RESUMO
Recently developed direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) have been groundbreaking for their high efficacy across disease genotypes and lack of severe side effects. This study uses a cost-of-illness (COI) approach to estimate the net value conferred by this class of drugs using the cost and efficacy of one of these novel drug combinations, sofosbuvir and velpatasvir (SOF/VEL), recently licensed for generic manufacture in India. This study considers COI of lifetime earnings lost by patients and potential secondarily infected individuals due to disability and premature death from HCV infection. Expected net benefits of treatment are substantial for non-cirrhotic (NC) and compensated cirrhotic (CC) patients (ranging from 5,98,003 INR for NC women to 1,05,25,504 INR for CC men). Increased earnings are not sufficient to fully offset cost of treatment for decompensated cirrhotic individuals but treatment may still be justified on the basis of the intrinsic value of health improvements and other treatment benefits.
Assuntos
Antivirais/economia , Carbamatos/economia , Efeitos Psicossociais da Doença , Hepatite C/economia , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Sofosbuvir/economia , Adolescente , Adulto , Idoso , Antivirais/uso terapêutico , Carbamatos/uso terapêutico , Avaliação da Deficiência , Medicamentos Genéricos , Feminino , Hepatite C/complicações , Hepatite C/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Humanos , Índia , Coeficiente Internacional Normatizado , Cirrose Hepática/etiologia , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Sofosbuvir/uso terapêutico , Adulto JovemRESUMO
The approval of sofosbuvir (Sovaldi) in 2013 transformed chronic hepatitis C virus (HCV) care, but its high cost was criticized in part because of reports of substantial public involvement in its development. We developed a methodology to assess the public's contribution through the National Institutes of Health (NIH) in developing sofosbuvir. Using key terms from the timeline of sofosbuvir, we identified articles in PubMed; linked them to federal funding using the NIH RePORTER; reviewed the title, organization, and investigator of each resulting award for relatedness; and converted related awards to 2018 US dollars. Of 6043 unique awards, we identified 29 that were directly (US$7.7 million) and 110 that were indirectly (US$53.2 million) related awards made to major academic institutions and companies engaged in the development of the drug. These findings indicate that public funding had a key role in developing sofosbuvir, with an estimated US$60.9 million provided in NIH funding.
Assuntos
Desenvolvimento de Medicamentos , Financiamento Governamental , Hepatite C Crônica/tratamento farmacológico , Sofosbuvir/economia , Antivirais/economia , Antivirais/farmacologia , Custos de Medicamentos , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/métodos , Financiamento Governamental/métodos , Financiamento Governamental/estatística & dados numéricos , Humanos , National Institutes of Health (U.S.)/economia , Sofosbuvir/farmacologia , Estados UnidosRESUMO
OBJECTIVES: Recently, the results of two economic evaluations were published both of which seemingly demonstrate the cost-effectiveness of sofosbuvir-based regimens for the treatment of chronic hepatitis C genotype 1 infection in Germany. Both analyses were sponsored by the manufacturer of sofosbuvir and use a different methodology: Whereas one evaluation is based on a conventional cost-utility analysis, the other rests upon the efficiency-frontier method used by the German Institute for Quality and Efficiency in Health Care (IQWiG). The purpose of this study is to reanalysis the results of both economic evaluations in combination. DESIGN: Reanalysis of published decision modelling results. SETTING: Primary care in Germany. PARTICIPANTS: Patients with chronic hepatitis C genotype 1 infection (treatment-naïve and -experienced, cirrhotic and non-cirrhotic). INTERVENTIONS: Sofosbuvir, other anti-hepatitis C virus drugs, and no treatment. PRIMARY AND SECONDARY OUTCOME MEASURES: Cost per unit of health benefit and cost per quality-adjusted life year. RESULTS: Reanalysis of the results of both economic evaluations in combination reveals an unclear rationale for choosing the selected cost-effectiveness methods as well as a potential publication bias, favoring the product of the manufacturer. Based on the reanalysis, sofosbuvir is not cost-effective in treatment-experienced non-cirrhotic patients, potentially lacks cost-effectiveness in treatment-experienced cirrhotic patients, and is only partially cost-effective in treatment-naïve non-cirrhotic patients. Taken together, these results indicate a lack of cost-effectiveness in three quarters of the German patient population. CONCLUSIONS: Two economic evaluations on sofosbuvir suggest, in combination, that sofosbuvir cannot be considered a cost-effective treatment in three quarters of the German patient population.
Assuntos
Antivirais/economia , Hepacivirus/genética , Hepatite C Crônica/economia , Sofosbuvir/economia , Antivirais/uso terapêutico , Quimioterapia Combinada , Genótipo , Alemanha/epidemiologia , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/virologia , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Ribavirina/economia , Ribavirina/uso terapêutico , Sofosbuvir/uso terapêuticoRESUMO
BACKGROUND: Novel oral regimes have been approved for treating hepatitis C virus (HCV) infection in adolescents due to their superior effectiveness and safety. However, its economic outcome is still unclear in this population. The current analysis investigates the cost-effectiveness of novel oral regimens compared with that of pegylated interferon α with ribavirin (PR) therapies in adolescents in the context of the United States and China. METHODS: A Markov model was developed to measure the economic and health outcomes of ledipasvir/sofosbuvir (LS) for genotypes 1 and 4, sofosbuvir/ribavirin (SR) for genotype 2, and ledipasvir/sofosbuvir/ribavirin (LSR) for genotype 3 HCV infection compared with the outcomes of PR treatment. Clinical costs and utility inputs were gathered from published sources. Lifetime discounted quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs) were measured. The uncertainty was facilitated by 1-way and probabilistic sensitivity analyses. RESULTS: In the United States, the ICERs of LS strategy were $14,699 and $14,946/QALY for genotypes 1 and 4 HCV infection, respectively; the ICER of SR strategy for genotype 2 was $42,472/QALY; and the ICER of LSR for genotype 3 was $49,409/QALY in comparison with the PR strategy. In Chinese adolescents, LS for genotypes 1 and 4, SR for genotype 2, and LSR for genotype 3 were the dominant alternatives to the PR strategy. The results were robust to sensitivity analyses. CONCLUSIONS: Novel oral regimes for adolescents with HCV infection are likely to be cost-effective in the context of the United States and China.
Assuntos
Antivirais/economia , Antivirais/uso terapêutico , Análise Custo-Benefício , Quimioterapia Combinada/economia , Hepatite C Crônica/tratamento farmacológico , Administração Oral , Adolescente , Benzimidazóis/economia , Benzimidazóis/uso terapêutico , Criança , China , Fluorenos/economia , Fluorenos/uso terapêutico , Genótipo , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , Cadeias de Markov , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Ribavirina/economia , Ribavirina/uso terapêutico , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Estados UnidosAssuntos
Antivirais/uso terapêutico , Hepatite C/diagnóstico , Hepatite C/tratamento farmacológico , Programas de Rastreamento , Adolescente , Adulto , Antivirais/economia , Egito , Humanos , Programas de Rastreamento/economia , Programas de Rastreamento/métodos , Sofosbuvir/economia , Sofosbuvir/uso terapêuticoAssuntos
Antivirais/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Hepatite C Crônica/diagnóstico , Hepatite C Crônica/tratamento farmacológico , Imidazóis/uso terapêutico , Programas de Rastreamento , Adolescente , Adulto , Antivirais/economia , Carbamatos , Egito/epidemiologia , Feminino , Hepatite C Crônica/epidemiologia , Hepatite C Crônica/prevenção & controle , Humanos , Imidazóis/economia , Masculino , Programas de Rastreamento/economia , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Pirrolidinas , Estudos Soroepidemiológicos , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Valina/análogos & derivados , Adulto JovemRESUMO
INTRODUCTION: The objective of the study was to evaluate the cost-effectiveness of glecaprevir/pibrentasvir versus other direct-acting antivirals (DAAs) for treating chronic hepatitis C virus (HCV) infections in Japan. METHODS: We developed a health state transition model to capture the natural history of HCV. A cost-effectiveness analysis of DAAs from the perspective of a public healthcare payer in Japan with a lifetime horizon over annual cycles was performed. Treatment attributes, baseline demographics, transition probabilities, health-state utilities, and costs data were extracted from publications. Costs and outcomes were discounted at 2% per annum. In the base case we focused on genotype 1 (GT1) treatment-naïve patients without cirrhosis. The scenario analysis examined a pan-genotype treatment in GT1-3 (i.e., portfolio), treatment-naïve, and treatment-experienced patients. The portfolio cost-effectiveness of DAAs was derived by calculating a weighted average of patient segments defined by treatment history, cirrhosis status, and genotype. RESULTS: The base case results indicated that glecaprevir/pibrentasvir was dominant (i.e., generating higher quality-adjusted life years [QALYs] and lower lifetime costs) compared to all other DAAs. The predicted lifetime risk of hepatocellular carcinoma was 3.66% for glecaprevir/pibrentasvir and sofosbuvir/ledipasvir, 4.99% for elbasvir/grazoprevir, and 5.27% for daclatasvir/asunaprevir/beclabuvir. In scenario analysis the glecaprevir/pibrentasvir (GLE/PIB) portfolio dominated the sofosbuvir (SOF)-based portfolio (namely sofosbuvir/ledipasvir in GT1-2 and sofosbuvir + ribavirin in GT3). The base case probabilistic sensitivity analysis (PSA) showed that glecaprevir/pibrentasvir was cost-effective in 93.4% of the simulations for a willingness-to-pay/QALY range of Japanese yen (JPY) 1.6-20 million. The PSA for the portfolio scenario indicated that the GLE/PIB portfolio was cost-effective in 100% of simulations until the willingness-to-pay/QALY reached JPY 5.2 million; this proportion decreased to 69.4% at a willingness-to-pay/QALY of JPY 20 million. Results were also robust in deterministic sensitivity analyses. CONCLUSION: In GT1 treatment-naïve non-cirrhotic patients GLE/PIB was a cost-effective strategy compared to other DAAs. When a pan-genotypic framework was used, the GLE/PIB portfolio dominated the SOF-based portfolio.
Assuntos
Antivirais/economia , Benzimidazóis/economia , Fluorenos/economia , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/economia , Quinoxalinas/economia , Sulfonamidas/economia , Uridina Monofosfato/análogos & derivados , Adulto , Ácidos Aminoisobutíricos , Antivirais/uso terapêutico , Benzimidazóis/uso terapêutico , Análise Custo-Benefício , Ciclopropanos , Quimioterapia Combinada , Feminino , Fluorenos/uso terapêutico , Humanos , Japão , Lactamas Macrocíclicas , Leucina/análogos & derivados , Prolina/análogos & derivados , Pirrolidinas , Quinoxalinas/uso terapêutico , Ribavirina/economia , Sofosbuvir/economia , Sulfonamidas/uso terapêutico , Uridina Monofosfato/economia , Uridina Monofosfato/uso terapêuticoRESUMO
While health care providers have largely turned a blind eye, the cost of health care in the US has been skyrocketing, in part as a result of rising drug prices. Patent protections and market exclusivity, while serving to incentivize targeted new drug development, have exacerbated inequitable outcomes and reduced access, sometimes fueling national epidemics. Branded drug manufacturers face few barriers to exorbitant pricing of drugs with exclusivity-as in the cases of Sovaldi, Zyvox, and Truvada. Furthermore, albendazole, pyrimethamine, and penicillin demonstrate that generic medications without patent exclusivity are not guaranteed to have durably low costs, especially where manufacturer competition is lacking. There is a way forward: through education and awareness, cost-conscious guideline development, government regulation, and market-level incentives, health care providers can collaborate to contain drug prices, curbing expenditures overall while expanding health care access to patients.
Assuntos
Doenças Transmissíveis/tratamento farmacológico , Custos de Medicamentos , Indústria Farmacêutica/economia , Medicamentos Genéricos/economia , Albendazol/economia , Doenças Transmissíveis/economia , Custos e Análise de Custo , Combinação Emtricitabina e Fumarato de Tenofovir Desoproxila/economia , Regulamentação Governamental , Gastos em Saúde , Humanos , Linezolida/economia , Penicilinas/economia , Pirimetamina/economia , Sofosbuvir/economiaRESUMO
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 , Ácidos Aminoisobutíricos , Antivirais/uso terapêutico , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Ciclopropanos , 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 , Lactamas Macrocíclicas , Leucina/análogos & derivados , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Cadeias de Markov , Prolina/análogos & derivados , Quinoxalinas , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Medicina Estatal/organização & administração , Medicina Estatal/estatística & dados numéricos , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Reino UnidoRESUMO
OBJECTIVES: A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan. METHOD: A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness. RESULTS: Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis. CONCLUSIONS: The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.
Assuntos
Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Ribavirina/uso terapêutico , Sofosbuvir/uso terapêutico , Adulto , Idoso , Antivirais/economia , Análise Custo-Benefício , Quimioterapia Combinada/economia , Feminino , Hepatite C Crônica/economia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Ribavirina/economia , Sofosbuvir/economia , Resposta Viral SustentadaAssuntos
Antivirais/uso terapêutico , Custos de Medicamentos , Indústria Farmacêutica/legislação & jurisprudência , Hepatite C/tratamento farmacológico , Patentes como Assunto/legislação & jurisprudência , Sofosbuvir/uso terapêutico , Antivirais/economia , Brasil , Erradicação de Doenças , Medicamentos Genéricos , Órgãos Governamentais , Hepatite C/prevenção & controle , Humanos , Legislação de Medicamentos , Prática de Saúde Pública , Sofosbuvir/economiaRESUMO
OBJECTIVE: This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework. STUDY DESIGN: Taking the example of new direct-acting antivirals against hepatitis C virus, the paper asks whether and how the cost-effectiveness (CE) opinions issued by the French National Health Authority improve the information available to support the pricing decisions. METHODS: The analysis compares the assessment of these drugs based on three different sources: CE opinions, clinical opinions, and the published cost-utility analyses (CUA) available in the literature and identified through a systematic review. RESULTS: The results show that CE opinions bring to the fore three issues prone to impact the incremental cost utility ratio and those were not available to the decision maker through clinical opinions or published CUA: the stage of treatment initiation, the modeling of the disease progression, and the uncertainty around the efficacy rates. CONCLUSIONS: France has introduced the criterion of the cost per QALY gained in the pricing and regulation of innovative pharmaceuticals since 2013. Our analysis shows that the use of CUA does enhance the information available to the decision makers on the value of the treatments.
Assuntos
Antivirais/economia , Análise Custo-Benefício/métodos , Hepatite C/economia , Terapias em Estudo/economia , Antivirais/farmacologia , Antivirais/uso terapêutico , Carbamatos , Economia Médica , França/epidemiologia , Hepatite C/tratamento farmacológico , Hepatite C/epidemiologia , Humanos , Imidazóis/economia , Imidazóis/uso terapêutico , Pirrolidinas , Sofosbuvir/economia , Sofosbuvir/uso terapêutico , Terapias em Estudo/métodos , Valina/análogos & derivadosRESUMO
BACKGROUND: Chronic hepatitis C (CHC) is a leading cause of morbidity and mortality and has imposed a high health care burden in the United States. Direct-acting antiviral (DAA) regimens are well tolerated and highly effective for CHC therapy but were initially marketed at a high price. Studies of their real-world use with a nationwide population are limited. OBJECTIVE: To examine patient characteristics, treatment adherence, effectiveness, and health care costs in a large U.S. population with commercial and Medicare supplemental insurance plans who received simeprevir (SIM), sofosbuvir (SOF), or ledipasvir/sofosbuvir (LED/SOF) during the years 2013-2015. METHODS: Patients with at least 1 diagnosis code for CHC and at least 1 claim for SIM, SOF, or LED/SOF prescriptions were selected. The date of the first claim for SIM, SOF, or LED/SOF was defined as the index date. Analyses were stratified by 4 regimens: SOF + SIM ± ribavirin (RBV), SOF + peginterferon alpha-2a or 2b (PEG) + RBV, SOF + RBV, and LED/SOF ± RBV. Adherence was defined by the proportion of days covered (PDC) ≥ 80%. Sustained virologic response (SVR12) was defined as a hepatitis C virus (HCV) RNA load of ≤ 25 IU/mL measured at ≥ 12 weeks following the end of the days supply of the last DAA refill. Health care costs such as DAA drug costs and medical costs (inpatient costs plus outpatient costs) were described. RESULTS: Of 10,808 CHC patients, approximately two thirds were male, and mean age was 55 years. The proportion of patients with compensated cirrhosis among each regimen ranged from 7.4% in LED/SOF ± RBV to 13.8% in SOF + SIM ± RBV, and the proportion of patients with decompensated cirrhosis ranged from 3.9% in LED/SOF ± RBV to 10.7% in SOF + SIM ± RBV. The majority of patients (89.0%) used the newer regimen LED/SOF ± RBV in 2015. Adherence rates were estimated at 80.5%, 81.5%, 85.7%, and 91.4% for SOF + SIM ± RBV (n = 1,761); SOF + PEG + RBV (n = 1,314); SOF + RBV (n = 1,994); and LED/SOF ± RBV (n = 5,739), respectively. Regimen-specific adherence predictors included sex, age group, payer type, health plan, and treatment option with RBV. Being born during 1945-1965, liver disease severity, and Charlson Comorbidity Index levels did not predict adherence in any regimen. Overall SVR12 was 92.6% in 203 patients with available HCV RNA results: 100% (41/41) in SOF + SIM ± RBV; 83.3% (25/30) in SOF + PEG + RBV; 90.6% (29/32) in SOF + RBV; and 93% (93/100) in LED/SOF ± RBV. While the drug costs for these DAA regimens were initially high, they had decreased 18.9% (P < 0.001) during 2013-2015. Medical costs decreased 9.2% (P < 0.001) 1 year after the index dates. CONCLUSIONS: These results indicate that DAA drug costs decreased steadily during 2013-2015 and that 89% of patients on SOF-based DAA regimens took newer, lower-cost regimens with adherence rates above 80%. Available data show that SVR12 rates were close to those obtained in clinical studies. Medical costs also significantly decreased 1 year after the index dates. DISCLOSURES: No outside funding supported this study. All authors are U.S. federal employees of the Centers for Disease Control and Prevention. The authors declare that they have no competing interests. The findings and conclusions in this research are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Assuntos
Antivirais/administração & dosagem , Custos de Cuidados de Saúde , Hepatite C Crônica/tratamento farmacológico , Sofosbuvir/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antivirais/economia , Benzimidazóis/administração & dosagem , Custos de Medicamentos , Quimioterapia Combinada , Feminino , Fluorenos/administração & dosagem , Hepatite C Crônica/economia , Humanos , Seguro Saúde/economia , Interferon-alfa/administração & dosagem , Masculino , Medicare/economia , Adesão à Medicação , Pessoa de Meia-Idade , Polietilenoglicóis/administração & dosagem , Proteínas Recombinantes/administração & dosagem , Ribavirina/administração & dosagem , Simeprevir/administração & dosagem , Sofosbuvir/economia , Resposta Viral Sustentada , Resultado do Tratamento , Estados Unidos , Uridina Monofosfato/administração & dosagem , Uridina Monofosfato/análogos & derivados , Adulto JovemRESUMO
BACKGROUND: Daclatasvir (DCV) combinated with Sofosbuvir (SOF) has shown good efficacy and safety profile for HCV patients. The aim was to evaluate the cost-effectiveness of DCV/SOF regimen versus HCV alternative treatments for patients who failed to achieve the SVR12 after a first DAA treatment from Italian perspective (PITER cohort). METHODS: A Markov model of HCV chronically infected patients was used to develop two scenarios: 1) DCV+ SOF versus Ledipasvir (LDV)+ SOF in Genotype (Gt)1 and Gt4; 2) DCV+ SOF versus no retreatment option in Gt1, Gt3, and Gt4. The percentage of patients who failed the first line with SOF/Simeprevir/Ribavirin (RBV) or SOF/RBV and were retreated or not according to evidences from PITER cohort, were used to populate the model. HCV resources consumption and SVR rates were quantified using PITER data. Transition probabilities and utility rates were derived from the literature. The outcomes were expressed in terms of Quality adjusted life years (QALYs). Probabilistic sensitivity analysis (PSA) was performed considering a cost-effectiveness threshold of 30,000/QALY. RESULTS: In the base-case analysis, DCV+ SOF represents a cost-effectiveness therapy with ICERs lower than the threshold. The PSA showed robust results, ICERs remain below the threshold in 94% and 99% simulations in Scenario 1 and 2, respectively.
Assuntos
Antivirais/administração & dosagem , Hepatite C Crônica/tratamento farmacológico , Imidazóis/administração & dosagem , Sofosbuvir/administração & dosagem , Antivirais/economia , Benzimidazóis/administração & dosagem , Benzimidazóis/economia , Carbamatos , Estudos de Coortes , Análise Custo-Benefício , Quimioterapia Combinada , Fluorenos/administração & dosagem , Fluorenos/economia , Genótipo , Hepatite C Crônica/economia , Humanos , Imidazóis/economia , Itália , Cadeias de Markov , Pirrolidinas , Anos de Vida Ajustados por Qualidade de Vida , Ribavirina/administração & dosagem , Simeprevir/administração & dosagem , Sofosbuvir/economia , Uridina Monofosfato/administração & dosagem , Uridina Monofosfato/análogos & derivados , Uridina Monofosfato/economia , Valina/análogos & derivadosRESUMO
BACKGROUND AND AIM: For genotype 2 chronic hepatitis C (CHC), the efficacy and safety of sofosbuvir plus ribavirin therapy (SOF + RBV) was better than pegylated interferon plus ribavirin therapy (PR) at a greater drug cost. This study investigated the cost-effectiveness of SOF + RBV compared with PR for treatment-naïve genotype 2 CHC in South Korea. METHODS: Using a decision analytic Markov model, a cost-effectiveness analysis comparing SOF + RBV with PR or no treatment for treatment-naïve genotype 2 CHC was performed with probabilistic and deterministic sensitivity analyses from the payer's perspective in 2017. Three cohorts of patients aged 40-49, 50-59, and 60-69 years were simulated to progress through the fibrosis stages F0-F4 to end-stage liver disease, hepatocellular carcinoma, or death. Published and calculated data on the clinical efficacy of the regimen, health-related quality of life, costs, and transition probabilities were used. RESULTS: While the incremental cost-effectiveness ratio for PR was dominant over no treatment, the incremental cost-effectiveness ratios for SOF + RBV were $20 058 for the patients in their 40s, $19 662 for those in their 50s, and $22 278 for those in their 60s compared with PR. Probabilistic sensitivity analysis indicated an 89.0% probability for the SOF + RBV to be cost-effective at a willingness to pay of $29 754.4 (per-capita gross domestic product in 2017) for the patients in their 40s and 94.1% and 89.1% for the patients in their 50s and 60s, respectively. CONCLUSIONS: The SOF + RBV is a cost-effective option for genotype 2 treatment-naïve CHC patients, especially for the patients with liver cirrhosis in Korea.
Assuntos
Antivirais/administração & dosagem , Antivirais/economia , Genótipo , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/virologia , Ribavirina/administração & dosagem , Ribavirina/economia , Sofosbuvir/administração & dosagem , Sofosbuvir/economia , Idoso , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Hepatite C Crônica/economia , Humanos , Interferon-alfa/administração & dosagem , Interferon-alfa/economia , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/economia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , República da Coreia , Resultado do TratamentoAssuntos
Antivirais/economia , Benzimidazóis/economia , Carbamatos/economia , Custos de Medicamentos , Fluorenos/economia , Hepatite C Crônica/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Sofosbuvir/economia , Uridina Monofosfato/análogos & derivados , Erradicação de Doenças , Combinação de Medicamentos , Hepatite C Crônica/prevenção & controle , Humanos , Estados Unidos , Uridina Monofosfato/economiaRESUMO
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 JovemRESUMO
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 TratamentoRESUMO
BACKGROUND: New direct-acting antivirals (DAAs) can cure chronic hepatitis C virus (HCV) infection. High DAA prices combined with a large number of patients needing treatment may pose substantial economic burden on health systems. OBJECTIVES: To examine Medicaid reimbursement for medications for HCV infection before and after the availability of new DAAs overall and by state and to also assess the impact of Medicaid expansion on reimbursement for DAAs. METHODS: We calculated Medicaid reimbursements for medications for HCV infection between 2012 and 2015 in all 50 states and the District of Columbia. Outcomes included inflation-adjusted Medicaid reimbursement for medications for HCV infection, market share of individual DAAs, percentages of Medicaid outpatient pharmacy reimbursement for DAAs, and Medicaid reimbursement per Medicaid enrollee with HCV infection. RESULTS: Medicaid reimbursement for medications for HCV infection increased from $723 million in 2012 to $2.35 billion in 2015. We found variations in Medicaid reimbursement for DAAs between states in 2014 (up to 7.4 times HCV infection prevalence) that widened in 2015 (0.1-11.4 times HCV infection prevalence). Expansion states had significantly higher increases in reimbursement for DAAs per enrollee with HCV infection compared with non- or late-expansion states ($2178.60; 95% confidence interval $1558.90-$2798.40), controlling for pre-expansion reimbursement. CONCLUSIONS: Medicaid reimbursement for DAAs differs across states after controlling for HCV infection prevalence. A third of states contributed more than 5% to 15% of pharmacy reimbursements to DAAs. Medications for HCV infection are only one class of highly priced specialty drugs. Innovative policy strategies are needed for health systems to manage coverage for an increasing number of expensive specialty medications indicated for an increasing number of patients.