UNITAID UNITAID s approach to funding innovations in TB diagnosis and treatment Robert Matiru & Janet Ginnard, UNITAID Geneva, 29 April 2015
Page 2 UNITAID's role in the global response By connecting the upstream to the downstream and enabling others to do more with less
Page 3 UNITAID strategy & market impact approach
Strategic framework: UNITAID's contribution to the global response maps to global goals and challenges Disease Global Goals Challenges Opportunities UTD projects & results HIV TB What are targets the world agrees on? What are the needs, gaps, limitations? Where can UNITAID play a catalytic, enabling role? How does each project fit? Malaria Landscapes + engagement & alignment with partners Solicitation of ideas, development of grants, alignment with partners What are the objectives, impact and value for money? 4
Strategic framework: UNITAID work in TB diagnostics Global Goals Challenges Opportunities UTD projects & results 90% reduction in new cases 95% reduction in deaths Underdiagnosis; need for inexpensive POC tests Poor access to drug susceptibility testing; evolving testing needs Foster competitive market to improve diagnostic speed and access Improve access to appropriate drug susceptibility testing EXPAND TB WHO Global TB programme / FIND / Stop TB Partnership / GDF Expanded access to quality TB diagnostics: 3 new technologies scaled up >106,000 MDR-TB cases detected No catastrophic costs due to TB Diagnostics not adapted for specific patient groups (e.g., children) Encourage better diagnostics for underserved patient groups TBXpert WHO Global TB programme / Stop TB Partnership / Cepheid Reduced price Scaled up Xpert MTB/RIF: >1.4 m cartridges in 21 countries 5
Strategic framework: UNITAID work in TB medicines Global Goals Challenges Opportunities UTD projects & results 90% reduction in new cases 95% reduction in deaths No catastrophic costs due to TB Medicines not adapted for children Long, complex, toxic, expensive MDR-TB regimens Limited experience with new MDR-TB drugs Small, fragmented markets, especially for MDR TB: Many untreated cases Poor visibility on demand Many treatment options, many variations of each Develop better paediatric medicines (new formulations) Inform use of new medicines & regimens: Speed access Improve outcomes Focus market on better, shorter, less toxic regimens Stabilize / sustain TB medicines markets with targeted interventions Paediatric TB drugs GDF Improved uptake in 58 countries STEP TB TB Alliance/WHO New paediatric FDCs endtb PIH, MSF, IRD Accelerate access Develop shorter, less toxic, novel regimens MDR-TB Strategic Rotating Stockpile GDF Stabilize supply: reduce stock-outs and lead times 6
An integrated approach to diagnosis and treatment Market scoping & consultations Market intelligence Landscape reports Dashboard Expert consultation with stakeholders 7 Page 7 Source: UNITAID Market Dynamics Dashboard, April 2015
Informed by an understanding of the technology landscape TB diagnostics pipeline (Dec 2014) Source: UNITAID 2014 Tuberculosis Diagnostics Technology and Market Landscape 8
And review of market challenges & opportunities Donor-funded medicines purchases by product formulation, 2012 ($m) HIV/AIDS (total $858M) Malaria (total $189M) TB (total $66M) 9 Page 9 Source: Analysis of market & partner data; see: UNITAID 2014 Tuberculosis Medicines Technology and Market Landscape
Page 10 Looking ahead: what s next in TB diagnostics & medicines? TB diagnostics TB diagnostics Define market opportunity and accelerate market entry for innovative TB diagnostics that address unmet needs Alignment with identified priorities More diversified market Testing closer to point of care Diagnostics to support access to new medicines/regimens May include support for demonstration of performance and/or scale-up TB medicines TB medicines Support responsible introduction of new medicines Accelerate access to new drugs: shift the uptake curve for early and sustained access Special consideration for new TB medicines: need for further evidence + support for introduction in countries (e.g., pharmacovigilance) Develop shorter, more effective regimens
Page 11 Fostering continued innovation in TB diagnostics: Xpert and beyond Current molecular diagnostics Complement Xpert & encourage a more competitive market: Diagnose more patients, faster Future Product selection illustrative only Address gaps: Diagnose closer to point of care Anticipate new diagnostic needs (DST): companion diagnostics to enable broad access for new drug regimens Other supportive measures in parallel (non-product-specific): Connectivity: promote actionable, rapid results & reporting Linkage to care: full DST after rapid testing, if needed; initiation on appropriate treatment External quality assurance
Page 12 Innovation in MDR-TB medicines: endtb PIH, MSF & IRD project supporting access to new TB drugs Goal: Increase uptake of new TB drugs in regimens that are better, shorter, and less toxic Activity # Patients Outcome Impact Cohort 2600 treated Experience with new MDR-TB drugs (safety and efficacy) Evidence to inform WHO guidance Increase access to new medicines (short-term) Trial 600 enrolled Priority MDR-TB regimens that are shorter (< 1 year) and less toxic (no injectable) Evidence to inform WHO guidance Simplify regimens (long-term) Simpler regimens will enable further access gains: Fewer medicines needed for an effective regimen Harmonize and optimize treatment (donors, countries, private sector) Consolidation in quality assurance Focused market allowing more efficient production, supply chain, etc.
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