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Addressing Tuberculosis Innovation and Access Challenges

Explore ways to enhance TB treatment through innovation and access improvements, focusing on the urgent need for new drugs and diagnostic tools. Learn about the current status and key recommendations.

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Addressing Tuberculosis Innovation and Access Challenges

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  1. How to address the need for innovation and access for tuberculosis Tido von Schoen-Angerer, MD, MSc

  2. TB and Médecins Sans Frontières • 32,068 TB patients in 80 countries (138 projects) in 2008 • 900 MDR patients in 18 projects in 2008 • 3360 children < 15 years

  3. TB DIAGNOSIS AND TREATMENT AN OLD REGIME AND A PREDICTABLE CRISIS • Streptomycine 1944 • PAS 1946 • Isoniazide 1952 • Cycloserine 1952 • Pyrazinamide 1952 • Ethionamide 1956 • Kanamycine 1957 • Ethambutol 1961 • Quinolones 1963 • Rifampicine 1966

  4. Multi and extensively drug resistant TB • 440,000 new cases a year, 150,000 deaths • Highest proportion of MDR TB: North Western Russia 24-28% of all new TB cases • China and India account for 50% of all cases • Treatment possible but 18-24 months long, complex, severe side effects, drug cost 50-200 times higher than for drug sensitive TB • Cost: €11 billion over next six years, funding needs to increase 16 times Source: WHO M/XDR-TB 2010 Global Report

  5. 1,6000,000 30,000 MDR-TB Treatment scale up- only 1% receive treatment in GLC programmesGap between requests to WHO Green Light Committee and revised Global Plan, 2006-2015 1,800 1,582 Response Plan Thousands 1,600 1,389 1,400 GLC 1,187 1,200 979 1,000 766 800 548 600 400 328 176 200 66 30 25 10 12 3 7 1 2 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Adapted from D.Weil, WHO

  6. New TB drugs – how close are we? • Pipeline still weak: number of compounds in the pipeline needs to double or triple • A completely new regimen will take time: Likelihood to introduce a novel TB regimen with at least 2 new drugs by 2015 is < 1% (Glickman et al., Science 2006) • Improvement of MDR treatment therefore most be immediate objective • 2 new drugs in phase IIb trials in MDR-TB (Tibotec/J&J, Otsuka) • Need accelerated approval mechanism, then additional trials to determine best new MDR-TB regimen

  7. TB Diagnostics Smear microscopy the frontline TB test detects 40-60% of cases, even less in HIV infected and children. Requires at least 2 expectorated sputum

  8. TB Liquid Culture now being implemented BD BACTEC MGIT 960 Mycobacterial Detection System

  9. From Expert Meeting on Defining Test Specifications for a TB point-of-care test, Paris, March 17 –18, 2009 Diagnostics: the TB test we need ! (and feasible in 5 – 10 years) • Point-of-care: easy to perform in peripheral health centres • Detect active TB in adults regardless of HIV status • Improved diagnosis of TB in children • Result that allow decision on treatment initiation • Patient can receive result on the same day • DST (preferable but not minimum requirement)

  10. Tropical diseases: 15 Tuberculosis: 4 Innovation – fatal imbalance • 1,556 new chemical entities were marketed globally between 1975 and 2004. • Only 20 of these (1.3%) were for tropical diseases and tuberculosis, which account for 12 per cent of the total disease burden Torreele, Chirac Lancet, 2005

  11. R&D funding gap - TB Treatment Action Group 2008

  12. TB R&D funding contributions – according to fair share • EC (2007): € 35.8 M for all neglected diseases; €18.7 M for TB – fair share would be € 101 M/yr MSF 2008, 2009

  13. Innovation prizes – rewards that can stimulate innovation and ensure access • Large financial reward at the end – paying for success • Principle of crowdsourcing • Successfully used in many technology fields • In return for prize reward: sell at low price and allow competition from day one • Needed: a prize fund for a TB point-of-care test

  14. Not just money but right policies:WHO Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property • Among others: • WHO to explore innovative ways for stimulating R&D, such as Prize fund, and that do not cause high prices • Explore utility of an essential health and biomedical R&D treaty as a mechanism for sustainable financing of essential R&D • Report of WHO Expert Working Group on R&D Financing for World Health Assembly 2010

  15. Recommendations to the EC • Put TB high on the political agenda! • Boost contribution to TB and other neglected disease R&D • € 100 million for TB per year • Mid-term review of FP7 • Include TB and neglected diseases within IMI, ERC • Invest in alternative mechanism for R&D • Invest in a prize fund for a point-of-care TB test • Implement WHO Global Strategy and Plan of Action

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