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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.

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slide1

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

slide2

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)

slide3

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

drug regulatory database http 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)
slide7
The Global Price Reporting Mechanism [GPRM] and Improvements currently being implementedhttp://apps.who.int/hiv/amds/price/hdd/
slide11
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

slide12
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

slide13
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

slide14
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

url for the different databases
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/
contacts
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