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WHO Global Price Reporting Mechanism, the importance of data registration for the regulation of antiretrovirals (ARV) and PSM issues related to access to treatment. Boniface Dongmo Nguimfack & Vincent Habiyambere HIV/Technology and Commodities World Health Organization October 2012. - PowerPoint PPT Presentation
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WHO Global Price Reporting Mechanism, the importance of data registration for the regulation of
antiretrovirals (ARV) and PSM issues related to
access to treatment
WHO Global Price Reporting Mechanism, the importance of data registration for the regulation of
antiretrovirals (ARV) and PSM issues related to
access to treatment
Boniface Dongmo Nguimfack & Vincent Habiyambere HIV/Technology and Commodities
World Health Organization
October 2012
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Objectives Collect, consolidate, analyse and disseminate strategic
information regarding affordability, accessibility, and availability of HIV, TB and Malaria medicines and diagnostics: data on price, API and registration
In-house Products related to strategic information (next slide)
AMDS Strategic Information & Clearing house
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AMDS Clearing House: AMDS Information Platform
Global Price
Repor-ting
Mecha-nism
API
Regula-tory
status
OpioïdSub-
stitution
Therapy data-base
HTM H HT
HTM
H H
H
HTM
H
Fore-casting portal
(surveys, back-
ground, papers)
Treat-ment
guide-linesrepo-sitory
PQ
(EMP)
Corpo-rate
Pricing Policies(MSF)
Capacity building tools: PSM
Toolbox
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Drug Regulatory Databasehttp://apps.who.int/hiv/amds/patents_registration/drs/
Drug Regulatory Databasehttp://apps.who.int/hiv/amds/patents_registration/drs/
WHY
Limited access to information on ARV marketing authorizations by countries
Inform stakeholders and WHO management team in making strategic decision and advocacy
Inform state and non state procurement officers, donation programmes, countries using the GFATM grant on options (A and B) on which drug is registered and where
How
Collect regulatory information and make it available in the public domain
Contributors: all R&D and generic ARV producers and AMDS partners (SCMS, UNICEF, MissionPharma)
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The Global Price Reporting Mechanism [GPRM] and Improvements currently being implemented
http://apps.who.int/hiv/amds/price/hdd/
The Global Price Reporting Mechanism [GPRM] and Improvements currently being implemented
http://apps.who.int/hiv/amds/price/hdd/
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Our ObjectiveOur Objective
Promote access to life saving medicines and technologies
Work with all concerned parties to remove or minimize obstacles to old and new commodities adoption and sustainable implementation
Provide countries with reliable data to make their owned decision (informed)
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Current situationGPRM Sources (2002-2012): GPRM Sources (2002-2012):
Source Active Duplicate rate
Automatic Generation
% GPRM Records
CHAI Yes Low Yes 1.07% 548
GDF Yes Low No 6.19% 3,177
GF Yes High Yes 26.19% 13,445
IDA Yes High Yes 11.70% 6,004
JSI No - Yes 0.36% 186
MP Yes High Yes 8.94% 4,591
MSH No - Yes 0.36% 183
PEPFAR Yes High Yes 21.27% 10,921
UNICEF Yes High Yes 13.71% 7,038
UNITAID Yes Med Yes 9.53% 4,890
WHO Yes Low No 0.24% 123
WHO/CPS Yes Low No 0.45% 230
total 100% 51,336
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Current View
Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
IN Name
Current SelectionsIN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)Strength 30 mg + 50 mg + 60 mg
Manufacturer Matrix Laboratories Ltd.Generic generic
30 mg + 50 mg + 60 mg
150 mg + 200 mg + 300 mg
Strength
Matrix Laboratories Ltd.
Manufacturer
generic
Generic
East Asia and Pacific
Latin America and the Caribbean
South Asia
Sub-Saharan Africa
RegionLow income
Lower-middle income
Upper-middle income
Income LevelLow
Medium
n/a
HDI Group
Treatment Cost per Year Number of Treatment Years of Formulation
Data2008 2009 2010 2011 2012
Median treatment cost per yea 105.36 109.37 104.13 101.48 103.42Number of treatment years of
4,382 11,550 34,784 113,487 7,636Number of transcations 12 18 52 57 4
Data for 2011-2012 is provisional
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Current View
Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF)
IN Name
Treatment Cost per Year Number of Treatment Years of Formulation
Current SelectionsIN Name Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF)Strength 600 mg + 300 mg + 300 mgManufacturer Matrix Laboratories Ltd.Generic generic
600 mg + 300 mg + 300 mg
Strength
Matrix Laboratories Ltd.
Manufacturer
generic
Generic
Benin
Bolivia
Democratic Republic of the Congo
More...
Country
Data for 2011-2012 is provisional
Data2010 2011 2012
Median treatment cost per yea 197.63 172.40 164.86Number of treatment years of
14,342152,340 17,957Number of transcations 7 44 4
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Current View
Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
IN Name
Current SelectionsIN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)Strength 150 mg + 200 mg + 300 mg
Manufacturer Apotex Inc.; Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Hetero Drugs Ltd.; Matrix Laboratories Ltd.; Micro Labs Generic generic
150 mg + 200 mg + 300 mg
30 mg + 50 mg + 60 mg
Strength
Apotex Inc.
Aspen Pharmacare Ltd.
Aurobindo Pharma Ltd.
More...
Manufacturer
generic
Generic
East Asia and Pacific
Latin America and the Caribbean
South Asia
Sub-Saharan Africa
RegionHigh income
Low income
Lower-middle income
Upper-middle income
Income LevelLow
Medium
n/a
HDI Group
Treatment Cost per Year Number of Treatment Years of Formulation
Data2004 2005 2006 2007 2008 2009 2010 2011 2012
Median treatment cost per yea 231.05 259.51 221.45 190.85 148.78 136.79 130.83 128.26 129.24Number of treatment years of
470 570 7,601 74,834 207,259 490,876 1,104,634 536,493 72,990Number of transcations 4 4 4 42 118 123 251 131 16
Data for 2011-2012 is provisional
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Current View
Lopinavir (LPV) + Ritonavir (RTV)
IN Name
Current SelectionsIN Name Lopinavir (LPV) + Ritonavir (RTV)Strength 200 mg + 50 mg
Manufacturer Abbott Laboratories Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Matrix Laboratories Ltd.; Not ProvidedGeneric originator; generic
200 mg + 50 mg
100 mg + 25 mg
133.3 mg + 33.3 mg
80 mg + 20 mg/ml
Strength
Abbott Laboratories Ltd.
Aurobindo Pharma Ltd.
Cipla Ltd.
More...
Manufacturer
originator
generic
Generic
East Asia and Pacific
Europe and Central Asia
Latin America and the Caribbean
More...
RegionHigh income
Low income
Lower-middle income
Upper-middle income
Income LevelHigh
Low
Medium
n/a
HDI Group
Treatment Cost per Year Number of Treatment Years of Formulation
Data2005 2006 2007 2008 2009 2010 2011 2012
Median treatment cost per yea1,492.25 460.11 500.05 500.05 495.73 442.01 403.49 371.82Number of treatment years of
224 1,897 59,424 88,871 105,780 176,595 133,714 24,936Number of transcations 2 11 213 376 325 463 244 19
Data for 2011-2012 is provisional
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Multi-partner approachMulti-partner approach
Nairobi, 5-7 September 2011 1. CHAI2. Global Fund3. STB/GDF4. ESTHER5. Grant Management Service
(GMS), 6. MSH/SPS7. SCMS8. PEPFAR 9. i+solutions10.JSI/DELIVER11. UNDP12.UNICEF13.UNITAID14.WHO. (HQ, RO, CO)
Bangkok, 8-10 February 2012 1. Global Fund 2. Medicine Patent Pool-MPP 3. MSH/SIAPS 4. MSH/GMS Project5. PEPFAR/SCMS-Vietnam6. STB/GDF7. UNDP8. UNITAID 9. i+solutions 10.UNAIDS11. WHO (HQ, RO, CO)
128 participants (25 countries: AFRO & EMRO)
96 participants (20 countries: SEARO & WPRO)
Leading PSM Challenges (Bangkok)
0 2 4 6 8 10 12 14
Countries per PSM area
Inventory management
Funding
Lead time
Management and M & E
Quantification
Procurement
Use
Distribution
Overstock
Stock-out
No. of countries (n=19)
PSM
are
a
Leading PSM Challenges (Nairobi)
0 3 6 9 12 15 18 21
Countries per PSM areaManagement/ Monitor & Evaluation
Quantification
Inventorymanagement/ LMIS
Distribution
Price and procurement
Funding
Lead time
Storage
Use
Human resources
Quality assurance
Stock-out
Overstock
No. of countries (n=23)
PSM
are
a
Needs for Technical Assistance
0 2 4 6 8 10 12 14
No. of countries per TA
Inventory Management LMISQuantificationStorageMonitor & EvaluationQuality AssuranceDistributionPrice and ProcurementHuman ResourcesSelection & Rational Use
No. of countries (n=17)
PSM
are
a
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URL for the different databasesURL for the different databases Global Price Reporting Mechanism (GPRM):
http://www.who.int/hiv/amds/price/hdd/
The Drug Regulatory Status Database:
http://www.who.int/hiv/amds/patents_registration/drs/
PSM Toolbox website: http://psmtoolbox.org/en/
SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS
http://www.who.int/hiv/amds/api.pdf
Controlled Medicines:
http://www.who.int/entity/hiv/amds/ControlledMedicineDatabase.xls
Forecasting antiretroviral demand:
http://www.who.int/hiv/amds/forecasting/en/index.html
Prequalification Project : http://apps.who.int/prequal/
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ContactsContacts
Boniface Dongmo Nguimfack: [email protected] – Global Price Reporting Mechanism (GPRM)– The Drug Regulatory Status Database– SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS– Controlled Medicines– Summary report from the Global Price Reporting Mechanism
Vincent Habiyambere: [email protected]– PSM Toolbox– PSCM system strengthening– ARV use survey – Global ARV demand forecasts– Early warning indicators to prevent stock-out and overstock
