1. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 0 “Securing timely access to quality, affordable TB drugs” Global TB Drug Facility Robert Matiru, Manager, GDF Nov. 1 2006, Paris, IUATLD

2. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 1 An initiative of the Global Partnership to Stop TB Housed in WHO and managed by Stop TB Partnership secretariat Aims to supply quality assured, affordable drugs, where they are needed, when they are needed More than a traditional procurement mechanism  A bundled facility not a procurement agent What is the GDF?

3. Working Draft Last Modified 30.08.2006 18:21:46 W. Europe Standard Time Printed How is the GDF organized?

4. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 3 UNITAID – Innovative financing initiative for HIV, TB and Malaria. Funding targeted at niches where innovative changes can be made through market interventions backed by sustainable financing Housed in 2006/2007 at WHO, Geneva Oct. 9 GDF approved as programmatic partner to UNITAID for Paediatric TB Oct. 12 Official Call for Grant Applications issued with deadline of Nov. 6 (sensitization communications sent Sept. 20) TRC meets 13 – 16 Nov. including Prof. Robert Gie & Dr. Hastings Banda GDF & UNITAID

5. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 4 ACTION DESCRIPTION: PEDIATRIC TB 0-4 YRS Action: Tuberculosis pediatric formulations (ages 0-4) Cost $0.86m for both pediatric programs (advance payment for 2007 drugs) in 2006, $3.9m for 0-4s in 2007 and $5.6m in 2008 Cost for developing and pre-qualifying new formulations should be borne by producers given incentive of expanding market Price of new drugs is unclear – likely higher than products for 5-15 year-olds (see next slide) but with more reduction potential Will be an extra cost to train providers in use of new drugs. Can be partly mitigated by selecting beneficiary countries where strong health infrastructures already exist. May also be a cost to upgrade diagnostic capacity Impact 17% of 0-4 year-olds with active TB to benefit from UNITAID drugs in 2007 and 35% in 2008. Treatment to improve immediately by providing appropriate strength (but not yet child-friendly) FDCs in 2007 Catalyze development of child-friendly formulations, to be delivered from 2008 onwards, by creating sustainable market Achieve significant price reduction (>25%) through large volume of purchases What need will be addressed? Scale-up pediatric programs into 20 countries to reach ~120,000 0-4 year-olds in 2007 and ~250,000 in 2008 List of countries (to be reviewed once UNITAID eligibility criteria are defined) Priority countries include Afghanistan, Bangladesh, Indonesia, Kenya, Myanmar, Mozambique, Nigeria, Pakistan, Philippines, Tanzania, Uganda, DR Congo, Cambodia, Ethiopia, Thailand, Vietnam, Zimbabwe ~720,000 0-4 year-olds develop active TB worldwide each year. Current lack of high-quality, pre-qualified FDCs in child-friendly (CF) formulations and little momentum for development A A Value added of UNITAID Ensure creation of appropriate pediatric formulations, not currently available, which are unlikely to be developed otherwise Stimulate latent demand from donors/countries by making appropriate formulations available and pre-qualified Purchase in sufficient volume to generate significant price reductions Catalyst role means UNITAID may choose to withdraw from market once drugs exist and are being used since other donors should be prepared to fund care once appropriate products exist Source:WHO; Stop TB/GDF

6. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 5 ACTION DESCRIPTION: PEDIATRIC TB 5-15 YRS Action: Tuberculosis pediatric formulations (ages 5-15) Cost $0.86m for both pediatric programs in 2006 (advance payment for 2007 drugs), $0.97m for 5-15s in 2007 and $1.4m in 2008 Cost for developing and pre-qualifying products should be borne by producers given incentive of expanding market Cost per treatment is $20 - 42 depending on regimen (cheaper regimens most common). Potential to reduce by 15% by 2008 Will be an extra cost to train providers in use of new drugs. This can be partly mitigated by selecting beneficiary countries where strong health infrastructures already exist. May also be a cost to upgrade diagnostic capacity Impact 17% of 5-15 year-olds with active TB to benefit from UNITAID drugs in 2007 and 35% in 2008. Generate sufficient demand to persuade more manufacturers to produce appropriate and high-quality products and submit drugs for prequalification Achieve significant reduction in price of drugs (>15%) through large volume of purchases What need will be addressed? Scale-up pediatric programs into 20 countries to reach ~30,000 5-15 year-olds in 2007 and ~65,000 in 2008 List of countries (to be reviewed once UNITAID eligibility criteria are defined) Priority countries include Afghanistan, Bangladesh, Indonesia, Kenya, Myanmar, Mozambique, Nigeria, Pakistan, Philippines, Tanzania, Uganda, DR Congo, Cambodia, Ethiopia, Thailand, Vietnam, Zimbabwe ~180,000 5-15 year-olds develop active TB worldwide each year Current lack of pre-qualified FDCs, in doses suitable for 5-15 year-olds A A Value added of UNITAID Act as catalyst for more manufacturers to produce high-quality appropriate-strength FDCs Provide sustained demand to ensure manufacturers have an incentive to submit formulations to prequalification Purchase in sufficient volume to generate major price reductions and stimulate latent demand from other donors/countries Catalyst role means UNITAID may choose to withdraw from market once drugs exist and are being used since other donors should be prepared to fund care once appropriate products exist Source:WHO; Stop TB/GDF

7. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 6 COST & IMPACT PROJECTIONS: PEDIATRIC TB *Figure includes cost of drug, insurance, shipping, quality control and procurement agent fee **Advance payment to manufacturers for new drugs to be delivered in 2007 ***Includes 20% advance payment for following year and 80% of cost of drugs for current year not yet disbursed Source:GDF; team analysis B B YearQ4 20062007200820092010 0-4 yr5-15 yr0-4 yr5-15 yr0-4 yr5-15 yr0-4 yr5-15 yr0-4 yr5-15 yr Total Costs ($ million)0.86**3.9***0.97***5.6***1.4***6.6***1.6***8.22.0 Cost towards continuing treatments ($ million) 0000000000 Costs towards new patients ($ million) 0.0 3.90.975.61.46.61.68.22.0 Total Patients00120,00030,000252,00063,000372,00093,000488,000122,000 Number of patients continuing treatment 0000000000 Number of new patients00120,00030,000252,00063,000372,00093,000488,000122,000 Cost per patient per year* ($)n/a 28.80 21.75 16.75 Number of patients per year per ‘000 $ n/a 35 46 60 Price of treatment 200520062007200820092010 UNITAID first action Initiation of UNITAID phase out

8. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 7 KEY SUCCESS FACTORS: PEDIATRIC TB C C Strong commitment from governments and medical community to tackling pediatric TB, including introducing new guidelines and drugs Sufficient capacity in beneficiary countries to manage, distribute and administer new pediatric products Lack of effective diagnosis tools mitigated by policy of ‘over treatment’ New FDCs and formulations developed within timescale proposed by GDF Manufacturers submit more new/existing products to prequalification due to UNITAID’s sustainable demand GDF quality assessment sufficiently robust to enable launch of action even before products are pre-qualified Countries given time and support to submit sufficiently high-quality proposals to GDF Source: GDF Awareness among private sector practitioners of new pediatric products available through national TB treatment plans

9. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 8 WORKPLAN AND KEY MILESTONES: PEDIATRIC TB Source:WHO, Stop TB/GDF D D Key milestone for UNITAID

10. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 9 KEY PERFORMANCE MILESTONES: PEDIATRIC TB OPERATIONAL IMPACT 20062007 Q1-Q2 Successful call for proposals with 8 countries recommended for approval Pediatric FDC prices negotiated and orders placed with suppliers Commitments secured from min. 2 suppliers to produce child-friendly formulations Tender for pediatric FDCs launched to secure more suppliers and lower prices Monitoring, evaluation and data collection process launched Second wave of proposals approved and drugs ordered First appropriate-dose FDCs delivered to countries for at least 150,000 patients Child-friendly formulations available E E Source: GDF

11. Working Draft - Last Modified 30.08.2006 18:21:46 Printed UNITAID action plan - pediatric TB 10 KEY ISSUES TO CONSIDER FURTHER: PEDIATRIC TB Source:Partner proposals; expert calls; team analysis Technical Strategic F F What is the optimal price reduction strategy that would leverage the value-added of UNITAID? (e.g., could cost-plus work here?) Is UNITAID open to providing drugs to private sector partners to help overcome insufficient national health system capacity? What is UNITAID’s long term role once low cost pediatric formulations are available? When could UNITAID first consider ending this action? What will be the driving factors of this decision? Will UNITAID support strengthening diagnostic capacity of national TB programmes and the provision of TB diagnostic tools