SUMMARY MEETING REPORT. Annual Partners meeting AIDS Medicines and Diagnostics Service. Geneva, September 2014

Transcription

1 SUMMARY MEETING REPORT Annual Partners meeting AIDS Medicines and Diagnostics Service Geneva, September 2014 Department of HIV/AIDS HIV Technologies and Commodities September 2014 WHO/HIV/2014

2 Contents 1. Introduction Meeting Summary Treatment Guidelines Procurement Initiatives and Challenges PSM Interventions Including Logistic Management Information Systems (LIMS) Access to HIV Diagnostics Forecasting of diagnostics Pricing Quality Financing Next steps Outcome of the discussion on procurement and supply management Outcome of the discussion on diagnostics... 9 Page 1 of 9

3 1. Introduction The September 2014 annual partners meeting of the WHO AIDS Medicines and Diagnostics Service (AMDS) discussed their activities and possible collaboration in procurement and supply management of HIV drugs and diagnostics. This meeting follows the unveiling of the targets by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in January 2014, an ambitious set of benchmarks to expand HIV testing and treatment by The targets consist of increasing the proportion of people living with HIV who know their diagnosis to 90%, increasing the proportion of people living with HIV receiving antiretroviral treatment to 90%, and increasing the proportion of people on HIV treatment who have an undetectable viral load to 90%. In addition to the announcement of these targets, at the 20th International AIDS conference in Melbourne, Australia, in July 2014, the a new Diagnostics Access Initiative (DAI) was launched by UNAIDS, WHO, the Clinton Health Access Initiative (CHAI), the African Society for Laboratory Medicine (ASLM), UNICEF, and the US President s Emergency Plan for AIDS Relief (PEPFAR). The DAI aims to facilitate achievement of the targets by improving laboratory capacity for diagnosis, monitoring and surveillance. Dr Gottfried Hirnschall, Director of the WHO Department of HIV/AIDS, made the opening remarks for the meeting, welcoming the targets, highlighting the centrality of efficient procurement and supply chain management of ARVs and HIV diagnostics. He also discussed the recent undertaking to revise the WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be completed in 2015, summarizing the guidelines and their development process. Furthermore, Dr. Hirnschall encouraged participants to share relevant challenges and successes. Presentations and post-presentation discussions included gaps, best practices, action points and next steps, which are presented in the following section. Dr Joseph Perriëns (WHO) introduced the agenda, in which the joint ARV demand forecasting work possible joint action to support investment in logistics management information systems and diagnostics stand out as focus issues. The new funding model of the Global Fund creates opportunities to invest in capacity-building and logistics management systems, and was mentioned as an opportunity not to be missed to reduce stock out rates and develop mainstream health commodity supply chains. The presentations, final agenda, final list of participants and concept note can be accessed at: As all the presentations discussed below are on the above drop box link, readers are encouraged to visit the link for more information on the topics presented during the annual AMDS partners and stakeholders meeting. The outcome of the discussions and challenges identified will be more detailed. 2. Meeting Summary 2.1. Treatment Guidelines Dr Marco Vitoria (WHO) summarised the WHO HIV/AIDS treatment guidelines, stressing the importance of consolidating maternal, clinical and operational aspects of treatment in the upcoming (2015) revision of the guidelines. He spoke about the format and development process of the guidelines, which should be based on evidence, cost-effectiveness, feasibility and local preferences. Dr Vitoria also highlighted the current challenges to treatment, including the fact that initiation of HIV/AIDS treatment occurs far too late in the majority of settings. Page 2 of 9

4 The following challenges were identified: Late initiation: need to better understand the causes of late initiation, streamline services. Loss to follow-up: need to gather evidence to evaluate the major reasons why patients are lost to follow-up, how patients can be aided to return for follow-up, and how same-day test and treat strategies influence follow-up rates. HIV treatments for children: treatment formulations for children are very challenging, and scientific improvements are required to address imprecision in treatments for children. Furthermore, forms of treatment best suited to children need to be developed (e.g. small pills that do not require much water, fixed dosages). Drug resistance: there are many issues involved with drug resistance, particularly relating to the quality of existing programmes. Medicines and laboratory supply chain management: stock-outs are always an issue. The outlook in ART is that new drug classes will likely be introduced, continuing focus on once daily administration, and further optimisation and tailoring of regimens (e.g. EFV, changes in timing of treatment) for specific situations and populations (e.g. pregnancy, co-infection). Improvements in viral load testing are anticipated to increase regular treatment monitoring Procurement Initiatives and Challenges David Jamieson (PfSCM) discussed the practical implications of the Targets defined in the Diagnostic Access Initiative. He showed that it requires unprecedented scale-up of VL and investment in the availability of medicines to meet international targets. Some of the requirements to meeting these targets would include strengthening of warehousing capacity and distribution systems; increased human resource capability; expanded utilization of the private sector; and, in diagnosis, improvements in sample referral. Mr Jamieson emphasized the need to focus on key populations where impact can be the greatest and for better linkages to care, especially if selftesting is to be used. Given the need to more than triple the population on therapy to meet the targets, Mr. Jamieson emphasized the importance of finding the balance between centralized and decentralized supply chains and simplifying drug regimens making it easier for patients and streamlining the supply chain. David Jamieson shared the SCMS work in procurement, Martin Auton (Global Fund) presented the new Global Fund framework to ensure procurement for impact (P4i). ( and Gavin Steel presented the procurement and guidelines implementation in South Africa. After their presentations, there were active discussions and the following challenges were identified: Poor supplier performance, as regards on time delivery, is a major issue. Recent challenges obtaining tenofovir, although the current situation is much improved with new production capacity coming on line. ART market faces competition from more lucrative generic diabetes and hypertension drug manufacturing. Need to more than triple current numbers of treatment which will require a massive effort to ensure proper monitoring. Self-testing will require quality access to care and treatment services. Expansion rate of VL uptake is unknown forecasting demand for services will be challenging. Greater enforcement of contractual obligations is required, especially for late suppliers. Need a change in manufacturing practice already close to capacity. Need to ensure drug and diagnostics stakeholders work together. Weak financial management systems benefit from standardized processes and master procurement catalogues. Page 3 of 9

5 The following suggestions were made for consideration and action: Produce PSM case studies of success studies to share lessons learned Continue collaboration in Paediatric ARV working group (PPWG) to ensure partner procurement coordination of paediatric ART Continue joint forecasts 2.3. PSM Interventions Including Logistic Management Information Systems (LIMS) Etienne Guillard (SOLTHIS) presented tools they have been using for projects in Mali, Sierra Leone, Guinea and Niger; David Mabirizi (USAID/SIAPS, MSH) reported on the USAID/SIAPS West Africa HIV and AIDS Regional Dashboard, called HIV and AIDS Commodity Tracking Tool and described the dashboard functions that capture, track, aggregate, and disseminate information about antiretrovirals (ARVs), rapid test kits, and other HIV and AIDS commodities to support evidencebased decision making in the West Africa sub region. For more information on the dashboard, please visit the link below: Link: Abdourhahmane Diallo (USAID DELIVER PROJECT, JSI) presented the functionalities of tools used by the project in Pakistan, Ethiopia, Tanzania and Zambia. He emphasized the laboratory assets management module of the open source LMIS that the USAID DELIVER PROJECT is implementing in Tanzania and Zambia. The advantages and limitations of paper based tools and computerized tools were discussed. Dominique Zwinkels (PfSCM) presented a risk analysis tool for HIV RDT and ARV stock outs. The purpose of the tool was to reduce risk by improving planning and enabling more rapid financing. After discussion of these tools and the PSM Toolbox which was presented jointly by AMDS and i+solutions, the following challenges were identified: Inaccurate data from the field, lack of reporting make logistics management a continuing challenge Too many tools are being used in different countries and there is a collection of too much data without linking it to supply chain management intervention i.e. forms filled and sent to next level but no feedback on action to be taken. In some countries, limited political commitment and limited support for the operationalization of LMIS makes it difficult to achieve a more effective national PSM systems with less frequent stock outs and oversupply as those observed in CPP initiative risk monitoring activities Access to HIV Diagnostics Badara Samb (UNAIDS) provided a history of HIV treatment scale-up leading into the new 90/90/90 targets for post Dr Samb made the investment case for scaleup citing evidence that shows costsavings can be great. 1 The 90/90/90 targets (figure 1) have been adopted by numerous countries, including South Africa. The first and last goals, knowing ones status and achieving viral suppression, are heavily dependent upon laboratory testing. International stakeholders may have Figure 1. UNAIDS targets for HIV treatment scale-up post Cost benefit of scaling up treatment: Page 4 of 9

6 to engage in serious discussion concerning CD4 and its use as an entry point for treatment. Access to testing (and treatment) is critical 2 therefore stakeholders must work to advocate for sharing of funds to support laboratory services. The presentation on raised the following challenges which will be dealt with as move toward the targets: The proportion of persons who know their status is very low CD4 is a highly variable marker (between individuals, during pregnancy and even post-exercise), it is therefore likely that by 2020, VL will become the treatment entry marker the international community must be prepared Limited capacity to scale-up could threaten ability to reach 90/90/90 Many systems need to be put in place for VL scale-up In South Africa, returning results to the patient in a timely manner is a major challenge Funding gaps and lack of political will have to be addressed as we move forward. Countries find it difficult to select products require guidance on what to use and where: the WHO procurement and specification tool and other relevant tools should be disseminated for wider user. Private sector must be engaged in VL scale-up. Suggested next steps and future outcomes: WHO to takes lead in normative guidance for HIV diagnostics Include benchmarks for price in the revised specification tool for efficient procurement of HIV lab commodities Inclusion of diagnostics pricing info in GPRM was suggested Discuss DAI communication planning and more advocacy in DAI steering committee Forecasting of diagnostics Vincent Habiyambere (WHO AMDS) discussed the expected exponential increase in demand for VL in the near future and the need for accurate forecasting to ensure suppliers can meet the demand for HIV diagnostics at the lowest possible price. The goal for forecasting HIV diagnostics is to inform manufacturers and partners about the demand and to prevent a global shortage of HIV diagnostics. In order to meet the goal, greater collaboration between partners is required. Currently, a technical working group (TWG) on ARV forecasting meets every year to work together on global ARV demand forecasts. This approach has greatly reduced confusion amongst manufacturers. The diagnostics surveys started in 2012, looking at a variety of lab technologies being used and their performance. As the survey has now covered 3 years, it is possible to use the data on number of tests to contribute to the diagnostic forecasting activities. David Jamieson (PfSCM) discussed reliance on global pricing for cost-per test and the negative impact equipment underutilization has on cost. Network optimization is vital to equipment optimization. David presented information on ForLabs, a forecasting tool developed in collaboration with CHAI. ForLabs employs a multiple approach to forecasting using consumption, target and other data for comparison. ForLabs can be linked to the LMIS and is intended for national level planning. ForLabs will allow any commodity associated with a device and includes control but with some caveats. Repeat tests are not factored in. SCMS is completing quantification and projected procurement of HIV diagnostics in 12 PEPFAR supported countries. The resulting 2 year quantification could be additional information used in forecasting the future demand for diagnostics. 2 Status report on access to diagnostic and treatment services StatusReportProgresstowards2015Targets_en.pdf Page 5 of 9

7 Paolo Maggiore and Meghan Wareham (CHAI) presented an overview of CHAI forecasting intended to provide market intelligence for suppliers. CHAI relies on service data, consumption data, and country targets in its diagnostics forecasts to minimize wastage and more accurately model growth. Most models rely on a combination of different forecasting methods and do not rely on morbidity or service statistics-based forecasts alone. EID coverage remains low with high loss to follow-up. Lists of specific commodities by test are not included. Lama Suleiman (UNICEF) presented on the increasing demand for tests and treatment in coming years. Demand for therapy expected to increase from 11 million in LMIC now to 34 million when a test and treat approach is fully implemented. Lama noted that few countries have adopted WHO CD4 recommendations mostly less than 50%. Access is an issue with bottlenecks related to population size i.e. huge differences in estimated need versus demand. Important to provide the complete treatment cascade. The following challenges derived from the plenary discussions: Data on lab equipment and usage is very weak compared to data collected on drugs and treatment: there is need to develop and strengthen the LMIS for diagnostics There are significant variations among country in access to VL and other diagnostics As several lab technologies can do the same tests (CD4 tests or VL tests can are done by several different equipment in the country), there is a big challenge to know which technologies apply to which number of tests in the total volume of tests reported in the country. Several CD4 & VL technologies are found in various countries. Their performance in number of tests per day remain low compared to their full capacity and several machines are not in use due to lack of installation, training, reagents etc. Next steps and future outcomes: Perform the global forecast for VL, EID, CD4 and if possible RDT through WHO AMDS TWG. It was noted that Global forecasts are useful mainly for advocacy and resource mobilization (2-3 year period would be enough). Publicize the ForLab tool and other tools to support the procurement and supply chain management of diagnostics Pricing Mercedes Perez Gonzalez (WHO/EMP/PQT) presented the pricing analyses of diagnostic procurement performed by WHO, the Global Fund, UNICEF and SCMS. The range of prices for the HIV RDT market was $ HIV S/R Assay (for stringently regulated assays procured by SCMS). However, the main pricing bracket ranges from $0.17 to $4.00 USD for HIV simple/rapid assays. The market share held by Alere is 68% in terms of volume procured. VL, EID and other consumables / instruments ranged in price from $10 to25 for amplification reagents (for some assays, prices may include extraction reagents as well). The market share held by Abbott was 72% for EID assays. Added costs for VL and EID include extraction reagents, calibrators, controls, plus servicing at 20% (for most countries).. Cara Kosack (MSF) shared pricing information for the approx. 300,000 supported on ART (with <2% on 2 nd line therapy). VL manufacturer costs per test ranged from $ and ex-works from the supplier at a price of $ The lowest, CHAI price was $ Price surveys conducted across 6 countries were found to be much higher: $ Estimated costs for POCT were $18-36 per test and at least $24 per test including additional supplies. Cara suggested task shifting for DBS collection to reduce cost for VL and training lay workers to use POCT equipment. Partners were urged to work together and assist countries to perform pooled procurement and increase country Page 6 of 9

8 negotiating power. Higher demand for testing should bring down equipment maintenance contract costs from 20% to 10% but there remains a need for more efficient use of equipment. Vincent Habiyambere (WHO AMDS) and Paula Fernandes (GSSHealth) presented recent updates to the Tool to Guide Specifications & Quantities for Efficient Procurement of Essential Equipment and Laboratory Commodities for HIV. 31 new technologies (from PQ & partner lists) have been added and more items are expected soon. 26 obsolete or un-pq d tests have been removed. Test tables have been revised to include specimen type, eligibility criteria and regulatory status. Number of tests and UN hazard code have been deleted. Specification table structure has been revised to include manufacturer and price range columns. HIV RDT and EIA tables have been separated and items are ordered alphabetically, not by manufacturer. Other items are being updated. The revised version will be shared with ASMDS partners for comments. Manufacturers will be also asked to comments on their respective technologies. The new version should be released early Quality Anita Sands (WHO/EMP/PQT) presented the latest information on the Prequalification of In Vitro Diagnostics Programme. The PQ programme works directly with manufacturers and the process requires a pre-submission form, dossier review, site inspection and laboratory evaluation followed by PQ decision. Procedures have changed recently in order to reduce the timelines and make the expectations for manufacturers much clearer. WHO/EMP/PQT is working to harmonize the assessment processes with USAID and CDC in order to make joint recommendations. New abbreviated WHO PQ procedure that reduces time for products that have already undergone high risk (stringent) regulatory review by CE, FDA, Ministry of Health of Japan, TGA Australia or Health Canada requirements (no dossier required, just laboratory evaluation and shorter inspection). The abbreviated procedure should take no more than 180 WHO days. There are three possible scenarios for products: previously assessed stringently, not previously assessed but regulated version exists and not stringently assessed. Once a product is prequalified, an LTA is signed but there is no commitment to purchasing for specific volumes. The PQ programme has a change notification procedure as products may be changed over time. WHO/EMP/PQT is currently putting an emergency quality assessment in place for Ebola diagnostics. The PQ pipeline is updated monthly 11 HIV RDT, 1 CD4 (but 4 in pipeline) and most VL assays are already prequalified. HCV EIAs have also been submitted. WHO/EMP/PQT also preforms post-market surveillance and has a submission process for complaints on the PQ website. Angelica Perez (The Global Fund) presented requirements for principal recipients (PR) who are all required to comply with the Global Fund quality policy (Feb 2014 latest version). All RDTs, key lab products e.g. microscopes and imaging are subject to the policy. Many consumables such as gloves, needles are not covered. The policy requires manufacturers to comply with ISO PRs must have a quality system in place. There is a competitive selection process for malaria RDTs and for HIV RDT where there exists no algorithm. The costs of developing testing algorithms can be included in the Global Fund grant. Tsehaynesh Messele (ASLM) discussed the initiative across Africa to get laboratories working towards accreditation. The regulatory issues are quite great many facilities have no quality system in place or it is not fully functional. ASLM focuses of the establishment of quality systems in all of its strategic areas. ASLM also manages SLIPTA audits and training of SLIPTA auditors throughout the region. WHO AMDS meeting participants were strongly encouraged to attend the ASLM 2014 conference and to contribute to ASLM communications AJLM and Lab Culture. Theresa NeSmith (CDC ILB) presented PEPFAR laboratory program work to strengthen quality as part of health systems strengthening. Grounded in the Maputo Declaration, effects focus on collaboration with national and international partners to support countries to strengthen Page 7 of 9

9 sustainable, integrated laboratory systems to provide quality diagnostic services for effective implementation of prevention, surveillance and treatment programs across diseases (HIV, TB, Malaria, OIs). The notion of one linked laboratory network and the importance of the entire treatment cascade to deliver HIV treatment and care services was highlighted. The ACILT training centre in South Africa was highlighted as an important player in the provision of integrated hands-on training courses to improve quality and expand laboratory capacity in Africa for diagnosis and monitoring of major infectious diseases including HIV, TB and malaria. CDC s focus has been to work with partners to ensure completion of the cycle that is necessary for planning, implementation and monitoring and evaluating QA efforts. After the above presentations, the following challenges were identified: Certifications of quality are issued to manufactures by accrediting bodies these certificates should be reviewed as part of the procurement process procurement staff require guidelines to help them determine whether quality certification is appropriate and accurate. Facilities and procurement offices suffer from a lack of quality assurance staff Can use of SMS printers assist with scale-up of QA activities? Next steps and future outcomes: Examine opportunities to use barcoding to manage laboratory products especially for POCT data can be transmitted to central point and this may streamline supply chain management as it has for South Africa pilot sites Consider organizing a session on logistics management plus elmis required at next International ASLM Conference 2.8. Financing Robert Matiru (UNITAID) provided an overview of UNITAID s financing approach, 65% of which comes from of voluntary contributions from air levy sources. UNITAIDS strategy for focuses on 6 objectives: 1. Simple POCT, 2. Affordable paediatric medicine, 3-5. Treatment of HIV coinfections, malaria and MDR-TB and 6. Prevention of HIV/AIDS, TB and malaria. UNITAID distils landscape analyses into a one-page monthly summary on a dashboard: and is also pioneering investments in HIV POCT. Current laboratory diagnostic tools are not able to meet patients needs throughout the continuum of care and coverage of EID remains low. POCT could transform HIV treatment and care. UNTAID is funding a variety of partners to impact the landscape for POCT. 3. Next steps 3.1. Outcome of the discussion on procurement and supply management 1. Forecasting: it was agreed that the 2014 forecast will go beyond 3 years. It will be extended to 2020, so as to provide visibility on the introduction of new medicines and formulations, according to scenarios which WHO, MPP, and UNITAID will propose i. In addition, the demand for individual formulations will be added as a new feature in the forecast. The Department of Health of South Africa will join the technical working group. The Technical working group will meet in Wash DC on 21 and 22 Oct. The meeting with the manufacturers will take place in Geneva on March LMIS and other PSM Tools: In LMIS, the development of an open source elmis package was noted and welcomed. The recommendation was made to revise the website to publicize it and make it explicit what is needed to customize/implement it at country level. As any suggestion to improve the PSM Toolbox will require funding, we decided to explore off line how to secure financial support for It is Page 8 of 9

10 maintained for AMDS by i+solutions, but needs at least 12K per year for the maintenance and update of the PSM Toolbox database. An off-line discussion between the most important contributors and stakeholders (WHO, USAID/Deliver, USAID/SIAPS, USAID, Global Fund and UNAIDS) will take place to explore possibility of funding after the development of a funding proposal which included not only the maintenance mentioned above but also operating costs to ensure the PSM Toolbox functioning and better expansion to other areas such as diagnostics. In addition, the PSM toolbox also needs to add new functionalities and information (target group, prerequisites to use different tools, assessment of utility of tools by users). Of note is that the site gets 8000 visitors per year and was downloaded in its entirely by over 2000 people last year, with 2/3rds of the downloads by people based in Africa. 3. Stock out management: the issue of stock out in Global Fund-supported countries is dealt with efficiently between the Global Fund secretariat and the countries. 4. WHO, MSF and the Global Fund (which all have important products to benchmark the price of ARVs) will meet to assess whether and how they can increase the impact of their work in tracking ARV prices and ensuring their use in/by countries Outcome of the discussion on diagnostics 1. The AMDS partners agreed to create a diagnostics forecasting working group. The focus of the working group will be VL, EID and CD4. RDT will be covered if there are enough data. Hepatitis diagnostics will not be included in the scope of work for now. WHO will convene it, and the following organizations agreed to collaborate in it: CHAI, UNICEF, SCMS, USAID, Dept of Health of South Africa, UNITAID, the Global Fund, Esther. The time line for the forecasts is to be confirmed SCMS needs to check their readiness to provide for quantification data for 12 countries we expect to have this done in the next week. Technical level discussion leads us to believe that they will have completed their quantification in 3 to 4 weeks from now. After that we will be able to confirm the dates of the meeting with the Diagnostic manufacturers. 2. The AMDS partners agreed to proceed with the update of our joint procurement guide with price benchmarks, as planned. 3. Several recommendations/suggestions/calls were made, the last 3 of which would need to be discussed at the SG of the DAI: There were strong calls (from UNAIDS, IDA, SOLTHIS, MSF) for us to include information on diagnostics procurement in GPRM, so as to create the ability to do between country comparison of the efficiency of procurement. Linked with the PSM country profile this would generate accountability for cost effective procurement. There is a great need to do this as procurement of diagnostic is often through local distributors which demand 100 to 200% mark-ups. For the revision of the WHO treatment guidelines, it was suggested to strengthen the PSM part of the WHO guidelines development process. David Jamieson (SCMS) volunteered (subject to USAID agreement) as an expert, and both USAID and the Department of Health of South Africa offered to nominate an expert to support the work. As soon as available, the ForLAB planning suite developed by USAID/Deliver and SCMS need to be publicized and made available via PSMToolbox.org 4. A discussion on communication and advocacy in DAI is urgent, and will need to feature prominently on the agenda of the next Steering Group of the DAI. 5. Case studies on contracting mechanisms (the Global Fund), Delivery systems (USAID), implementation concerns other than the unit cost of reagents (MSF), decision models to decide between POC, DBS and central lab deployment of VL (CHAI, UNICEF, MSF) could all be promoted to advance the advocacy agenda. Our technical products need to be promoted to a larger audience. Page 9 of 9

11 6. To support the introduction of VL the economics of VL introduction needs to be examined v.a.v. the long term outcome of ART programmes (impact, the risk of HIV drug Resistance) with a longer planning horizon than the current short term planning horizon of 1 to 3 years. CDC, Harvard were mentioned as resources to do so. Department of Health of South Africa offered to nominate expert to support the work too. To make progress a lead convener needs to be identified. This convener could be identified in the DAI Steering Group. 7. A recommendation was made to insert in the 2015 ASLM conference a special session on linking quality assurance and supply chain management. Several models to do so were identified, each with different human resources and financial requirements. People need to know about them so that they can pick the best fit for their country and optimize resource use. i Subsequent to the technical working group meeting on ARV forecast, it was agreed to split forecast of currently recommended/used ARVs and forecast modeling of new ARV formulations due to the number of assumptions for their uptake: the forecast will cover and forecast modeling of new formulations will cover Page 10 of 9