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”

UNITAID action plan - pediatric TB

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“Securing timely access to quality, affordable TB drugs”

Global TB Global TB Drug FacilityDrug Facility

Robert Matiru, Manager, GDF

Nov. 1 2006, Paris, IUATLD


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• 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?

Working Draft Last Modified 30.08.2006 18:21:46 W. Europe Standard Time

Printed

How is the GDF organized?


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• 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


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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

AA

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


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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

AA

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


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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

BB

Year Q4 2006 2007 2008 2009 2010

0-4 yr 5-15 yr 0-4 yr 5-15 yr 0-4 yr 5-15 yr 0-4 yr 5-15 yr 0-4 yr 5-15 yr

Total Costs ($ million) 0.86** 3.9*** 0.97*** 5.6*** 1.4*** 6.6*** 1.6*** 8.2 2.0

Cost towards continuing treatments ($ million)

0 0 0 0 0 0 0 0 0 0

Costs towards new patients ($ million)

0.0 0.0 3.9 0.97 5.6 1.4 6.6 1.6 8.2 2.0

Total Patients 0 0 120,000 30,000 252,000 63,000 372,000 93,000 488,000 122,000

Number of patients continuing treatment

0 0 0 0 0 0 0 0 0 0

Number of new patients 0 0 120,000 30,000 252,000 63,000 372,000 93,000 488,000 122,000

Cost per patient per year* ($) n/a n/a 28.80 28.80 21.75 21.75 16.75 16.75 16.75 16.75

Number of patients per year per ‘000 $

n/a n/a 35 35 46 46 60 60 60 60

Price of treatment

2005 2006 2007 2008 2009 2010

UNITAID first action

Initiation of UNITAID phase out


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KEY SUCCESS FACTORS: PEDIATRIC TBCC

•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


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WORKPLAN AND KEY MILESTONES: PEDIATRIC TB

Source: WHO, Stop TB/GDF

DD

Key milestone for UNITAID

Develop and finalise scale-up plan with global expertsIdentify priority countries and demand for scale-up in year 1Review of appliations by GDF technical review panel (TRC)Recommendations of grants awards by TRCEndorsement of grant awards by UNITAID-IDPF BoardInform the drug procurement agency about scale-up plan

Negotiate prices for year 1 drugs

Engage and negotiate with industry to produce CF drugsLauch tender and then finalise year 1 contracts with suppliers Place drug orders (year 2 includes new CF drugs)Coordinate registration of year 1 drugsChild-friendly drugs available to supplyCoordinate registration of child-friendly drugsArrival of drugs in country (year 2 includes CF drugs)GDF technical support to ensure quality scale-up

July Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun July Aug Sep Oct Nov Dec

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Monitoring, evaluation and data collection

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KEY PERFORMANCE MILESTONES: PEDIATRIC TB

OPERATIONAL

IMPACT

2006 2007

Q1-Q2 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

EE

Source: GDF


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KEY ISSUES TO CONSIDER FURTHER: PEDIATRIC TB

Source:Partner proposals; expert calls; team analysis

Technical

Strategic

FF

•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

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”

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