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Boniface Dongmo Nguimfack & Vincent Habiyambere HIV/Technology and Commodities

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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Boniface Dongmo Nguimfack & Vincent Habiyambere HIV/Technology and Commodities

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  1. 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

  2. AMDS Strategic Information & Clearing house 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)

  3. AMDS Clearing House: AMDS Information Platform PQ (EMP) Regula-tory status Fore-casting portal (surveys, back-ground, papers) Treat-ment guide-lines repo-sitory API Global Price Repor-ting Mecha-nism Opioïd Sub-stitution Therapy data-base Capacity building tools: PSM Toolbox HTM Corpo- rate Pricing Policies (MSF) HTM HTM H H H HT H H

  4. 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)

  5. The Global Price Reporting Mechanism [GPRM] and Improvements currently being implementedhttp://apps.who.int/hiv/amds/price/hdd/

  6. Our Objective

  7. GPRM Sources (2002-2012): Current situation

  8. Current View IN Name Strength Generic Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV) 30 mg + 50 mg + 60 mg generic 150 mg + 200 mg + 300 mg Region Income Level HDI Group Manufacturer East Asia and Pacific Low income Low Matrix Laboratories Ltd. Latin America and the Caribbean Lower-middle income Medium South Asia Upper-middle income n/a Sub-Saharan Africa Current Selections IN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV) Strength 30 mg + 50 mg + 60 mg Manufacturer Matrix Laboratories Ltd. Generic generic Number of Treatment Years of Formulation Treatment Cost per Year Data for 2011-2012 is provisional Data 2008 2009 2010 2011 2012 Median treatment cost per yea 105.36 109.37 104.13 101.48 103.42 Number of treatment years of 4,382 11,550 34,784 113,487 7,636 Number of transcations 12 18 52 57 4

  9. Current View IN Name Strength Generic Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF) 600 mg + 300 mg + 300 mg generic Country Manufacturer Benin Matrix Laboratories Ltd. Bolivia Democratic Republic of the Congo More... Current Selections IN Name Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF) Strength 600 mg + 300 mg + 300 mg Manufacturer Matrix Laboratories Ltd. Generic generic Number of Treatment Years of Formulation Treatment Cost per Year Data for 2011-2012 is provisional Data 2010 2011 2012 Median treatment cost per yea 197.63 172.40 164.86 Number of treatment years of 14,342 152,340 17,957 Number of transcations 7 44 4

  10. Current View IN Name Strength Generic Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV) 150 mg + 200 mg + 300 mg generic 30 mg + 50 mg + 60 mg Region Income Level HDI Group Manufacturer East Asia and Pacific High income Low Apotex Inc. Latin America and the Caribbean Low income Medium Aspen Pharmacare Ltd. South Asia Lower-middle income n/a Aurobindo Pharma Ltd. Sub-Saharan Africa Upper-middle income More... Current Selections IN 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 Number of Treatment Years of Formulation Treatment Cost per Year Data for 2011-2012 is provisional Data 2004 2005 2006 2007 2008 2009 2010 2011 2012 Median treatment cost per yea 231.05 259.51 221.45 190.85 148.78 136.79 130.83 128.26 129.24 Number of treatment years of 470 570 7,601 74,834 207,259 490,876 1,104,634 536,493 72,990 Number of transcations 4 4 4 42 118 123 251 131 16

  11. Current View IN Name Strength Generic Lopinavir (LPV) + Ritonavir (RTV) 200 mg + 50 mg originator 100 mg + 25 mg generic 133.3 mg + 33.3 mg 80 mg + 20 mg/ml Region Income Level HDI Group Manufacturer East Asia and Pacific High income High Abbott Laboratories Ltd. Europe and Central Asia Low income Low Aurobindo Pharma Ltd. Latin America and the Caribbean Lower-middle income Medium Cipla Ltd. More... Upper-middle income n/a More... Current Selections IN Name Lopinavir (LPV) + Ritonavir (RTV) Strength 200 mg + 50 mg Manufacturer Abbott Laboratories Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Matrix Laboratories Ltd.; Not Provided Generic originator; generic Number of Treatment Years of Formulation Treatment Cost per Year Data for 2011-2012 is provisional Data 2005 2006 2007 2008 2009 2010 2011 2012 Median treatment cost per yea 1,492.25 460.11 500.05 500.05 495.73 442.01 403.49 371.82 Number of treatment years of 224 1,897 59,424 88,871 105,780 176,595 133,714 24,936 Number of transcations 2 11 213 376 325 463 244 19

  12. Multi-partner approach

  13. Leading PSM Challenges (Bangkok)

  14. Leading PSM Challenges (Nairobi)

  15. Needs for Technical Assistance

  16. URL for the differentdatabases • Global Price ReportingMechanism (GPRM): • http://www.who.int/hiv/amds/price/hdd/ • The Drug RegulatoryStatusDatabase: • http://www.who.int/hiv/amds/patents_registration/drs/ • PSM Toolboxwebsite: http://psmtoolbox.org/en/ • SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS • http://www.who.int/hiv/amds/api.pdf • ControlledMedicines: • 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/

  17. Contacts • Boniface Dongmo Nguimfack: dongmonguimfackb@who.int • Global Price ReportingMechanism (GPRM) • The Drug RegulatoryStatusDatabase • SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS • ControlledMedicines • Summary report from the Global Price ReportingMechanism • Vincent Habiyambere: habiyamberev@who.int • PSM Toolbox • PSCM system strengthening • ARV use survey • Global ARV demandforecasts • Early warning indicators to preventstock-out and overstock

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