1 global drug facility: procurement arm of the stop tb partnership john loeber procurement team...

Global Drug Facility:Procurement Arm of the Stop TB PartnershipJohn LoeberProcurement Team ManagerMeeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation holdersCopenhagen, November 2009

An initiative of the Global Partnership to Stop TB (2002)Housed in WHO and managed by Stop TB Partnership secretariatAims to supply uninterrupted, quality assured, affordable anti-TB medicines, where they are needed, when they are needed More than a traditional procurement mechanism, GDF is a bundled facility (ie, supplies drugs, provides TA in drug management, and conducts quality assurance)What is the GDF?

Global TB estimatesEstimated number of cases (incidence)Estimated number of deaths p.a.1.65 million(25 per 100,000)9.15 million(139 per 100,000)~130,000 ~489,000All forms of TB Greatest number of cases in Asia; greatest rates per capita in AfricaMultidrug-resistant TB (MDR-TB)Extensively drug-resistant TB (XDR-TB)~35,000~20,000HIV-associated TB

~709,000 (8%)~231,000

GDF SERVICES

Supply treatments for 15 million patients by 2010 and for 25 million by 2015Improve the quality and reduce prices of anti-TB medicines worldwide Contribute to the achievement of health MDGsReduce the emergence of drug resistant (MDR-) TBDiagnosis and treat MDR-TB patientsWhat GDF aims to achieve

The GDF/GLC model : One Stop AccessPharmaceuticalsTech. Review Comm.GLC Expert Comm.GDF/ GLCSecretariatProcurementCountry/ProjectNTPTechnical Support / M&EWHOGDFApplicationGrant/Tech. AgreementLoADelivery

Orders Placed First-Line Anti-TB Drugs (USD)No. of shipments in 2008: 375No. of purchase order lines: 816

Orders Placed Second LineAnti-TB Drugs (USD)Approx. 70 % y-on-y growth rate

Second line drug quantities delivered 2007 - 08

STRATEGIC ROTATING STOCKPILE 5,800 patient treatments

Drug description Drug unitsCapreomycin 1000 mg 540,000 Kanamycin 1000 mg 360,000 Ethionamide 250 mg 540,000 Prothionamide 250 mg 540,000 Ofloxacin 200 mg 1,080,000 Levofloxacin 250 mg 630,000 Levofloxacin 500 mg 630,000 PAS 4g 1,800,000 Cycloserin 250 mg 2,700,000

Countries receiving First Line TB drugs

GLC / GDF Second Line Drug Deliveries

Chart1

12002

72003

122004

202005

242006

305

3610

Countries (#)

UNITAID Countries (#)

Year

Number of Countries

MDR Drug Deliveries 2001 - 2008

Sheet1


GLC/GDF

2002200320042005200620072008

USD (mln)1.21.51.72.63.74.39.8

Countries (#)171220243036

UNITAID Countries (#)510

Sheet2

Sheet2

12002

72003

122004

202005

242006

305

3610

Countries (#)

UNITAID Countries (#)

Year

Number of Countries


Sheet3

Sheet3

1.2

1.5

1.7

2.6

3.7

4.3

9.8

USD (mln)

Year

USD (Mln)

TB-product portfolioSusceptible TBAdult medicinessingle drugs & FDCPatient kits contain all drugs needed to treat one patientPaediatric medicinesMostly FDCsDiagnostic kits4 separate kits serve a lab for 1,000 sputum tests

Resistant TBAdult medicinessingle drugsDiagnosticsIn collaboration with Global Laboratory InitiativeRapid diagnostic testsLaboratory commodities reagents, pipettes, centrifuges, work stations, incubators

Product Selection: Standardized list of products in blisters, patient kits and bulk following WHO guidelines and regimensProductsRHZE (4FDC) RHE (3FDC)

UnitsBulk 1000 tabs Blisters 672 tabsBulk 1000 tabs Blisters 672 tabs Bulk 1000 tabs Blisters 672 tabsBulk 1000 tabs Blisters 672 tabsBulk 1000 tabs Blisters 672 tabs50 VialsRH150/75RH150/150EH400/150E400, Z400, H300S1gCat. I & III Patient KitCat. II Patient Kit

Product Selection: Paediatric TB drugsProducts RHZ (3FDC)UnitsBulk 1000 tabs StripsBulk 1000 tabs StripsBulk 1000 tabs StripsBulk 1000 tabs Strips

50 VialsRH60/30RH60/60E100, H100, Z150S1g

Prices and Sources of Second Line Anti-TB drugs delivered through GDF (USD):*Limited quota/partnershipPrices are subject to change. Please refer to GDF webpage for most recent list:http://www.stoptb.org/gdf/drugsupply/drugs_available.asp

Product Selection:

Diagnostic KitsEquipment starter kitConsumables kit

Approved Suppliers (Nov. 09)For susceptible TB 8 suppliers for 12 main productsFor multi-drug resistant TB *8 suppliers for 11 products For extensively drug resistant TB **3 suppliers for 5 products

* MDR TB = TB bacteria are resistant to at least isoniazid and rifampicin (two most powerful anti-TB drugs today)**XDR TB = MDR-TB is present, plus resistance to at least three of the six classes of available second-line drugs

Forecasting Procedures(First Line Drugs) Client completes and Order Form/Technical agreement

Client works with GDF to finalize patient numbers & required quantities using Standardized GDF quantification tool: drugs & diagnostics

GDF supports client with technical and drug management support via annual monitoring mission

DIRECT PROCUREMENT ORDER FORM & TECHNICAL AGREEMENT

SECTION A. CONTACT DETAILS

Country:

Contact person:

Position:

Address:

Telephone:

Fax:

Email:

SECTION B. ESTIMATES OF PATIENTS TO BE TREATED WITH DOTS

Year:

Date drugs required:

Category

Regimen

Total estimated cases to be treated with DOTS

Estimated cases to be treated with drugs supplied through the GDF

1

2

3

EMBED MSPhotoEd.3

_1103975694.bin

GLC approved projects at beginning 2009Uncertain demandHigher priceGLC-approved projects in 60 countries ~ 50'000 patients approved for enrolmentBangladeshIndiaIndonesiaMyanmarNepalTimor-LesteBurkina FasoCameroonDR CongoEthiopiaGuineaKenya LesothoMozambiqueRwandaUgandaTanzaniaBelizeBoliviaCosta RicaDominican RepublicEcuadorEl Salvador GuatemalaHaitiHondurasMexicoNicaraguaParaguayPeruUruguayEgyptJordan LebanonPakistanSyriaTunisiaAzerbaijanArmeniaBelarusBulgariaEstonia GeorgiaKazakhstanKyrgyzstanLatvia LithuaniaMoldova RomaniaRussia SerbiaUkraineUzbekistanCambodiaChinaMicronesiaMongoliaPhilippinesSamoa Vietnam

MDR-TB Patient enrollmentTotal of 130,842 patients have been approved for funding by Global Fund from 2003 until 2013To date a total of 61,205 patients have been approved by the GLC to be treated from 2003 until 2011

Chart1

3534303275

25259894474

446487466833

14592142059000

261961918712968

38766303892008

60711459272009

82457556222010

10175920112011

11904720122012

13084220132013

GFATM

GLC

GLC reported as enrolled

Year

Patients

FINAL FORECAST

YEAR(Multiple Items)

Sum of Unit Expected to be ordered in 2009

Name of DrugForecast per Durg 09SRSTotal

Levofloxacin 500 mg0.0630,000630,000

Capreomycin 1000 mg1132875.058914375400001,672,875

Kanamycin 1000 mg911676.535845353600001,271,677

Amikacin 1000 mg278609.8486241730278,610

Ethionamide 250 mg6190531.678600615400006,730,532

Prothionamide 250 mg7748436.981702755400008,288,437

Ofloxacin 200 mg5575587.4641213510800006,655,587

Ciprofloxacin 250 mg0.00.00.0

Levofloxacin 250 mg7,707,408630,0008,337,408

PAS 4g929264.57735355818000002,729,265

Cycloserin 250 mg12545071.794273270000015,245,072

Moxifloxacin 400 mg929264.5773535580929,265

Grand Total52,768,726

Raw Data

YEARY-o-Y increaseDelivered to All ProgramsDelivered to All Programs adjGrupName of Drug2008 Grup Total2008% Grup distributionGrup2008 Grup Distribution2009-10 % Grup distributionGrup Total for 2009 ForecastForecast per Durg 09SRSUnit Expected to be ordered in 2009

20030.0%137,745137,745InjectableCapreomycin 1000 mg0.00Carbothionamides95664000

20030.0%104,250104,250InjectableKanamycin 1000 mg0.00Cycloserin80511000

20030.0%00InjectableAmikacin 1000 mg0.00Floroquinalones100768600

20030.0%1,467,3001,467,300CarbothionamidesEthionamide 250 mg0.00Injectable17354720

20030.0%00CarbothionamidesProthionamide 250 mg0.00PASER22352400

20030.0%638,200638,200FloroquinalonesOfloxacin 200 mg0.000

20030.0%1,201,8001,201,800FloroquinalonesCiprofloxacin 250 mg0.000

20030.0%00FloroquinalonesLevofloxacin 250 mg0.000

20030.0%113,190113,190PASPAS 4g0.000

20030.0%1,615,9401,615,940CycloserinCycloserin 250 mg0.000

200425.5%172,808172,808InjectableCapreomycin 1000 mg0.000

2004-49.9%52,20052,200InjectableKanamycin 1000 mg0.000

20040.0%00InjectableAmikacin 1000 mg0.000

2004-14.3%1,257,0001,257,000CarbothionamidesEthionamide 250 mg0.000

20040.0%77,00077,000CarbothionamidesProthionamide 250 mg0.000

200424.2%792,400792,400FloroquinalonesOfloxacin 200 mg0.000

2004-41.9%698,600698,600FloroquinalonesCiprofloxacin 250 mg0.000


2004208.1%348,690348,690PASPAS 4g0.000

2004-28.1%1,161,1901,161,190CycloserinCycloserin 250 mg0.000


2005238.0%176,410176,410InjectableKanamycin 1000 mg0.000

20050.0%00InjectableAmikacin 1000 mg0.000

20053.6%1,302,7001,302,700CarbothionamidesEthionamide 250 mg0.000

2005196.7%228,460228,460CarbothionamidesProthionamide 250 mg0.000

2005-5.9%745,800745,800FloroquinalonesOfloxacin 200 mg0.000



2005105.8%717,440717,440PASPAS 4g0.000


2006-10.5%222,902222,902InjectableCapreomycin 1000 mg0.000


20060.0%17,12017,120InjectableAmikacin 1000 mg0.000

2006107.8%2,706,4002,706,400CarbothionamidesEthionamide 250 mg0.000

2006354.5%1,038,3001,038,300CarbothionamidesProthionamide 250 mg0.000

2006233.0%2,483,3602,483,360FloroquinalonesOfloxacin 200 mg0.000



2006-7.2%666,060666,060PASPAS 4g0.000




2007-100.0%00InjectableAmikacin 1000 mg0.000

2007-63.2%997,200997,200CarbothionamidesEthionamide 250 mg0.000

200744.5%1,500,6001,500,600CarbothionamidesProthionamide 250 mg0.000

200723.8%3,074,0003,074,000FloroquinalonesOfloxacin 200 mg0.000

2007106.2%1,092,8001,092,800FloroquinalonesCiprofloxacin 250 mg0.000


200733.3%887,940887,940PASPAS 4g0.000

2007-33.3%2,451,7002,451,700CycloserinCycloserin 250 mg0.000

2008216.6%846,292846,292InjectableCapreomycin 1000 mg1,735,47249%49%2,323,1611,132,875540,0001,672,875

2008108.3%681,050681,050InjectableKanamycin 1000 mg1,735,47239%39%2,323,161911,677360,0001,271,677

20080.0%208,130208,130InjectableAmikacin 1000 mg1,735,47212%12%2,323,161278,6100.0278,610

2008326.1%4,248,6004,248,600CarbothionamidesEthionamide 250 mg9,566,40044%44%13,938,9696,190,532540,0006,730,532

2008254.4%5,317,8005,317,800CarbothionamidesProthionamide 250 mg9,566,40056%56%13,938,9697,748,437540,0008,288,437

2008176.1%8,487,2608,487,260FloroquinalonesOfloxacin 200 mg10,076,86084%30%18,585,2925,575,5871,080,0006,655,587

200867.5%1,830,0001,830,000FloroquinalonesCiprofloxacin 250 mg10,076,86018%0%15,414,8150.00.00.0

20080.0%674,600674,600FloroquinalonesLevofloxacin 250 mg10,076,8607%50%15,414,8157,707,408630,0008,337,408

2008151.7%2,235,2402,235,240PASPAS 4g2,235,24010%9,292,646929,2651,800,0002,729,265

2008228.4%8,051,1008,051,100CycloserinCycloserin 250 mg8,051,10090%13,938,96912,545,0722,700,00015,245,072

2009000FloroquinalonesMoxifloxacin 400 mg0.020%4,646,323929,2650.0929,265

2009000FloroquinalonesLevofloxacin 500 mg0.00.0630,000630,000

Pivot_Drug Delivery by Year

Sum of Delivered to All Programs adj

YEARGrupName of DrugY-o-Y increaseTotal

2007CarbothionamidesEthionamide 250 mg-63.2%997,200

Prothionamide 250 mg44.5%1,500,600

Carbothionamides Total2,497,800

CycloserinCycloserin 250 mg-33.3%2,451,700

Cycloserin Total2,451,700

FloroquinalonesOfloxacin 200 mg23.8%3,074,000

Ciprofloxacin 250 mg106.2%1,092,800

Levofloxacin 250 mg0.0%0.0

Floroquinalones Total4,166,800

InjectableCapreomycin 1000 mg19.9%267,314

Kanamycin 1000 mg48.7%326,950

Amikacin 1000 mg-100.0%0.0

Injectable Total594,264

PASPAS 4g33.3%887,940

PAS Total887,940

2007 Total10,598,504

2008CarbothionamidesEthionamide 250 mg326.1%4,248,600

Prothionamide 250 mg254.4%5,317,800

Carbothionamides Total9,566,400

CycloserinCycloserin 250 mg228.4%8,051,100

Cycloserin Total8,051,100

FloroquinalonesOfloxacin 200 mg176.1%8,487,260

Ciprofloxacin 250 mg67.5%1,830,000

Levofloxacin 250 mg0.0%674,600

Floroquinalones Total10,991,860

InjectableCapreomycin 1000 mg216.6%846,292

Kanamycin 1000 mg108.3%681,050

Amikacin 1000 mg0.0%208,130

Injectable Total1,735,472

PASPAS 4g151.7%2,235,240

PAS Total2,235,240

2008 Total32,580,072

Grand Total43,178,576

% drug per group

YEAR(Multiple Items)

Sum of 2009-10 % Grup distribution

GrupName of DrugTotal

CarbothionamidesEthionamide 250 mg44%

Prothionamide 250 mg56%

Carbothionamides Total100%

CycloserinCycloserin 250 mg90%

Cycloserin Total90%

FloroquinalonesOfloxacin 200 mg30%

Ciprofloxacin 250 mg0%

Levofloxacin 250 mg50%

Moxifloxacin 400 mg20%

Floroquinalones Total100%

InjectableCapreomycin 1000 mg49%

Kanamycin 1000 mg39%

Amikacin 1000 mg12%

Injectable Total100%

PASPAS 4g10%

PAS Total10%

Grand Total400%

Patients data

GF proposal planned patientsGLC approved patientsGLC project enrolled patientsproportion of GLC enrolled/approvedProportion of GLC approved/GF planned (*)

200711,1924,9823,96880%0.4

200811,17411,2028,9221.0

200917,35015,50812,3520.9

201024,48721,88717,4330.9

2nd half 09-1st half 10)20918.518,69814,892

Explanation

period with major bottlenecks

stabilizing period, increased demand and supply, establishment of a buffer stock

estimated figures - 80% of patients planned approved will be enrolled

(*)

Verification deliveries patient

Carbothionamides -250 mgInjectables - 1000 mgFloroquinalones -250 mg

GLC Patients enrolledamount of drug units deliveredDrug units per patient per year (3 pillsx 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (1 vialx 26 days x 6 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (4 pills x 26 days x 12 months)Patients /year derived from drug units

20073,9682,497,8009362,669594,2641563,8094,166,8001,2483,339

20088,9229,566,40093610,2211,735,47215611,12510,991,8601,2488,808

Forcast group of drugs

Carbothionamides- 250 mgInjectables - 1000 mgOfloxacin -200 mgLevofloxacin - 250 mgMoxifloxacin- 400 mgCycloserin - 240 mgPAS- 8 g

GLC Patients to be enrolled 2nd half 09- 1st half 10amount of drug units deliveredDrug units per patient per year (3 pillsx 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (1 vialx 26 days x 6 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (4 pills x 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (4 pills x 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (1 pills x 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (3 pills x 26 days x 12 months)Patients /year derived from drug unitsamount of drug units deliveredDrug units per patient per year (2 sachets x 26 days x 12 months)Patients /year derived from drug units

200914,89213,938,96993614,8922,323,16115614,89218,585,2921,24814,89218,585,2921,24814,8924,646,32331214,89213,938,96993614,8929,292,64662414,892

InjectableCapreomycin

InjectableKanamycin

InjectableAmikacin

CarbothionamidesEthionamide

CarbothionamidesProthionamide

FloroquinalonesOfloxacin

FloroquinalonesMoxifloxacin

FloroquinalonesLevofloxacin

PASERPASER

CycloserinCycloserin

Edits for word

GroupDrug descriptionDrug units deliveredGroupDrug descriptionCoeficientCoeficient

2007CarbothionamidesEthionamide 250 mg997,200CarbothionamidesEthionamide 250 mg100%44%

Prothionamide 250 mg1,500,600Prothionamide 250 mg56%

Carbothionamides2,497,800InjectableCapreomycin 1000 mg100%49%

FloroquinalonesOfloxacin 200 mg3,074,000Kanamycin 1000 mg39%

Ciprofloxacin 250 mg1,092,800Amikacin 1000 mg12%

Levofloxacin 250 mg0.0FloroquinalonesOfloxacin 200 mg100%30%

Floroquinalones4,166,800Ciprofloxacin 250 mg0%

InjectableCapreomycin 1000 mg267,314Levofloxacin 250 mg50%

Kanamycin 1000 mg326,950Moxifloxacin 400 mg20%

Amikacin 1000 mg0.0PASPAS 4g10%10%

Injectables594,264CycloserinCycloserin 250 mg90%90%

PASPAS 4g887,940

CycloserinCycloserin 250 mg2,451,700

2008CarbothionamidesEthionamide 250 mg4,248,600

Prothionamide 250 mg5,317,800

Carbothionamides9,566,400

FloroquinalonesOfloxacin 200 mg8,487,260

Ciprofloxacin 250 mg1,830,000

Levofloxacin 250 mg674,600

Floroquinalones10,991,860

InjectablesCapreomycin 1000 mg846,292

Kanamycin 1000 mg681,050

Amikacin 1000 mg208,130

CycloserinCycloserin 250 mg8,051,100

PASPAS 4g2,235,240

Carbothionamides -250 mgInjectables - 1000 mgFloroquinalones -250 mg

amount of drug units deliveredDrug units patient/yearPatients /year derived from drug unitsamount of drug units deliveredDrug units patient/yearPatients /year derived from drug unitsamount of drug units deliveredDrug units patient/yearPatients /year derived from drug units

20072,497,8009362,669594,2641563,8094,166,8001,2483,339

20089,566,40093610,2211,735,47215611,12510,991,8601,2488,808

Drug descriptionDrug units


Capreomycin 1000 mg540,000

Kanamycin 1000 mg360,000

Ethionamide 250 mg540,000

Prothionamide 250 mg540,000

Ofloxacin 200 mg1,080,000


PAS 4g1,800,000

Cycloserin 250 mg2,700,000

Drug descriptionArithmetic forecast drug unitsStrategic Rotating StockpileTotal Drug Units to be orderedTotal drug units (rounded)

Capreomycin 1000 mg1,132,8755400001,672,8751,700,000

Kanamycin 1000 mg911,6773600001,271,6771,300,000

Amikacin 1000 mg278,6100278,610275,000

Ethionamide 250 mg6,190,5325400006,730,5327,700,000

Prothionamide 250 mg7,748,4375400008,288,4378,300,000

Ofloxacin 200 mg5,575,58710800006,655,5876,700,000

Levofloxacin 500 mg0.0630000630,000630,000

Levofloxacin 250 mg7,707,4086300008,337,4088,300,000

Moxifloxacin 400 mg929,2650929,265900,000

PAS 4g929,26518000002,729,2652,800,000

Cycloserin 250 mg12,545,072270000015,245,07215,200,000

The coefficients assigned to each drug have been estimated according to the data collected and analysed from different sources, i.e.: Treatments and regimens described by the programs in their GLC applications Coefficients calculated based on percentage of total drugs delivered within their particular subgroup and using the recommendations on treatment guidelines Drug Coefficients

Group Drug descriptionCoeficient I (% full drug consumption/year)Coeficient II (share within drug group)CarbothionamidesEthionamide 250 mg100%44%Prothionamide 250 mg56%InjectableCapreomycin 1000 mg100%49%Kanamycin 1000 mg39%Amikacin 1000 mg12%FloroquinalonesOfloxacin 200 mg100%30%Ciprofloxacin 250 mg0%Levofloxacin 250 mg50%Moxifloxacin 400 mg20%PAS PAS 4g30%100%CycloserinCycloserin 250 mg90%100%

FORECAST OF DRUGS UNITS FOR 2009

Drug Costs as share of Annual Costs based on median required quantities of drugs per patient

Global Plan chart

16651545.411969412454808.107604974229328.791025984062921.17517541283905.31731918151232884.536701171368027.78154139256788.964277311056016.2726911

20789850.291325415550124.000993192677081.592782104954555.450881602986.30997431188817851.488023213957056.48660149013034.243585913803699.1426924

30122628.239723222530734.8441541134280778.170235152069736.511352322583.37660416273580130.000752310004583.07775871015490.190248720000321.8773443

29746545.147400722249437.0647885132604273.388121150171135.3567392293585.76286679270164463.198046306134154.46474970128856.894475119750616.4784921

29209787.763232621847960.2015451130211514.075716147461393.2541782252199.47453175265289518.230731300610159.42126668863426.519456919394229.2347241

28465341.237971821291138.6940452126892917.241383143703162.5300112194799.46578811258528296.217212292948748.44309667108359.382184118899944.0081099

27678364.883424720702506.2735336123384730.756154139730226.1074572134120.22544078251380809.22932284849645.17953365253026.204032118377420.5325506

26403950.508994219749286.2515831117703641.026932133296529.2672072035857.43052787239806306.25246271734113.10611862248535.334728217531256.0647333

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

# of units of drugs

Optimistic Scenario: The Global Plan

Chart5

128876.432769021

160905.289993208

233137.332128487

230226.596448156

226072.304745941

220310.580522197

214219.692094827

204356.224507722

year

# of patients

Optimistic Scenario: Number of Patients to be Treated According to the Global Plan

Chart8

16651545.411969412454808.107604924743109.597008621015730.293793810271242.538553450410961.512233557122675.927180413085596.32142583685338.75756369

20789850.291325415550124.000993130892360.530927326238638.8627212823890.479794562939283.829341171319018.82886716337678.08119534601233.04756413

30122628.239723222530734.844154144760259.390078338017434.127837518580667.012833391193376.6669173103334861.02591923671830.06341626666773.95911476

29746545.147400722249437.064788544201424.46270737542783.839184718348686.102934390054821.0660154102044718.15491623376285.63149176583538.82616402

29209787.763232621847960.201545143403838.025238836865348.313544618017595.79625488429839.4102435100203386.47375522954475.50648566464743.07824137

28465341.237971821291138.694045242297639.080460935925790.632502717558395.726304986176098.739070697649582.814365222369453.12739476299981.33603664

27678364.883424720702506.273533641128243.585384834932556.526864317072961.803526283793603.076440194949881.72651121751008.73467746125806.84418354

26403950.508994219749286.251583139234547.008977433324132.316801816286859.444222979935435.417486790578037.702039420749511.77824275843752.02157775

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

# of daily doses

Optimistic Scenario: Drug Needs

Chart9

263293678.134493

328728416.230595

476297988.450589

470351375.195665

461864185.421563

450093021.907247

437649378.157242

417498380.76873

year

cost inUSD

Cost of Treatment on the Global Plan

Chart10

0.203010802

0.0241249702

0.0056385196

0.0095782309

0.0384254342

0.057438859

0.3319399645

0.3235445403

0.0062986793

ETHIONAMIDE (6%)

PAS(4%)

OLFLOXACIN (1%)

CIPROFLOXACIN (1%)

KANAMYCIN(2%)

CAPREOMYCIN (20%)

PASER(32%)

PROTHIONAMIDE (1%)

CYCLOSERIN (33%)

optimistic GP scenario

OPTIMISTIC GLOBAL MARKETETHIONAMIDE

This scenario uses the updated patient numbers from the Global Plan to Stop TB for 2006-2015.# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily DosagesAnnual Cost

It assumes that the Global Plan is completed, that all funding is available, and that all patients that require treatment will receive it.YEARtreated in high burden countriesto be treated(unit = 250 mg tab)

It has been calculated using ratios from past numbers of treated patients and past drug delivery data (see drug unit ratio calculation spreadsheet).(85% of total burden)TOTAL

2008109,545128,8761,173151,232,88550,410,96215,123,288

CAPREOMYCIN2009136,769160,9051,173188,817,85162,939,28418,881,785

# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosagesannual cost2010198,167233,1371,173273,580,13091,193,37727,358,013

YEARtreated in high burden countriesto be treated(unit = 1 g powder inj vial)2011195,693230,2271,173270,164,46390,054,82127,016,446

(85% of total burden)TOTAL(coefficient %)2012192,161226,0721,173265,289,51888,429,83926,528,952

2008109,545128,87612916,651,54516,651,54553,451,4612013187,264220,3111,173258,528,29686,176,09925,852,830

2009136,769160,90512920,789,85020,789,85066,735,4192014182,087214,2201,173251,380,80983,793,60325,138,081

2010198,167233,13712930,122,62830,122,62896,693,6372015173,703204,3561,173239,806,30679,935,43523,980,631

2011195,693230,22712929,746,54529,746,54595,486,410CYCLOSERIN1,898,800,259

2012192,161226,07212929,209,78829,209,78893,763,419# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosages

2013187,264220,31112928,465,34128,465,34191,373,745YEARtreated in high burden countriesto be treated(unit = 250 mg cap)

2014182,087214,22012927,678,36527,678,36588,847,551(85% of total burden)TOTAL

2015173,703204,35612926,403,95126,403,95184,756,6812008109,545128,8761,330171,368,02857,122,67687,397,694

209,068,0132009136,769160,9051,330213,957,05671,319,019109,118,099

KANAMYCIN2010198,167233,1371,330310,004,583103,334,861158,102,337

# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosagesannual cost2011195,693230,2271,330306,134,154102,044,718156,128,419

YEARtreated in high burden countriesto be treated(unit = 1 g powder inj vial)2012192,161226,0721,330300,610,159100,203,386153,311,181

(85% of total burden)TOTAL2013187,264220,3111,330292,948,74897,649,583149,403,862

2008109,545128,8769712,454,80812,454,8086,351,9522014182,087214,2201,330284,849,64594,949,882145,273,319

2009136,769160,9059715,550,12415,550,1247,930,5632015173,703204,3561,330271,734,11390,578,038138,584,398

2010198,167233,1379722,530,73522,530,73511,490,6752,151,606,488

2011195,693230,2279722,249,43722,249,43711,347,213

2012192,161226,0729721,847,96021,847,96011,142,460

2013187,264220,3119721,291,13921,291,13910,858,481

2014182,087214,2209720,702,50620,702,50610,558,278

2015173,703204,3569719,749,28619,749,28610,072,136

156,375,995

CIPROFLOXACINPASER

# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosagesannual cost# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosages

YEARtreated in high burden countriesto be treated(unit = 500 mg tab)YEARtreated in high burden countriesto be treated(unit = 4 g granule)

(85% of total burden)TOTAL(85% of total burden)TOTAL

2008109,545128,87657674,229,32924,743,1101,484,5872008109,545128,87630539,256,78913,085,59685,187,232

2009136,769160,90557692,677,08230,892,3611,853,5422009136,769160,90530549,013,03416,337,678106,358,284

2010198,167233,137576134,280,77844,760,2592,685,6162010198,167233,13730571,015,49023,671,830154,103,614

2011195,693230,227576132,604,27344,201,4242,652,0852011195,693230,22730570,128,85723,376,286152,179,619

2012192,161226,072576130,211,51443,403,8382,604,2302012192,161226,07230568,863,42722,954,476149,433,636

2013187,264220,311576126,892,91742,297,6392,537,8582013187,264220,31130567,108,35922,369,453145,625,140

2014182,087214,220576123,384,73141,128,2442,467,6952014182,087214,22030565,253,02621,751,009141,599,067

2015173,703204,356576117,703,64139,234,5472,354,0732015173,703204,35630562,248,53520,749,512135,079,322

931,984,265310,661,42218,639,685492,887,518164,295,8391,069,565,913

OFLAXACINPROTHIONAMIDE

# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosages# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily Dosages

YEARtreated in high burden countriesto be treated(unit = 200 mg tab)YEARtreated in high burden countriesto be treated(unit = 250 mg tab)

(85% of total burden)TOTAL(85% of total burden)TOTAL

2008109,545128,87665284,062,92121,015,7302,521,8882008109,545128,8768611,056,0163,685,3391,658,402

2009136,769160,905652104,954,55526,238,6393,148,6372009136,769160,9058613,803,6994,601,2332,070,555

2010198,167233,137652152,069,73738,017,4344,562,0922010198,167233,1378620,000,3226,666,7743,000,048

2011195,693230,227652150,171,13537,542,7844,505,1342011195,693230,2278619,750,6166,583,5392,962,592

2012192,161226,072652147,461,39336,865,3484,423,8422012192,161226,0728619,394,2296,464,7432,909,134

2013187,264220,311652143,703,16335,925,7914,311,0952013187,264220,3118618,899,9446,299,9812,834,992

2014182,087214,220652139,730,22634,932,5574,191,9072014182,087214,2208618,377,4216,125,8072,756,613

2015173,703204,356652133,296,52933,324,1323,998,8962015173,703204,3568617,531,2565,843,7522,629,688

1,055,449,660263,862,41531,663,490138,813,50446,271,16820,822,026

PAS

# of MDR-TB Patients to be# of MDR-TB Patients# of Units/PatientNeeded # of Units# of Daily DosagesYEARtotalcapreomycinkanamycinoflaxacinPASethionamidecycloserinPASERprothionamide

YEARtreated in high burden countriesto be treated(unit = 100 g granule)

(85% of total burden)TOTAL2008561,596,2260.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2008109,545128,876101,283,90510,271,24310,117,1742009701,166,2390.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2009136,769160,905101,602,98612,823,89012,631,53220101,015,926,9860.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2010198,167233,137102,322,58318,580,66718,301,95720111,003,243,0680.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2011195,693230,227102,293,58618,348,68618,073,4562012985,140,1880.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2012192,161226,072102,252,19918,017,59617,747,3322013960,032,7070.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2013187,264220,311102,194,79917,558,39617,295,0202014933,490,8490.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2014182,087214,220102,134,12017,072,96216,816,8672015890,509,4750.02965038690.02217751390.14968569450.00228617160.26929113380.305144550.06990215950.0196867709

2015173,703204,356102,035,85716,286,85916,042,5577,051,105,739

16,120,037128,960,299127,025,8947,051,105,739

yeartotal annual costCAPREOMYCINKANAMYCINCIPROFLOXACINOLFLOXACINPASETHIONAMIDECYCLOSERINPASERPROTHIONAMIDE

2008263,293,6780.200.020.010.010.040.060.330.320.011

2009328,728,4160.2030108020.02412497020.00563851960.0095782309

2010476,297,9880.2030108020.02412497020.00563851960.0095782309

2011470,351,3750.2030108020.02412497020.00563851960.0095782309

2012461,864,1850.2030108020.02412497020.00563851960.0095782309

2013450,093,0220.2030108020.02412497020.00563851960.0095782309

2014437,649,3780.2030108020.02412497020.00563851960.0095782309

2015417,498,3810.2030108020.02412497020.00563851960.0095782309

Country Projection Chart

5968907.013243024464546.060009626608218.651620930133164.6608322460228.24088014154210885.705251961428521.951818614071974.53263673963135.63911962

6181537.096609174623586.3665222827556081.926683931206596.9156325476622.92905482456142037.442292963616787.192790714573259.7949744104314.22666802

6424536.880436264805342.2097715528639327.379498432433346.2153557495359.25093031658349013.271908766117599.740547215146143.0316984265657.18299936

6702244.032713175013058.0226973629877291.484569633835310.6501315516771.65924705960871208.819303468975600.353049715800850.49584534450044.56078648

7019615.765358935250441.6367155331292072.521926435437515.9881089541242.37623034863753646.539704272241805.774320716549069.04394154660767.76718037

7382317.32294125521730.4683677232908925.042500237268562.3979655569208.21644870467047779.391763275974519.408905517404154.75224994901588.31707825

7796823.110132525831767.1593314734756710.674522739361134.9762603601168.38417295470812409.29866980240372.066878718381371.32942985176804.97805061

8270532.263080196186086.020002436868413.31806241752587.192796637693.38442278675114736.791960885115511.357214819498162.58139055491330.5054979

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

number of units

Intermediate Scenario: Country Projections

Chart4

46197

47842.6734774846

49723.3965292182

51872.7410047264

54329.0737806445

57136.2416287032

60344.3539025906

64010.6770150416

year

# of patients

Intermediate Scenario: Patients to be Treated as Projected by Countries

Chart1

5968907.013243024464546.06000968869406.217206977533291.165208063681825.9270411318070295.23508420476173.98393954690658.177545551321045.21303987

6181537.096609174623586.366522289185360.642227967801649.228908133812983.4324385918714012.480764321205595.73093024857753.264991341368104.74222267

6424536.880436264805342.209771559546442.459832798108336.553838923962874.0074425219449671.090636222039199.91351575048714.343899331421885.72766645

6702244.032713175013058.022697369959097.161523218458827.662532884134173.2739764720290402.939767822991866.78434995266950.165281781483348.18692883

7019615.765358935250441.6367155310430690.84064218859378.997027214329939.0098427921251215.513234724080601.92477365516356.347980521553589.25572679

7382317.32294125521730.4683677210969641.68083349317140.599491384553665.7315896322349259.797254425324839.80296855801384.917416621633862.77235942

7796823.110132525831767.1593314711585570.22484099840283.744065084809347.0733836323604136.432889726746790.68895966127123.77647661725601.6593502

8270532.263080196186086.020002412289471.106020710438146.7981995101547.0753822925038245.597320328371837.11907166499387.527130161830443.50183263

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

# of daily doses

Intermediate Scenario: Drug Needs

intermediate scenario

INTERMEDIATE SCENARIOETHIONAMIDE

This scenario uses projections made by countries predicting the number of patients that will be treated,# of MDR-TB Patients# of Units/PatientNeeded # of Units

including GLC and non-GLC approved programs. It assumes that their projections are correct.YEARto be treated(unit = 250 mg tab)

It has been calculated using ratios from past numbers of treated patients and past drug delivery

data (see drug unit ratio calculation spreadsheet).200846,1971,17354,210,88618,070,295

200947,8431,17356,142,03718,714,012

CAPREOMYCIN201049,7231,17358,349,01319,449,671

# of MDR-TB Patients# of Units/PatientNeeded # of Units201151,8731,17360,871,20920,290,403

YEARto be treated(unit = 1 g powder inj vial)201254,3291,17363,753,64721,251,216

201357,1361,17367,047,77922,349,260

200846,1971295,968,9075,968,907201460,3441,17370,812,40923,604,136

200947,8431296,181,5376,181,537201564,0111,17375,114,73725,038,246

201049,7231296,424,5376,424,537

201151,8731296,702,2446,702,244CYCLOSERIN

201254,3291297,019,6167,019,616# of MDR-TB Patients# of Units/PatientNeeded # of Units

201357,1361297,382,3177,382,317YEARto be treated(unit = 250 mg cap)

201460,3441297,796,8237,796,823

201564,0111298,270,5328,270,532200846,1971,33061,428,52220,476,174

200947,8431,33063,616,78721,205,596

KANAMYCIN201049,7231,33066,117,60022,039,200

# of MDR-TB Patients# of Units/PatientNeeded # of Units201151,8731,33068,975,60022,991,867

YEARto be treated(unit = 1 g powder inj vial)201254,3291,33072,241,80624,080,602

201357,1361,33075,974,51925,324,840

200846,197974,464,5464,464,546201460,3441,33080,240,37226,746,791

200947,843974,623,5864,623,586201564,0111,33085,115,51128,371,837

201049,723974,805,3424,805,342

201151,873975,013,0585,013,058

201254,329975,250,4425,250,442

201357,136975,521,7305,521,730

201460,344975,831,7675,831,767

201564,011976,186,0866,186,086

CIPROFLOXACINPASER

# of MDR-TB Patients# of Units/PatientNeeded # of Units# of MDR-TB Patients# of Units/PatientNeeded # of Units

YEARto be treated(unit = 500 mg tab)YEARto be treated(unit = 4 g granule)

200846,19757626,608,2198,869,406200846,19730514,071,9754,690,658

200947,84357627,556,0829,185,361200947,84330514,573,2604,857,753

201049,72357628,639,3279,546,442201049,72330515,146,1435,048,714

201151,87357629,877,2919,959,097201151,87330515,800,8505,266,950

201254,32957631,292,07310,430,691201254,32930516,549,0695,516,356

201357,13657632,908,92510,969,642201357,13630517,404,1555,801,385

201460,34457634,756,71111,585,570201460,34430518,381,3716,127,124

201564,01157636,868,41312,289,471201564,01130519,498,1636,499,388



YEARto be treated(unit = 200 mg tab)YEARto be treated(unit = 250 mg tab)

200846,19765230,133,1657,533,291200846,197863,963,1361,321,045

200947,84365231,206,5977,801,649200947,843864,104,3141,368,105

201049,72365232,433,3468,108,337201049,723864,265,6571,421,886

201151,87365233,835,3118,458,828201151,873864,450,0451,483,348

201254,32965235,437,5168,859,379201254,329864,660,7681,553,589

201357,13665237,268,5629,317,141201357,136864,901,5881,633,863

201460,34465239,361,1359,840,284201460,344865,176,8051,725,602

201564,01165241,752,58710,438,147201564,011865,491,3311,830,444

PAS

# of MDR-TB Patients# of Units/PatientNeeded # of Units

YEARto be treated(unit = 100 g granule)

200846,19710460,2283,681,826

200947,84310476,6233,812,983

201049,72310495,3593,962,874

201151,87310516,7724,134,173

201254,32910541,2424,329,939

201357,13610569,2084,553,666

201460,34410601,1684,809,347

201564,01110637,6935,101,547

Funding Chart

2004365.099388251499199.147756978935067.1243283210118747.6109594154545.11550043618204071.042396120627760.69958144725383.486477311330825.01395464

844487.222948598631648.6578830393764558.674957124263271.7324328365113.57409339577669812.952562428690971.696800361990917.71208765560708.585780156

1079770.45933008807632.7775288494813405.270290195451065.1572737483254.91718153429806705.4535746911112370.02297442545608.83107657716928.037234511

2846009.801084572128721.6932664812686954.396156814367669.2855413219439.51905679725848067.611091329289478.81967896709599.823157081889646.2697337

889579.946450596665376.5314450313965573.206407564490915.8319767568590.41579452718079354.678456599155039.799949582097225.89469453590648.502615724

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

number of units

Limited Scenario: Global Fund and UNITAID Funding

Chart7

15513

6536

8357

22027

6885

year

# of patients

Limited Scenario: Number of Patients to Be Funded for Treatmentby Global Fund and UNITAID

Chart2

2004365.099388251499199.147756972978355.708109442529686.902739851236360.924003496068023.68079876875920.23319381575127.82882577443608.337984881

844487.222948598631648.6578830391254852.891652371065817.93310821520908.5927471652556604.317520812896990.56560012663639.23736255186902.861926719

1079770.45933008807632.7775288491604468.423430061362766.28931844666039.3374522743268901.817858233704123.34099146848536.277025525238976.012411503

2846009.801084572128721.693266484228984.798718923591917.321385331755516.152454388616022.537030429763159.606559642236533.27438569629882.089911235

889579.946450596665376.5314450311321857.735469191122728.95799419548723.3263562172693118.22615223051679.93331653699075.298231511196882.834205241

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

# of daily doses

Limited Funding Scenario: Drug Needs

realistic funding scenario

GLOBAL FUND AND UNITAID SCENARIO (data only available through 2012)PAS

This scenario is the most realistic and most limited.# of MDR-TB Patients# of Units/PatientNeeded # of Units

It uses only the number of patients approved to be funded by the GF and UNITAID for the upcoming yearsYEARto be treated(unit = 100 g granule)

(and therefore includes only GLC programs). The data comes from GF and UNITAID proposals, and the scenario

assumes that the proposed numbers of patients will not be changed and that the number of patients proposed200815,51310154,5451,236,361

for a given year will be the same as the number treated that year. (so # of approved patients = # of enrolled patients)20096,5361065,114520,909

It has been calculated using ratios from past numbers of treated patients and past drug delivery data20108,3571083,255666,039

(see drug unit ratio calculation spreadsheet).201122,02710219,4401,755,516

20126,8851068,590548,723

CAPREOMYCIN

# of MDR-TB Patients# of Units/PatientNeeded # of UnitsETHIONAMIDE

YEARto be treated(unit = 1 g powder inj vial)# of MDR-TB Patients# of Units/PatientNeeded # of Units

YEARto be treated(unit = 250 mg tab)

200815,5131292,004,3652,004,365

20096,536129844,487844,487200815,5131,17318,204,0716,068,024

20108,3571291,079,7701,079,77020096,5361,1737,669,8132,556,604

201122,0271292,846,0102,846,01020108,3571,1739,806,7053,268,902

20126,885129889,580889,580201122,0271,17325,848,0688,616,023

20126,8851,1738,079,3552,693,118

KANAMYCIN

# of MDR-TB Patients# of Units/PatientNeeded # of UnitsCYCLOSERIN


YEARto be treated(unit = 250 mg cap)

200815,513971,499,1991,499,199

20096,53697631,649631,649200815,5131,33020,627,7616,875,920

20108,35797807,633807,63320096,5361,3308,690,9722,896,991

201122,027972,128,7222,128,72220108,3571,33011,112,3703,704,123

20126,88597665,377665,377201122,0271,33029,289,4799,763,160

20126,8851,3309,155,0403,051,680

CIPROFLOXACINPASER


YEARto be treated(unit = 500 mg tab)YEARto be treated(unit = 4 g granule)

200815,5135768,935,0672,978,356200815,5133054,725,3831,575,128

20096,5365763,764,5591,254,85320096,5363051,990,918663,639

20108,3575764,813,4051,604,46820108,3573052,545,609848,536

201122,02757612,686,9544,228,985201122,0273056,709,6002,236,533

20126,8855763,965,5731,321,85820126,8853052,097,226699,075



YEARto be treated(unit = 200 mg tab)YEARto be treated(unit = 250 mg tab)

200815,51365210,118,7482,529,687200815,513861,330,825443,608

20096,5366524,263,2721,065,81820096,53686560,709186,903

20108,3576525,451,0651,362,76620108,35786716,928238,976

201122,02765214,367,6693,591,917201122,027861,889,646629,882

20126,8856524,490,9161,122,72920126,88586590,649196,883

Chart6

180000

150000

120000

95000

67000

38000

12000

year

# of patients

Patients to be Treated from 2020-2050 (Extrapolated from the Global Plan)

Chart3

23256992.064067917395464.874379934558372.169129129352391.058671614345707.878593970408319.637965979782481.91677218276478.38513755147263.63935271

19380826.720056614496220.728649928798643.474274224460325.882226311954756.565494958673599.69830566485401.5973115230398.65428134289386.36612726

15504661.376045211596976.582919923038914.779419419568260.70578119563805.2523959446938879.75864453188321.27784812184318.9234253431509.09290181

12274523.58936929180939.7948116118239140.867040315491539.725417571345.8248134537159946.475593142107421.01162969645919.147711482716611.36521393

8656769.268291936474978.592130312863394.085175810925612.22739445339791.2659210726207541.198576229696812.71346516802911.398912311915925.91020351

4909809.435747663672375.917924657295656.346816136196615.8901643028538.3299253814863978.590237316842968.40465193858367.659084591086644.54608557

1550466.137604521159697.658291992303891.477941941956826.07057811956380.5252395944693887.97586445318832.12778481218431.8923425343150.909290181

Capreomycin

Kanamycin

Ciprofloxacin

Oflaxacin

PAS

Ethionamide

Cycloserin

PASER

Prothionamide

year

# of daily doses

Extrapolated Scenario: Drug Needs

2015-2050

OPTIMISTIC GLOBAL MARKET THROUGH 2050

This scenario is a vision-based extrapolation of the Global Plan numbers.

It is not based on any published numbers but instead assumes that the trend seen in the patient numbers stated in the Global Plan will continue past 2015.

It has been calculated using ratios from past numbers of treated patients and past drug delivery data (see drug unit ratio calculation spreadsheet).

EXTRAPOLATION GRAPHS:

USING TREND LINE

year# of MDR-TB patients to be treated

2020180,000

2025150,000

2030120,000

203595,000

204067,000

204538,000

205012,000

CAPREOMYCINETHIONAMIDE


YEARto be treated(unit = 1 g powder inj vial)YEARto be treated(unit = 250 mg tab)

2020180,00012923,256,99223,256,9922020180,0001,173211,224,95970,408,320

2025150,00012919,380,82719,380,8272025150,0001,173176,020,79958,673,600

2030120,00012915,504,66115,504,6612030120,0001,173140,816,63946,938,880

203595,00012912,274,52412,274,524203595,0001,173111,479,83937,159,946

204067,0001298,656,7698,656,769204067,0001,17378,622,62426,207,541

204538,0001294,909,8094,909,809204538,0001,17344,591,93614,863,979

205012,0001291,550,4661,550,466205012,0001,17314,081,6644,693,888

KANAMYCIN

# of MDR-TB Patients# of Units/PatientNeeded # of UnitsCYCLOSERIN


YEARto be treated(unit = 250 mg cap)

2020180,0009717,395,46517,395,465

2025150,0009714,496,22114,496,2212020180,0001,330239,347,44679,782,482

2030120,0009711,596,97711,596,9772025150,0001,330199,456,20566,485,402

203595,000979,180,9409,180,9402030120,0001,330159,564,96453,188,321

204067,000976,474,9796,474,979203595,0001,330126,322,26342,107,421

204538,000973,672,3763,672,376204067,0001,33089,090,43829,696,813

205012,000971,159,6981,159,698204538,0001,33050,528,90516,842,968

205012,0001,33015,956,4965,318,832

CIPROFLOXACIN


YEARto be treated(unit = 500 mg tab)PASER


2020180,000576103,675,11734,558,372YEARto be treated(unit = 4 g granule)

2025150,00057686,395,93028,798,643

2030120,00057669,116,74423,038,9152020180,00030554,829,43518,276,478

203595,00057654,717,42318,239,1412025150,00030545,691,19615,230,399

204067,00057638,590,18212,863,3942030120,00030536,552,95712,184,319

204538,00057621,886,9697,295,656203595,00030528,937,7579,645,919

205012,0005766,911,6742,303,891204067,00030520,408,7346,802,911

204538,00030511,575,1033,858,368

OFLAXACIN205012,0003053,655,2961,218,432


YEARto be treated(unit = 200 mg tab)

PROTHIONAMIDE

2020180,000652117,409,56429,352,391# of MDR-TB Patients# of Units/PatientNeeded # of Units

2025150,00065297,841,30424,460,326YEARto be treated(unit = 250 mg tab)

2030120,00065278,273,04319,568,261

203595,00065261,966,15915,491,5402020180,0008615,441,7915,147,264

204067,00065243,702,44910,925,6122025150,0008612,868,1594,289,386

204538,00065224,786,4646,196,6162030120,0008610,294,5273,431,509

205012,0006527,827,3041,956,826203595,000868,149,8342,716,611

204067,000865,747,7781,915,926

PAS204538,000863,259,9341,086,645

# of MDR-TB Patients# of Units/PatientNeeded # of Units205012,000861,029,453343,151

YEARto be treated(unit = 100 g granule)

2020180,000101,793,21314,345,708

2025150,000101,494,34511,954,757

2030120,000101,195,4769,563,805

203595,00010946,4187,571,346

204067,00010667,4745,339,791

204538,00010378,5673,028,538

205012,00010119,548956,381

Extrapolation

128876.432769021

160905.289993208

233137.332128487

230226.596448156

226072.304745941

220310.580522197

214219.692094827

204356.224507722

year

# of MDR-TB patients to be treated

Global Plan Numbers(2008-2015)

Extrapolation 2

233137.332128487

230226.596448156

226072.304745941

220310.580522197

214219.692094827

204356.224507722

year


Subset of Global Plan Numbers(2010 - 2015)

Extrapolation 3

233137.332128487

230226.596448156

226072.304745941

220310.580522197

214219.692094827

204356.224507722

year


Extrapolated Global Plan Numbers(2010-2050)

drug unit ratio calculation

to determine the units per patient ratios each year for each drug:YEAR# of MDR-TB Patients# of PAS UnitsUnits/Patient for

the total number of units of a specific drug delivered to GLC programs during a given yearTreated Through GLCDelivered to All ProgramsPAS

has been divided by the total number of patients treated through the GLC during that year200395639,71142

to determine the units per patient ratio to be used for future years:20041,2445,1924

the median of the 2003-2006 ratios has been calculated and is used for all future years20052,08317,9469

20062,02522,90111

The drug delivery data has been compiled from the Procurement Summary Reportsmedian10

in the GLC Drug Monitoring Database.

We assume that the drugs delivered in a specific year went towards treatment during that year.YEAR# of MDR-TB Patients# of Ethionamide UnitsUnits/Patient for

Treated Through GLCDelivered to All ProgramsEthionamide

YEAR# of MDR-TB Patients# of Capreomycin UnitsUnits/Patient for20039561,467,3001,535

Treated Through GLCDelivered to All ProgramsCapreomycin20041,2441,257,0001,010

2003956137,74514420052,0831,302,700625

20041,244172,80813920062,0252,706,4001,336

20052,083248,914119median1,173

20062,025222,902110

median129YEAR# of MDR-TB Patients# of Cycloserin UnitsUnits/Patient for

Treated Through GLCDelivered to All ProgramsCycloserin

YEAR# of MDR-TB Patients# of Kanamycin UnitsUnits/Patient for20039561,615,9401,690

Treated Through GLCDelivered to All ProgramsKanamycin20041,2441,161,190933

2003956104,25010920052,0832,018,640969

20041,24452,2004220062,0253,675,0001,815

20052,083176,41085median1,330

20062,025219,900109

median97YEAR# of MDR-TB Patients# of PASER UnitsUnits/Patient for

Treated Through GLCDelivered to All ProgramsPASER

YEAR# of MDR-TB Patients# of Ciprofloxacin UnitsUnits/Patient for2003956113,190118

Treated Through GLCDelivered to All ProgramsCiprofloxacin20041,244348,690280

2003956870,50091120052,083717,440344

20041,2441,029,90082820062,025666,060329

20052,083675,000324median305

20062,025530,000262

median576YEAR# of MDR-TB Patients# of Prothionamide UnitsUnits/Patient for

Treated Through GLCDelivered to All ProgramsProthionamide

YEAR# of MDR-TB Patients# of Oflaxacin UnitsUnits/Patient for200395600

Treated Through GLCDelivered to All ProgramsOflaxacin20041,24477,00062

2003956638,20066820052,083228,460110

20041,244792,40063720062,0251,038,300513

20052,083745,800358median86

20062,0252,483,3601,226

median652

total units/patient

4,358

Capreomycin0.0297

Kanamycin0.0222

Ciprofloxacin0.1322

Oflaxacin0.1497

PAS0.0023

Ethionamide0.2693

Cycloserin0.3051

PASER0.0699

Prothionamide0.0197

drug unit ratio calculation

144.0847280335

138.9131832797

119.4978396543

110.0750617284

year

units/patient

Capreomycin

y = -12.144x + 24472

Capreo

4.1736334405

8.6154584734

11.3091358025

year

units/patient

PAS

y = 3.5678x - 7145.3

Kanamycin

118.39958159

280.2974276527

344.4263082093

328.9185185185

year

units/patient

PASER

y = 69.569x - 139182

Cipro

0

61.8971061093

109.6783485358

512.7407407407

year

units/patient

Prothionamide

y = 158.6x - 317743

Oflaxacin

0.0296503869

0.0221775139

0.1321756189

0.1496856945

0.0022861716

0.2692911338

0.30514455

0.0699021595

0.0196867709

Drug Delivery Data:Proportion of Each Drug in the Total Number of Drugs per Patient

PAS

16651545.41196945968907.013243022004365.09938825

20789850.29132546181537.09660917844487.222948598

30122628.23972326424536.880436261079770.45933008

29746545.14740076702244.032713172846009.80108457

29209787.76323267019615.76535893889579.946450596

28465341.23797187382317.32294122013

27678364.88342477796823.110132522014

26403950.50899428270532.263080192015

Global Plan

Country Projections

GF and UNITAID funding (data not available for 2013-2015)

# of units needed

Demand for Capreomycin(unit = 1 g powder inj. vial)

Ethionamide

12454808.10760494464546.06000961499199.14775697

15550124.00099314623586.36652228631648.657883039

22530734.84415414805342.20977155807632.777528849

22249437.06478855013058.022697362128721.69326648

21847960.20154515250441.63671553665376.531445031

21291138.69404525521730.46836772

20702506.27353365831767.15933147

19749286.25158316186086.0200024

Global Plan

Country Projections

GF and UNITAID funding (data not available for 2013-2015)

year

# of units needed

Demand for Kanamycin(unit = 1 g powder inj. vial)

Cycloserin

74229328.791025926608218.65162098935067.12432832

92677081.59278227556081.92668393764558.67495712

134280778.17023528639327.37949844813405.27029019

132604273.38812129877291.484569612686954.3961568

130211514.07571631292072.52192643965573.20640756

126892917.24138332908925.04250022013

123384730.75615434756710.67452272014

117703641.02693236868413.3180622015

Global Plan

Country Projections

GF and UNITAID Funding (data not available for 2013-2015)

year

# of units needed

Demand for Ciprofloxacin(unit = 500 mg tab)

PASER

84062921.175175430133164.660832210118747.6109594

104954555.4508831206596.91563254263271.73243283

152069736.5113532433346.21535575451065.15727374

150171135.35673933835310.650131514367669.2855413

147461393.25417835437515.98810894490915.83197675

143703162.53001137268562.39796552013

139730226.10745739361134.97626032014

133296529.26720741752587.1927962015

Global Plan

Country Projections


year

# of units needed

Demand for Oflaxacin(unit = 200 mg tab)

Prothionamide

1283905.31731918460228.240880141154545.115500436

1602986.30997431476622.92905482465113.5740933957

2322583.37660416495359.25093031683254.9171815342

2293585.76286679516771.659247059219439.519056797

2252199.47453175541242.37623034868590.4157945271

2194799.46578811569208.2164487042013

2134120.22544078601168.3841729542014

2035857.43052787637693.3844227862015

Global Plan

Country Projections


year

# of units needed

Demand for PAS(unit = 100 g granule)

151232884.53670154210885.705251918204071.0423961

188817851.48802356142037.44229297669812.95256242

273580130.00075258349013.27190879806705.45357469

270164463.19804660871208.819303425848067.6110913

265289518.23073163753646.53970428079354.67845659

258528296.21721267047779.39176322013

251380809.2293270812409.2986692014

239806306.2524675114736.79196082015

Global Plan

Country Projections


year

# of units needed

Demand for Ethionamide(unit = 250 mg tab)

171368027.78154161428521.951818620627760.6995814

213957056.48660163616787.19279078690971.69680036

310004583.07775866117599.740547211112370.0229744

306134154.46474968975600.353049729289478.8196789

300610159.42126672241805.77432079155039.79994958

292948748.44309675974519.4089055

284849645.17953380240372.0668787

271734113.10611885115511.3572148

Global Plan

Country Projections


year

# of units needed

Demand for Cycloserin(unit = 250 mg cap)

39256788.964277314071974.53263674725383.48647731

49013034.243585914573259.7949741990917.71208765

71015490.190248715146143.0316982545608.83107657

70128856.894475115800850.49584536709599.82315708

68863426.519456916549069.04394152097225.89469453

67108359.382184117404154.7522499

65253026.204032118381371.3294298

62248535.334728219498162.5813905

Global Plan

Country Projections


year

# of units needed

Demand for PASER(unit = 4 g granule)

11056016.27269113963135.639119621330825.01395464

13803699.14269244104314.22666802560708.585780156

20000321.87734434265657.18299936716928.037234511

19750616.47849214450044.560786481889646.2697337

19394229.23472414660767.76718037590648.502615724

18899944.00810994901588.317078252013

18377420.53255065176804.978050612014

17531256.06473335491330.50549792015

Global Plan

Country Projections

GF and UNITAID Funding (data available for 2013-2015)

year

# of units needed

Demand for Prothionamide(unit = 250 mg tab)

GF Round 9- 2.38 billion USD is the total requested for TB- 44/48 proposals have an MDR component

Proportion of GLC-enrolled MDR-TB casesin 2007Estimated MDR total Estimated MDR SS+ Reported MDR cases

New multi-year Agreement to be signed with USAID for US$ 15M p.a. making USAID main GDF donorCIDA, Netherlands and Norway continue to be donorsUS$ 71M for MDR-TB drugs from UNITAID over 5 yearsUS$ 11M from UNITAID for Paediatric Grants over 4 yearsGDF to supply new Diagnostic Tools funded by UNITAID in partnership with FIND and GLI over 5 yearsDirect Procurement

External evaluation of STB Partnership/GDF gives GDF strong vote of confidence & confirmation of mandate for 2008 2012GDF retains ISO 9001:2000 certificationGDF Funding Horizon

GDF competitively & transparently contracts its procurement agentsThe Procurement Agent contracts manufacturers through Limited International Competitive BiddingGDF Quality Assurance Process fully compliant with Global Fund requirementsBulk procurement, standardization and prompt payment policy secure low pricesProducts supplied by GDF are registered by the National Regulatory Authority where requiredGDF adheres to Interagency Operational Principles for Good Pharmaceutical Procurement, WHO Manual on Procurement of Goods and Services

Procurement

GUIDING PRINCIPLESIntegrity

Competition

Equal treatment

WHO / GDF objectives

Customer ServiceTransparent and fairCompetitive tendering

Same conditions

Meets programme objectives

Customer satisfaction while best value for moneySame as UN guiding principlesAdded by WHO / GDF

All anti-TB Drugs supplied by GDF are subject to GDF's new Quality Assurance Policy, effective July 2009:

Option A: WHO Prequalification (PQ)Option B: Stringent (Strict) National Drug Regulatory Authority approvalOption C: Interim Assessment & Approval Process

Note:Products shall be found acceptable to the GDF where they are (i) manufactured at a site meeting the standards defined in options A or B and (ii) approved through an Expert Review Committee in an Interim Assessment & Approval Process which assesses products based on the information provided in a Pharmaceutical Product Questionnaire (PPQ) under the condition that the product approval process described under either options A or B (ii) is pending.GDF Quality Assurance Policy

PQ website: http://mednet3.who.int/prequal/ GDF Quality Assurance Policy: WHO Prequalification Programme

GIVEN DRUG PRE-QUALIFICATION PIPELINE, THERE SHOULD SOON BE MORE QUALITY-ASSURED SUPPLIERS PER 1ST LINE DRUG

Drug

Pre-qualified suppliers2007

*

*

*

*

*

*

*

There are currently 13 pre-qualified drugs for 1st line TB35 dossiers are currently being reviewed by WHO. Based on historical success rates, 15 to 20 new products are expected to be pre-qualified within 2 yearsUNITAID supports up to 50% of WHO pre-qualification budget

*Dosing unknown

Dossiers submitted*2007

Drugs currently supplied by GDF

4

GDF Procurement MechanismWHO (legal entity)Stop TB Partnership/GDFControl Agent/PSI (Sampling)Laboratory/Quality AssuranceClient (National TB Programme)Procurement AgentsSuppliers/Manufacturers Freight Forwarders & InsuranceLICBLICBGDFOrder Management System

Supplier/Product SourcingTrade fairsUN Global Marketplace (www.ungm.org)Publications, journals, Chambers of Commerce, business seminarsDatabasesPrevious tenders, recommendations (e.g. FIND)Procurement AgentOther market research (internet)Approaches by suppliersExpressions of Interest (every 2 3 years; last: September 2008; now rolling submissions with window for entry every 12 months), advertisements

ITB/RFP ELEMENTS

Cover Letter - pages 1 and 2Section 1: Instructions to Bidders page 3Section 2: Bid Data Sheet page 6Section 3: Bid Submission Form page 8Section 4: Special Contract Conditions page 9Annex 1: Price Schedule Form/Delivery ScheduleAnnex 2: Packing and Delivery Schedule SheetAnnex 3: General Purchase ConditionsAnnex 4: Standard Operational Procedures (to be sent electronically)Annex 5. Long Term Agreement (LTA)Annex 6. Data Sheet for SuppliersAnnex 7: Code of ConductAnnex 8: Product Specifications (CD ROM)Annex 9: Any other specific P.A. requirementsPublic Bid opening, consensus-based Evaluation Committee, recourse facility

First Line TB Drugs LTAAward CriteriaTechnical / quality compliance Currently, 6 - 7 suppliers are competing for 18 products(52 short listings)

Evaluation Criteria Point Value

A.Price (ex-works)70B.Statement of undertaking regarding PFSCMs requirements for Stock Pile Management10C.Guaranteed maximum lead time for fresh production per line < 90 days4D.Pre-qualification status per formulation WHO PQ/ SRA4E.Statement of undertaking registrations5F.Total number of months shelf-life per formulation 7Total Points 100

First Line TB Drugs LTAs Realisable volume bandwidths

2 IQC AwardsMinimum Maximum 1. 40 %80 %2. 20 %60%

3 IQC AwardsMinimum Maximum 1. 35 %75 %2. 15 %55 %3. 10 %50 %

4 IQC AwardsMinimum Maximum 1.30 %75 %2. 15 %60 %3. 10 %55 %4. 0 %45 %

First Line TB DrugsIndividual RFQ Competitions RFQ awards based on best value, including:

Price (IQC or lower)Lead timeRegistrationVendor Performance

MDR TB Drugs:Procurement Challenges butGrowth Area and High-Profile Market -> WHO/GLC/GDF Price Negotiation Task Force-> Direct Contracts with Suppliers

High level of prices leads to constraints in country planning and increased donor vigilanceLimited number of products, increasing number of suppliers; changing production capacity / production on demandForecasting poses a challenge (variations in treatment regimes; dependency on first-line TB treatment success, diagnostics)Volatility of demand; DF Strategic Rotating StockpileRegistration issues (regulations, fast track / waiver, supplier representation, costs)Short expiry dates: 24, 36 monthsCold chain needed for PASERDisbursement of funds, delays; GDF Strategic Revolving FundMDR Treatment Scale Up through breakthrough in DiagnosticsProfile: High media and public awareness

GDF Staffing19 Staff at HQ and 4 in the regionsGDF staff divided into sub teams:Susceptible TB: 4MDR-TB: 3QA: 1Applications and Review, Monitoring: 5Others: data management, business coordination, GDF Manager, technical assistance (TB Team), administrative (2)

Thank YouFor Your Attention

Q & A

TB BasicsGrants: FLD, SLD (Unitaid)

DP: SLD, FLD

Paediatrics: FLD,Grants ( financed by UNITAID), DP

Diagnostics: Standard and Advanced (New) Diagnosics

TA: Missions for in-country drug management monitoring and training

Programme and Procurement Cycle

GDF operates through Procurement Agents (currently 3). Lean team attending to core business.

Procurement and Supply Management involves planning, selection and quantification, purchasing, transportation, distribution / storage, use, monitoring.

1 global drug facility: procurement arm of the stop tb partnership john loeber procurement team...

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