Earlier, safer and simpler antiretroviral therapy can push the HIV epidemic into irreversible decline. -WHO Director-General Dr.

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1 1616 Fort Myer Drive, 12th Floor Arlington, Virginia USA Telephone: Fax: SCMS Supply Lines August 2013 Content: Feature Article Trends News Dose Can supply meet demand? Supply chain implications of the World Health Organization s call for earlier treatment of HIV On June 30, 2013 the World Health Organization (WHO) released their new Consolidated Guidelines on the Use of Antiretrovirals for the Treatment and Prevention of HIV Infections: Recommendations for a Public Health Approach. WHO based its recommendations on evidence that treating people with HIV earlier, with safe, affordable, and easier-to-manage medicines can keep them healthy and lower the amount of virus in the blood, reducing the risk of passing it to someone else. The new guidelines will likely result in increased demand for many medicines to treat HIV/AIDS. Yes, demand for the medicines could quickly outpace supply. Earlier, safer and simpler antiretroviral therapy can push the HIV epidemic into irreversible decline. -WHO Director-General Dr. Margaret Chan As countries consider applying these guidelines, critical supply chain considerations must be taken into account to inform strategies to transition patients to new regimens. Limited manufacturing capacity, tight active pharmaceutical ingredient (API) markets and usage of existing stocks of the current regimens (to avoid wastage) will all impact the speed of scale-up. Key WHO recommendations Overall, application of the following recommendations will increase treatment eligibility from 15 million to 26 million patients. Earlier treatment The guidelines recommend initiating treatment in adults living with HIV when their CD4 cell count falls to 500 CD4 cells/mm³ or less, while their immune systems are still strong. The previous WHO recommendation, set in 2010, was to offer treatment at 350 CD4 cells/mm³ or less. SCMS Project Team Booz Allen Hamilton Crown Agents USA, Inc. i+solutions JSI Research & Training Institute, Inc. Management Sciences for Health The Manoff Group MAP International North-West University Northrop Grumman Imperial Health Sciences UPS Supply Chain Solutions Voxiva 3i Infotech

2 Preferred regimens The guidelines recommend a preferred treatment regimen based on tenofovir (TDF) in combination with lamivudine and efavirenz (TLE) or tenofovir with efavirenz and emtricitabine (TEE). The WHO recommends that countries should discontinue stavudine (d4t) use in firstline regimens. Implementation of these recommendations implies transition of nearly one million patients currently on stavudine-based regimens, and a gradual shift of between 2,000,000 and 3,800,000 patients on zidovudine regimens to TLE or TEE. As previous regimen changes have demonstrated, any major transition of patients requires careful procurement and supply chain management planning if major disruption is to be avoided. Option B+, Prevention of Mother to Child Transmission (PMTCT) and Pediatrics The new recommendations also include providing antiretroviral therapy (ART) - irrespective of their CD4 count - to all children with HIV under 5 years of age, all pregnant and breastfeeding women with HIV, and all HIV-positive partners where one partner in the relationship is uninfected. For details, the new guidelines can be accessed at: Challenges There are three key challenges facing the supply chain with these new recommendations: 1. First, the approved 1 suppliers of fixed-dose combination (FDC) formulations of TEE and TLE are operating at near capacity to support the current level of patients on one of the recommended TDF regimens. Major buyers, the WHO and donor agencies are in discussions with manufacturers to bring additional capacity on line as soon as possible, but this will be phased in over the remainder of 2013 and At present, order-to-delivery lead times for TEE and TLE formulations are averaging eight months, inclusive of manufacturing time and delivery to country. 3. Purchasers and implementing partners with patients on d4t-based and AZT-based regimens have stocks and orders in process that should be considered in the transition process to avoid wastage or expiry of usable products. 1 Either approved or tentatively approved by the United States Food and Drug Administration, or pre-qualified by the World Health Organization. 2

3 We re in this together Decisions made by one country will cause ripple effects that directly affect other countries. Supply would not meet demand if all countries adopt the WHO recommendations now. A coordinated approach for the next months is essential. For the good of all, transition slowly This will require a graduated process of transition. Programs should plan carefully and discuss with their suppliers the pace at which increased quantities of TDF-based product can be made available. In order to ensure that supply meets anticipated demand, a phased program is highly recommended. A policy brief on procurement and supply chain management issues related to the transition, issued by WHO, and supported by PEPFAR, The Global Fund and UNITAID, recommends (in order of priority): 1. Initiation of new patients eligible for ART on a tenofovir-based regimen. 2. Transition of patients currently on stavudine-based regimens to a tenofovir-based regimen, in a phased approach to enable usage of current stavudine stocks and stocks already on order. 3. Transition of patients currently on zidovudine-based regimens to a tenofovir-based regimen, in a phased approach to enable usage of current zidovudine stocks and stocks on order, taking into account the speed at which increased deliveries of TDF products can be ordered and delivered. For the full brief, go to: Factors impacting procurement decisions include: Supply of the TDF FDC formulations TLE and TEE is constrained at present; supply cannot currently keep up with demand. Delivery lead times are long (6-8 months, 9 months for ocean freighting) due to the newness of the TDF triple fixed-dose combination formulations. Lead times for delivery are not likely to reduce over the next 12 months. Procurements should be planned and initiated with a minimum lead time of 9-12 months before medicines are needed in each country. Countries cannot all transition at the same time or at the same pace. Advice on these challenges and how countries and programs can coordinate their transitions and product requirements is available from: 1. The World Health Organization: AIDS Medicines and Diagnostic Service; Vincent Habiyambere - habiyamberev@who.int. 3

4 2. United States Government: Supply Chain for Health Division, Office of HIV/AIDS at USAID: Christine Malati - cmalati@usaid.gov; Mike Hope - mhope@usaid.gov and to questions: USGTx@usaid.gov. 3. The Global Fund to Fight AIDS, Tuberculosis and Malaria- Martin Auton - Martin.Auton@theglobalfund.org, Ade Fakoya - ade.fakoya@theglobalfund.org. 4. UNITAID - Taufiqur Rahman, rahmant@unitaid.who.int. 5. In countries with SCMS offices, we recommend speaking with your country representative. You can find country contact information on our website, 6. For general inquiries, please us at SCMSInfo@pfscm.org. Forward, united SCMS is working closely with USAID, OGAC, WHO and other partners to help countries plan the transition and has prepared the Interactive Tenofovir Forecast Tool to support HIV/AIDS programs in modeling and planning their transition. For more information on the tool, please contact Robert Burn, SCMS Principal Quantification Advisor (rburn@pfscm.org). Trends Each month, Supply Lines reports on global trends in HIV/AIDS supply chains. For more information, SCMSInfo@pfscm.org. Here are some current highlights: SCMS hits significant milestone, $1.5 billion in total commodity procurements. As of June 2013, the value of commodities delivered by SCMS over the life of the project totaled $1.5 billion. These life-saving commodities support an estimated 2.5 million patients on lifesaving antiretroviral (ARV) medicines. 2 million male circumcision (MC) kits procured This month, SCMS achieved a major procurement milestone when we ordered the 2 millionth MC single-use kit. This milestone clearly reflects the rapid scale up in MC programs, as we had just surpassed the 1 million kit mark at the end of March While the MC single-use kit for forceps-guided method is the most popular kit to date, SCMS has other MC kits available to accommodate dorsal-slit procedures as well as reusable instruments for both surgical methods. Currently, SCMS procures VMMC commodities to support MC campaigns in 12 countries. New Quality Assurance Technology in Tanzania SCMS recently used a portable near-infrared spectrometer (NIR) to assess product manufacturing consistency and approve seven lots of co-trimoxazole tablets for distribution from one manufacturer. Until now, SCMS had been using a tabletop (stationary) version of the NIR instrument to release selected lots of product in Tanzania; this was the first application of the portable technology. The seven lots of co-trimoxazole tablets were approved for distribution based on data from more than 20 lots of known good product produced by the same manufacturer and compared to good product from other manufacturers. Growing success in tackling PMTCT A new report from UNAIDS entitled the Global Plan towards elimination of new HIV infections among children by 2015 and keeping their mothers alive (Global Plan) has revealed a marked increase in progress in stopping new infections in children across the Global Plan priority countries in Africa. More pregnant women living with HIV were receiving ARV medicines to prevent HIV 4

5 from being transmitted to their children and for their own health in 2012 than in 2009, with coverage levels exceeding 75% in many countries. Increased coverage has reduced HIV transmission rates from mother to child in most countries. Botswana and South Africa have reduced transmission rates to 5% or below. News Dose The health supply chain: Still the Cinderella of development? The Guardian, July 18, 2013 Our own David Jamieson reported to The Guardian on why ignoring the importance of effective supply chains in healthcare has wider repercussions for development. As part of their discussion on public health supply chains, The Guardian also included David Jamieson in this lively discussion: From USAID: Global Health Programs: Report to Congress FY 2012 USAID, June 20, 2013 On page 14 of their new report to Congress, USAID recognizes SCMS: SCMS was the only public sector organization to be nominated for the Supply Chain Innovation Award presented by the Council of Supply Chain Management Professionals in Transition to New HIV/AIDS Treatment Regimens Procurement and Supply Chain Management Issues IATT, July 25, 2013 This policy brief was developed by the WHO to advise a phased approach to implementing partners, ART program managers, procurement managers and other relevant parties. An AIDS-free generation is closer than we might think The Washington Post, July 11, 2013 Thirteen countries receiving PEPFAR funds have reached a key tipping point at which the annual increase in new patients on antiretroviral treatment exceeds the annual number of new HIV infections. The curve of new HIV infections in many countries is trending downward. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health Abuja+12: African leaders to review strategies against AIDS, TB, malaria SAFAIDS, July 12, 2013 Nigerian President Goodluck Jonathan hosted fellow heads of state and government at the Abuja +12 Summit on HIV/AIDS TB and other infectious diseases. The summit was organized to adopt a set of actions to enhance the continent s effort to reverse the impact of these diseases by ensuring universal access to services and strengthened health systems. 5

6 Massive Seizures of Fake Drugs in 23 African Ports E-Drug, July 2, 2013 A customs operation of an unequalled scale was carried out in April 2013 in 23 African countries. More than one billion articles and in particular 550 million doses of illicit, potentially dangerous, if not deadly, medicines were intercepted. 6