WHO Global Price Reporting Mechanism the importance of data registration for the regulation of antiretrovirals (ARV) and access to treatment

Transcription

1 WHO Global Price Reporting Mechanism the importance of data registration for the regulation of antiretrovirals (ARV) and access to treatment Boniface Dongmo Nguimfack HIV/Technology and Commodities 1

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) 2

3 AMDS Clearing House: AMDS Information Platform Capacity building tools: PSM Toolbox HTM A P I Global Price Reporting Mechanism Regulatory status HTM H HT H Opioïd Substitution Therapy database Forecasting portal (surveys, background, papers) H Treatment guidelines repository H PQ (EMP) HTM Corporate Pricing Policies (MSF) H 3

4 Drug Regulatory Database 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) 4

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7 7 The Global Price Reporting Mechanism [GPRM] and Improvements currently being implemented

8 Our 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) 8

9 GPRM Sources ( ): Current situation 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 9

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

12 IN Name Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF) Strength 600 mg mg mg Generic generic Current View Country Benin Bolivia Democratic Republic of the Congo More... Manufacturer Matrix Laboratories Ltd. Current Selections IN Name Strength Manufacturer Generic Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF) 600 mg mg mg Matrix Laboratories Ltd. generic Treatment Cost per Year Number of Treatment Years of Formulation Data for is provisional Data Median treatment cost per yea Number 12 of treatment years of 14, ,340 17,957 Number of transcations

13 IN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV) Current View Strength 150 mg mg mg 30 mg + 50 mg + 60 mg Generic generic Region East Asia and Pacific Latin America and the Caribbean South Asia Sub-Saharan Africa Income Level High income Low income Lower-middle income Upper-middle income HDI Group Low Medium n/a Manufacturer Apotex Inc. Aspen Pharmacare Ltd. Aurobindo Pharma Ltd. More... Current Selections IN Name Strength Manufacturer Generic Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV) 150 mg mg mg Apotex Inc.; Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Hetero Drugs Ltd.; Matrix Laboratories Ltd.; Micro Labs generic Treatment Cost per Year Number of Treatment Years of Formulation Data for is provisional Data Median treatment cost per yea Number 13 of treatment years of ,601 74, , ,876 1,104, ,493 72,990 Number of transcations

14 IN Name Lopinavir (LPV) + Ritonavir (RTV) Current View Strength 200 mg + 50 mg 100 mg + 25 mg mg mg 80 mg + 20 mg/ml Generic originator generic Region East Asia and Pacific Europe and Central Asia Latin America and the Caribbean More... Income Level High income Low income Lower-middle income Upper-middle income HDI Group High Low Medium n/a Manufacturer Abbott Laboratories Ltd. Aurobindo Pharma Ltd. Cipla Ltd. More... Current Selections IN Name Strength Manufacturer Generic Lopinavir (LPV) + Ritonavir (RTV) 200 mg + 50 mg Abbott Laboratories Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Matrix Laboratories Ltd.; Not Provided originator; generic Treatment Cost per Year Number of Treatment Years of Formulation Data for is provisional Data Median treatment cost per yea 1, Number 14 of treatment years of 224 1,897 59,424 88, , , ,714 24,936 Number of transcations

15 15 URL for the different databases Global Price Reporting Mechanism (GPRM): The Drug Regulatory Status Database: PSM Toolbox website: SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS Controlled Medicines: Forecasting antiretroviral demand: Prequalification Project :

16 Contacts Boniface Dongmo Nguimfack: 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: PSM Toolbox Forecasting antiretroviral demand Early warning indicators to prevent stock-out and overstock 16