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WHO’s new End TB Strategy Mukund Uplekar, Diana Weil, Knut Lonnroth, Ernesto Jaramillo, Christian Lienhardt, Hannah Monica Dias, Dennis Falzon, Katherine Floyd, Giuliano Gargioni, Haileyesus Getahun, Christopher Gilpin, Philippe Glaziou, Malgorzata Grzemska, Fuad Mirzayev, Hiroki Nakatani, Mario Raviglione, for WHO’s Global TB Programme

On May 19, 2014, the 67th World Health Assembly (WHA) adopted WHO’s “Global strategy and targets for tuberculosis prevention, care and control after 2015”.1 This post-2015 global tuberculosis strategy, labelled the End TB Strategy, was shaped during the past 2 years. A wide range of stakeholders—from ministries of health and national tuberculosis programmes to technical and scientific institutions, financial and development partners, civil society and health activists, non-governmental organisations, and the private sector—contributed to its development.2 The strategy has a vision of making the world free of tuberculosis, with zero deaths, disease, and suffering due to the disease (see appendix p 1 for summary of the End TB Strategy). In 2013, 9 million people fell ill with tuberculosis and 1·5 million died; about a quarter of them were HIV positive.3 Poor and deprived groups also bore the brunt of the enormous socioeconomic burden imposed by the disease and deaths. Concerned by this persistent human suffering due to tuberculosis, but encouraged by the progress achieved during the past two decades and recognising the need to mount a multisectoral response to effectively address the problem, the health ministers at the WHA approved WHO’s proposal to push the limit of ambition to “end the global tuberculosis epidemic” by 2035, marked by well defined milestones and targets set along the way.4 Ending the tuberculosis epidemic implies bringing the levels of tuberculosis in the whole world down to converge with those already attained by many rich countries: fewer than ten new tuberculosis cases occurring per 100 000 population per year amounting to 90% reduction in tuberculosis incidence and tuberculosis deaths reduced by 95%. The rich countries achieved remarkable reductions in the tuberculosis burden not only by delivering adequate tuberculosis services, but also by pursuing universal access to health care and social protection while rapidly improving nutrition and economic conditions. Ending the tuberculosis epidemic in high-incidence countries needs a similar approach that guarantees access to high-quality tuberculosis care and prevention to all while simultaneously addressing the social determinants of tuberculosis.5 To this effect, elimination of catastrophic costs that tuberculosis-affected families face is an important milestone to be achieved under the End TB Strategy well within the next decade. Importantly, though, achievement of universal access to currently available methods of tuberculosis care and prevention will not be enough to end the epidemic within two decades. Global investments and efforts are also essential to develop improved methods to diagnose, treat, and prevent tuberculosis. Equal emphasis on achievement

of universal access to tuberculosis care and prevention, addressing of weaknesses in health systems and social determinants of tuberculosis, and pursuing of research and innovation for improved approaches and strategies constitute the core of the End TB Strategy. The achievements of the past two decades provide the basis for further progress. The DOTS (directly observed treatment, short-course) strategy of 1995 expanded access to high-quality tuberculosis care. The Stop TB Strategy of 2006 widened its scope to address management of all forms of tuberculosis including HIV-associated and drug-resistant tuberculosis, through engagement of communities, involvement of all care providers, strengthening of health systems, and fostering of research. Subsequently, the tuberculosis-related Millennium Development Goal to “halt and begin to reverse the incidence of tuberculosis” was achieved; 37 million lives were saved between 2000 and 2013; and a new rapid molecular test to simultaneously diagnose tuberculosis and rifampicin resistance was developed and two novel drugs were introduced.3 These achievements notwithstanding, the enormity of the task ahead cannot be overemphasised. Overall, the current 2% annual reduction in the global tuberculosis incidence is too slow to achieve an end to the epidemic in the foreseeable future. Tuberculosis remains a top infectious killer of men and women. A third of estimated incident tuberculosis cases go un-notified or undiagnosed and close to half a million multidrug-resistant cases emerge each year. HIV-associated tuberculosis affects more than a million people a year.3 An estimated 2 billion people with latent tuberculosis infection form a reservoir that sustains the global epidemic. Analyses of constraints to global tuberculosis control bring four major persisting barriers to the fore.6 First, weak health systems including the unregulated non-state sector prevent reaching the currently available methods of diagnosis and treatment to all sections of the populations and a lack of universal health coverage and social protection inhibit provision of comprehensive tuberculosis care and prevention without further impoverishment to those who need it most. Second, determinants such as poverty, undernutrition, migration, and ageing populations enhance vulnerability and maintain the cycle of infection and disease. The risk of tuberculosis is further enhanced by non-communicable health problems such as diabetes, harmful use of alcohol, and tobacco smoking.5 Third, the lack of optimum methods—a point-of-care test for rapid diagnosis of disease and latent infection; better and safer drug regimens to shorten treatment; and a vaccine to prevent

www.thelancet.com Published online March 24, 2015 http://dx.doi.org/10.1016/S0140-6736(15)60570-0

Published Online March 24, 2015 http://dx.doi.org/10.1016/ S0140-6736(15)60570-0 Global TB Programme, World Health Organization, Geneva, Switzerland (M Uplekar MD, D Weil MSc, K Lonnroth MD, E Jaramillo MD, C Lienhardt MD, H M Dias MSc, D Falzon MD, K Floyd PhD, G Gargioni MD, H Getahun MD, C Gilpin MD, P Glaziou MD, M Grzemska MD, F Mirzayev MD, H Nakatani MD, M Raviglione MD) Correspondence to: Dr Mukund Uplekar, Global TB Programme, World Health Organization, Geneva 1211, Switzerland [email protected] See Online for appendix

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the disease—stands in the way of tuberculosis elimination. And fourth, despite substantial increases in domestic funding and recent external financing mechanisms, unmet funding needs undermine intensification of efforts.7 The new strategy aims to address these barriers by eliciting a strong, systemic response to end the tuberculosis epidemic drawing on the opportunities of the post-2015 development agenda especially those related to achievement of universal health coverage and social protection.8 Remarkably, more than half the global tuberculosis burden and two-thirds of the global burden of multidrug-resistant tuberculosis are borne by Brazil, Russia, India, China, and South Africa and other emerging economies. Their increased and sustained commitment can go a long way towards meeting ambitious global targets.9 Ambitious targets of 95% reduction in tuberculosis deaths and 90% reduction in tuberculosis incidence by 2035 and achieving the stated milestones on the way will need the governments to abide by four important principles in putting the new End TB Strategy into operation: (1) government stewardship and accountability with monitoring and evaluation; (2) strong coalition with civil society organisations and communities; (3) protection and promotion of human rights, ethics, and equity; and (4) adaptation of the strategy and targets at country level, with global collaboration. National adaptation of the global strategy based on in-depth analysis of the characteristics of the local tuberculosis epidemics and health systems will be as crucial as committing to international collaboration in view of increased travel and migration and threat to health security. The strategy is designed to drive change through coordinated action in three crucial spheres represented by its three pillars and ten components. The first pillar— “integrated, patient-centred care and prevention”— focuses on early detection and treatment of all patients with tuberculosis. It incorporates a patient-centred approach—tuberculosis care and support sensitive and responsive to patients’ educational, emotional, and material needs—and addresses diverse barriers that men, women, and children encounter while seeking care and adhering to treatment. The first pillar is meant to take a departure from previous incremental approaches by modernising all aspects of tuberculosis care and prevention through use of rapid molecular diagnostics,10 universal drug susceptibility testing, and systematic screening of high-risk individuals along with preventive treatment to those who will benefit from it.11,12 Among many new interventions, the addition of prevention to care is an important advance introduced by the End TB Strategy. The strategy promotes service integration essential for improved management of tuberculosis and HIV and other comorbidities, for improvement of access for women and children, and for gaining of efficiencies in general. It also emphasises innovations to improve care provision, programme management, and surveillance 2

including through swift and wide application of information and communication technology. The second pillar—“bold policies and supportive systems”—comprises enacting, if necessary, and enforcing health and social sector policies that can strengthen the national responses to the tuberculosis epidemic. The success in achieving the milestones and the targets set for the first decade of the End TB Strategy—75% reduction in deaths and 50% reduction in incidence—will depend largely on how effectively the broad multisectoral policies that address universal health coverage, social protection, and major social determinants of tuberculosis are implemented.13 The End TB Strategy gives increased attention to tackling of tuberculosis among vulnerable groups such as people with HIV, migrants, refugees, prisoners, and slum-dwellers. This process will need close collaboration across sectors, ministries, and programmes. Scale-up of involvement of communities and engagement of all care providers approached by the people are integral to the second pillar. This step is essential to ensure that high-quality tuberculosis care of international standards is accessible and affordable to all who need it. The second pillar of the strategy also necessitates building of national capacity for and enforcement of regulatory frameworks to ensure mandatory case notification, rational use of tuberculosis medicines, pharmacovigilance, infection control, and vital registration—all systemic interventions that have yet to receive the attention they deserve. Achievement of the milestones and targets set for the second decade, leading to an end of the tuberculosis epidemic, will depend largely on effective implementation of the third pillar that calls for “intensified research and innovation”—from fundamental research for development of new approaches to epidemiological, health systems, social, and operational research to enhance performance, introduce innovations, and address stigma and discrimination. This process needs urgent intellectual and financial boosts so that new methods and approaches are developed, and made rapidly and widely accessible during the next two decades.14 Operational research is the key to design, implementation, refinement, and scale-up of many new elements of the End TB Strategy. Clearly, translation of the strategy on the ground will need unprecedented commitment to break the boundaries of the current programme-focused response and make it a systemic one. Some interventions such as formulation of a tuberculosis-sensitive policy for universal health coverage and strengthening of regulatory frameworks will demand interventions from beyond national tuberculosis programmes. Additionally, actions needed to address social determinants, provide social protection, and alleviate poverty will also need interministerial coordination and close collaboration with communities and civil society. Henceforth, tuberculosis control cannot be the responsibility of national programmes or ministries of health alone. Political

www.thelancet.com Published online March 24, 2015 http://dx.doi.org/10.1016/S0140-6736(15)60570-0

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capital will need to be invested to mobilise all relevant ministries and departments, such as health, finance, education, food, housing, social welfare, justice, labour, trade transport, and migration, and enable them to play their part and be collectively accountable for results. To effectively coordinate a multisectoral response, the leadership of tuberculosis programmes in countries will also have to be elevated. A high-level national mechanism involving actors within and beyond government might help to drive coordination and stimulate unrelenting political advocacy. WHO has produced several evidence-based guidelines and will produce more to help national implementation of new interventions proposed under the End TB Strategy. A consolidated document pointing to available guidance and sharing early experiences of implementation is also under preparation. Encouragingly, the WHA endorsement has already begun prompting action on the ground. Supported by WHO and partners, some governments have begun issuing vision statements and incorporating components of the new strategy into their national tuberculosis strategic plans that might, in turn, be used to leverage international resources. Recently, representatives of more than 30 countries with the lowest tuberculosis incidence developed a framework to adapt the new strategy for their settings.15 Demonstration of progress and garnering of support for further progress are crucial. Importantly, similar action will now be needed in high-incidence settings. Weak systems and inadequate resources will pose increased challenges and present bottlenecks to action and implementation. WHO will work closely with partners to prepare a global action and investment plan. Momentum linked with the overall post-2015 Sustainable Development Goals will also need to be seized. To measure progress of the new strategy, routine surveillance and monitoring will be upgraded with standardised methods ensuring data quality and adopting modern technology. A provisional top-ten list of priority indicators for monitoring the implementation of the End TB Strategy, and recommended target levels that apply to all countries, is provided in the appendix p 2. Measurement of effect by assessment of trends in mortality and incidence will need additional investments. The extent of tuberculosis burden in a society is a good indicator of gaps in health and social development. Therefore, ending of the tuberculosis epidemic is an important health and development goal, achievable in the foreseeable future and measurable too. Contributors MR conceived this article. HN suggested the structure and oversaw preparation. MU and DW prepared the first draft and coordinated inputs

in revising subsequent drafts. Besides contributing to draft revisions, KL, EJ, and CL prepared the content related to the three pillars. The content related to the targets and measurement was provided by KF and PG. HMD (overall presentation), DF (information and communication technology), GG (ground implementation), HG (service integration), CG (tuberculosis diagnostics), MG (country adaptation) and FM (drug-resistant tuberculosis) contributed to revising multiple drafts of the Viewpoint besides contributing the content related to their areas of expertise indicated in parentheses. Declaration of interests We declare no competing interests. Acknowledgments We acknowledge the contribution of WHO regional tuberculosis advisers: M Abdel Aziz, M Dara, M Del Granado, K Hyder, D Kibuga, and N Nishikiori, as well as all partners involved in the numerous consultations held during the development of the strategy. ©2015. World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved. References 1 WHO. Documentation for World Health Assembly 67. http://apps. who.int/gb/ebwha/pdf_files/WHA67/A67_11-en.pdf (accessed Nov 14, 2014). 2 Raviglione MC, Ditiu L. Setting new targets in the fight against tuberculosis. Nat Med 2013; 19: 263. 3 WHO. Global tuberculosis control: WHO report 2014 (WHO/HTM/ TB/2014.08). Geneva: World Health Organization, 2014. 4 WHO. Documentation for World Health Assembly 67. http://apps. who.int/gb/ebwha/pdf_files/WHA67/A67_R1-en.pdf (accessed Nov 12, 2014). 5 Lönnroth K, Castro KG, Chakaya JM, et al. Tuberculosis control and elimination 2010–50: cure, care, and social development. Lancet 2010; 375: 1814–29. 6 Nathanson E, Nunn P, Uplekar M, et al. MDR tuberculosis—critical steps for prevention and control. N Engl J Med 2010; 363: 1050–58. 7 Floyd K, Fitzpatrick C, Pantoja A, Raviglione M. Domestic and donor financing for tuberculosis care and control in low-income and middleincome countries: an analysis of trends, 2002–11, and requirements to meet 2015 targets. Lancet Glob Health 2013; 1: e105–15. 8 UN. Open Working Group proposal for Sustainable Development Goals. http://sustainabledevelopment.un.org/sdgsproposal.html (accessed Nov 12, 2014). 9 Raviglione M, Uplekar M, Vincent C, Pablos-Méndez A. Rebalancing the global battle against tuberculosis. Lancet Glob Health 2014; 2: e71–72. 10 WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children—policy update 2013. WHO/HTM/TB/2013.16. Geneva. 11 WHO. Systematic screening for active tuberculosis: principles and recommendations. WHO/HTM/TB/2013.04. Geneva: World Health Organization, 2013. 12 WHO. Guidelines on the management of latent tuberculosis infection. WHO/HTM/TB/2015.01. Geneva: World Health Organization, 2014. 13 Lönnroth K, Glaziou P, Weil D, Floyd K, Uplekar M, Raviglione M. Beyond UHC: monitoring health and social protection coverage in the context of tuberculosis care and prevention. PLoS Med 2014; 11: e1001693. 14 WHO. An international roadmap for tuberculosis research: towards a world free of tuberculosis. Geneva: World Health Organization, 2011. 15 Lönnroth K, Migliori GB, Raviglione M. Toward tuberculosis elimination in low-incidence countries: reflections from a global consultation. Ann Intern Med 2014; 161: 670–71.

www.thelancet.com Published online March 24, 2015 http://dx.doi.org/10.1016/S0140-6736(15)60570-0

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WHO's new end TB strategy.

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