UNTANGLING THE WEB OF ANTIRETROVIRAL PRICE REDUCTIONS 14th Edition July 2011 utw.msfaccess.org Untangling the Web Online! Médecins Sans Frontières’ guide to the prices of AIDS medicines is now in its 14th edition – and is also available in an online version. Stay up-to-date with the latest news on ARV prices and availability by checking: utw.msfaccess.org THE MSF Campaign FOR ACCESS TO ESSENTIAL MEDICINES In 1999, on the heels of Médecins Sans Frontières (MSF) being awarded the Nobel Peace Prize – and largely in response to the inequalities surrounding access to AIDS treatment between rich and poor countries – MSF launched the Campaign for Access to Essential Medicines. Its sole purpose has been to push for access to, and the development of life-saving and life-prolonging medicines, diagnostics and vaccines for patients in MSF programmes and beyond. Médecins Sans Frontières | July 2011 T Table of contents able of C BacKground: Access to Antiretrovirals ontents 3 Treat AIDS: Save Lives, Stop the Virus 4 Ensuring access to improved first-line treatment options 5 Ensuring access to treatment options for second-line and beyond 6 Ensuring generic production and reining in drug costs 9 Highlights from the 14th edition of ‘Untangling the Web of Antiretroviral Prices’ 12 Quality Issues 13 Methodology 14 How to Read the Drug Profiles Drug Profiles 15 Abacavir (ABC) 17 Atazanavir (ATV) 19 Darunavir (DRV) 21 Didanosine (ddI) 23 Efavirenz (EFV) 25 Emtricitabine (FTC) 26 Enfuvirtide 27 Etravirine (ETV) 28 Fosamprenavir (FPV) 29 Indinavir (IDV) 30 Lamivudine (3TC) 32 Lopinavir/ritonavir (LPV/r) 35 Maraviroc (MVC) 36 Nelfinavir (NFV) 38 Nevirapine (NVP) 40 Raltegravir (RAL) 42 Rilpivirine (TMC 278) 44 Ritonavir (RTV) 46 Saquinavir (SQV) 47 Stavudine (d4T) 49 Tenofovir disoproxil fumarate (TDF) 52 Tipranavir (TPV) 53 Zidovudine (AZT) Continued overleaf Untangling the Web of ARV Price Reductions | Please check utw.msfaccess.org 1 Contents continued ontents C FIXed-Dose Combinations and CO-PacKS of 55 Abacavir/lamivudine (ABC/3TC) 57 Lamivudine/stavudine (3TC/d4T) able 59 Lamivudine/stavudine/nevirapine (3TC/d4T/NVP) T 61 Lamivudine/stavudine + efavirenz (3TC/d4T + EFV) 63 Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 65 Tenofovir disoproxil fumarate/emtricitabine/efavirenz (TDF/FTC/EFV) 67 Tenofovir disoproxil fumarate/lamivudine (TDF/3TC) 69 Tenofovir disoproxil fumarate/lamivudine/efavirenz (TDF/3TC/EFV) 71 Tenofovir disoproxil fumarate/lamivudine + nevirapine (TDF/3TC + NVP) 72 Zidovudine/lamivudine (AZT/3TC) 74 Zidovudine/lamivudine/abacavir (AZT/3TC/ABC) 76 Zidovudine/lamivudine/nevirapine (AZT/3TC/NVP) 78 Zidovudine/lamivudine + efavirenz (AZT/3TC + EFV) AnneXes 80 Annex 1: Summary Table of All Prices 84 Annex 2: Conditions of Offer by Company 87 Annex 3: Least-Developed Countries (LDCs) 87 Annex 4: Human Development Index (HDI) 87 Annex 5: Sub-Saharan Countries 87 Annex 6: World Bank Classification of Economies 87 Annex 7: Bristol-Myers Squibb Eligible Countries 88 Annex 8: Abbott Eligible Countries 88 Annex 9: Gilead Eligible Countries 88 Annex 10: Merck Eligible Countries 89 Annex 11: Suggested Resources for Further Information 90 Annex 12: Company Contacts 92 Annex 13: The Clinton Health Access Initiative Antiretroviral Price List 95 References 106 Glossary and Abbreviations 2 Médecins Sans Frontières | July 2011 B ac BacKground: K ground Access to : A Antiretrovirals ccess to ARV Treat AIDS: save LIVES, STOP THE VIRUS S A ntiretrovirals At the United Nations High Level Meeting on AIDS in New York in June 2011, governments committed to reaching 15 million people with HIV treatment by 2015 – nearly nine million more than are on treatment today.1 New data adds to a growing body of Countries will also need to ensure evidence that as well as saving lives, that the medicines needed to break treating HIV can also help prevent the back of the epidemic remain HIV transmission, making the scale-up affordable. And here, the following of treatment all the more urgent. challenges need to be addressed: In May 2011, a study called HPTN • Ensuring access to improved 052 supported by the US National first-line treatment options Institutes of Health found a 96% reduction in transmission when • Ensuring access to treatment options HIV-positive persons in a relationship for second-line and beyond with an HIV-negative person were started early on antiretroviral therapy • Ensuring generic production and © Sven Torfinn compared to people whose treatment reining in drug costs was deferred.9 Early treatment also significantly reduced the development of tuberculosis, which remains the Médecins Sans Frontières (MSF) how simplified patient-friendly number one killer of people living began providing antiretroviral treatment, with several medicines with HIV/AIDS. treatment (ART) for HIV/AIDS in combined into one pill, facilitates 2000 in Thailand, Cameroon and adherence and improves results; If HIV treatment and prevention South Africa, to a limited number how providing treatment for HIV interventions are ambitiously of people living with HIV/AIDS in and TB under the same roof by expanded, according to UNAIDS, 3 urgent need of treatment. Today, the same health worker reduces twelve million infections and more MSF treats more than 170,000 the burden on patients; and than seven million deaths can be people in 19 countries, and some how tasks can be shifted, so that averted by 2020. The number of new MSF projects have been able to nurses can perform many of the infections could be reduced by more reach and maintain ‘universal access’ duties previously reserved for than half by 2015.ii i to treatment in their districts. doctors to overcome health worker In order to reach such a target, The past ten years have been rich shortages. For more details on countries need to commit significant in lessons learnt: how bringing these and other issues on HIV/AIDS financial resources to the epidemic treatment to primary health treatment, read MSF’s May 2011 – an additional US$ 6 billion annual centres and rural clinics, closer to report Getting Ahead of the Wave: top up by 2015.ii However, funding for where people lives, means more Lessons for the Next Decade of the ii AIDS declined in both 2009 and 2010, people can be reached with care; AIDS Response. leaving the Global Fund to Fight AIDS, TB and Malaria, the US government’s PEPFAR and national programmes i Defined as reaching 80% of people in need of HIV/AIDS treatment. short of resources. ii Available in English, French, Spanish and Portuguese. Untangling the Web of ARV Price Reductions | Please check utw.msfaccess.org 3 ENSURING ACCESS TO IMPROVED FIRST-LINE treatment OPTIONS options Today, the majority of people on first-line of ARVs in low- and middle-income countries receive the combination of lamivudine/stavudine/nevirapine (3TC/d4T/NVP).4 Thanks to generic competition, this regimen now costs $61 per patient per year (ppy). treatment Stavudine (d4T) has played a crucial likely to have to switch regimens But in some lower middle-income role in ART scale-up in resource- compared to those taking d4T and countries, patents prevent access to limited settings, due to its availability twice less likely than AZT.10 It is therefore generic products, meaning that countries line - in fixed-dose combinations and, most critical that treatment providers move have to rely on the ‘discounted’ price significantly its low cost. But despite away from d4T as has been done for offered by originator companies – $1,033 its affordability, using this standard example in Zambia, Lesotho, Guyana, ppy for tenofovir/emtricitabine/efavirenz first combination comes at a medical cost South Africa and Botswana. A survey (TDF/FTC/EFV), nearly six times the cost of for some patients. Stavudine causes conducted in 16 countries where MSF the alternative equivalent generic version. serious side effects, some intolerable works showed that seven had changed Companies are increasingly excluding (peripheral neuropathy), stigmatising their protocols to provide all new patients middle-income countries from even (lipodystrophy) and potentially life- with better-tolerated ARVs.10 This is these offers of discounted prices, iii improved threatening (lactic acidosis). For these encouraging news, but some countries however. ViiV considers Global reasons, stavudine is virtually no longer have been prevented from making the Fund-financed programmes in middle- to switch because of funding constraints. income countries to be ineligible for used in wealthy countries (in 2006, for discounted prices, which will have to example, fewer than 2% of patients In the price analysis for this edition we 5 negotiate prices on a case-by-case basis. in Switzerland were taking the drug), found a noteworthy downward trend in Merck has ceased to offer standardised where patients are offered better-tolerated the prices of improved (tenofovir-based) access price discounts to all lower middle- and alternatives, such as tenofovir (TDF). first-line combinations, and prices can upper middle-income countries. Abbott Since 2006, WHO has recommended be expected to fall further as demand specifically excludes lower middle- in its HIV/AIDS treatment guidelines increases. In countries where the drugs are income and low-income countries that treatment providers begin moving not under patent or where patents owners outside of Africa from standardised price permit generic competition, the one-pill- nsuring away from d4T because of its long- discounts for the heat-stable ritonavir E term irreversible side effects, towards once-a-day generic triple combination 100mg tablet. Tibotec / Johnson & TDF or zidovudine (AZT).6 This call containing tenofovir/lamivudine/efavirenz Johnson are also excluding all middle- was repeated in the latest guidelines (TDF/3TC/EFV) is now available for income countries from standardised released by WHO in 2010,7 with a clear $173 ppy (see graph 1). price discounts for all their ARVs. recommendation to phase out d4T. In February 2011, the European Medicines Graph 1: Patents as A barrier Agency recommended that, in view of to improved treatment.