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Priorities for Drug Optimization. 1. Funding needs for HIV is expected to grow significantly. Funding needs for HIV is expected to grow significantly. Lofty treatment goals and new prevention approaches make this an exciting time for HIV treatment…. - PowerPoint PPT Presentation
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Priorities for Drug Optimization
Funding needs for HIV is expected to grow significantly
Source: AIDS 2031
Treatment: 3 by ‘05 to 15 by ’15Treatment 2.0Better drugs and regimensBetter diagnostics
Turning the tide - Prevention:Microbicide gelOral PrEP
Funding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsLofty treatment goals and new prevention approaches make this an exciting time for HIV treatment…
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Funding needs for HIV is expected to grow significantly
Projected needs (USD billions)
Source: AIDS 2031
Funding to date for HIV (USD billions)
…but given limited scope for growth, a funding gap is looming
Resources for HIV have grown considerably over the past 10 years…
Funding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocols…But a looming funding gap threatens continued scale up of ART
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Many countries already adopting emerging products in treatment protocolsThe Use of Newer, Better Therapeutics is Adding Additional Pressure to
Systems
# Patients on TDFin Generic Accessible Countries
Note: Generic inaccessible markets include Argentina, Brazil, China, and MexicoSource: GLOPRO forecasting model, CHAI country teams
.7M
1.6M
2.4M
3.4M
4.3M5M
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Optimizing ARV Regimens is an Important Approach to Improving Care While Reducing Costs
Short term: Value for Money1-3 years to market
• Objective: Chose the best products we have and make them less expensive
Long term: Game-changers5-10 years to market
• Objective: Develop new products that could change the landscape of HIV treatment
Medium term: Dose Optimization3-5 years to market
• Objective: Reduce the dose of drugs we have
$ $
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Short term: Value for money
Short term: Value for Money1-3 years to market
• Objective: Chose the best products we have and make them less expensive
Approaches
• Use solid evidence to select best regimens
• Consolidate volumes
• More efficient manufacturing technology (Chemistry and sourcing)
• TDF, EFV, ATV, LPV, DRV, Pediatric formulations$ $
LOWER PRICES OF TENOFOVIR RESULTED FROM SEVERAL STRATEGES
Does it work? TDF example
2006 Price 2010 Price
$207
$87
Price Reduction for TDF From 2006 to 2010 (per patient per year)
- $60 New suppliers
- $34- $26
Cheaper inputsNew process
58% price reduction for TDF from (from $207 in 2006 to $87 in 2010)
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Medium term: Dose reduction
Short term: Value for Money1-3 years to market
• Objective: Chose the best products we have and make them less expensive
Approaches
• Dose optimization – Phase III studies to demonstrate equivalent efficacy and equal or better tolerability
• Reformulation – use novel formulation technology to increase amount of drug reaching its target
EFV, TDF, AZT, ATV/r, DRV/r
$ $
Medium term: Dose Optimization3-5 years to market
• Objective: Reduce the dose of drugs we have
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Long term: Novel transformative drugs and formulations
Short term: Value for Money1-3 years to market
• Objective: Chose the best products we have and make them less expensive
Approaches
• Catalyze the development of new drugs that represent a transformation in treatment
• Question everything
RIL, DLG, CMX-157, GS-7340, GSK-744
$ $
Medium term: Dose Optimization3-5 years to market
• Objective: Reduce the dose of drugs we have
Long term: Game-changers5-10 years to market
• Objective: Develop new products that could change the landscape of HIV treatment
How do we set our priorities for optimization?
WHO treatment guidelines,
Consensus meetings convened by WHO and UNAIDS
Expert consultations such as the Conference on Antiretroviral Drug Optimization
Ongoing process as new data and drugs become available
Set a short-list of top priorities
The result: A set of short-term priorities and a process for setting medium and long term goals
Treatment 2.0 Blueprint & ARV Short Term Priorities on ARV Optimization
Priorities:
1st line: Optimize TDF/3TC/EFV FDC tablet
2nd line: Develop and optimize ATV/r FDC
Pediatrics: LPV/r sprinkle, RTV 25mg, AZT/3TC and ABC/3TC dispersible, scored adult TDF FDC