Transcript action description: pediatric tb 0-4 yrs

UNITAID action plan - pediatric TB
Working Draft - Last Modified 30.08.2006 18:21:46
Global TB
Drug Facility
“Securing timely access
to quality, affordable TB drugs”
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Robert Matiru, Manager, GDF
Nov. 1 2006, Paris, IUATLD
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UNITAID action plan - pediatric TB
What is the GDF?
Working Draft - Last Modified 30.08.2006 18:21:46
• 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
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are needed, when they are needed
• More than a traditional procurement mechanism
 A bundled facility not a procurement agent
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How is the GDF organized?
Last Modified 30.08.2006 18:21:46 W. Europe Standard Time
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UNITAID action plan - pediatric TB
GDF & UNITAID
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• UNITAID – Innovative financing initiative for HIV, TB
and Malaria.
• Funding targeted at niches where innovative changes
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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
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ACTION DESCRIPTION: PEDIATRIC TB 0-4 YRS
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UNITAID action plan - pediatric TB
Action: Tuberculosis pediatric formulations (ages 0-4)
• Scale-up pediatric programs into 20 countries to reach ~120,000 0-4 year-olds in 2007 and ~250,000 in 2008
What need will be addressed?
• ~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
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Impact
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•
•
•
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
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
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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
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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
Source: WHO; Stop TB/GDF
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ACTION DESCRIPTION: PEDIATRIC TB 5-15 YRS
A
UNITAID action plan - pediatric TB
Action: Tuberculosis pediatric formulations (ages 5-15)
• Scale-up pediatric programs into 20 countries to reach ~30,000 5-15 year-olds in 2007 and ~65,000 in 2008
What need will be addressed?
• ~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
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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
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
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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 $20 - 42 depending on regimen (cheaper regimens most common). Potential to reduce by 15% by 2008
Will be an extra cost to train providers in use of new drugs. This can be partly mitigated by selecting beneficiary countries
where strong health infrastructures already exist. May also be a cost to upgrade diagnostic capacity
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•
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List of countries (to be reviewed once UNITAID eligibility criteria are defined)
• Priority countries include Afghanistan, Bangladesh, Indonesia, Kenya, Myanmar, Mozambique, Nigeria, Pakistan, Philippines,
Tanzania, Uganda, DR Congo, Cambodia, Ethiopia, Thailand, Vietnam, Zimbabwe
Source: WHO; Stop TB/GDF
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B
UNITAID action plan - pediatric TB
COST & IMPACT PROJECTIONS: PEDIATRIC TB
Year
Q4 2006
0-4 yr
Total Costs ($ million)
2007
5-15 yr
0.86**
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
3.9***
0.97***
5.6***
1.4***
6.6***
1.6***
8.2
2.0
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
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Cost towards continuing
treatments ($ million)
Price of treatment
UNITAID first
action
2005
*
**
***
Source:
2006
2007
Initiation of UNITAID phase out
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
GDF; team analysis
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C
KEY SUCCESS FACTORS: PEDIATRIC TB
UNITAID action plan - 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
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•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
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•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
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D
WORKPLAN AND KEY MILESTONES: PEDIATRIC TB
UNITAID action plan - pediatric TB
Engage drug procurement agent and industry to
lower costs
Negotiate prices for year 1 drugs
Engage and negotiate with
industry to produce CF drugs
Lauch tender and then finalise
year 1 contracts with suppliers
Place drug orders (year 2
includes new CF drugs)
Coordinate registration of year 1
drugs
Child-friendly drugs available to
supply
Coordinate registration of childfriendly drugs
Arrival of drugs in country (year 2
includes CF drugs)
GDF technical support to ensure
quality scale-up
Monitoring, evaluation and data
collection
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Ensure
effective
use of
drugs
Develop and finalise scale-up
plan with global experts
Identify priority countries and
demand for scale-up in year 1
Review of appliations by GDF
technical review panel (TRC)
Recommendations of grants
awards by TRC
Endorsement of grant awards by
UNITAID-IDPF Board
Inform the drug procurement
agency about scale-up plan
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Technical
reviwe and
approval
Develop
plans and
strategies
Key milestone for UNITAID
July Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun July Aug Sep Oct Nov Dec
Source: WHO, Stop TB/GDF
2006
2007
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UNITAID action plan - pediatric TB
KEY PERFORMANCE MILESTONES: PEDIATRIC TB
2006
• Successful call for
OPERATIONAL
• Pediatric FDC prices
negotiated and orders
placed with suppliers
from min. 2 suppliers to
produce child-friendly
formulations
IMPACT
Q1-Q2
• Tender for
• Monitoring,
pediatric FDCs
launched to
secure more
suppliers and
lower prices
evaluation and
data collection
process launched
• Second wave of
proposals
approved and
drugs ordered
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• Commitments secured
Q1-Q2
• First appropriate-dose
FDCs delivered to
countries for at least
150,000 patients
• Child-friendly
formulations
available
Source: GDF
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proposals with 8 countries
recommended for approval
2007
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F
KEY ISSUES TO CONSIDER FURTHER: PEDIATRIC TB
Strategic
UNITAID action plan - pediatric TB
•Is UNITAID open to providing drugs to private sector partners to help
overcome insufficient national health system capacity?
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•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
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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
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