improving access for quality-assured tb medicines and ... · live report 20.02.2015 ... 5 gdf...
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Improving Access for Quality-Assured TB Medicines and Diagnostics
Wolfheze 2015
Dr Kaspars Lunte
Team Leader Sourcing and Special Projects, GDF
Update on MDR TB medicines
supplies through GDF
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An initiative of the Stop TB Partnership (2001), mainly funded by USAID, hosted in UNOPS and managed by the Stop TB
Partnership secretariat
An operating mechanism to support the Stop TB Strategy: • expanding access to quality-assured first (FLD) and
second-line TB drugs (SLD) and diagnostics, • contributing to the development of sustainable
procurement and supply management for countries in need
GDF began supplying FLDs in 2001, and in 2008 added the supply of SLDs, pediatric TB medicines and diagnostics and is a major source for GeneXpert
What is the Global Drug Facility (GDF)?
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Key GDF Milestones
133 countries benefited from GDF procurement / bundled mechanism with
> 24 M Adult FLDs > 1,3 M pediatric treatments > 150,000 SLDs patient treatments
=> 26M treatments delivered since GDF inception in 2001
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Live Report 20.02.2015 https://extranet.who.int/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/MDR+Patient+treatments+supplied+-+method+Injectable+standard+180-240dose+Rev+3.0&userid=GDF_ro&password=gdfread1
SLD Patient treatments supplied by year SLD cumulative Patient treatments supplied per year
6 m
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SLD Patient treatments supplied per year by regions
MDR Treatments delivered
• The GDF QA Policy is fully harmonised and aligned with major global partners
• FPP procured through GDF shall be: i) WHO pre-qualified; or
ii) SRA authorised;
iii) ERP approved for a limited period of use:
- GMP compliance;
- Dossier accepted for an assessment by WHO PQP/SRA
http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp
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GDF Quality Assurance Policy
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GDF market shaping activities towards increased supply security and MDR-TB cost decrease
Increased SLDs supply security (36 products / 27 suppliers => x 3 > since 2011)
Significant price reductions achieved => more than 21 M USD savings in 2014 on
SLDs
Reductions in lead times with SLDs Strategic Rotating Stockpile
Decreased stock-outs with a risk management approach for sensitive products
(Km/Cfz)
• Supporting market entry of new manufacturers for both active pharmaceutical ingredients and finished pharmaceutical products
• More sustainable supply of Cs API: there are 3 API manufacturers (Dong A, Shasun and Macleods), with new supplier from South Korea expected to file API PQ around June 2015
• GDF dramatically reduced the price of Cycloserine capsule, by -66.6%, since last 5 years through regular ITBs fostering market competition
2015 GDF price reductions: regimen examples
• GDF 2015 price reductions could provide savings of 7 million USD per 10.000 patient treatments if compared with 2013 prices (based on mid range treatment regimen)
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Regimens cost, USD 2013 2014 2015
High 7891 5818 4645
Mid 1947 1667 1232
Low 2070 1561 1023
Savings per Regimen, USD 2014 vs 2013 2015 vs 2014 2015 vs 2013
High -2073 -1173 -3245
Mid -280 -434 -715
Low -508 -539 -1047
Savings per 10.000 treatments, USD 2014 vs 2013 2015 vs 2014 2015 vs 2013
High -20 725 900 -11 725 300 -32 451 200
Mid -2 802 900 -4 343 700 -7 146 600
Low -5 084 500 -5 387 400 -10 471 900
Value for money: Savings on MDR-TB Treatments
List of eligible suppliers (1)
# SLDs# Eligible suppliers,
2011
# Eligible
suppliers, 2012
# Eligible
suppliers, 2013
# Eligible
suppliers, 2014
# Eligible
suppliers, 2015
Eligible Manufacturer & QA
status *
1 Amikacin 500mg/2ml via l 2 2 4 4 5
Medochemie (SRA)
Mylan (SRA)
Cipla (PQP)
Pharmatex (SRA)
Vianex (SRA)
2 Bedaqui l ine 100mg 0 0 0 1 1 Jannsen (SRA)
3 Capreomycin 1 g via l 1 1 3 2 4
E. Li l ly unti l 2011
Akorn (SRA)
Vianex (SRA)
Hisun (PQP)
Macleods (ERP)
4 Capreomycin 0.75 g via l 0 0 0 1 1 Macleods (ERP)
5 Capreomycin 0.5 g via l 0 0 0 1 1 Macleods (ERP)
6 Cycloserine 250mg tablet 3 3 6 7 7
Aspen (PQP, backup)
Chao Centre (SRA, backup)
Macleods (PQP)
Dong-A (WHO PQP)
Cipla (ERP)
Microlabs (ERP)
Biocom (PQP, backup)
7 Ethionamide 250mg tablet 1 1 4 4 4
Macleods (PQP)
Cipla (PQP)
Lupin (PQP)
Microlabs (PQP)
8 Kanamycin 1gr via l/amp 0 0 0 0 1 pending ERP outcome
9 Kanamycin 1gr via l/amp 1 2 2 2 2Mei ji (SRA)
Panpharma (SRA)
List of eligible suppliers (2) # SLDs
# Eligible suppliers,
2011
# Eligible
suppliers, 2012
# Eligible
suppliers, 2013
# Eligible
suppliers, 2014
# Eligible
suppliers, 2015
Eligible Manufacturer & QA
status *
10 Levofloxacin 250mg tablet 3 3 4 4 7
Cipla (PQP)
Hetero (PQP)
Microlabs (PQP)
Macleods (PQP)
HEC/Sunshine Lake (PQP)
Medochemie (SRA)
Apotex (PQP)
11 Levofloxacin 500mg tablet 3 3 4 4 7
Cipla (PQP)
Hetero (PQP)
Microlabs (PQP)
Macleods (PQP)
HEC/Sunshine Lake (PQP)
Medochemie (SRA)
Apotex (PQP)
12 Levofloxacin 750mg tablet 0 0 0 0 4
Ipca (ERP)
Hetero (ERP)
Macleods (PQP)
Apotex (PQP)
13 Moxifloxacin 400mg tablet 2 2 4 5 6
Bayer (SRA)
Cipla (PQP)
Hetero (SRA)
Macleods (PQP)
Sandoz (ERP)
Ranbaxy (PQP)
14 Ofloxacin 200mg tablet 1 1 3 4 4
Cipla (PQP)
Microlabs (PQP)
Macleods (PQP)
Remedica (SRA)
15 Ofloxacin 400mg tablet 2 2 2 3 3
Cipla (WHO PQP),
Microlabs (WHO PQP)
Remedica (SRA)
PAS acid granules Jacobus (SRA)
PAS sodium granules 3 3 Macleods (WHO PQP)
PAS sodium powder Ola infarm (WHO PQP/SRA)
3 316 3
List of eligible suppliers (3) # SLDs
# Eligible suppliers,
2011
# Eligible
suppliers, 2012
# Eligible
suppliers, 2013
# Eligible
suppliers, 2014
# Eligible
suppliers, 2015
Eligible Manufacturer & QA
status *
17Prothionamide 250mg
tablet1 2 2 3 3
Fatol (SRA)
Microlabs (PQP)
Lupin (PQP)
18 Terizidone 250 mg capsule 1 1 1 1 1 Fatol (SRA)
19Amoxi/Clavunate
875+125mg tablet0 0 2 3 3
Medochemie (SRA)
Reig Jofre (SRA)
Microlabs (WHO PQP)
20Amoxi/Clavunate 500+125
mg tablet0 0 3 4 4
Remedica (SRA)
Medochemie (SRA)
Reig Jofre (SRA)
Microlabs (PQP)
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Amoxi/Clavunate 250+125
mg tablet (+2 suppl iers for
suspens ion)
0 0 0 3 3
Remedica (SRA)
Medochemie (SRA)
Microlabs (PQP)
22Amoxi/Clavunate 125+31.25
mg suspens ion 0 0 0 0 1 Microlabs (SRA)
23Clari thromycin 500 mg
tablet0 0 2 2 4
Remedica (SRA)
Medochemie (SRA)
Microlabs (SRA)
HEC/Sunshine Lake (SRA)
24Clari thromycin 250 mg
tablet0 0 2 2 4
Remedica (SRA)
Medochemie (SRA)
Microlabs (SRA)
HEC/Sunshine Lake (SRA)
25Clofazimine 50/100 mg
capsule0 0 1 1 1
Novartis via Victoria
Pharmacy (SRA)
26 Linezol id 600 mg tablet 0 0 2 2 3
Pfizer (SRA)
Hetero (SRA)
Macleods (ERP)
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Imipenem/Ci lastatin
500mg + 500mg inj, IV
(via l/ampoule)
0 0 2 3 3
Panpharma (SRA)
Labatec (SRA)
Demo (SRA)
28 Rifabutin 0 0 0 1 1 Pfizer (SRA)
NOTE: backup suppl ier: suppl ier approved, but ei ther cannot produce large volumes and/or does not provide appropriate packaging (i .e. loose
product only)
* - LTAs not necesari ly are concluded with a l l el igible suppl iers
Thank You for your attention
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