Access to ARVs in low and middle income

countries-

Joseph PerriënsCoordinator HIV technology and

commodities HIV dept.

World Health Organization

ARV price transparency

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 -

20

40

60

80

100

120

140

160

180

147 160

145

128 131 128

108 117 113 115

US$

ppy

2008 2009 2010 2011 2012 20130

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

325 336

[ZDV+3TC]+[ATV]+[r] [300+150]mg+[300]mg+[100]mg [ZDV+3TC]+[ATV/r] [300+150]mg+[300+100]mg [ZDV+3TC]+[LPV/r] [300+150]mg+[200+50]mg

Med

ian

price

(US$

/ppy

)

2009 2010 2011 2012 2013DRV (600 mg) NA 3833 3287 5215 5180DRV (300 mg) 5805 1123 1013 732 664ETV (100 mg) 1173 1178 854 854 439RAL (400 mg) NA 980 973 883 553

Median price (US$ ppy) paid for third-line drugs by LMICs, 2008-2013

Average price (US$ ppy) paid for first line treatment by LMICs, 2004-2013

Median price (US$ ppy) paid for second line treatment regimens by LMICs, 2008-2013

Source: Global Price Reporting Mechanism http://www.who.int/hiv/amds/gprm/en/

Using price data…Median price and range (US$ ppy) of first line treatment regimens in LMIC, 2013

Source: Global Price Reporting Mechanism http://www.who.int/hiv/amds/gprm/en/

Increasing supply security

Stock-outs require action in financing, supply planning and distribution

2008 2009 2010 2011 2012 20130

5

10

15

20

25

30

35

40

45

50

37 37 38

45

3035

Year

%

% of countries reporting stock out, 2008-2013

Regulatory approvals: a neglected area

% of 139 countries with at least 1 registered supplier of:

[ABC+3TC+NVP] 60+ 50+6 mg

[ABC+3TC] 60+30 mg

[AZT+3TC+NVP] 60+ 50+6 mg

[d4T+3TC+NVP] 30+ 50+6 mg

ABC 60 mg

[d4T+3TC] 60+ 12 mg

[d4T+3TC] 30+6 mg

[d4T+3TC+NVP] 60+ 100+12 mg

[AZT+3TC] 60+30 mg

AZT 10 mg/ml

ABC 20 mg

NVP 10 mg/ml

LPV/r 100+25 mg

3TC 10 mg/ml

LPV/r 80+20 mg/ml

0 10 20 30 40 50 60 70

4

5

10

10

11

11

12

12

15

28

39

48

50

56

58

%

Red bars denote liquid, and blue bars solid for-mulations.

ATV/r

ATV

TDF+FTC

LPV/r

TDF

TDF+3TC

AZT+3TC

TDF+FTC+EFV

TDF+3TC+EFV

EFV 600 mg

NVP

DRV

ETV

AZT+3TC+NVP

0 10 20 30 40 50 60 70 80

1

2

9

13

18

29

31

37

55

55

61

62

68

68

%

Adult formulations Paediatric formulations

In 2012, WHO launched a collaborative procedure with national regulatory authorities to fast-track registration of prequalified medicines. 19 countries now participate.

Progress in intellectual property

• Geographic scope of voluntary licenses increased, and new drugs were licensed, e.g.:• TDF: to 112 countries (Gilead via MPP)• ATV: to 110 countries (BMS via MPP)• Dolutegravir: to 144 countries (ViiV via MPP)• RPV: to 112 countries (J&J, bilaterally)

• Countries with no access to voluntary licenses negotiated lower prices, and have at times resorted to compulsory licenses

• Newer drugs like DRV, RAL, EVG, RPV and TAF remain concerns

Concentration: a threat for competition and supply security

2,006 2,009 2,0120

100000000

200000000

300000000

400000000

500000000

600000000

700000000

800000000

900000000

1000000000

ARV sales to LMIC registered in GPRM (in Million US$)

All others *Macleods Pharmaceuticals Ltd.Abbott/AbbVieRanbaxy Laboratories Ltd.Strides Arcolab Ltd.Cipla Ltd.Aurobindo Pharma Ltd.Hetero Drugs Ltd.Mylan (Matrix Laboratories Ltd.)

Mill

ions

Source: Global Price Reporting Mechanism http://www.who.int/hiv/amds/gprm/en/

Acknowledgements

Organizations (contributed data)CHAI, CPS/WHO, GFATM, IDA, JSI, MissionPharma, UNICEF, SCMS, SIAPS/MSH, UNAIDS ,UNITAID, USAID.

Companies(contributed data)Abbvie, Anhui Biochem United Pharm. Co., APIChem Chemical Technology Co. Arch Pharmalabs, Aurobindo Pharma, Aspen Pharmacare, Boehringer Ingelheim, Bristol-Myers-Squibb, CIPLA, Emcure Pharmaceuticals, Gilead Sciences, Glaxo-Smith-Kline, Hoffmann La Roche, Hetero, J&J, Lonzeal Pharmaceuticals, McLeod, Merck Sharp & Dohme, Microlabs, Mylan, Ranbaxy, Shandong Xinhua Pharm. Co., Shanghai Desano Chem. Pharm. Co, Strides Arcolab, Varichem, ViiV.

People(helped write)Vincent Habiyambere (WHO), Boniface Dongmo-Nguimfack (WHO), Peter Beyer (WHO), Francis Aboageye-Nyame (SIAPS/MSH), Martin Autun (GFATM), Nathan Ford (WHO), Robert Matiru (UNITAID), David Jamieson (SCMS), Laurence Läser (WHO), Martina Penazzato (WHO), Chris Wright (JSI), Dominque Zwinkels (SCMS), G Hirnschall (WHO), Andrew Ball (WHO), Michel Beusenberg (WHO), Esteban Burone (MPP), Cees De Joncheere (WHO), Meg Doherty (WHO), Jane Galbao (UNITAID), Zafar Mirza (WHO), Taufiqur Rahman (UNITAID), Jaqueline Sawyer (WHO), Marco Vitoria (WHO), Gundo Weiler (WHO), colleagues in WIPO and WTO.