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Major Gaps in the Global Mechanisms for Addressing MDR TB

Major Gaps in the Global Mechanisms for Addressing MDR TB . KJ SEUNG, MD HARVARD MEDICAL SCHOOL ■ BRIGHAM AND WOMEN’S HOSPITAL ■ PARTNERS IN HEALTH The Union—North American Region February 25, 2012. Photo: Open Society Institute/Pep Bonet. Overview.

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Major Gaps in the Global Mechanisms for Addressing MDR TB

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  1. Major Gaps in the Global Mechanisms for Addressing MDR TB KJ SEUNG, MD HARVARD MEDICAL SCHOOL ■ BRIGHAM AND WOMEN’S HOSPITAL ■ PARTNERS IN HEALTH The Union—North American Region February 25, 2012 Photo: Open Society Institute/Pep Bonet

  2. Overview • Historical background of global efforts to combat MDR TB • Challenges to scaling-up of MDR TB diagnosis and treatment • Lack of diagnostic capacity • Cost of MDR TB drugs • Can we make it easier?

  3. HISTORICAL BACKGROUND

  4. The Global Burden of TB Estimated number of cases Estimated number of deaths 8.8 million (range: 8.5–9.2 million) 1.45 million (range: 1.2–1.6 million) All forms of TB 1.1 million (13%)(range: 1.0–1.2 million) 350,000 (range: 320,000–390,000) HIV-associated TB 650,000 (460,000 – 870,000) Multidrug-resistant TB (Prevalent) about 150,000 Source: WHO Global Tuberculosis Control, 2011

  5. The MDR TB death sentence as public health policy “MDR-TB is too expensive to treat in poor countries; it detracts attention and resources from treating drug-susceptible disease.” - World Health Organization Groups at Risk, 1996 Photo: Open Society Institute/Pep Bonet

  6. Multi-institutional partnership created by WHO, PIH, MSF, CDC, IUATLD, KNCVin 2000. • Ensure access to affordable quality-assured second-line drugs • Ensure that projects were able to use the drugs appropriately • Use data from “DOTS-Plus” pilot projects to shape policy

  7. Reduced prices of second-line TB drugs (2000) Result of negotiations based on plans for pooled procurement Drug Formulation 1997 price 2000 price % Decline Amikacin 1gm vial $9.00 $0.90 90 Cycloserine 250mg tab $3.99 $0.50 87 Ethionamide 250mg tab $0.90$0.14 84 Kanamycin 1gm vial $2.50 $0.39 84 Capreomycin 1gm vial $29.90 $0.90 97 Ofloxacin 200mg tab $2.00 $0.05 98

  8. The Global Fund to Fight AIDS, Tuberculosis and MalariaThird Board MeetingGeneva, 10-11 October 2002 To help contain resistance to second-line tuberculosis drugs and consistent with the policies of other international funding sources, all procurement of medications to treat Multi Drug Resistant TB (MDR-TB) must be conducted through the Green Light Committee (GLC).[1] [1]http://www.who.int/gtb/policyrd/DOTSplus.htm

  9. Source: WHO, Global Tuberculosis Control, 2011

  10. 10 YEAR TOTAL: PATIENTS REQUIRING MDR-TB TREATMENT (2000–2009) 3.5 million patients Treatment unknown Drug quality unknown ~5 million new cases Treated in GLC-approved programmes with quality-assured drugs <0.5% 1.5 million patients – DIED Source: based on WHO estimates 2008, 2009, 2010

  11. Gap between the Global Plantargets and GLC projections Source: Adapted from a slide of Dr. Ernesto Jaramillo, WHO, Geneva

  12. GLC Mechanism Number of people receiving antiretroviral treatment in 15 PEPFAR focus countries compared to the GLC mechanism 367,000 TB/HIV Patients Treated Countries included: Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam (added in 2004), Zambia Source: PEPFAR 2008; WHO 2008

  13. Global trends in TB and MDR TB Source: WHO, Global Tuberculosis Control, 2011

  14. 19 settings with ≥6% MDR among new cases, 1994-2007 Indicates survey data reported in an earlier phase of the project Source: Dr. MatteoZignol, Stop TB Department, WHO

  15. Challenges Inadequate Laboratory capacity

  16. Building TB laboratory capacity

  17. LAB CAPACITY BUILDING: EXPAND-TB 2009: 6 countries 2010: 18 countries including India (43 labs) 2011: 3 countries EXPAND-TB is a joint projected between FIND, the Stop TB Partnership and the World Health Organization under a Grant from UNITAID Source: Dr. FuadMirzayev, WHO, Geneva

  18. Source: WHO, Global Tuberculosis Control, 2010

  19. Xpert MTB/RIF • Detects M. Tuberculosis as well as rifampicin resistance-conferring mutations using three specific primers and five unique molecular probes • Provides results directly from sputum in less than 2 hours

  20. Source: WHO, Global Tuberculosis Control, 2011

  21. Challenges The Cost of MDR TB drugs Photo: Open Society Institute/Pep Bonet

  22. Drugs are a significant proportion of the total cost of care Source: World Health Organization, 2005

  23. Source: Multidrug and extensively drug-resistant TB (M/XDR TB): 2010 global report on surveillance and response

  24. Source: MSF/IUATLD. DR TB drugs under the microscope (2011)

  25. Pricing trends with introduction of generics Off-patentdecades old MDR-TB drugs

  26. Decreasing the cost of MDR TB drugs Supply Demand Increase demand through scale-up of diagnosis and treatment Consolidate demand Forecast accurately • Facilitate entry into the market • Simplify regulatory approval • Reduce lead time variability Photo: Open Society Institute/Pep Bonet

  27. Can WE MAKE IT EASIER? Photo: Open Society Institute/Pep Bonet

  28. 1st global GLC meeting, 6th October, 2011New global framework to support scale-up of MDR-TB management Paul Nunn, Stop TB Department, WHO Geneva

  29. Rationale for the revision of current mechanism to support MDR-TB scale-up • Slow scale up of MDR-TB management • Limited political commitment and capacity of countries • The current mandate of the GLC acting as bottleneck • Member states have committed to achieve universal access to diagnosis and treatment of MDR-TB by 2015 (WHA Resolution 62.15) • GLC not completely in conformity to WHO rules and practice Stakeholder consensus to revise the Global Framework to support expansion of MDR-TB services which "should explicitly shift from a controlling to a supporting mode"

  30. Streamlined process for GF • Previously • Separate application process to GLC after grant agreement is signed. • Created differences between GF and GLC. • On average added some 3 months, often more • Agreed in principle with Global Fund - Separate application to GLC no longer needed • Early TA to countries to develop/update national MDR-TB scale-up plans, • National MDR-TB expansion plans as part of grant negotiation process, with "sign off" at that stage by global or regional GLC • At least an outline of MDR-TB expansion plan to be included in GF application

  31. Can we make it easier? • Decrease emphasis on laboratory and hospital wards • Increase emphasis on treatment as the most important strategy for infection control • Increase emphasis on community-based care and social support for patients

  32. Hospital-based care vs. community-based care Source: World Health Organization, 2005

  33. Community-based care for DR TB Photo: Open Society Institute/Pep Bonet

  34. http://www.pih.org/news/entry/treating-pulane/ Major Gaps in the Global Mechanisms for Addressing MDR TB Can we make it Easier?

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