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Access to anti-TB medicines

Access to anti-TB medicines. WHO/EDM Technical briefing seminar for international staff active in pharmaceutical support programmes Salle G, WHO HQ 30 Sept - 4 Oct 2002.

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Access to anti-TB medicines

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  1. Access to anti-TB medicines WHO/EDM Technical briefing seminar for international staff active in pharmaceutical support programmes Salle G, WHO HQ 30 Sept - 4 Oct 2002 Dr S. Phanouvong Focal point for access to TB drugsEDM and STBAcknowledgements to Drs I. Smith and L. Blanc STB for the materials used in this presentation

  2. Presentation outline • The Global targets in TB control • The constraints in DOTS expansion • The Global TB Drug Facility (GDF) • Operations • to date achievements • The Green Light Committee

  3. DOTS case detection and cure • In 2002 • Smear+ cases ave. cure rate of 80% in all DOTS programmes (70% in African region) • 148 countries adopted DOTS strategy (incl. 22 high- burden ones which bear 80% of est. incidents cases) • 55% of global pop had access to DOTS • 27% of infectious cases were detected and treated under DOTS • TB remains as global health problems •  2 billion of the world pop. is infected with TB bacillus • 75% of cases in economically productive age group • About 8.7 million develop active TB every year • About 2 million deaths annually

  4. Constraints in DOTS expansion • Some political/programmatic constraints • Lack of or weak political will and commitment • Lack of institutional/infra. to provide services • inadequate supply of good quality TB drugs • shortages of 1 or 2 drugs • Emergence of MDR-TB • >3% of new cases 1996-1999 • HIV-AIDS epidemic

  5. Constraints in DOTS expansion (c.) • Operational and managerial • TB treatment is seen as complicated&takes time • many tablets/capsules to be taken • too many drug formulations (different dosage strengths- esp. the FDCs) • requires DOT for potential success in treatment.DOT is not strictly applied in drug taking • Lack of effective co-ordination in a decentralised system • for drug procurement, distribution and use

  6. No. formulations Combination (mg) R H Z E T 1 [HE] 150 400 3 [RH] 60 30 150 75 300 150 2 [RH] int. 3x w 60 60 150 150 2 [RHZ] daily 60 30 150 150 75 400 1 [RHZ] int.3x w 150 150 500 1 [RHZE] 150 75 400 275 Compl. 2 [TH] 50 100 150 300 Essential anti-TB FDCs in WHO Model List R- rifampicin, H- isoniazid, E- ethambutol, Z- pyrazinamide, T- thioacetazone

  7. Global TB Drug Facility “Securing access to high-quality TB drugs”

  8. What is the GDF? • A global initiative to secure access to high quality drugs to accelerate DOTS expansion, addressing four needs: • The need for more resources for TB drugs • The need for high quality TB drugs • The need for efficient procurement systems • The need for standardised products

  9. What does the GDF offer? • Now • Grants of first line drugs, to support DOTS expansion • A direct procurement mechanism for countries and NGOs, for use in DOTS programmes • A web-based tool for placing orders and tracking shipments • Future • A list of ‘prequalified’ manufacturers of quality TB medicines • Diagnostics and second line medicines

  10. Application Eligibility criteria Specific conditions Standard form Supporting documents Monitoring Quarterly reports Existing monitoring Independent verification Results based Review Independent Committee 12-15 members meets 3x/year Country visit Supply Pooled procurement Standard products High quality Low cost GDF Operations

  11. Applications & Review • Eligibility for grants of first line drugs • Annual per capita GNP under $3,000 (low and lower middle income countries) • Priority for countries with a per capita GNP under $1,000 • Documents needed to support application • National plan & budget for DOTS expansion to meet global targets • Technical guidelines demonstrating commitment to principles of DOTS • Annual report on DOTS performance (WHO TB database collection form) • Recent external review • Review • Technical review committee of independent experts • Continuous application and review process, with TRC meetings at least 3 times a year • Emergency applications can be reviewed urgently • Support provided in principle for three years (renewable)

  12. Who are the donors of GDF? • An initiative of the Global Partnership to Stop TB aiming to provide free drugs for 10 million people with TB by 2005 • Needs $250 million over the next 5 years • Initial funding from Canada, Netherlands & US

  13. To date achievements • Processed applications from 43 countries; 33 countries approved for support, and 1 pending • Drugs ordered for 21 countries and delivered to 11 countries • Drugs committed for almost 1,600,000 patients • New funds received from donors (CIDA, US & Dutch) ~ $11m • Drug prices down ~30% • Average drug cost per patient: ~$11.2 • Catalyst for introduction and expansion of DOTS • Catalyst for standardisation - FDCs

  14. Country makes application GDF monitoring Review by TRC Review by TRC Review by TRC Review by TRC Country visit Monitoring mission Monitoring mission Monitoring mission Grant agreement Desk audit Desk audit Desk audit Assessment Year 1 Year 2 Year 3 First delivery Second delivery Third delivery

  15. Countries approved for regular GDF support Countries approved for emergency GDF support Countries under consideration for GDF support Countries

  16. Cost of MDR-TB treatment regimens Source: Rajesh Gupta et al. Responding to market failures in tuberculosis control. Policy Forum: Public Health. Science’s Compass, Science, vol. 293 10 Aug 2001. www.sciencemag.org

  17. The Green Light Committee Established in WHO: March 2000 Major obstacle to implementing DOTS-Plus pilot projects is the high costs of SL anti-TB drugs Members: Centers for Disease Control and Prevention, Harvard Medical School, Médecins Sans Frontières, National TB Programme - Peru, The Royal Netherlands Tuberculosis Association, and World Health Organization

  18. Examples of GLC drug prices • Capreomycin: monopoly,non-patent - Eli Lilly&Com. • Open market unit price: $22.00 - $31.00 • GLC unit price: $1.00 - $1.75 • Cycloserine:monopoly, non-patent - Eli Lilly&Com. • Open market unit price: $2.99 - $3.99 • GLC unit price: $0.13 - $0.75 • Ofloxacin:monopoly, patent - Aventis • Open market unit price: $1.27 • GLC unit price: $0.40 - $0.45 Reasons for price decrease: concessional price with Lilly, increased competition, expired patent, and pooled procurement

  19. Contact the GDF mailto:gdf@who.int http://www.stoptb.org/GDF/default.asp Contact the MDR-TB/GLC Mailto:dotplus@who.ch http://www.who.int/gtb/policyrd/DOTSplus.htm

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