Getting Patients & Programs the Drugs They Need
AA&D and the Lilly Global Health Partnership are leading a global initiative to map activities working to address supply and access challenges to second line drugs. The goal is to provide data on partnerships and projects to help inform decision-making, to understand programmatic overlaps where appropriate, take advantage of shared strengths, and improve areas where there are intervention gaps.
An Interactive Tool to Help Decision Making: Coming November 2017
The TB Drug Access Atlas focuses on various market activities within the Internationally Quality Assured - Second Line Drugs (IQA-SLDs) landscape, giving users the ability to dive into multiple data areas across the site.
Visualizations help contextualize and bring data to life, and various selection features allow users to further interact with key information.
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Learn More: Executive Summary
Internationally quality-assured (IQA) second-line drugs (SLDs) are essential to treat and cure drug-resistant forms of tuberculosis, but only a fraction of patients around the world who need these drugs receive them each year. This shortfall reflects market challenges regarding the drugs themselves, limited care delivery capacity in high-burden settings, and a fractured, uncoordinated donor and implementer landscape compared to other disease areas. From July 2015 through April 2016, building upon background research on this topic, a survey and interview review was conducted to map out the leading international partners, funders, and implementers working to improve this situation regarding IQA SLD. This review synthesized publicly available information on these initiatives with self-reported information on the priorities, linkages, and budgets of these projects. This project was conducted by a team of researchers from Duke University’s Sanford School of Public Policy and Advance Access & Delivery, a US-based non-profit.
The goal of this exercise is to provide data-driven tools to inform decision-making, reduce programmatic redundancy where appropriate, take advantage of shared strengths, and address clear gaps in the areas of intervention where needed. This study focuses necessarily on more established international development assistance providers but may be augmented in the future to include other regional efforts or national-level initiatives in-scope. The audience for this review and associated tools ranges from international and national policy-makers, the partners identified in the review themselves, and global health implementation researchers. The findings do not assign value to the projects in terms of outcomes, but identify existing work within the scope of this project on a global level. A summary of findings is as follows:
- 40 defined projects and partnerships were identified working on in-scope activities, with most activities involving multiple institutional partners. Information was collected on 20 additional projects that were deemed to be either suspended, or only marginally in-scope.
- Projects within the scope of this review are implementing projects in 72 countries from 2014 through 2020. Of these, 66 countries are identified as receiving financial support for these activities in-country from identified.
- The programmatic activities more often identified by projects as key areas of work were procurement (24), regimen complexity (20) and delivery challenges (19). The lack of work addressing the other four categorical areas may reflect the difficulty designing and assessing successful “market-shaping” or affordability and market incentives projects across so many stakeholders, regulators, and economic systems.
- In terms of spending distribution, low-income and lower-middle income countries received an expectedly large share of the pledged resources, but several high-burden countries (in both raw number of patients and percentage terms) with relatively stronger economies received a much smaller share of resources than their disease profile may have suggested. India is a notable exception to this trend, being the only so-called “BRICS” nation with very high spending on in-scope projects.
- In terms of direct interviewee feedback on global challenges, the following were recurring issues identified during the interview phase:
- SLD stock outs continue to be a challenge despite some improvements and new mechanisms designed to decrease frequency of these events
- Countries where many or most patients seek care in the private sector do not effectively or frequently share best practices with one another through a systematic mechanism
- No global market review for small SLD sector inspires confidence for a new manufacturing market entrant in terms of predictability, frequency of forecast updates, or the size of the market.
- Slow progress generating completed, rigorous clinical trials data for new drugs is a major blockage keeping national health authorities from utilizing new drugs and regimens
- Efficiency issues for funding agencies, including lack of engaged oversight and accountability for many sub-recipients in this space
- Poor logistics is a frequent challenge during shipping, storing, and documenting SLDs
According to World Health Organization (WHO) estimates, an average of 3.9% of new cases of tuberculosis (TB) and 21% of previously treated TB cases had multidrug-resistant forms of TB (MDR-TB) in 2015. Some 480,000 new MDR-TB cases emerged that same year, with a global burden of 580,000 cases of MDR-TB including retreatment cases, and close to 250,000 people died of these strains of the disease. Detection of MDR-TB cases has improved over the years, and efforts are in place by the highest burden countries to increase the number of patients patient diagnosed and treated. Yet, timely access by patients to IQA SLDs continues to be a serious concern.
Market barriers and challenges all along the global and local supply chains mean that the gains made in diagnosing patients could be lost if those patients aren’t appropriately treated with medications they need. The need to address drug supply and access problems is even more urgent with the promise of newer, more effective drugs and less toxic regimens on the horizon. The global health community, including large donor organizations, technical experts, governments, NGOs, and the private sector, are prioritizing their efforts in different ways to address these challenges. However, well-planned and executed initiatives are often done without close coordination – which can lead to duplication or missed opportunities, even among closely linked organizations.
To replicate successful models and avoid repeating errors, visibility into the SLD supply and access initiatives is critical to ensure that no major gaps are left unaddressed, that overlaps are avoided, that linkages between programs can occur, and that lessons learned are shared amongst stakeholders. In 2015, the Global Fund and the Lilly MDR-TB Partnership launched a TB Program Mapping exercise to identify all ongoing efforts and major initiatives to address IQA SLD supply, procurement, and access challenges, and to identify the existing linkages, partnerships, and coordinating mechanisms where these issues are discussed and planned. This effort was not intended to evaluate these projects for effectiveness or value, but to provide information on the partner landscape for the benefit of Global Fund planners and the broader TB community in its collective efforts to improve access to IQA SLDs.
The goals of this mapping exercise were as follows:
- Map the current major initiatives to address IQA SLD supply and access challenges
- Identify the existing forums/coordinating mechanisms where these issues are discussed
- Establish channels or tools to ensure this information is shared, updated and acted on
The exercise was designed to create a product that could be used by the TB community to add value and increase the impact of current and future activities. The parameters were set to include the ongoing existing and planned or funded activities of projects that were fully or partially focused on access to IQA SLDs. Not included in the scope of this exercise were projects primarily focused on research and development of new therapies. However, projects addressing regimen complexity of existing therapies or other strategies intended to increase market availability for drugs once they are approved by stringent regulatory authorities were included in the scope of this exercise. Finally, this exercise did not take into account projects that were mainly focused on access or delivery of non-IQA drugs, unless there was a significant component addressing access or delivery gaps for the IQA drug market.
Within the scope of this project, the following sub-categories were created to understand the range of activities performed by each entity, organization, or partnership. These are informed primarily by the frameworks set forth by Management Sciences for Health (MSH) and the WHO to understand and address market dynamics issues in health systems contexts. This categorization serves to outline the main challenges facing TB projects globally, and highlights areas of improvement for market functionality. While it is analytically useful to distinguish the major categories in this way, it is important to remember that in reality, all seven categories are intricately dependent on one another. It is crucial to note that interviewees may have somewhat different interpretations of each of these categories and how they may or may not overlap, regardless of survey prompting or interviewer guidance. This study ultimately reflects how representatives from different projects themselves would describe their work within the scope of this exercise. These market indicators include:
- Market incentives: Can apply to patients, institutional customers, or most typically to manufacturing firms as a way to increase their involvement within the IQA drug market. This category of activities can facilitate market entrance, participation, and functionality via financial, institutional, or informational innovations or reforms.
- Forecasting: Can represent a range of predictive methods that quantify needs within a specified time frame. Strong forecasting is an integral part of the market, according to interviewees, as forecasting inaccuracies negatively affect all other market dynamics.
- Procurement/supply chain management: Can refer to tendering, ordering, transportation, and administrative facilitation of SLDs, on both the national and global levels. Despite progress made by GDF and other multilateral instruments, procurement in the SLD market is often characterized by delays and regulatory holdups due to small batch sizes, irregular forecasting, and other issues.
- Regimen complexity: Can refer to activities that simplify or streamline treatment options for patients. MDR-TB treatments currently take upwards of 24 months from start to finish and can manifest in many different combinations. The length of treatment time, negative reactions to medications, and low cure rates all contribute to the complexity of treating MDR-TB.
- Regulatory complexity: Can refer either to the evidentiary, financial, and administrative burden to register drugs in different settings, or to a country’s qualification to receive IQA medicines from multilateral procurement agencies. This can be an extremely lengthy series of processes that require licensures, guideline adherence, and funding.
- Price affordability: Can be understood as the relationship between the purchasing organization’s ability or willingness to pay, and the purchase price of an SLD order. Beyond the purchase price, all costs that go into monitoring, storing, and maintaining of SLD stocks are considered part of the overall cost of the order. Purchasing cost is directly affected by the market stability and manufacturing competition.
- Delivery Challenges: Can refer to the practical linking of drug procurement efforts to functioning treatment projects. Once SLDs arrive at a clinic, organization, or national stockpile, the storage, domestic transfer, and clinically/programmatically appropriate utilization of these drugs for patients is a key consideration that can involve many different institutional, governmental, and private sector players.
The research team used a combination of publicly available information via websites and reports to populate a spreadsheet of project drivers, regions of work, project budgets, partner organizations, project contacts, milestone dates, and activity timelines. Over the course of the next two months, all project leads were contacted by email sent from a group of stakeholders at Lilly MDR-TB Partnership, The Global Fund, and Duke University to request their participation in the mapping exercise.
Each contact who agreed to participate was first asked to fill out a Qualtrics survey intended to summarize project goals, approximate budget range, primary funders, activity timeline, partner organizations, regions where the project is working, and other projects they might be aware of working in a similar space. Participants were also asked to participate in a 30-45 minute telephone interview with a member of the research team. Interviews were conducted either by telephone or Skype at the convenience of the project contact and were attended by at least two members of the research team, one leading the interview and the other taking notes and ensuring the details of the interview were properly recorded.
The main goal of the telephone interviews was to better understand how project representatives linked their work to one or more of the seven market categories listed above. Through the interview process, interviewees also identified the forums and coordinating mechanisms whereby this information could be shared and used as a catalyst for discussions amongst stakeholders, leading to actin of new projects and more effective approaches to current and future work in these areas.
Of the 60 projects the research team initially identified, 21 phone interviews were conducted and 26 pre-interview Qualtrics surveys were completed. Multiple efforts were made to reach the project leads in cases where the team did not receive an email response. In the end 40 projects were considered firmly in-scope, with another 20 projects with informational collected by the team that were either suspended or only marginally in-scope.
Key Market Indicators
Within the scope of the TB Drug Access Atlas, the following sub-categories were created to understand the range of activities performed by each entity, organization, or partnership. These are informed primarily by the frameworks set forth by Management Sciences for Health (MSH) and the WHO to understand and address market dynamic issues in health systems contexts. These market indicators include: