UNITAID UNITAID’s approach to funding innovations in TB diagnosis and treatment Robert Matiru & Janet Ginnard, UNITAID Geneva, 29 April 2015
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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
4
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
Malaria
What are targets
the world agrees
on?
What are the
needs, gaps,
limitations?
Landscapes +
engagement &
alignment with
partners
Where can UNITAID
play a catalytic,
enabling role?
Solicitation of ideas,
development of
grants, alignment
with partners
How does each
project fit?
What are the
objectives, impact
and value for
money?
5
Strategic framework: UNITAID work in TB diagnostics
Global Goals Challenges Opportunities UTD projects & results
90% reduction in new
cases
95% reduction in
deaths
No catastrophic costs
due to TB
Underdiagnosis; need
for inexpensive POC
tests
Poor access to drug
susceptibility testing;
evolving testing needs
Diagnostics not
adapted for specific
patient groups (e.g.,
children)
Foster competitive
market to improve
diagnostic speed and
access
Improve access to
appropriate drug
susceptibility testing
Encourage better
diagnostics for
underserved patient
groups
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
TBXpert
WHO Global TB
programme / Stop TB
Partnership / Cepheid
→ Reduced price
→ Scaled up Xpert
MTB/RIF: >1.4 m
cartridges in 21
countries
6
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
7
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Market scoping & consultations • Market intelligence • Landscape reports • Dashboard • Expert consultation with stakeholders
An integrated approach to diagnosis and treatment
Source: UNITAID Market Dynamics Dashboard, April 2015
8
Informed by an understanding of the technology landscape
Source: UNITAID 2014 Tuberculosis Diagnostics Technology and Market Landscape
TB diagnostics pipeline (Dec 2014)
9
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And review of market challenges & opportunities
HIV/AIDS (total $858M)
Malaria (total $189M)
TB (total $66M)
Source: Analysis of market & partner data; see: UNITAID 2014 Tuberculosis Medicines Technology and Market Landscape
Donor-funded medicines purchases by product formulation, 2012 ($m)
Page 10
Looking ahead: what’s next in TB diagnostics & medicines?
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
• 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
TB diagnostics TB medicines
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Fostering continued innovation in TB diagnostics: Xpert
and beyond
Complement Xpert & encourage a more competitive market: Diagnose more patients, faster
Current molecular diagnostics Future
Address gaps: Diagnose closer to point of care
Anticipate new diagnostic needs (DST): companion diagnostics to enable broad access for new drug regimens
Product selection illustrative only
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
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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)
Goal: Increase uptake of new TB drugs in regimens that are better, shorter, and less toxic
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.
Innovation in MDR-TB medicines: endTB –
PIH, MSF & IRD project supporting access to new TB drugs
Thank you !
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