital, a tertiary care center performing approximately 1300 deliveries per year, between June 2014 and April 2015. Patients were randomly allocated to receive either DACC impregnated dressing or standard surgical dressing (SSD) following skin closure. In order to analyze cost-effectiveness of the selected dressings in the group of patients who developed SSI, the costs of ambulatory visits, additional hospitalization, nursing care, and systemic antibiotic therapy were assessed. Independent risk factors for SSI were determined by multivariable logistic regression. RESULTS: Five hundred and forty-three women undergoing elective or emergency CS were enrolled. The SSI rates in the DACC and SSD groups were 1.8% and 5.2%, respectively (p = 0.04). The total cost of SSI prophylaxis and treatment was greater in the control group as compared with the study group (5775 EUR vs. 1065 EUR, respectively). Independent risk factors for SSI included higher pre-pregnancy body mass index (adjusted odds ratio [aOR] = 1.08; [95% confidence interval [CI]: 1.0-1.2]; p < 0.05), smoking in pregnancy (aOR = 5.34; [95% CI: 1.6-15.4]; p < 0.01), and SSD application (aOR = 2.94; [95% CI: 1.1-9.3]; p < 0.05). CONCLUSION: The study confirmed the efficacy and cost-effectiveness of DACC impregnated dressings in SSI prevention among women undergoing CS.


Assuntos
Anti-Infecciosos/administração & dosagem , Cesárea/efeitos adversos , Curativos Oclusivos , Infecção da Ferida Cirúrgica/prevenção & controle , Adulto , Assistência Ambulatorial/economia , Anti-Infecciosos/economia , Antibioticoprofilaxia , Carbamatos/administração & dosagem , Carbamatos/economia , Cesárea/economia , Análise Custo-Benefício , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Gravidez , Método Simples-Cego , Deiscência da Ferida Operatória/economia , Deiscência da Ferida Operatória/etiologia , Infecção da Ferida Cirúrgica/economia , Resultado do Tratamento , Adulto Jovem
15.
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
16.
Expert Opin Pharmacother ; 15(9): 1289-98, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24819446

RESUMO

INTRODUCTION: Cobicistat (Cobi), a selective novel CYP3A4 inhibitor, is an orally administered, non-antiretroviral pharmacokinetic enhancer which boosts the plasma levels of several drugs, including HIV-1 protease inhibitors and the integrase strand transfer inhibitor elvitegravir (ELV). AREAS COVERED: PubMed and www.clinicaltrials.gov were searched with the term 'cobicistat' for all clinical trials conducted up to date, as well as for those ongoing and to be opened in the near future as well as for pharmacology data. A review of abstracts from major HIV, infectious diseases and pharmacology conferences from 2010 to 2014 was also conducted. EXPERT OPINION: Cobi has shown good efficacy in HIV-infected treatment-naïve subjects, either in combination with ELV, within a quadruple drug, single tablet regimen, and in combination with atazanavir and darunavir. Coformulations containing cobi will mark the near future of antiretroviral therapy, therefore it will be necessary for physicians to become familiar with their management. In particular, the inhibition of creatinine secretion by the proximal renal tubule will require the acquisition of competences in estimating the real glomerular filtration rate, since studies with iohexol clearance have shown that the eGFR reduction is cosmetic. The long-term metabolic advantages of cobi versus ritonavir can be hypothesized, given the initial data from current trials.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Carbamatos/uso terapêutico , Infecções por HIV/tratamento farmacológico , Tiazóis/uso terapêutico , Fármacos Anti-HIV/efeitos adversos , Fármacos Anti-HIV/economia , Carbamatos/efeitos adversos , Carbamatos/economia , Ensaios Clínicos como Assunto , Cobicistat , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Cuidados de Saúde , Humanos , Tiazóis/efeitos adversos , Tiazóis/economia , Resultado do Tratamento
17.
Curr Med Res Opin ; 30(1): 89-97, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24040862

RESUMO

OBJECTIVES: Review of the available data on the currently available single-tablet regimens (STRs), from the analysis of efficacy and safety to the key points of value in terms of adherence, quality of life and pharmacoeconomic evaluation. METHODS: For this narrative review, literature searches have been performed in PubMed, IndexRevMed and Cochrane, using the search terms HIV, single-tablet, one-pill, single dose, fixed-dose, and STR. These have been reviewed and complemented with the most recent publications of interest. RESULTS: Fixed-dose combinations are a significant advance in antiretroviral treatment simplification, contributing to an increase in compliance with complex chronic therapies, thus improving patients' quality of life. Reducing the number of pills and daily doses is associated with higher adherence and better quality of life. As a fixed-dose combination tablet given once daily, EFV/FTC/TDF was the first available STR combining efficacy, tolerability and convenience, with the simplest dosing schedule and smallest numbers of pills of any ART combination therapy. The RPV/FTC/TDF is a next-generation NNRTI-based STR, a once daily complete ART regimen for the treatment of HIV-1 infection. Recently the combination of EVG/COBI/FTC/TDF was also approved by the European Commission, and is the first integrase inhibitor-based STR. Receiving antiretroviral therapy as once daily STR is associated with both clinical and economic benefits, which confirms previous research. CONCLUSIONS: The associated benefits of STRs provide a valid strategy for the treatment of HIV-infected patients.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , Adenina/administração & dosagem , Adenina/análogos & derivados , Adenina/economia , Adenina/uso terapêutico , Fármacos Anti-HIV/economia , Carbamatos/administração & dosagem , Carbamatos/economia , Carbamatos/uso terapêutico , Cobicistat , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Desoxicitidina/economia , Desoxicitidina/uso terapêutico , Esquema de Medicação , Combinação de Medicamentos , Emtricitabina , Humanos , Nitrilos/administração & dosagem , Nitrilos/economia , Nitrilos/uso terapêutico , Organofosfonatos/administração & dosagem , Organofosfonatos/economia , Organofosfonatos/uso terapêutico , Pirimidinas/administração & dosagem , Pirimidinas/economia , Pirimidinas/uso terapêutico , Quinolonas/administração & dosagem , Quinolonas/economia , Quinolonas/uso terapêutico , Inibidores da Transcriptase Reversa/administração & dosagem , Inibidores da Transcriptase Reversa/economia , Inibidores da Transcriptase Reversa/uso terapêutico , Rilpivirina , Comprimidos/uso terapêutico , Tenofovir , Tiazóis/administração & dosagem , Tiazóis/economia , Tiazóis/uso terapêutico
18.
Acta Neurol Scand ; 127(6): 419-26, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23368976

RESUMO

OBJECTIVES: To calculate comparative incremental cost-effectiveness ratios (cost per quality-adjusted life year, QALY) and net marginal benefits for retigabine as add-on treatment for patients with uncontrolled focal seizures as compared to add-on lacosamide treatment and no add-on treatment, respectively. MATERIALS & METHODS: Calculations were performed using a validated decision-tree model. The study population consisted of adult patients with focal-onset epilepsy in published randomized placebo-controlled add-on trials of retigabine or lacosamide. Healthcare utilization and QALY for each treatment alternative were calculated. Probabilistic sensitivity analysis was performed using the specification of this model as a basis for Monte Carlo simulations. 2009 prices were used for all costs. RESULTS: Results were reported for a 2-year follow-up period. Retigabine add-on treatment was both more effective and less costly than lacosamide add-on treatment, and the cost per additional QALY for the retigabine no add-on (standard) therapy comparison was estimated at 2009€ 15,753. Using a willingness-to-pay threshold for a QALY of € 50,000, the net marginal values were estimated at 2009€ 605,874 for retigabine vs lacosamide and 2009€ 2,114,203 for retigabine vs no add-on, per 1,000 patients. The probabilistic analyses showed that the likelihood that retigabine treatment is cost-effective is at least 70%. CONCLUSIONS: The estimated cost per additional QALY, for the retigabine vs no add-on treatment comparison, is well within the range of newly published estimates of willingness to pay for an additional QALY. Thus, add-on retigabine treatment for people with focal-onset epilepsy with no/limited response to standard antiepileptic treatment appears to be cost-effective.


Assuntos
Anticonvulsivantes/economia , Anticonvulsivantes/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Epilepsias Parciais/tratamento farmacológico , Custos de Cuidados de Saúde , Fenilenodiaminas/economia , Fenilenodiaminas/uso terapêutico , Acetamidas/economia , Acetamidas/uso terapêutico , Adulto , Análise Custo-Benefício , Quimioterapia Combinada , Epilepsias Parciais/economia , Humanos , Lacosamida , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Suécia
19.
Pharmacoeconomics ; 31(2): 101-10, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23341194

RESUMO

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of retigabine (GlaxoSmithKline) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of adults with partial-onset seizures in epilepsy, with and without secondary generalization, as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination was commissioned to act as the Evidence Review Group (ERG). The ERG undertakes a critical review of the clinical and cost-effectiveness evidence of the technology based upon the manufacturer's submission to NICE. The ERG also independently searches for relevant evidence and evaluates modifications to the manufacturer's decision-analytic model. This paper provides a description of the company submission, the ERG review and NICE's subsequent decisions. The clinical effectiveness data were derived from three placebo-controlled randomized controlled trials (RCTs). A meta-analysis pooling across all doses of retigabine found beneficial effects of retigabine in terms of responder rate (odds ratio [OR] 2.79; 95 % CI 2.08, 3.76) and rate of seizure freedom (OR 2.54; 95 % CI 0.92, 6.98) [both double-blind phase analyses]. When compared in a network meta-analysis with the selected comparator antiepileptic drugs (AEDs) [eslicarbazepine acetate, lacosamide, pregabalin, tiagabine and zonisamide], retigabine offered broadly similar efficacy in terms of responder rate and freedom from seizure. The de novo decision-analytic model presented within the submission evaluated the cost effectiveness of retigabine compared with these AEDs and no treatment (i.e. maintenance therapy). After numerous additional analyses, the ERG considered the use of retigabine to be not cost effective for NICE at thresholds below £43,000 if no treatment was considered a relevant comparator. The NICE Appraisal Committee decided that an appropriate comparator was an active treatment. The Committee recommended that retigabine is offered as an option for the adjunctive treatment of partial-onset seizures with or without secondary generalization in adults aged 18 years and older with epilepsy, only when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate has not provided an adequate response, or has not been tolerated.


Assuntos
Anticonvulsivantes/uso terapêutico , Carbamatos/uso terapêutico , Epilepsias Parciais/tratamento farmacológico , Fenilenodiaminas/uso terapêutico , Adolescente , Adulto , Anticonvulsivantes/economia , Carbamatos/economia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Indústria Farmacêutica , Epilepsias Parciais/economia , Epilepsias Parciais/fisiopatologia , Humanos , Modelos Teóricos , Fenilenodiaminas/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Convulsões/tratamento farmacológico , Convulsões/economia , Convulsões/fisiopatologia , Adulto Jovem
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