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This report was presented to the 12th session of the Executive Board, on 9 June 2010. It contains the most recent data on the performance of Operations Unit, including an overview of the HIV/AIDS, malaria and tuberculosis portfolio.
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OPERATIONS
&
MARKET DYNAMICS
UPDATES
12th Executive BoardGeneva, 8-9 June 2010
A. Portfolio Overview
− Legal Agreements
− Trends 2007-2009
B. Updates on Project Progress
– EB Approval Status
– Key Performance Indicators
– Market Levers
– Eligibility Criteria
– Regional grouping
– Top 5 countries
C. Update on Other Activities
– Validation Tools
– Viral Load
– Evaluation of Projects
D. Challenges and Outlook
– Transition of Projects
– Outlook
SUMMARY
A. Portfolio Overview
OVERVIEW: Current Legal Agreements
HIV/AIDS
TB
Malaria
Transversal
NicheMoU amounts (US$)
% of total
HIV/AIDS 560,114,896 48
TB 174,811,131 15
Malaria 315,274,252 27
Transversal 106,971,914 9
Total 1,157,172,193 100
Paediatric
PMTCT
2nd Line
Supply ChainSupport (ESTHER)*
ALLOCATION OF FUNDS: HIV/AIDS
HIV/AIDSMoU amounts (US$)
% of total
Paediatric 235,499,008 42
PMTCT 72,029,262 13
2nd Line 252,135,000 45Supply Chain Support (ESTHER)* 451,626 0.08Total 560,114,896 100*Phase 1
Paediatric
1st Line
MDR TB treatments
MDR TB Diagnostics
ALLOCATION OF FUNDS: TB
TBMoU amounts (US$)
% of total
Paediatric 11,288,409 61st Line 26,840,725 15MDR TB treatments 49,120,000 28MDR TB Diagnostics 87,561,997 50Total 174,811,131 100
Treatment(including AMFm)
Prevention (LLINs)
Supply (A2S2)
ALLOCATION OF FUNDS: MALARIA
MalariaMoU amounts (US$)
% of total
Treatment (including AMFm) 196,747,712 62Prevention (LLINs) 109,246,140 35Supply (A2S2) 9,280,400 3Total 315,274,252 100
ALLOCATION OF FUNDS: TRANSVERSAL
PQ Diagnostics
PQ Medicines
Round 6*
TransversalMoU amounts (US$)
% of total
PQ Diagnostics 7,500,000 7PQ Medicines 47,000,000 44Round 6* 52,471,914 49Total 106,971,914 100*MoU amount, actual amount is less because Mozambique withdrew from the paediatric HIV programme.
TRENDS: 2007-2009
TRENDS BY NICHE
*Excludes PMTCT diagnostics and OI medicines.
Estimated patients treated or number of products provided, 2007-2009
HIV*
2009200820070
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
TB
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
2007 2008 2009
Malaria
0
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
30,000,000
35,000,000
2007 2008 2009
TRENDS BY NICHE
*As reported to UNITAID through Partner annual reports
Monies spent (US$) by partners on medicines and diagnostics, 2007-2009*
HIV
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
2007 2008 2009
TB
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
18,000,000
2007 2008 2009
Malaria
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
2007 2008 2009
TRENDS BY NICHE
*As reported to UNITAID through CHAI annual reports
Prices paid (US$) per patient per year for two leading 2nd line regimens, 2007-2009*
TDF+ 3TC (300 mg + 300mg) & LPV/r (200 mg +50 mg)
0
200
400
600
800
1000
1200
2007 2008 2009
TDF+ FTC (300 mg + 200mg) & LPV/r (200 mg +50 mg)
0
200
400
600
800
1000
1200
2007 2008 2009
41% reduction, 2007-2009 43% reduction, 2007-2009
Abacavir 60 mg/ Lamivudine 30 mg
0
50
100
150
200
250
2008 2009
TRENDS BY NICHE
*As reported to UNITAID through CHAI annual reports
Prices paid (US$) per patient per year for a leading paediatric regimen, 2008-2009*
53% reduction, 2008-2009
B. Updates on Project Progress Activities
•EB Approval Status
•Key Performance Indicators
•Market Levers
•Eligibility Criteria
•Regional grouping
•Top 5 countries per niche
Approved Projects EB10/EB11
TB: 2
HIV: 2
Signed MoUs EB10/EB11HIV: 2 MoU extensions (2nd line and Paediatric HIV/AIDS Projects);
TB: MDR-TB diagnostics (FIND/GDF/GLI).
Pending MoUs
3 MoUs, Combined ceiling of US$ 54,114,575
EB APPROVAL STATUS
ESTHERAID Phase 2 15,498,374
MDR-TB Acceleration of Access Initiative: Strategic Revolving Fund 22,232,201
MDR TB Scale-Up Initiative (inclusion of India) 16,384,000
Total 54,114,575
– Price reductions on key paediatric, 1st line (TDF) & 2nd line ARVs have facilitated treatment of 66,366 children and 133,322 adults through CHAI in 2009;
– 18 UNITAID priority medicines prequalified through UNITAID funded WHO/UN Prequalification programme in 2009 (29 prequalified since 2007);
– TB medicines stockpiles in 2009 have reduced delivery lead times by over 50% for MDR-TB rotating stock pile; and
– UNITAID funding to TGF and UNICEF has created a market for fixed dose combination ACTs.
KEY PERFORMANCE INDICATORSArea 1 - Strategy
– HIV/AIDS: nearly 600,000 patients in 46 countries from 2006 to 2009;
– TB: 1.5 million treatments purchased for 72 countries from 2007-2009;
– Malaria: nearly 19 million ACTs and 20 million LLINs purchased for countries with high malaria burden from 2007 to 2009.
KEY PERFORMANCE INDICATORS
Area 3 – Health outcomes
MARKET LEVER: ACCESS HIV/AIDS
• Pediatric ARV: Over 260.000 treatments since 2006, including 66,366 new children on ART in 2009 (3% above the target)
• Second-Line ARV: ~67,490 second line and ~49,834 tenofovir regimen patients in 2 countries since 2009;
PMTCT (component I ): 184,170 treatments for pregnant women new in 2009.Malaria• ACT treatments: 16.6 million treatments delivered as of cumulative to
December 2009 with a further 2 million patients treated through support to TGF; 8.3 million treatments were provided in 2009
• A2S2: financial facility for production of target 40 metric tonnes of Artemisia on track
• 20 million LLINs delivered to countries as of January 2010. This represents the total number expected to be delivered;
TB Pediatric TB: 373,960 treatments delivered in 2009 (since 2007 668,141) First Line: 41,703 treatments delivered in 2009 (since 2007 785,080) MDR-TB: ~ 1,535 treatments delivered in 2009 (since 2007 3,133)
MARKET LEVER: AVAILABILITY
HIV/AIDS Proportion of generic suppliers being used in CHAI supplier
selection process for paediatric ARV FDCs increased to 84% in 2009 (from 75% in 2007)
TB Peds TB - 1 additional supplier (total of 2) for the key
paediatric products and 2 suppliers for 5 products MDR-TB drugs - from 2 to 7 manufacturers/11 MDR
products with more than 2 sources MDR-TB Diagnostics - 2 additional suppliers identified for
rapid speciation and 1 for Line Probe Assay
MARKET LEVER: QUALITY
18 UNITAID priority formulations prequalified out of 44 prequalified medicines (39 generics) in 2009. 10 ARVs 5 anti-TB 3 ACTs
FDC formulations TB: First line 4 FDC (RHZE), 3FDC (RHE) and 2 FDC (R150/H75) and Pyrazinamide
400 mg 8 out of 9 of the ACTs prequalified since 2007 are FDCs
3 medicines quality control laboratories were prequalified 1 in Kenya 2 in Singapore
13 out of 42 HIV and Malaria diagnostic tests evaluated and accepted as Priority Products
Lower Income
Lower Middle Income
Upper Middle Income
RECIPIENT COUNTRIES
INCOME CLASSIFICATION
LI LMI UMI
WB 2009 87.2% 9.6% 3.2%
WB Classification 2009
(based on quantities)
REGIONAL GROUPINGRECIPIENT COUNTRIES
HIV/AIDS Tuberculosis Malaria
Region %
AFR 91.24%
AMR 0.35%
EMR 0.52%
EUR 0.18%
SEAR 5.46%
WPR 2.25%
TOTAL 100.00%
Region %
AFR 49.43%
AMR 0.04%
EMR 16.73%
EUR 4.47%
SEAR 27.81%
WPR 1.53%
TOTAL 100.00%
Region %
AFR 88.99%
AMR 0.00%
EMR 9.97%
EUR 0.00%
SEAR 0.40%
WPR 0.64%
TOTAL 100.00%
AFR
AMR
EMR
EUR
SEAR
WPR
AFR
AMR
EMR
EUR
SEAR
WPR
AFR
AMR
EMR
EUR
SEAR
WPR
(based on quantities)
Country HIV TB Malaria
Brazil 263 142 24
Chile 81 42 10
France 58 10 1
Norway 15 5 0
United Kingdom 34 10 0
DALYS for comparison
DALY rates ('000)*, 2004
*per 100,000 population
Uganda
Zambia
Nigeria
Kenya
Mozambique
HIV/AIDS
WHO
RegionIncome group
DALY rates ('000), 2004
Country* US$ % total value
AFR LI 9,450 Uganda 49,057,563 12%
AFR LI 18,906 Zambia 47,699,645 12%
AFR LI 3,522 Nigeria 40,502,211 10%
AFR LI 10,288 Kenya 36,531,323 9%
AFR LI 10,792 Mozambique 24,541,801 6%
TOTAL 198,590,564 50%
Top 5 Recipient Countries, Value (US$)
*All countries have a generalized HIV epidemic.
India
Azerbaijan
Myanmar
Kenya
Bangladesh
TUBERCULOSIS
WHO
RegionIncome group
DALY rates ('000), 2004
Country US$ % total value
SEAR LI 652 India* 17,342,126 15
EUR LMI 252 Azerbaijan 9,977,861 9
SEAR LI 474 Myanmar 6,317,182 6
AFR LI 2042 Kenya 5,571,026 5
SEAR LI 1144 Bangladesh 5,182,437 5
TOTAL 39%
Top 5 Recipient Countries, Value (US$)
*Support for India is for TGF Round 6 and additional support in the MDR-TB was approved by EB 10 and this support will make India the leading recipient.
Nigeria
DRCongo
Sudan
Guinea
Ethiopia
Top 5 Recipient Countries, Value (US$)
MALARIA
WHO
RegionIncome group
DALY rates ('000), 2004 Country US$ % total value
AFR LI 6,230 Nigeria 30,550,000 10
AFR LI 6,467Democratic Republic of the Congo 25,850,000 9
EMR LI 3,148 Sudan 20,778,979 7
AFR LI 5,806 Guinea 15,740,344 5
AFR LI 2,347 Ethiopia 13,883,410 5
TOTAL 94,601,102 35
MALARIA
C. Update on Other Activities
•Validation Tools
•Viral Load
•Evaluation of Projects
Pilot tested on a TB project Narrowing the Gap: Expanding and accelerating access to diagnostics for patients at risk of multi-drug resistant tuberculosis (MDR-TB). The partners for this project are:a. WHO-GLI (Global Laboratories Initiative)b. GDF (Global Drug Facility)c. FIND (Foundation for Innovative New Diagnostics)
January 2010: Swiss Tropical Institute incorporated the Secretariat comments, with partners feedback, into its final submission
Post January 2010: - Secretariat resources strengthened – Director DFA, Director MDO, Coordinator Market Dynamics
-Drawing on the expanded in-house expertise; ongoing discussions on how to further refine the tools, main topics:
• at what stage of the proposal/project cycle would the assessment add most value• human resource requirements • assessing complex partnerships
Next steps• Roll out plan to be developed by September 2010• Application of tools on new projects• Further refinements to be made
VALIDATION TOOLS
Follow up on EB11:
Explore ways of working together to prepare a comprehensive proposal that is innovative and with geographical scope
• Key topics for clarification– Expectations and priorities on market impact and public
health needs– 1 versus 3 proposals approach
• In-person meeting on 16 April:– 3 proponents are interested in moving with initiative– Outstanding Points :
• Collaborative approach confirmed• Identification of funds for technical assistance required
• Proposed schedule: submission of proposal to EB 13 in November 2010
VIRAL LOAD
EVALUATIONS 2010/2011
Steps Taken:
• Identified 9 projects for which the MoUs have a provision for evaluation;
• Preliminary discussions with Partners held;
• Terms of Reference for evaluations written, discussed with and commented on by WHO Office of Internal Oversight;
Next Steps:
• Tender for evaluation providers by project type and select evaluation teams;
• Improve capacity for M&E related to project implementation in the Secretariat;
• Implement evaluations from Q3 2010 into 2011.
D. Challenges and Outlook•Transition of Projects
•Maximizing Returns
TRANSITION OF PROJECTS
Ended in 2009 and transition is ongoing• Second Line ARV: EB9 approved US$ 120 million for 2010-11. Transition is
on track, and scaled down from 24 countries in 2009 to 17 in 2010.
Ending in 2010 and transition support required• PMTCT 1 ending in June 2010. 2 year proposal not approved by EB11.
Bridge funding is being required for 2010-2011 (12 months). It's not yet certain that all countries will transition within this period.
• Paediatric ARV funds available until December 2010. Bridge funding request for 2011-12 being submitted to EB12 in the amount of US$ 150.8 million. A "green light status" of US$ 83 million for 2011 is proposed to the Board.
Ending in 2011 and transition support required• First Line TB ending in December 2011. 18 of 19 countries have
transitioned, 11 of which to the GF
• Implementation of the UNITAID 2010-2012 Strategy – Funding requirements (PMTCT 1, Paediatric TB, Viral Load)– Smooth transition of projects to other sources:
• Stronger Transition strategy built into new projects• On going projects: Increase Partners accountability
– Evaluation of projects: on going process 2010-2011– Initiate new Calls for Proposals: availability of funds
• Maximizing returns– Strategic interventions
• Fostering Partnerships– Price reduction/sustainability– Improve demand forecasting– Fostering relationships with suppliers
• Patent Pool: better products and lower prices for HIV/AIDS
OUTLOOK
Thank youThank you
