Impact of economic sanctions on access to noncommunicable diseases medicines in the Islamic Republic of Iran

Background: It has been argued that economic sanctions and the economic crisis have adversely affected access to drugs. Aim: To assess the impact of economic sanctions on the Iranian banking system in 2011 and Central Bank in 2012 on access to and use of drugs for noncommunicable diseases [NCDs]. Methods: An interrupted time series study assessed the effects of sanctions on drugs for diabetes [5 drug groups], asthma [5 drug groups], cancer [14 drugs] and multiple sclerosis [2 drugs]. We extracted data from national reference databases on the list of drugs on the Iranian pharmaceutical market before 2011 for each selected NCD and their monthly sales. For cancer drugs, we used stratified random sampling by volume and value of sales, and source of supply [domestic or imported]. Data were analysed monthly from 2008 to 2013. Results: Market availability of 13 of 26 drugs was significantly reduced. Ten other drugs showed nonsignificant reductions in their market availability. Interferon alpha2b usage reduced from 0.014 defined daily doses per 1000 inhabitants per day [DID] in 2010 to 0.008 in 2013; and cytarabine from 1.40 mg per 1000 population per day in 2010 to 0.96 in 2013. Selective beta2-adrenoreceptor agonists usage reduced from 8.4 to 6.8 DID in the same time period. Conclusion: There is strong evidence that sanctions have had a negative effect on access to drugs, particularly those that depended on the import of their raw material or finished products

Compras públicas de medicamentos para hepatite C no Brasil no período de 2005 a 2015 / Public procurement of hepatitis C medicines in Brazil from 2005 to 2015

Resumo O artigo analisa as compras de medicamentos para hepatite C, feitas pelo Ministério da Saúde (MS), de 2005 a 2015. Os dados são do Sistema Integrado de Administração de Serviços Gerais (SIASG). Para estimar o gasto contratado anual selecionou-se medicamentos previstos nos Protocolos Clínicos e Diretrizes Terapêuticas para Hepatite C do MS e incluiu-se todas as apresentações e concentrações que apareceram no SIASG. Houve aumento de 159,5 vezes no gasto com os medicamentos selecionados de 2005 a 2006 porque esses produtos passaram a ser comprados de forma centralizada. Em 2007 houve aumento de 730% no gasto pela incorporação de alfapeginterferona 2a e 2b. Em 2012 a compra de dois novos antivirais de ação direta (AAD) representou 99% do gasto anual. Em 2015, a adoção de novos AAD provocou aumento de 230% (R$ 945 milhões) no gasto do MS. No período estudado houve aumento dos gastos do MS com os medicamentos para Hepatite C devido ao aumento do volume adquirido e à incorporação tecnológica de alfapeginterferona e de novos AAD. Garantir acesso universal ao tratamento da hepatite C depende da implementação de estratégias que aumentem o poder de barganha do MS em negociações de redução de preços de produtos em situação de monopólio.

Abstract This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expenditure of the selected medicines from 2005 to 2006, because procurement of those medicines became centralized. In 2007 there was 730% increase in spending due to the incorporation of pegainterferons alfa 2a and 2b. In 2012 the purchase of only two new direct-acting antivirals (DAA) accounted for 99% of total annual expenditure. In 2015 the adoption of a new DAA led to an increase of 230% (R$945 million) in MoH spending. The significant increase of MoH expenditure on medicines for hepatitis C from 2005 to 2015 was due to the increase of volumes purchased as well as the incorporation of alfapeginterferon and new DAAs. Ensuring universal access to treatment for hepatitis C will depend on the implementation of strategies that strengthen the MoH's bargaining power in price reduction negotiations with the manufacturers of monopoly medicines.

Custo-efetividade da inclusão dos respondedores virológicos lentos no tratamento da hepatite C na presença da coinfecção com o HIV / Cost-effectiveness of hepatitis C treatment in slow virologic responders coinfected with HIV / Coste-efectividad del tratamiento de la hepatitis C en coinfectados con el VIH con respuesta virológica lenta

Evidências recentes demonstram que respondedores virológicos lentos podem se beneficiar com a extensão do tratamento antiviral. O estudo investigou a adoção desse protocolo diante da coinfecção VHC/HIV. O objetivo foi estudar a relação de custo/efetividade da terapêutica com peguinterferon associado à ribavirina em portadores do genótipo 1 do VHC coinfectados com o HIV, comparando-se a inclusão ou não de respondedores virológicos lentos. Simulou-se por meio de um modelo de Markov a progressão da doença hepática em uma coorte hipotética de mil homens, maiores de 40 anos, considerandose a perspectiva do Sistema Único de Saúde (SUS) e horizonte temporal de 30 anos. A extensão do tratamento para respondedores lentos resultou em uma razão incremental de custo efetividade de R$ 44.171/QALY, valor abaixo do limiar de aceitabilidade proposto pela Organização Mundial da Saúde. A análise de sensibilidade não modificou os resultados alcançados. A inclusão de indivíduos coinfectados VHC/HIV respondedores virológicos lentos no protocolo de tratamento apresenta-se como uma estratégia custo-efetiva para o SUS.

Recent evidence has demonstrated that slow responders may benefit from antiviral treatment in HCV/HIV coinfection. This study aimed to evaluate the cost-effectiveness of HCV treatment in individuals with genotype 1 coinfected with HIV, with peg-interferon in combination with ribavirin, compared to the inclusion (versus non-inclusion) of slow responders. A Markov model was developed that simulated the progression of liver disease in a hypothetical cohort of one thousand men over 40 years of age, considering the Brazilian Unified National Health System (SUS) perspective and a 30-year timeline. The extension of treatment to slow responders provided a 60% increase in the number of individuals who eliminated HCV and an incremental cost-effectiveness ratio of 44,171 BRL/QALY, below the acceptability threshold proposed by World Health Organization. Sensitivity analysis did not alter the results. The inclusion of HCV/ HIV-coinfected slow virologic responders in the treatment protocol is shown to be a cost-effective strategy for the SUS.

La evidencia reciente ha demostrado que los individuos con respuesta virológica lenta pueden beneficiarse de una extensión del tratamiento antiviral. El estudio investigó la adopción de este protocolo antes de la coinfección por VHC/HIV. El objetivo fue estudiar la relación coste-efectividad de la terapia con peginterferon asociado con ribavirina en pacientes con genotipo 1 del VHC, coinfectados por el HIV respondedores virológicos lentos. Se simula mediante un modelo de Markov la progresión de la enfermedad hepática en una cohorte hipotética de un millar de hombres, más de 40, teniendo en cuenta la perspectiva del Sistema Único de Salud (SUS) y un horizonte temporal de 30 años. El grado de tratamiento a los respondedores lentos dio lugar a un incremento de coste-efectividad de R$ 44.171/QALY, por debajo del umbral de aceptabilidad propuesto por la Organización Mundial de la Salud. El análisis de sensibilidad no modificó los resultados. La inclusión de los individuos coinfectados y con respuesta virológica lenta en el protocolo de tratamiento se presenta como una estrategia económica para el SUS.

Economic evaluation of treatments for chronic hepatitis B

The aim of this study was to conduct a cost-utility study of adefovir, entecavir, interferon alpha, pegylated interferon alpha, lamivudine and tenofovir for chronic hepatitis B in the context of Brazilian Public Health Care System. A systematic review was carried out for efficacy and safety. Another review was performed to collect utility data and transition probabilities between health states. A Markov model was developed in a time horizon of 40 years with annual cycles for three groups of: HBeAg positive, HBeAg negative, and all patients. These strategies were compared to a fourth group that received no treatment. Discount rates of 5% were applied and sensitivity analyses were performed. Tenofovir offered the best cost-utility ratio for the three evaluated models: U$397, U$385 and U$384 (per QALY, respectively, for HBeAg positive, negative, and all patients). All other strategies were completely dominated because they showed higher costs and lower effectiveness than tenofovir. The sequence of cost-utility in the three models was: tenofovir, entecavir, lamivudine, adefovir, telbivudine, pegylated interferon alpha, and interferon alpha. In the sensitivity analysis, adefovir showed lower cost-utility than telbivudine in some situations. The study has some limitations, primarily related to the creation of scenarios and modeling. In this study, tenofovir presented the best cost-utility ratio. The results obtained in this study will be valuable in decision-making and in the review of the clinical protocol, mainly involving the allocation of available resources for health care.

Custo-efetividade do tratamento da infecção pelo vírus da hepatite C em candidatos a transplante renal submetidos à diálise / Cost-effectiveness of hepatitis C treatment in patients on dialysis awaiting renal transplantation

O estudo tem como objetivo geral avaliar a razão de custo-utilidade do tratamento da infecção pelo vírus da hepatite C (VHC) em pacientes dialisados, candidatos a transplante renal, tendo como esquemas terapêuticos alternativos o interferon-a em monoterapia; o interferon peguilado em monoterapia; o interferon-a em terapia combinada com ribavirina e o interferon peguilado em terapia combinada com ribavirina, comparando-os com o não-tratamento. A perspectiva do estudo foi a do Sistema Único de Saúde(SUS), que também serviu de base para estimar o impacto orçamentário da estratégia de tratamento mais custo efetiva. Para o alcance dos objetivos, foi construído um modelo de Makov para simulação de custos e resultados de cada estratégia avaliada. Para subsidiar o modelo, foi realizada uma revisão de literatura, a fim de definir os estados de saúde relacionados à infecção pelo vírus da hepatite C em transplantados e a probabilidade de transição entre os estados. Medidas de utilidade foram derivadas de consultas a especialistas. Os custos foram derivados da tabela de procedimentos do SUS. Os resultados do estudo demonstraram que o tratamento da infecção pelo VHC antes do transplante renal é mais custo-efetivo que o não tratamento, apontando o interferon-a como a melhor opção. O impacto orçamentário para adoção dessa estratégia pelo SUS corresponde a 0,3 por cento do valor despendido pelo SUS com terapia renal substitutiva ao longo do ano de 2007.

Analysis of the cost-effectiveness of antiviral therapies in chronic hepatitis B patients in Korea / 대한간학회지

BACKGROUND/AIMS: The purpose of this study was to evaluate the cost-effectiveness of 1 year and up to 5 years of antiviral treatment for chronic hepatitis B (CHB). METHODS: Two ten-health-state Markov models were developed for CHB patients. The proportion of patients remaining alive in each health state, and healthcare costs and quality-adjusted life years (QALYs) were determined during annual cycles of these Markov models. The total healthcare costs, life years, and QALYs over the 40-year time horizon of the model were calculated. The perspectives of the cost-effectiveness analysis were the Korean healthcare system and the healthcare needs of the CHB patient. RESULTS: Short-course therapy with alpha-interferon or 1-year treatment with pegylated interferon alpha-2a, lamivudine (LMV), or adefovir (ADV) had limited impact on disease progression. In contrast, either LMV-ADV or ADV-LMV as rescue medication administered for 5 years resulted in a more sustained decrease in the rate of disease progression. The cost-effectiveness threshold in Korea was estimated to be approximately 25,000,000 South Korean won. LMV administered for 1 year is cost-effective in comparison with no treatment for both HBeAg-positive and HBeAg-negative CHB patients, but longer duration antiviral therapies administered for up to 5 years in CHB patients were found to be highly cost-effective by international standards. CONCLUSIONS: Antiviral treatment of CHB with LMV or ADV for up to 5 years using the alternative antiviral agent as rescue medication appears to be a cost-effective strategy for both HBeAg-positive and HBeAg-negative CHB patients in Korea. Economic evaluation of antiviral therapies should be studied further and updated, particularly for newer agents.

Treatment of chronic hepatitis B with interferon-alpha: cost-effectiveness in developing countries.

BACKGROUND: Treatment with interferon-alpha (IFN) has been shown to be cost-effective in developed countries. However, cost-effectiveness In developing countries such as India has not been studied. METHODS: Using the Markov transitional probability model, we studied two cohorts of young patients (30 years of age) with chronic hepatitis B, one untreated and the other treated with interferon (IFN), 5 million units daily for 16 weeks, with evidence of viral replication and chronic hepatitis, but not cirrhosis, and were followed up over a 30-year period. Rates of disease progression, efficacy of IFN and quality of life associated with various disease states were estimated from the available literature. Direct costs were estimated using Indian prices of IFN and from the usual costs of medical treatment in India based on expert opinion. Unrelated mortality rates were modelled on age-specific death rates of the general population. The efficacy of IFN was judged In terms of extra life-years and quality-adjusted life-years (QALY) gained, and marginal cost-effectiveness and cost-utility. Several sensitivity analyses, both undiscounted and with discounted analyses, were done. RESULTS: At the end of the 30-year period, fewer patients in the IFN-treated group developed cirrhosis or decompensated cirrhosis, or were dead. The average life span of the treated cohort was 25.14 years, a gain of 0.6 years over the untreated cohort (24.54years). The QALY lived bythetwocohortswere 23.69 and 22.75 years, respectively, representing a gain of 0.94 years for the IFN-treated group. The cost Incurred by the IFN-treated group was Rs 300,000, and that for the untreated cohort was Rs 40 700, a substantial difference. Using the baseline estimates, undiscounted costs per year of life gained and per QALY gained were Rs 432,500 and Rs 276,900, respectively; these estimates are 20.5 and 13.1 times the per capita gross national income of the Indian population. Sensitivity analyses showed that changes in various parameters led to only minor changes in these estimates. Use of discounting led to an increase in marginal cost per life-year or QALY gained. CONCLUSION: In developing countries with a low per capita Income, IFN therapy for chronic hepatitis B may not be cost-effective. A careful consideration of cost-effectiveness is therefore essential before Instituting IFN therapy in patients with chronic hepatitis B In such populations.

Interferón alfa intermitente en el tratamiento de la leucemia de células peludas / Intermittent alpha interferon in hairy cell leukemia

Objetivo. Evaluar si el interferón alfa utilizado en ciclos cortos e intermitentes es útil en el tratamiento a largo plazo de la leucemia de células peludas (LCP). Métodos. Nueve pacientes con leucemia de células peludas recibieron 3 megaunidades de IFN tres veces por semana por 12 semanas. Posteriormente recibieron tratamiento nuevamente de 8 semanas, al reactivarse la leucemia o después de 10 meses en observación cada año. Resultados. Todos tuvieron remisión hematológica antes de las 12 semanas de tratamiento. Unicamente tres pacientes recibieron tratamiento nuevamente antes de 10 meses por recaída. Todos están vivos y sin complicaciones con una mediana de seguimiento de 62 meses. Conclusiones. Los ciclos cortos de IFN intermitente fueron un tratamiento eficaz en la leucemia de células peludas. Esta opción terapéutica tiene un costo más bajo y fue efectiva y comparable a otras formas de terapia con IFN en el tratamiento y mantenimieto de pacientes con este tipo de leucemia