Global TB Drug Facility

1. UNITAID action plan - pediatric TB Global TB Drug Facility • “Securing timely access • to quality, affordable TB drugs” Robert Matiru, Manager, GDF Nov. 1 2006, Paris, IUATLD

2. What is the GDF? UNITAID action plan - pediatric TB • 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

3. How is the GDF organized?

4. GDF & UNITAID UNITAID action plan - pediatric TB • 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

5. Action: Tuberculosis pediatric formulations (ages 0-4) • Cost • Impact • What need will be addressed? • List of countries (to be reviewed once UNITAID eligibility criteria are defined) • Value added of UNITAID UNITAID action plan - pediatric TB A ACTION DESCRIPTION: PEDIATRIC TB 0-4 YRS • Scale-up pediatric programs into 20 countries to reach ~120,000 0-4 year-olds in 2007 and ~250,000 in 2008 • ~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 • 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 • 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 • $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 • Priority countries include Afghanistan, Bangladesh, Indonesia, Kenya, Myanmar, Mozambique, Nigeria, Pakistan, Philippines, Tanzania, Uganda, DR Congo, Cambodia, Ethiopia, Thailand, Vietnam, Zimbabwe Source: WHO; Stop TB/GDF

6. Action: Tuberculosis pediatric formulations (ages 5-15) • Cost • Impact • What need will be addressed? • List of countries (to be reviewed once UNITAID eligibility criteria are defined) • Value added of UNITAID UNITAID action plan - pediatric TB A ACTION DESCRIPTION: PEDIATRIC TB 5-15 YRS • Scale-up pediatric programs into 20 countries to reach ~30,000 5-15 year-olds in 2007 and ~65,000 in 2008 • ~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 • 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 • 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 • $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 • Priority countries include Afghanistan, Bangladesh, Indonesia, Kenya, Myanmar, Mozambique, Nigeria, Pakistan, Philippines, Tanzania, Uganda, DR Congo, Cambodia, Ethiopia, Thailand, Vietnam, Zimbabwe Source: WHO; Stop TB/GDF

7. UNITAID action plan - pediatric TB B COST & IMPACT PROJECTIONS: PEDIATRIC TB • Price of treatment • UNITAID first action • Initiation of UNITAID phase out • 2005 • 2006 • 2007 • 2008 • 2009 • 2010 * 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

8. UNITAID action plan - pediatric TB C KEY SUCCESS FACTORS: PEDIATRIC TB • Countries given time and support to submit sufficiently high-quality proposals to GDF • Strong commitment from governments and medical community to tackling pediatric TB, including introducing new guidelines and drugs • Awareness among private sector practitioners of new pediatric products available through national TB treatment plans • 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 Source: GDF

9. UNITAID action plan - pediatric TB D WORKPLAN AND KEY MILESTONES: PEDIATRIC TB • Key milestone for UNITAID Source: WHO, Stop TB/GDF

10. UNITAID action plan - pediatric TB E KEY PERFORMANCE MILESTONES: PEDIATRIC TB • 2006 • 2007 • Q1-Q2 • Q1-Q2 OPERATIONAL • Successful call for proposals with 8 countries recommended for approval • Tender for pediatric FDCs launched to secure more suppliers and lower prices • Monitoring, evaluation and data collection process launched • Pediatric FDC prices negotiated and orders placed with suppliers • Second wave of proposals approved and drugs ordered IMPACT • Commitments secured from min. 2 suppliers to produce child-friendly formulations • First appropriate-dose FDCs delivered to countries for at least 150,000 patients • Child-friendly formulations available Source: GDF

11. UNITAID action plan - pediatric TB F KEY ISSUES TO CONSIDER FURTHER: PEDIATRIC TB • Strategic • 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 • Technical • What is the optimal price reduction strategy that would leverage the value-added of UNITAID? (e.g., could cost-plus work here?) Source: Partner proposals; expert calls; team analysis