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Affordability of HIV/AIDS treatment in developing countries: an analysis of ARV drug price determinants. Luis Sagaon Teyssier ; Yves Arrighi; Boniface Dongmo Nguimfack; Jean-Paul Moatti. Aknowledgements. This study is part of a joint project funded by UNITAID and developed by:
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Affordability of HIV/AIDS treatment in developing countries: an analysis of ARV drug price determinants Luis SagaonTeyssier; Yves Arrighi; Boniface Dongmo Nguimfack; Jean-Paul Moatti
Aknowledgements This study is part of a joint project funded by UNITAID and developed by: The French National Agency for Research on AIDS and viral Hepatitis (ANRS-SESSTIM) AIDS Medicines and Diagnostics Service (AMDS/WHO) Foundation for Innovative New Diagnostics (FIND)
Outline • Context • Issues & Objectives • Data • Method • Results • Main conclusions
HIV/AIDS in developing countries 2010 Adults and children living with HIV Adults and children newly infected with HIV Adult prevalence (15‒49) [%] Sub-Saharan Africa 22.9 million [21.6 million – 24.1 million] 1.9 million [1.7 million – 2.1 million] 5.0% [4.7% – 5.2%] Middle East and North Africa 470 000 [350 000 – 570 000] 59 000 [40 000 – 73 000] 0.2% [0.2% – 0.3%] South and South-East Asia 4.0 million [3.6 million – 4.5 million] 270 000 [230 000 – 340 000] 0.3% [0.3% – 0.3%] East Asia 790 000 [580 000 – 1.1 million] 88 000 [48 000 – 160 000] 0.1% [0.1% – 0.1%] Latin America 1.5 million [1.2 million – 1.7 million] 100 000 [73 000 – 140 000] 0.4% [0.3% – 0.5%] Caribbean 200 000 [170 000 – 220 000] 12 000 [9400 – 17 000] 0.9% [0.8% – 1.0%] Eastern Europe and Central Asia 1.5 million [1.3 million – 1.7 million] 160 000 [110 000 – 200 000] 0.9% [0.8% – 1.1%] Western and Central Europe 840 000 [770 000 – 930 000] 30 000 [22 000 – 39 000] 0.2% [0.2% – 0.2%] North America 1.3 million [1.0 million – 1.9 million] 58 000 [24 000 – 130 000] 0.6% [0.5% – 0.9%] Oceania 54 000 [48 000 – 62 000] 3300 [2400 – 4200] 0.3% [0.2% – 0.3%] TOTAL 34.0 million [31.6 million – 35.2 million] 2.7 million [2.4 million – 2.9 million] 0.8% [0.8% - 0.8%] Source: WHO & UNAIDS
Number of people receiving antiretroviral therapy in low- and middle-income countries, by region, 2002–2010 Source: WHO. UNAIDS, UNICEF
ARV market structure • Demand-side • Donor funded ARV transactions • Supply-side • Branded segment • 8 manufacturers • 18 single and 6 co-formulations • Production: 31.8% in USA; 19.5 UK; 11.6% FR; 11.3 NL • Generic segment • 26 manufacturers • 17 single, 11 co-formulations, and 4 co-blisters • Production: 91% in India; 6.5% South Africa
Issues & Objectives • ↑ Resistance + Toxicity • Adoption of patented drugs especially for 2nd and 3rd lines • Switching to new guidelines (d4T to TDF, ZDV) • Financial crisis • Objectives • To identify the main price determinants • To study the evolution of prices of branded drugs through the life-cycle of patents
Data • Global Price Reporting Mechanism (AMDS/WHO) • Period of analysis: 2003-2012 • 44,354 transactions of Adult & Children ARVs • 128 countries • 20 ARVs ; 15 FDC/Co-blisters (88 formulations) • 12 Sources providing information on transactions: • Global Fund (38.2%); SCMS (20.9%); UNICEF (14.5%); UNITAID (12.7%); IDA (9.3%); PEPFAR (5.4%); Mission Pharma (2.1%); CHAI (1%); JSI (0.4%); WHO/CPS (0.4%); MSH (0.3%); WHO (0.3%)
Methods: Price descriptives & OLS • Econometric analysis of price determinants: • Dependent:price of patient-year treatment log(PYD) • Explanatory: • Year dummies • Geographical group (World Bank definition) • Gross National Income per capita (World Bank): log(GNIpc) • Purchased quantity of yearly doses per transaction: log(QYD) • Formulation type (single=ref., co-blister, FDC) • Target group (pediatric=1, adult=0) • Drug age since FDA approval • Number of observed suppliers • Present in 1st line (yes=1, no=0) • Segment(branded=1, generic=0) • Crossed effects:Segment & Present in 1st line • Crossed effects: Segment & years until expiration of the initial patent at the time of purchase of branded drugs (linear and squared effects)
Brand/Generic Market share in value* The numbers in the figure indicate millions of US$ Source: GPRM (AMDS/WHO): * 2011-2012 the bulk data has not still been provided by the sources
Treatment price per patient per year* From 2002 to 2012, 5% of the total yearly treatments was purchased in the branded segment: this represents 15% of the total expenditure in ARVs. Source: GPRM (AMDS/WHO): * 2011-2012 the bulk data has not still been provided by the sources
Treatment price per patient per year by therapeutic line* 3rd line: DRV and ETV, mean price from 1,362 US$ (2010) to 1,758 US$ (2011) Source: GPRM (AMDS/WHO): * 2011-2012 the bulk data has not still been provided by the sources
Mean price per patient per year:adults by therapeutic class Mean price per patient per year:adults by therapeutic class **FDC: FTC+TDF; 3TC+d4T; 3TC+TDF; 3TC+ZDV **FDC & *FDC: FTC+TDF; 3TC+d4T; 3TC+TDF; 3TC+ZDV **FDC & Co-blister: ABC+3TC+ZDV; ABC/[3TC+ZDV] ***FDC & Co-blister: EFV+FTC+TDF; EFV+3TC+TDF; EFV/[3TC+d4T]; 3TC+NVP+d4T; 3TC+NVP+ZDV; NVP/[3TC+ZDV]; EFV/[3TC+ZDV]Co-blister: ABC+3TC+ZDV; ABC/[3TC+ZDV] ***FDC & Co-blister: EFV+FTC+TDF; EFV+3TC+TDF; EFV/[3TC+d4T]; 3TC+NVP+d4T; 3TC+NVP+ZDV; NVP/[3TC+ZDV]; EFV/[3TC+ZDV]
Results (1/4) Time trend Significant at: ***1%; **5%; *10%
Results (2/4) Geographical group Prices in South Asia & East Asia and Pacific are 27% lower than prices in Europe and Central Asia GNI per capita. log(GNIpc): 0.024*** 10% of increase in GNIpc causes an increase of prices of 0.24%: In average, upper-middle income countries pay the highest prices. Significant at: ***1%; **5%; *10%
Results (3/4) Drug and market characteristics Significant at: ***1%; **5%; *10% • Co-blister formulation is 130% more expensive than single formulation • 1 additional supplier in the market reduces prices in average of about 3.3% • Drugs present in 1st line are 65.3% cheaper than drugs in 2nd line • Branded drugs are 56.3% more expensive than generic drugs
Results (4/4) Segment & Present in 1st line: 0.113*** Branded in 1st line are 11.3% more expensive than generic in 1st line. Segment & years until expiration of the initial patent at purchase of branded drugs (linear and squared effects): 0.026*** & 0.002*** 16% more expensive than… 22.4%more expensivethan… Ref: Purchase the same year of patent expiration 9.5%cheaper than…: Years before patent expiration Years after patent expiration
Main conclusions • Genericcompetition has been the driving force for ARV pricedecreasesalthoughwemaybe close to marginal cost for first line drugs • ARV priceremain a major barrier for switching to 2nd and 3rd lines • Brand firmstrategies (during the patent periodand at patent expiration) remain a majour source of higherprices
The debate on Intellectual Property Rights and TRIPS agreements is not over! Contacts: Jean-paul.moatti@inserm.fr luis.sagaon-teyssier@inserm.fr