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Transaction prices for antiretroviral medicines from 2010 to 2013: WHO AIDS medicines and diagnostics services: global price reporting mechanism: summary report December 2013

4 марта 2014 г. Всемирная организация здравоохранения

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SUMMARY report

AIDS medicines and diagnostics service Transaction Prices for Antiretroviral Medicines from 2010 to 2013

Global Price Reporting Mechanism December 2013

AIDS medicines and diagnostics service Transaction Prices for Antiretroviral Medicines from 2010 to 2013

Global Price Reporting Mechanism summary report - December 2013

WHO Library Cataloguing-in-Publication Data: Transaction prices for antiretroviral medicines from 2010 to 2013: WHO AIDS medicines and diagnostics services: global price reporting mechanism: summary report December 2013. 1.Drug costs. 2.Anti-HIV agents – economics. 3.HIV infections – drug therapy. 4.Anti-Retroviral agents – supply and distribution. 5.Drug industry. I.World Health Organization. ISBN 978 92 4 150675 5 (NLM classification: WC 503.2)

© World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Layout: Genève Design

Contents Introduction and methods 2 Acknowledgements 3 Abbreviations Price and price trends for antiretroviral treatment regimens Table 1a: First-line treatment for adults: median price (in US$ per person-year) of WHO preferred and alternative regimens Table 1b: Price trends in first-line treatment for adults: comparing 2013 to 2010 (% decrease or increase) Table 2a: Second-line treatment for adults: median price (in US$ per person-year) of most frequently used regimens Table 2b: Price trends in second-line treatment for adults: comparing 2013 to 2010 (% decrease or increase) Table 3a: ARV treatment for children 0–3 years of age: median price (in US$ per person-year) of WHO preferred and alternative regimens (standardized for a body weight of 10–13.9 kg) Table 3b: Price trends in ARV treatment for children: comparing 2013 to 2010 (% decrease or increase) (regimens standardized for a body weight of 10 kg) Table 4a: ARV treatment for children 3 years of age and to less than 10 years (and adolescents <35 kg): median price (in US$ per person-year) of WHO preferred and alternative regimens (standardized for a body weight of 20–24.9kg) Table 4b: ARV treatment for children 3 years of age and to less than 10 years (and adolescents <35 kg): Price trends in ARV treatment comparing 2013 to 2010 (% decrease or increase)

3 4 4 5 6 6 7 8

Discussion 11 Annex: Price evolution of selected antiretroviral formulations Table A: Median transaction price in low- and middle-income countries of selected formulations used in adult treatment (in US$ per patient per year based on the WHO recommended defined daily dose (DDD)) Table B: Median transaction price in low-, lower middle- and upper middle-income countries of selected 2-drug fixed-dose combinations and single drug formulations used in adult treatment (in US$ per patient per year based on the WHO recommended defined daily dose (DDD)) Table C: Median transaction price in low-, lower middle- and upper middle-income countries of selected 2-drug fixed-dose combinations and single drug formulations used in paediatric 0–3 year treatment (in US$ per patient per year based on the WHO recommended defined daily dose (DDD)) Table D: Median transaction price in low- lower middle- and upper middle-income countries of selected 2-drug fixed-dose combinations and single drug formulations used in paediatric 3 year – 35 kg treatment (in US$ per patient per year based on the WHO recommended defined daily dose (DDD))

12 12

References 14

Introduction and methods The present summary report contains information on the price of antiretroviral drugs, abstracted from the Global Price Reporting Mechanism (GPRM). The GPRM contains information on transaction prices, sources and quantities of antiretroviral medicines (ARVs) purchased by HIV/AIDS programmes in low-income countries, lower middle-income countries and upper middle-income countries. The data in GPRM were provided by: the Clinton Foundation HIV/ AIDS Initiative; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; the International Dispensary Association; Management Sciences for Health; Missionpharma; the President’s Emergency Plan For AIDS Relief (PEPFAR); Partnership for Supply Chain Management System; UNITAID; the United Nations Children’s Fund (UNICEF); USAID/Deliver (formerly John Snow Inc./Deliver); and the World Health Organization’s Contracting and Procurement Service. The data in the GPRM for the years 2010 and 2012 cover around 70% of all public procurement of ARVs. Data for 2013 are still incomplete. The present summary report features the transaction data for ARVs in 2010, 2011, 2012 and the first three quarters of 2013. In the report and in the GPRM, countries have been classified as low-, lower middle-, and upper middle-income countries according to the World Bank Atlas calculation method1,2,3. All data used in this summary report are available in the GPRM database, which can be accessed at http://apps.who. int/hiv/amds/price/hdd. The public interface of the database provides information on the quantity of drugs purchased, according to formulation, country or group of countries, and their estimated Ex Works (EXW) transaction price. An additional interface enables the downloading of data on individual procurement transactions, the price and the INCOTERMS under which the transactions were conducted. All prices refer to WHO prequalified, or stringent regulatory authority approved formulations. The prices of regimens were calculated by adding the median price 4 for each formulation used to administer the regimen. The medicines used in a regimen are presented between square brackets when the price of their fixed dose regimen has been used in the calculation of the price of the regimen. The annex to this report provides information on the median price of individual ARV formulations. 1 Low-income countries are countries with a gross national income (GNI) per capita of US$ 1,025 or less. 2 Lower middle-income countries are countries with a GNI per capita between US$ 1,026 and US$ 4,035. 3 Upper middle-income countries are countries with a GNI per capita between US$ 4,036 and US$ 12,476. 4 The median price is the price separating the 50% of transactions with higher prices from the 50% with lower prices. The choice to report median prices was made in view of the asymmetrically distributed nature of the data.

For the interpretation and use of the data in this report, it is important to note that: 1) All prices are shown in US Dollars (US$) per person per year of a defined daily dose of each medicine for adults or children. 2) Statistics are not given for formulations with fewer than five worldwide transaction lines in a given calendar year. 3) The prices in this report are the international transaction prices and not those paid by end-users at country level. End-user prices for antiretroviral drugs are typically lower that those reported here because of subsidies. However, for other medicines end-user prices are often higher than international transaction prices, owing to tariffs, taxes, transportation costs, and mark-ups. Health Action International provides more information on their contribution to end-user prices on its web site, http://www.haiweb.org/medicineprices. 4) On the public interface of the GPRM database, the prices are reported as Ex Works (EXW) prices. The prices reported under other International Commercial Terms (INCOTERMS) can be accessed via the GPRM download facility. 5) Individual transactions listed in the GPRM with a price of US$ 0 have been removed from the analysis, as were any transactions identified as duplications in reporting. 6) The median prices published in this report for 2013 may be different from those which will be published in later versions of this report as additional data on 2013 transactions continue to be included in the database. 7) The median price for specific regimens recommended by the new WHO guidelines and highlighted in this analysis is the sum of the median of specific formulations that make up the regimen. This summary report is intended to provide the pricing data of key ARVs to governments, nongovernmental organizations, donors, international organizations, academia and individuals or institutions directly involved or interested in the procurement of ARVs in resource-poor settings. Comments on this report would be greatly appreciated and should be sent to amds@who.int.

Acknowledgements The World Health Organization welcomes the continued support of the organizations named in this report, which provided data to the GPRM, the technical input of the French National Agency for AIDS Research (Agence nationale de recherche sur le Sida et les hépatites virales, ANRS) in the redevelopment and improvement of the quality control and duplicate removal algorithm of the GPRM database since 2011, and the financial support from UNITAID for the latter.

Abbreviations International Nonproprietary Name abacavir atazanavir darunavir didanosine efavirenz emtricitabine etravirine fosamprenavir indinavir lamivudine lopinavir maraviroc nelfinavir nevirapine raltegravir ritonavir saquinavir stavudine tenofovir tipranavir zidovudine

Abbreviation ABC ATV DRV ddI EFV FTC ETV FPV IDV 3TC LPV MRC NFV NVP RAL RTV SQV d4T TDF TPV ZDV

Price and price trends for antiretroviral treatment regimens Table 1a: First-line treatment for adults: median price (in US$ per person-year) of WHO preferred and alternative regimens Low-income countries and/or countries with low human developmenta First-line regimens Lower middle-income countries Upper middle-income countries

2010 2011 2012 2013 2010 2011 2012 2013 2010 2011 2012 2013

Regimens recommended in the 2013 WHO treatment guidelines [TDF+FTC+EFV] [300+200+600]mg [TDF+FTC]+EFV [300+200]mg+600mg [TDF+3TC+EFV] [300+300+600]mg [TDF+3TC]+EFV [300+300]mg+600mg [TDF+FTC]+NVP [300+200]mg+200mg [TDF+3TC]+NVP [300+300]mg+200mg 242 369 193 165 176 140 240 330 183 148 147 128 192 277 161 111 116 95 149 235 136 97 99 84 242 372 194 170 178 140 192 320 170 146 150 128 174 265 152 106 113 91 147 241 136 98 105 86 – 181 – 163 181 135 234 309 142 119 167 96 159 267 149 114 118 96 – 260 149 97 111 85

Other regimens [ZDV+3TC+NVP] [300+150+200]mg [ZDV+3TC]+EFV [300+150]mg+600mg [d4T+3TC+NVP] [30+150+200]mg 131 158 126 149 115 140 99 126 134 165 106 145 105 129 98 121 126 161 127 153 93 136 99 123

Regimens which according to the 2013 WHO treatment guidelines should be phased out 62 58 54 53 66 58 48 55 63 64 59 53