RESUMO
BACKGROUND & AIMS: More than 292 million people are living with hepatitis B worldwide and are at risk of death from cirrhosis and liver cancer. The World Health Organization (WHO) has set global targets for the elimination of viral hepatitis as a public health threat by 2030. However, current levels of global investment in viral hepatitis elimination programmes are insufficient to achieve these goals. METHODS: To catalyse political commitment and to encourage domestic and international financing, we used published modelling data and key stakeholder interviews to develop an investment framework to demonstrate the return on investment for viral hepatitis elimination. RESULTS: The framework utilises a public health approach to identify evidence-based national activities that reduce viral hepatitis-related morbidity and mortality, as well as international activities and critical enablers that allow countries to achieve maximum impact on health outcomes from their investments - in the context of the WHO's 2030 viral elimination targets. CONCLUSION: Focusing on hepatitis B, this health policy paper employs the investment framework to estimate the substantial economic benefits of investing in the elimination of hepatitis B and demonstrates how such investments could be cost saving by 2030. LAY SUMMARY: Hepatitis B infection is a major cause of death from liver disease and liver cancer globally. To reduce deaths from hepatitis B infection, we need more people to be tested and treated for hepatitis B. In this paper, we outline a framework of activities to reduce hepatitis B-related deaths and discuss ways in which governments could pay for them.
Assuntos
Erradicação de Doenças/economia , Saúde Global/economia , Financiamento da Assistência à Saúde , Vírus da Hepatite B , Hepatite B Crônica/economia , Investimentos em Saúde , Saúde Pública/economia , Adulto , Antivirais/economia , Antivirais/uso terapêutico , Criança , Análise Custo-Benefício , Feminino , Vacinas contra Hepatite B/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/prevenção & controle , Hepatite B Crônica/virologia , Humanos , Resultado do Tratamento , Vacinação/métodos , Organização Mundial da SaúdeRESUMO
BACKGROUND: The World Health Assembly calls for elimination of viral hepatitis as a public health threat by 2030 (ie, -90% incidence and -65% mortality). However, WHO's 2017 cost projections to achieve health-related Sustainable Development Goals did not include the resources needed for hepatitis testing and treatment. We aimed to estimate the incremental commodity cost of adding scaled up interventions for testing and treatment of hepatitis to WHO's investment scenarios. METHODS: We added modelled costs for implementing WHO recommended hepatitis testing and treatment to the 2017 WHO cost projections. We quantified additional requirements for diagnostic tests, medicines, health workers' time, and programme support across 67 low-income and middle-income countries, from 2016-30. A progress scenario scaled up interventions and a more ambitious scenario was modelled to reach elimination by 2030. We used 2018 best available prices of diagnostics and generic medicines. We estimated total costs and the additional investment needed over the projection of the 2016 baseline cost. FINDINGS: The 67 countries considered included 230 million people living with hepatitis B virus (HBV) and 52 million people living with hepatitis C virus (HCV; 90% and 73% of the world's total, respectively). Under the progress scenario, 3250 million people (2400 million for HBV and 850 million for HCV) would be tested and 58·2 million people (24·1 million for HBV and 34·1 million for HCV) would be treated (total additional cost US$ 27·1 billion). Under the ambitious scenario, 11â631 million people (5502 million for HBV and 6129 million for HCV) would be tested and 93·8 million people (32·2 million for HBV and 61·6 million for HCV) would be treated (total additional cost $58·7 billion), averting 4·5 million premature deaths and leading to a gain of 51·5 million healthy life-years by 2030. However, if affordable HCV medicines remained inaccessible in 13 countries where medicine patents are protected, the additional cost of the ambitious scenario would increase to $118 billion. Hepatitis elimination would account for a 1·5% increase to the WHO ambitious health-care strengthening scenario costs, avert an additional 4·6% premature deaths, and add an additional 9·6% healthy life-years from 2016-30. INTERPRETATION: Access to affordable medicines in all countries will be key to reach hepatitis elimination. This study suggests that elimination is feasible in the context of universal health coverage. It points to commodities as key determinants for the overall price tag and to options for cost reduction strategies. FUNDING: WHO, United States Centers for Disease Control and Prevention, Unitaid.
Assuntos
Erradicação de Doenças , Saúde Global , Recursos em Saúde , Hepatite C/prevenção & controle , Avaliação das Necessidades , Cobertura Universal do Seguro de Saúde , Antivirais/economia , Antivirais/uso terapêutico , Países em Desenvolvimento , Previsões , Custos de Cuidados de Saúde/tendências , Hepatite C/epidemiologia , Humanos , Programas de Rastreamento/economia , Desenvolvimento Sustentável , Organização Mundial da SaúdeRESUMO
Identifying women living with HIV, initiating them on lifelong antiretroviral treatment (ART), and retaining them in care are among the important challenges facing this generation of health care managers and public health researchers. Implementation research attempts to solve a wide range of implementation problems by trying to understand and work within real-world conditions to find solutions that have a measureable impact on the outcomes of interest. Implementation research is distinct from clinical research in many ways yet demands similar standards of conceptual thinking and discipline to generate robust evidence that can be, to some extent, generalized to inform policy and service delivery. In 2011, the World Health Organization (WHO), with funding from Global Affairs Canada, began support to 6 implementation research projects in Malawi, Nigeria, and Zimbabwe. All focused on evaluating approaches for improving rates of retention in care among pregnant women and mothers living with HIV and ensuring their continuation of ART. This reflected the priority given by ministries of health, program implementers, and researchers in each country to the importance of women living with HIV returning to health facilities for routine care, adherence to ART, and improved health outcomes. Five of the studies were cluster randomized controlled trials, and 1 adopted a matched cohort design. Here, we summarize some of the main findings and key lessons learned. We also consider some of the broader implications, remaining knowledge gaps, and how implementation research is integral to, and essential for, global guideline development and to inform HIV/AIDS strategies.
Assuntos
Comitês Consultivos/organização & administração , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/prevenção & controle , Transmissão Vertical de Doenças Infecciosas/prevenção & controle , Mães , Complicações Infecciosas na Gravidez/prevenção & controle , Gestantes , Organização Mundial da Saúde , Adulto , Comitês Consultivos/economia , Contagem de Linfócito CD4 , Canadá , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Malaui/epidemiologia , Área Carente de Assistência Médica , Nigéria/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde , Gravidez , Complicações Infecciosas na Gravidez/tratamento farmacológico , Serviços de Saúde Rural/organização & administração , Serviços de Saúde Rural/estatística & dados numéricos , Zimbábue/epidemiologiaRESUMO
Although not originally part of the MDGs, HIV treatment has been at the center of global HIV reporting since 2003, marked by achievement of the target of 15 million people receiving treatment before 2015 and 18.2 million (16.1-19.0 million) by mid 2016. Monitoring of treatment has been strengthened with harmonized partner reporting and accountability with regular, annual reports. Beyond treatment numbers, increasingly measures of treatment adherence, retention and outcomes have been reported though with varying quality and completeness. However, with the sustainable development goals (SDGs), monitoring treatment is changing in three important ways. First, treatment monitoring is shifting from numbers to coverage and gaps in a cascade of services to achieve universal access. Secondly, this requires greater emphasis on disaggregated, individual level patient and case monitoring systems, which can better support linkage, retention and chronic, long term care. Thirdly, the prevention, testing and treatment cascade with a clear results chain, links treatment numbers to impact, in terms of reduced viral load, mortality and incidence. This agenda will require a greater contribution of routine impact evaluation alongside monitoring, with treatment seen as part of a cascade of services to ensure impact on mortality and incidence. In conclusion, the shift from monitoring treatment numbers to treatment linked to universal access to prevention, testing and treatment and impact on mortality and incidence, will be critical to monitor, evaluate, and improve HIV programs as part of the SDGs.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Controle de Doenças Transmissíveis/organização & administração , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Programas Nacionais de Saúde/organização & administração , Vigilância da População/métodos , Avaliação de Programas e Projetos de Saúde , Controle de Doenças Transmissíveis/métodos , Programas Governamentais , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Acessibilidade aos Serviços de Saúde , Humanos , Incidência , Saúde Pública , Resultado do TratamentoRESUMO
Currently, access to treatment for HCV is limited, with treatment rates lowest in the more resource-limited countries, including those countries with the highest prevalence. The use of oral DAAs has the potential to provide treatment at scale by offering opportunities to simplify drug regimens, laboratory requirements, and service delivery models. Key desirable characteristics of future HCV treatment regimens include high efficacy, tolerability, pan-genotype activity, short treatment duration, oral therapy, affordability, and availability as fixed-dose combination. Using such a regimen, HCV treatment delivery could be greatly simplified. Treatment could be initiated following confirmation of the presence of viraemia, with an initial assessment of the stage of liver disease. A combination DAA therapy that is safe and effective across genotypes could remove the need for genotyping and intermediary viral load assessments for response-guided therapy and reduce the need for adverse event monitoring. Simpler, safer, shorter therapy will also facilitate simplified service delivery, including task shifting, decentralization, and integration of treatment and care. The opportunity to scale up HCV treatment using such delivery approaches will depend on efforts needed to guarantee that the new DAAs are affordable in low-income settings. This will require the engagement of all stakeholders, ranging from the companies developing these new treatments, WHO and other international organizations, including procurement and funding mechanisms, governments and civil society.
Assuntos
Antivirais/uso terapêutico , Atenção à Saúde/tendências , Recursos em Saúde/provisão & distribuição , Acessibilidade aos Serviços de Saúde/tendências , Hepacivirus , Hepatite C/tratamento farmacológico , Antivirais/economia , Antivirais/farmacologia , Atenção à Saúde/normas , Países em Desenvolvimento , Genótipo , Custos de Cuidados de Saúde , Acessibilidade aos Serviços de Saúde/normas , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C/genética , Humanos , Saúde Pública/normas , Saúde Pública/tendências , Resultado do Tratamento , Organização Mundial da SaúdeRESUMO
A viable market for antiretroviral drugs in low- and middle-income countries is key to the continued scale-up of antiretroviral treatment. We describe the price paid by low- and middle-income countries for 10 first- and 7 second-line adult and paediatric treatment regimens from 2003 to 2012, and compare the price of their finished formulations with the price of their active pharmaceutical ingredients in 2005, 2007, 2010 and 2012. Between 2003 and 2012 the median price of adult first-line treatment regimens per treatment-year decreased from USD499 to USD122, and that of second-line regimens from USD2,934 to USD497. In 2005 adult formulations were sold for a price 170% higher than the cost of their active pharmaceutical ingredients. This margin had decreased to 28% in 2012. Between 2004 and 2013, the price of paediatric treatment per treatment-year decreased from USD585 to USD147 for first-line and from USD763 to USD288 for second-line treatment. In 2005, paediatric treatment regimens were sold at a price 231% higher than the cost of their active pharmaceutical ingredients. This margin remained high and was 195% in 2012. The prices paid for antiretroviral drugs by low- and middle-income countries decreased between 2003 and 2012. Although the margins on their sale decreased, there is likely still space for price reduction, especially for the more recent World Health Organization recommended adult first-line regimens and for paediatric treatment.
Assuntos
Fármacos Anti-HIV/economia , Terapia Antirretroviral de Alta Atividade/economia , Comércio/estatística & dados numéricos , Indústria Farmacêutica/economia , Medicamentos Genéricos/economia , Infecções por HIV/economia , Adulto , Fármacos Anti-HIV/provisão & distribuição , Criança , Países em Desenvolvimento , Medicamentos Genéricos/provisão & distribuição , Guias como Assunto , Infecções por HIV/tratamento farmacológico , Humanos , Renda , Organização Mundial da SaúdeRESUMO
BACKGROUND: WHO's 2013 revisions to its Consolidated Guidelines on antiretroviral drugs recommend routine viral load monitoring, rather than clinical or immunological monitoring, as the preferred monitoring approach on the basis of clinical evidence. However, HIV programmes in resource-limited settings require guidance on the most cost-effective use of resources in view of other competing priorities such as expansion of antiretroviral therapy coverage. We assessed the cost-effectiveness of alternative patient monitoring strategies. METHODS: We evaluated a range of monitoring strategies, including clinical, CD4 cell count, and viral load monitoring, alone and together, at different frequencies and with different criteria for switching to second-line therapies. We used three independently constructed and validated models simultaneously. We estimated costs on the basis of resource use projected in the models and associated unit costs; we quantified impact as disability-adjusted life years (DALYs) averted. We compared alternatives using incremental cost-effectiveness analysis. FINDINGS: All models show that clinical monitoring delivers significant benefit compared with a hypothetical baseline scenario with no monitoring or switching. Regular CD4 cell count monitoring confers a benefit over clinical monitoring alone, at an incremental cost that makes it affordable in more settings than viral load monitoring, which is currently more expensive. Viral load monitoring without CD4 cell count every 6-12 months provides the greatest reductions in morbidity and mortality, but incurs a high cost per DALY averted, resulting in lost opportunities to generate health gains if implemented instead of increasing antiretroviral therapy coverage or expanding antiretroviral therapy eligibility. INTERPRETATION: The priority for HIV programmes should be to expand antiretroviral therapy coverage, firstly at CD4 cell count lower than 350 cells per µL, and then at a CD4 cell count lower than 500 cells per µL, using lower-cost clinical or CD4 monitoring. At current costs, viral load monitoring should be considered only after high antiretroviral therapy coverage has been achieved. Point-of-care technologies and other factors reducing costs might make viral load monitoring more affordable in future. FUNDING: Bill & Melinda Gates Foundation, WHO.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adulto , Contagem de Linfócito CD4/economia , Análise Custo-Benefício , Gerenciamento Clínico , Substituição de Medicamentos , Infecções por HIV/economia , Infecções por HIV/imunologia , Infecções por HIV/virologia , Custos de Cuidados de Saúde , Humanos , Modelos Teóricos , Anos de Vida Ajustados por Qualidade de Vida , Carga Viral/economiaRESUMO
Despite the exponential growth in the literature on modelling and simulation studies of impact and cost-effectiveness in different aspects of healthcare, there is no clear consensus on the appropriate role of modelling in the development of recommendations in clinical guidelines. This is compounded both by the lack of a standardised approach to assess the quality of modelling, and lack of clarity on its positioning within the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) method for decision-making in the development of WHO guidelines, that considers both evidence from systematic reviews of randomized clinical trials (RTCs) or observational studies, together with stakeholder values and preferences, resource use, and feasibility issues. In the development of the 2013 WHO Consolidated Guidelines on the use of Antiretroviral drugs for treating and preventing HIV infection, a series of modelling projects were undertaken to inform the recommendations on eligibility criteria for ART initiation, and approaches to monitoring for treatment response. We report our experiences, challenges encountered, and several key considerations to guide the future use of modelling in the development of WHO guidelines. These are: (1) Transparency in the conduct and reporting of model inputs and results; (2) The need for agreed standards for critical appraisal and use of modelling data in healthcare policy making; (3) recognition that modelling of cost-effectiveness is only one component of decision-making in development of WHO recommendations and in priority-setting; (4) The need for closer interaction and an ongoing dialogue between modellers and model end-users or decision-makers; (5) the important role of WHO in convening and facilitating comparative assessment of multiple models; and (6) The need to optimize research and data collection to inform modelling studies.
Assuntos
Terapia Antirretroviral de Alta Atividade , Infecções por HIV , Modelos Teóricos , Guias de Prática Clínica como Assunto , Humanos , Terapia Antirretroviral de Alta Atividade/métodos , Terapia Antirretroviral de Alta Atividade/normas , Política de Saúde , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/imunologia , Infecções por HIV/virologia , Organização Mundial da SaúdeAssuntos
Circuncisão Masculina/instrumentação , Circuncisão Masculina/métodos , Infecções por HIV/prevenção & controle , Adolescente , Adulto , África Oriental , Circuncisão Masculina/efeitos adversos , Circuncisão Masculina/economia , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/transmissão , Humanos , Masculino , Avaliação de Programas e Projetos de Saúde , Saúde Pública , África do Sul , Organização Mundial da Saúde , Adulto JovemRESUMO
PURPOSE OF REVIEW: This review provides an update on the WHO/UNAIDS Treatment 2.0 strategy by reviewing the documents and technical updates issued under the initiative. Launched in 2010, this global initiative provides a framework for the continued scale-up of access to HIV care and treatment. RECENT FINDINGS: WHO has prioritized once daily fixed-dose combination as the preferred antiretroviral (ARV) regimen to initiate HIV treatment, paving the way for programmatic simplification, with reduced toxicity and improved adherence. WHO also recommends the use of point-of-care diagnostics, with CD4 cell count technologies being implemented in the field and progress towards improving access to simplified viral load testing. The strategy also seeks mechanisms that can contribute to reducing treatment costs, such as pooled commodity procurement and public health-oriented licensing approaches. Improved service delivery, specifically through decentralization, task shifting, integration and community mobilization also has the potential to reduce costs and improve access. Support to countries has been provided through the timely release of a series of programmatic and technical updates on specific treatment-related topics. SUMMARY: The Treatment 2.0 strategy articulates how innovation and greater efficiency can make HIV care and treatment more accessible and affordable, and guide treatment and prevention scale-up.
Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Antirretrovirais/economia , Análise Custo-Benefício , Saúde Global , Infecções por HIV/economia , Humanos , Nações Unidas , Organização Mundial da SaúdeRESUMO
After 30 years we are still struggling to address a devastating HIV pandemic in which over 25 million people have died. In 2010, an estimated 34 million people were living with HIV, around 70% of whom live in sub-Saharan Africa. Furthermore, in 2009 there were an estimated 1.2 million new HIV-associated TB cases, and tuberculosis (TB) accounted for 24% of HIV-related deaths. By the end of 2010, 6.6 million people were taking antiretroviral therapy (ART), around 42% of those in need as defined by the 2010 World Health Organization (WHO) guidelines. Despite this achievement, around 9 million people were eligible and still in need of treatment, and new infections (approximately 2.6 million in 2010 alone) continue to add to the future caseload. This combined with the international fiscal crisis has led to a growing concern regarding weakening of the international commitment to universal access and delivery of the Millennium Development Goals by 2015. The recently launched UNAIDS/WHO Treatment 2.0 platform calls for accelerated simplification of ART, in line with a public health approach, to achieve and sustain universal access to ART, including maximizing the HIV and TB preventive benefit of ART by treating people earlier, in line with WHO 2010 normative guidance. The potential individual and public health prevention benefits of using treatment in the prevention of HIV and TB enhance the value of the universal access pledge from a life-saving initiative, to a strategic investment aimed at ending the HIV epidemic. This review analyzes the gaps and summarizes the evidence regarding ART in the prevention of HIV and TB.
Assuntos
Infecções Oportunistas Relacionadas com a AIDS/prevenção & controle , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Tuberculose Pulmonar/prevenção & controle , Terapia Antirretroviral de Alta Atividade/economia , Infecções por HIV/economia , Humanos , Modelos Teóricos , Saúde Pública , Tuberculose Pulmonar/economiaRESUMO
Expanding access to antiretroviral therapy (ART) has both individual health benefits and potential to decrease HIV incidence. Ensuring access to HIV services is a significant human rights issue and successful programmes require adequate human rights protections and community support. However, the cost of specific human rights and community support interventions for equitable, sustainable and non-discriminatory access to ART are not well described. Human rights and community support interventions were identified using the literature and through consultations with experts. Specific costs were then determined for these health sector interventions. Population and epidemic data were provided through the Statistics South Africa 2009 national mid-year estimates. Costs of scale up of HIV prevention and treatment were taken from recently published estimates. Interventions addressed access to services, minimising stigma and discrimination against people living with HIV, confidentiality, informed consent and counselling quality. Integrated HIV programme interventions included training for counsellors, 'Know Your Rights' information desks, outreach campaigns for most at risk populations, and adherence support. Complementary measures included post-service interviews, human rights abuse monitoring, transportation costs, legal assistance, and funding for human rights and community support organisations. Other essential non-health sector interventions were identified but not included in the costing framework. The annual costs for the human rights and community support interventions are United States (US) $63.8 million (US $1.22 per capita), representing 1.5% of total health sector HIV programme costs. Respect for human rights and community engagement can be understood both as an obligation of expanded ART programmes and as a critically important factor in their success. Basic rights-based and community support interventions constitute only a small percentage of overall programmes costs. ART programs should consider measuring the cost and impact of human rights and community support interventions as key aspects of successful programme expansion.
Assuntos
Terapia Antirretroviral de Alta Atividade/economia , Serviços de Saúde Comunitária/economia , Infecções por HIV/economia , Infecções por HIV/terapia , Acessibilidade aos Serviços de Saúde/economia , Direitos Humanos , Apoio Social , Custos e Análise de Custo , Prestação Integrada de Cuidados de Saúde/economia , Humanos , África do SulRESUMO
Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends. Until now, advocacy for resources has been done on the basis of a commodity approach that encouraged scaling up of numerous strategies in parallel, irrespective of their relative effects. We propose a strategic investment framework that is intended to support better management of national and international HIV/AIDS responses than exists with the present system. Our framework incorporates major efficiency gains through community mobilisation, synergies between programme elements, and benefits of the extension of antiretroviral therapy for prevention of HIV transmission. It proposes three categories of investment, consisting of six basic programmatic activities, interventions that create an enabling environment to achieve maximum effectiveness, and programmatic efforts in other health and development sectors related to HIV/AIDS. The yearly cost of achievement of universal access to HIV prevention, treatment, care, and support by 2015 is estimated at no less than US$22 billion. Implementation of the new investment framework would avert 12·2 million new HIV infections and 7·4 million deaths from AIDS between 2011 and 2020 compared with continuation of present approaches, and result in 29·4 million life-years gained. The framework is cost effective at $1060 per life-year gained, and the additional investment proposed would be largely offset from savings in treatment costs alone.