An estimated 463 million people are currently living with diabetes around the world and upwards of 80% of them live in low-and-middle-income countries (LMICs). Despite significant improvements and growing initiatives in recent years, many people with diabetes in LMICs (defined as countries with gross national income per capita of less than US$4,125/year) struggle to access affordable insulin and glucose monitoring supplies. Additionally, while significant international investments have funded strengthening local healthcare systems in LMICs to prevent the spread of infectious diseases, very limited attention have been given to noncommunicable and chronic conditions (NCDs), such as diabetes. Unfortunately, the result of this limited access to diabetes management therapies has resulted in substantial death tolls, which the 2017 Global Burden of Disease Study estimated at 1.37 million people in 2017 alone with over a quarter of these deaths among people with type 1.
Diabetes care in LMICs is complicated by under-resourced health systems, inaccessible and expensive insulin and blood glucose measuring technologies, and limited patient and provider education. In a study on the performance of health care systems for patients with diabetes in 28 low-and-middle-income countries published in 2019, only 23% of people with diabetes had achieved glycemic control and only 38% of patients had received treatment that included lifestyle advice and/or diabetes medications. Additionally, despite the WHO target for countries to ensure 80% availability of affordable essential medicines for NCDs, a 2019 study found only 3 of 13 LMICs studied meet this target for human insulin (Brazil, Pakistan, and Kyrgyzstan). Blood glucose monitoring is also prohibitively expensive for many people in LMICs; an IDF/Life for a Child study found that that no lower-middle-income countries or low-income countries could provide at least 2 strips/day at low or reasonable cost for children w/diabetes.
Stakeholders, including industry, providers, and policy makers, have the opportunity to play a significant role in improving diabetes care in LMICs. Specifically, by improving pricing transparency around diabetes therapies and encouraging expanded national health coverage for diabetes-related devices, advocates can help reduce treatment barriers for people with diabetes in LMICs. Additionally, continuing to involve local organizations, providers, and people with diabetes will be a necessary step to strengthen health system capacity and improve diabetes outcomes in LMICs.
The WHO recently launched a Global Diabetes Compact to create momentum for global partnerships to tackle the challenges of diabetes care in LMICs. The goal of the Global Diabetes Compact is to support governments, UN organizations, civil society, philanthropic foundations, businesses, academic institutions, and people living with diabetes in coming together to bring diabetes care to all who need it. Specifically, the compact aims to bring all stakeholders to the table to ensure that no person living with diabetes goes untreated and that all aspects of diabetes management, including prevention, detection, care, and recovery are addressed.
We sat down with a number of experts on diabetes management in LMICs, including Dr. David Beran (Researcher and Lecturer, University of Geneva), Dr. Marg Ewen (Senior Project Manager, Medicines Prices, Health Action International), Molly Lepeska (Project Manager, ACCISS Study, Health Action International), Dr. Graham Ogle (General Manager, Life for a Child), Emma Klatman (Health Systems Specialist, Life for a Child), and Dr. Fran Kaufman (Distinguished Professor Emerita of Pediatrics and Communications, Keck School of Medicine of USC) We have included insights from all of these highly-regarded leaders throughout the report on various topics including the current state of health systems in LMICs, the role of insulin donation programs in diabetes management in LMICs, and key roles for stakeholders working to improve diabetes management for people in LMICs.
This report is part of an effort to better educate our readers and ourselves about the state of diabetes management in low-and-middle-income countries (LMICs) around the world. As have many in the worlds of diabetes and chronic disease, we also hope to draw further attention to global inequities on all fronts, particularly related to lifesaving therapy for all people with diabetes as well as diabetes management technologies. We continue to look to learn more about relevant national and global stakeholders who are taking action so that we can amplify their work and help continue to advocate for equitable access to care for all people living with diabetes. This report is not designed to be comprehensive, but rather is an effort to discuss with our readers the state of diabetes care in LMICs, the challenges associated with access and affordability for insulin, and glucose monitoring supplies, and potential stakeholder actions moving forward to consider in our quest to learn more and educate where possible and needed.
There are a variety of factors to understand in thinking about the state of diabetes care in LMICs that we have tried to remain aware of in this report – effectively, while these are limitations, they are also potential future areas of further exploration:
Data on diabetes in LMICs is often limited. Specifically, data on the number of people living with diabetes in LMICs as well as the breakdown of people with type 1 versus type 2 diabetes is extremely limited due to under-resourced health systems and large rural populations. For this reason, much of the work to improve diabetes care in LMICs that we know about has focused on type 1. Additionally, while external researchers do sometimes collect data on diabetes and other non-communicable diseases, the majority of health-related research in LMICs focuses on communicable diseases and maternal mortality. Without sufficient data, it is challenging to craft health policy and address which interventions will be the most successful.
Health system and care delivery patterns vary, often significantly, across LMICs. No two countries follow the same path when it comes to procuring insulin and diagnostics for people with diabetes, making cross-country comparisons challenging. Additionally, internal health systems operate under a variety of models with different payer schemes making the success of interventions highly context dependent.
For most people with diabetes in LMICs, diabetes is not close to being the only challenge they face. Specifically, large percentages of the population in LMICs struggle with food insecurity and poverty that can exacerbate diabetes complications and make treatments even less accessible. In light of these compounding challenges, as so many have recommended prior to this report, comprehensive and integrated action is needed to address the multiple challenges of poverty, limited resources, and diabetes in LMICs. Identifying the ways in which organizations working with people with diabetes are themselves often working in environments of scarcity is also important to address as multi-stakeholder action is considered.
- Diabetes Burden in Low-and-Middle-Income Countries
- Challenges to Diabetes Care in LMICs
- Under-Resourced Health Systems
- Insulin Access and Affordability
- BGM and Testing Access and Affordability
- Stakeholder Actions
Diabetes Burden in Low-and-Middle-Income Countries
1. Diabetes Prevalence in LMICs
Across the world, an estimated 463 million people are currently living with diabetes and nearly 80% of them live in low-and-middle-income countries (LMICs), which for many, limits their access to high quality diabetes care. Despite significant improvements and growing initiatives in recent years, many people with diabetes in LMICs, defined as countries with gross national income per capita of less than US$4,125/year, struggle to access affordable insulin and glucose monitoring supplies. Additionally, while significant international funding has gone toward strengthening local healthcare systems in LMICs to prevent the spread of communicable and infectious diseases, there has historically been very limited attention given to noncommunicable conditions (NCDs), such as diabetes. Notably, a WHO statement on the accessibility of insulin and diabetes-related devices described non-communicable disease services as “conspicuous by their lack of progress in comparison to [services for] communicable diseases.” The Lancet’s NCDI Poverty Commission echoed this sentiment in an important 2020 publication, “The Lancet NCDI Poverty Commission: bridging a gap in universal health coverage for the poorest billion,” stating “NCDIs are commonly represented as complications of ageing and development. In fact, they also constitute a large and diverse burden of illness among children and young adults.” The authors go on to emphasize, “Public health discourse and global solutions have generally focused on preventing NCDIs through changes in human behaviors, and not on addressing the inadequate resources available” for people in LMICs to access health care. For example, despite efforts from insulin manufacturers and advocates to improve accessibility in LMICs, according to data from the WHO, roughly half of all people needing insulin are unable to access insulin due to high costs either at the personal or health system level. Unfortunately, this limited access to diabetes management therapies has resulted in substantial death tolls, which the 2017 Global Burden of Disease Study estimated at 1.37 million people in 2017 alone with over a quarter of these deaths among people with type 1. We heard similar data presented at ISPAD 2020 when JDRF Global Project volunteer Tom Robinson shared that “for every two people globally living with T1D, we miss out on the company of a third” due to premature death as a child or adolescent. Not only does the limited access to high quality care result in a stark preventable death toll, but diabetes also leads to unquantifiable productivity losses every year and substantial health system expenditures that could otherwise be used to improve health infrastructure and outcomes for everyone.
2. Limited Data and Resources
Recent efforts to improve diabetes care in LMICs are challenged by a general lack of data on health system infrastructure, resources, patient needs, and provider education. Namely, there is very limited data on the breakdown of type 1 and type 2 diabetes among people in LMICs, which can significantly complicate care. Additionally, a 2019 study on the burden of diabetes care in LMICs during crises indicated there is very little research on the impact of diabetes-related complications, such as cardiovascular disease and neuropathy on people with diabetes in LMICs. Furthermore, when it comes to accessing insulin and glucose monitoring technology, countries often encounter opaque supply chains and prohibitive prices. Additionally, education resources for patients and providers can be limited making systems challenging to use and resulting in a lack of education on best practices for diabetes management. Without significant data in LMICs, it is challenging for advocates and policy makers to target their actions toward the populations with the greatest need and the initiatives that will have the greatest impact.
Dr. David Beran (University of Geneva) on positive and negative developments for diabetes care in LMICs: “If I start with the positive changes, I think there’s been more recognition about diabetes and non-communicable diseases as a health problem for low-and-middle-income countries, both at a global level and then also at a national level. I think one of the changes is that [non-communicable diseases are] now on the agenda, even at WHO. At a national level, many countries now have some form of non-communicable disease policy, and most of the time it includes diabetes. But the challenge there is that oftentimes type 2 and type 1 are mixed together… [Looking at technologies,] you’ve seen rapid developments. CGMs, flash devices, a whole wide range of things. And in contrast, in many low-and-middle-income countries, people are still dying because they can’t access or afford insulin. You really have, I would say, unfortunately, a growing gap between the haves and have nots in terms of insulin, in terms of the diagnostics, in terms of everything.”
Challenges to Diabetes Care in LMICs
Under-Resourced Health Systems
1. Current Health System Outcomes
Health systems in LMICs struggle to meet the needs of patients with diabetes due to limited supplies, provider education, and overall health infrastructure. According to a 2019 study on the performance of health care systems for patients with diabetes in 28 LMICs, only 23% of people with diabetes had achieved glycemic control, and only 38% of patients had received treatment that included lifestyle advice and/or diabetes medications. Additionally, across the 28 countries studied, the total unmet need for diabetes, defined as “the sum of those [people with diabetes] not tested, tested but undiagnosed, diagnosed but untreated, and treated but with diabetes uncontrolled,” totaled 77% of all people with diabetes. Interestingly, patients in the oldest age group, those over the age of 55, often received the best quality of care and had “greater rates of testing, diabetes service utilization, and disease control, as compared to younger individuals.” It is worth noting however, that the authors cautioned against reading too far into improved outcomes among older individuals, instead suggesting the imbalance may “partially reflect a survivor bias” leading the report to capture more data from “healthier older adults with diabetes who have access to care” compared to others whose lack of access to care may have led to earlier severe diabetes complications and/or death. In order to address the challenges of diabetes care in LMICs, a 2019 study on progress towards universal access to insulin and BGM supplies argued that “comprehensive strengthening of national health systems is needed for adequate T1D care, including skilled health professionals, diabetes education, and inpatient services.”
Dr. Beran on the importance of an accurate diagnosis: “The fundamental first step is being diagnosed. If we’re focusing on type 1 diabetes, will an individual walking into a clinic sometimes with nondescript symptoms or in a coma be recognized as having type 1 diabetes? In many contexts, if that sick child enters into the national hospital of pediatrics, they’re probably lucky, and they probably will get the right diagnosis. But, if they walk into a rural health center, most likely, that child will be misdiagnosed with a common communicable disease and will unfortunately die. That’s a failure in the health system, and that number is impossible to quantify unless you follow up every sick child that enters the system.”
2. Limited, Unrealistic, and Incomplete Guidelines
Notably, across LMICs, guidelines are often limited and incomplete, complicating care delivery. While many groups such as the ADA and ISPAD and others globally have developed robust guidelines for diabetes care delivery, many of these recommendations are unrealistic in the context of LMICs. As noted in this 2019 PLoS Medicine report on health systems in 28 LMICs, there are “major gaps in guidelines used in resource-limited health systems as compared to guidelines used in the health systems of high-income settings.” Additionally, as is true in many geographies, especially LMICs, crafting guidelines for diabetes care in LMICs is complicated by a lack of data on the healthcare system itself. This lack of data makes it challenging to identify specific areas for improvement and craft targeted policy in response. However, some LMICs (e.g., Uzbekistan, Azerbaijan) have been able to achieve improved care for people with diabetes. Across these scenarios, government-provided health insurance coverage in tandem with policies and practices to prevent medication and diagnostics stock-outs have proven effective techniques for improving the quality of care and expanding access for people with diabetes. Research from Dr. Ogle and Life for a Child on effective methods to improve diabetes care in LMICs came to a similar conclusion and identified “an intermediate level of care,” in which MDI therapy, BGM, point-of-care A1c testing, and diabetes education are available for patients, as the most realistic option for cost-effective diabetes care in LMICs. Notably, in this research, an intermediate level of care was associated with long-term cost reductions compared to a minimal level of care (i.e., human insulin 2X/day, little to no BGM or A1c testing, and limited education) due to reduced complications and increased longevity. With the intention of addressing these gaps in guidelines, The Global Alliance for Chronic Diseases has developed a working group to develop guidelines for “individual and system level control of noncommunicable diseases” including diabetes in LMICs demonstrating that actionable and contextually relevant guidelines can be created.
Ms. Emma Klatman (Life for a Child) on providing an intermediate level of care: “Life for a Child would advocate for an intermediate level of care in less-resourced settings. Oftentimes in these countries, the health system is providing a minimal level of care. I know in the US and Australia and the UK, young people with diabetes get provided guidelines-based care, i.e., those set out in the ISPAD guidelines or in the American Diabetes Association guidelines. And those include CGM and eight to 12 glucose test strips per day and analog insulin and insulin therapy via a pump. And we just don’t see those as being, at this stage, realistic for a health system or government in many LMICs to be able to provide. So, we propose that governments provide an intermediate level of care, whereby decent health outcomes and HbA1c levels can be achieved. And now, this is in comparison to guidelines-based care; it’s a reduction in the number of daily test strips per day, and there’s no analog insulin, but decent health outcomes can be achieved. That’s what we advocate for governments to provide.”
3. Task-shifting and Growing Health System Capacity
LMICs and other resource-limited settings have seen a growing emphasis on utilizing community health workers and strengthening health system capacity. We have seen a similar trend in the US, especially with Stanford’s Project ECHO using tele-education and community health workers to support PCPs and people with diabetes where specialty care is limited. In the international arena, a study published in The Lancet on the burden of diabetes care in LMICs, the authors argue in favor of “building local health system capacity in diabetes management by developing integrated NCD programs, establishing referral pathways, and strengthening local supply chains, protocols, and policies [to] urban-based populations and promote sustainability.” The study also highlights the success of utilizing community health workers in efforts to treat and limit the spread of infectious diseases such as HIV and tuberculosis in LMICs, saying, “it is important to examine and identify what routine tasks can be done by non-health professionals at the community level (e.g. task cadres, and health education and treatment support to community health workers)” indicating there may be lessons from successful infectious disease management that could also be effective at improving non-communicable disease outcomes. While there is certainly a significant portion of diabetes care that requires a specialist, daily support from community health workers to interpret glucose values and calculate insulin doses would surely be welcome by many people with diabetes living in LMICs. Additionally, a number of studies highlight the disparity between health system infrastructure for communicable and noncommunicable diseases in LMICs with the majority of resources going toward the prevention of communicable diseases which often makes it challenging to expand resources for noncommunicable diseases such as diabetes.
Dr. Francine Kaufman (Children’s Hospital Los Angeles) on the importance of strong health systems: “The bottom line is that there has to be a strong health care system bigger than just an under resourced clinic and local healthcare provider. If volunteers want to come in and make a difference, it is not by delivering care in a system and in a language they poorly understand, but by educating the local providers on diagnosis, treatment and maintenance, and working to enrich the local efforts and the broader system that surrounds them.”
Ms. Molly Lepeska (Health Action International) on health systems: “Strengthening the health system, I think especially in rural areas so that people can get locally diagnosed, receive an understanding of how to inject insulin and test blood sugar, and support from at least the family doctor – that’s really important.”
4. Insulin Donation Programs
Diabetes care in LMICs often relies at least partially on insulin donation programs that provide lifesaving services but may not be sustainable for long-term patient care. A number of insulin donation programs exist to support people with diabetes in LMICs, but the largest programs tend to focus on children with type 1, meaning that as patients age out of the program, they may struggle to access affordable insulin and testing supplies and that growing type 2 populations are largely ineligible for program assistance. While donation programs such as Life for a Child (LFAC) also work to educate people on lifelong diabetes management skills, these skills can only go so far if people are unable to access insulin or BGM technologies – organizations like LFAC of course recognize this but do not have predictable or plentiful enough resources to address this, despite their deep knowledge base. In 2017, the ACCISS Study (Addressing the Challenges and Constraints of Insulin Sources and Supply) group from Health Action International published guidelines for sustainable insulin donation in LMICs, as well as a 10-step process to phase out insulin donation in favor of sustainable national health system initiatives. The publication recognized the incredible benefit of insulin donation programs and provided the following recommendations to improve the sustainability of current donation programs: (i) all donations of medications, diagnostics and equipment should follow the World Health Organization (WHO) guidelines for medical donations; (ii) donor agencies/organizations should regularly report program targets, the number of people with diabetes covered by the program, health outcomes, key health system data, partnerships, and program financing; (iii) donation agencies/organizations should collaborate with national programs to ensure a safe transition of donation recipients into the national health system; and (iv) donation programs should be expanded, as possible, into countries where diabetes and diabetes-related complications are not included in national health insurance schemes.
Insulin Access and Affordability
Insulin remains financially out of reach for many living with diabetes in low- and middle-income countries. The WHO has set a target for countries to ensure 80% availability of affordable essential medicines to treat NCDs. However, based on data from a 2016 study, only three countries meet this goal (Brazil, Pakistan, and Kyrgyzstan) and do so by providing insulin at no cost via the public sector. As WHO Director-General Dr. Tedros Abhanom Ghebreyesus put it, “It is a failure of society and the global community as a whole that people who need insulin should encounter financial hardship to buy it or go without it and risk their life.” A lack of transparency in supply channels, and regulatory inefficiencies are some of the contributors to prohibitive insulin prices in some countries; other countries have additional barriers beyond the scope of this report.
1. Insulin mark-ups, purchasing strategies, and taxes
Regulations, mark-up policies, and purchasing strategies vary dramatically among countries, requiring individualized solutions to lowering insulin prices. Insulin prices can increase up to fivefold and more from the product cost to the patient cost. As we understand it, based on a 2019 study on insulin pricing, human insulin (10mL of U100 insulin) generally costs $2-3 to produce, costs governments a median of $5 to purchase, and costs patients a median of $10 in the public sector and $16 in the private sector. Analog insulin costs between $4-6 to produce, costs governments $21-106 (median =$28), and costs patients a median of $28 in the public sector and $30 in the private sector. At these prices, low-income patients in LMICs must give up three to five days’ wages for a month’s supply human insulin or six to 16 days’ wages for a month’s supply of analog insulin, regardless of public or private sector purchase. Unfortunately, public sector supplies of insulin in LMICs are often unreliable when it comes to availability despite providing patients with a lower cost alternative. Because of the lack of standardization in pricing across countries, governments with similar resources find themselves paying different amounts for insulin to provide patients in the public sector. Additionally, due to the high prices many governments pay, they are often unable to purchase enough insulin to meet public sector demand, meaning that even though the public healthcare system may offer insulin for free, it may not be in stock when needed.
Dr. Beran on insulin margins and pricing: “The question is, are these taxes on sick people? I have no issue if there's margins or taxes on iPhones or candy bars or whatever else. But in a sense, if these are government-imposed taxes, it seems like governments are taxing the sick people... Most European countries set the price of medicine. If I want to sell insulin in Switzerland, I can't just say that I want to sell insulin at a thousand dollars a vial. There are government regulations that regulate the price to the system and then also regulate the markup and the patient price… Those rules should also apply in low and middle-income countries in terms of regulating prices, as well as the markets within the system, to ensure better affordability and also to make sure that the system itself doesn't take advantage of people needing medicines.”
2. Human vs. Analog Insulin
Human insulin is more affordable than analog counterparts in many LMICs, as it is throughout the world. In this 2016 study of 13 LMICs, short-acting human insulin was found to meet the WHO goal of 80% availability in the public sector, compared to only 63% for analog insulins. Median prices of government procured human insulin was $5/vial versus $33/vial of long-acting analog insulin – over six times more expensive for every 10 mL of insulin(!). According to these figures, the average low-wage adult needs to save four to seven day’s worth of wages to afford 10mL of insulin. Across these same countries, the median patient price of human insulin was $9. The same study also found that vials were cheaper than pens and cartridges for all human insulins, but not for all analogs, which further contributes to the huge variability in pricing of long-acting analog insulin in both the public and private sectors for patients. The authors of the study suggest improving availability and affordability by “prioritizing the supply of more affordable human insulin, increasing competition through the use of lower priced quality-assured biosimilars, negotiating lower prices from manufacturers, and improving distribution systems.”
Dr. Beran on insulin price variation: “I think the first thing to know in terms of the variability of the price of insulin is that you see it even without these add-ons. If you look at the government procurement prices, it's quite shocking to see this wide range of prices for, at the end of the day, the same product. Normally, you would expect some variation. Prices vary for a whole wide range of goods and services between countries, but even within the same geographies and even in the same income levels, you do see a wide range of prices. I think the first lesson is to say, why is there such a wide range of prices?”
Dr. Beran on analog insulin: “The WHO has turned them [analogue insulin] down three times, mainly because they offer only a minor or marginal benefit and their higher price. And I think it's an interesting phenomenon to think about: why is this product replacing human insulin on the market, given it is more expensive and that it doesn't bring that much benefit? Is it “innovation”? What's newer is always viewed as better?”
3. Prohibitive Cost of Insulin Injection Devices
Syringes remain the most popular form of insulin delivery in LMICs, but cost poses a significant barrier to full availability. A LFAC study in 37 countries found that insulin was injected via syringes 83% of the time, compared to pens 16.7% of the time and pumps only 0.2% of the time. Unfortunately, almost half of the countries surveyed did not provide syringes through their public healthcare systems, while the other half relied on donations from LFAC or other donation services. Each syringe costed an average of $0.32 for centers purchasing their own syringe supply ranging from $0.04 in Uzbekistan to $0.97 in Guatemala. For patients, syringes costed, on average, $0.23 at the six centers that charged a fee. All other centers in the LFAC study received syringe donations and/or provided them for free. If patients are unable to obtain syringes through public health clinics, they may seek out a retail pharmacy, where costs are higher and often not covered by health insurance. The LFAC study also found that due to the high cost of syringes, many people in LMICs resort to reusing needles, sometimes more than five times, and that there was significant improper disposal of syringes/pens. Specifically, needles were reused in 94% of the countries surveyed. These suboptimal practices lead to greater risk of secondary infection (46% of survey respondents said infections were either “common” or “not uncommon”), which adds to the cost and burden of diabetes, both on individuals and national healthcare systems as a whole. Additionally, stigma associated with syringe injections remains prevalent in many LMICs and can be a significant social barrier to improved diabetes management.
Dr. Beran on reusing syringes: “Insulin is often provided for free. It’s often available or subsidized. Syringes aren't. And if they are, they are often in insufficient quantities. There are people who have to reuse syringes. It happens everywhere to such an extent that people are using a single use syringe at least eight times, if not more.”
BGM and Testing Access and Affordability
1. BGM use in LMICs
Although CGM has quickly overtaken the diabetes management conversation in the US and Europe over the past few years, for individuals with diabetes in low-resource settings, BGM is still the primary tool for blood glucose monitoring and diabetes management. Studies in South Africa and Brazil demonstrated that testing via BGM four to five times a day was successful at reducing both A1c levels and diabetes-related complications in children and teens. The global TEENS study found that increased daily BGM was one of three self-management practices significantly associated with increased diabetes-specific quality of life. It is therefore crucial for BGM to remain available and affordable for populations living in LMICs who cannot afford expensive CGM technology. Unfortunately, the high financial costs associated with every purchase of BGM supplies have not only made BGM supplies scarce in primary care settings and health facilities, but also largely inaccessible to people with diabetes in LMICs.
Dr. Beran on the importance of accessible BGM: “Some people would definitely argue that those tools [BGM] are less than optimal because you're still with a vial, a syringe, and a blood glucose meter versus a CGM. But I think we have to remember that in terms of innovation, these are still relatively new innovations and that people have managed for many years with a vial, syringe, and a blood glucose meter. The next step up in terms of technology would place a huge financial burden on the individual or the health system in low- and middle-income countries. It's a difficult discussion to have in terms of having a lot of people say you're promoting second rate care for people in low and middle-income countries. And I would argue, no, I'm not promoting second rate care. I'm promoting something that's affordable, that does work, and that is also valid for people with low incomes in high income countries....It might not be the ideal, but it will keep you alive. And I think that's the main message in low and middle-income countries. You're still talking about keeping people alive and allowing them to survive in difficult circumstances and those circumstances need to include the financial burden that diabetes management places on the individual or the health system.”
2. Prohibitive Costs to BGM at the Patient and National Levels
At the patient level, high and recurring out-of-pocket costs for BGM make day-to-day diabetes management difficult to maintain. Public health insurance schemes are often more likely to provide insulin than test strips, which result in high out-of-pocket costs for patients. Unfortunately, BGM supplies can also be more expensive than insulin, and therefore the largest cost to households for type 1 diabetes care. In Brazil, where the average annual cost for managing type 1 diabetes is US$1214, BGM supplies make up 52% of this burden, while insulin is responsible for 26%. In Mexico, BGM accounts for 53% of the average total annual cost (US$1690), compared to insulin accounting for only 15%. An IDF LFAC Index study found that no lower-middle-income countries or low-income countries could provide at least 2 strips/day at low or reasonable cost for children with diabetes. In Benin, Burkina Faso, Cambodia, Central African Republic, Ecuador, India, Côte d’Ivoire, Malawi, North Korea, Mauritania, Mongolia, Nepal, Pakistan, and Somalia, the cost of two strips per day for a year is significantly greater than the cost of an annual supply of human insulin. In Ghana, the lack of public health coverage for strips means that proper treatment of diabetes is an “absolute impossibility” for most citizens.
On a national level, the cost of BGM supplies is exacerbated by taxes and duties. Klatman et al.’s 2018 study argues that “on a national level, countries should eliminate customs and import duties on SMBG supplies, as has already been done for most essential medicines.” Diabetes is not a disease of affluence, and diabetes management products as a whole must be taken seriously as essential treatments because their equitable availability makes a difference between life or death. Additionally, with significant international attention focused on access to insulin, small national health budgets often overlook the necessity to also prioritize the subsidization or provision of BGM supplies.
Ms. Klatman on national health insurance: “What tends to be the case in low- and middle-income countries is that in health insurance funds or in the public health systems, in-hospital services can be covered, but consumables are not. So that means, possibly being admitted for diabetic ketoacidosis can be covered or a diagnosis can be covered with the costs associated there. But insulin, glucose meters, test strips, A1C testing – those sorts of components of care are really quite hard to come by in national health insurance schemes.”
3. Limited Market Competition and Rapid Technological Development
From a global manufacturing perspective, issues with compatibility and rapid turnover add to the cost of BGM supplies in LMICs. For the time being, it is unknown how manufacturers’ market share stands, since LifeScan and Ascencia are no longer public and since Abbott is not itself focused on traditional monitoring. Although the test strip market does enjoy greater competition and brand variety than the insulin market, test strips from different manufacturers are not compatible with blood glucose meters from different manufacturers and are frequently phased out as newer generations of technology become available. Frequent product turnover renders many meters inoperable due to incompatibility or obsolete pairings. Generic test strips have been developed, and while some believe their uptake has been held back by the limited availability of accuracy data, there is also data that shows accuracy has improved enormously, which has added to commoditization, which has led to J&J and Bayer exiting the market over the last several years. Collectively, these factors add to the challenge of providing SMBG supplies in LMICs.
Dr. Beran on interoperability between meters and strips: “In terms of self-monitoring, you have some people who were able to buy their initial blood glucose meter that comes with the free strips. But then the question is, can they afford the refill of strips? And if they can afford it, has the meter changed in the meantime? And that's a huge problem in the meters is the frequency with which they change and the fact that meter A strips don't fit with meter B and also that it is quite a hefty cost for many people to have to continuously buy test strips.”
Ms. Klatman on technology phase outs: “There are also other problems with sustaining access to glucose monitoring that perhaps aren't as pronounced as they are for insulin. And, yes, I'm speaking about the implications of technological phase out. So, let's say you have a LifeScan meter, and they utilize a certain kind of test strips that were offered with the meter in 2009, but, suddenly in 2010, they've made new test strips which offer no added clinical benefit but are somehow more expensive -- possibly more expensive to manufacture, or maybe not, in reality. But suddenly someone has a meter that's now rendered useless because they can't keep up with the ongoing strips issue.”
4. Patient Education and Meter Accuracy
In addition to financial barriers associated with BGM in LMICs, patient education and meter accuracy present significant limitations to widespread SMBG adoption. Accuracy guidelines for blood glucose monitoring vary by country, with no established international consensus. According to a 2018 study, in 2012, only 79% of meters met the ISO’s 2003 standards, while only 53% met the ISO’s much tighter 2013 standards. Because the potential for inaccuracy increases in low glycemic ranges, the risk for hypoglycemia among patients using less accurate meters increases. Patients are also often undereducated on BGM and struggle to interpret glucose values and relate values to management interventions. Likewise, low numeracy and literacy in many LMICs can limit the effectiveness of BGM technology and can prevent patients from effective self-management. Additionally, providers in many LMICs, especially when diabetes is not their specialty, often don’t have time to keep themselves and their patients up to date on the latest techniques and technologies, indicating that providers may need more BGM education. Notably, research from the IDF Life for a Child program found that shifting the responsibility of educating patients to nurses helped improve BGM usage indicating there are solutions to today’s SMBG access challenges. On a more practical note, hot and humid climates found in many developing countries make it difficult to store and distribute meters and strips according to manufacturer guidelines, which risks reduced device accuracy.
Dr. Beran on the lack of BGM education: “It’s also the education and information that's received and how the meter is able to become a tool that enables the individual to actively manage their diabetes versus just saying, I'm high, I'm low. Most of the time people know what to do when they’re low; they know that they need to ingest sugar or honey or something sweet. But if they're high, and they haven't been taught properly, very few people know what to do. And so that would be the first level. The next level is some doctors provide a scale for their people they follow. They say, look, if your blood glucose is between this and this, you add a unit. If it's between that and that, you add two units.”
Dr. Graham Ogle (Life for a Child) on the importance of BGM: “I don't think you can rank [the importance of insulin versus BGM]. Children with diabetes will die without insulin, but they'll also die if they can't monitor their blood glucose levels. They'll also die if the family doesn't know what to do. They’ll die if the health professionals don't know what to do. It’s four critical components of care: insulin, blood glucose monitoring including A1C, diabetes education of the family, and health professionals who are skilled in treating type one diabetes. If any of those four components are not there, then the child is likely to die, frankly. Except possibly education in a very resourced setting. So, we've been jumping up and down about this for a long time and the focus has been largely on insulin and it should be. But these other components are critical as well. And they're often more expensive than insulin.”
5. Limited Access to A1c Testing
Although A1C testing every three months is recommended for young people with type 1 diabetes, the lack of access to A1c testing supplies in LMICs makes it difficult to reach this target. Unfortunately, according to this 2020 study A1c testing is “substantially less available than insulin provision and clinic blood glucose measurement in all country income levels except for high-income countries.” The largest challenges to providing A1c testing are the costs associated with testing machine purchases and maintenance, cartridge purchases, and frequent stockouts. Out of the 37 surveyed countries, 31 provided testing, 20 of which bought A1c testing equipment at a mean cost of $6.89/test. Eighteen centers offered free testing for young people with T1D, but the remaining centers charged a mean cost of $9.34/test, which racks up to almost $40 in annual testing fees if patients aim to achieve the suggested testing frequency. As a result, 76% (26 out of 34) of surveyed testing centers reported young people with T1D who skipped A1c testing due to financial and other barriers.
Given the challenges outlined above that can significantly limit the quality and accessibility of diabetes care in LMICs, there are substantial opportunities for stakeholders, including manufacturers, financial institutions, clinicians, payers, governments, healthcare economists, policy makers, professional societies, and patient advocacy organizations to lend support to diabetes programs in LMICs. We haven’t included information on which are currently already involved and which are not and merely point out that cohesive approaches among stakeholders are not yet in the mainstream. Included in this section are a number of suggestions from working groups and experts to increase availability for insulin and BGM supplies, build health care system capacity, and transition away from dependence on insulin donation systems.
1. Improving Affordability of Insulin and SMBG supplies
As outlined above, national health systems in LMICs often struggle to procure affordable insulin and BGM supplies, maneuvering through a complex landscape rife with taxes, duties, and mark-ups that increase prices and place insulin and blood glucose monitoring supplies out of reach for many people with diabetes in LMICs. Due to the complexity of the insulin procurement system in many LMICs, it is not always clear where pricing components originate, leaving national health systems vulnerable to higher prices. To reduce this risk, increasing transparency in the insulin purchasing process, both for national and private sales, has the potential to reduce prices. In our conversation with Dr. Ewen she emphasized, “Transparency is needed to help procurers assess what is a reasonable price.” There is also the potential for increased transparency to reduce intra-regional pricing differences that result in more limited drug supplies in certain LMICs.
On BGM systems, we would like to understand ways in which industry manufacturers can make a concerted effort to reduce technology phase-outs in LMICs, which severely limit the longevity of BGM meters and result in increased costs for people living with diabetes. Additionally, while more national health systems are starting to cover the cost of insulin, including consumables such as BGM meters and test strips in coverage must become an integral part of diabetes management to ensure that patients are able to accurately track their glucose levels and adjust therapies as needed. As well, for those with type 2 diabetes, movement away from MDI and moving toward approaches that are associated with glycemic-dependent therapy as these become generic is an area that we’d recommend more focus. While currently this is not possible because most of these therapies, though not all, are more costly than insulin, with better and earlier diagnoses of T2D, some of the medicine that could be taken early on in diabetes progression would obviate the need for frequent BGM.
Looking at insulin and BGM together, many patients and health systems face higher prices due to taxes, duties, and mark-ups. We’d like to see multi-stakeholder discussion in areas to better understand how regulation might help address these challenges. We are also curious how greater investment in companies that are working on providing greater help to those in LMICs could help, such as Biocon. Far more work that addresses reducing the financial burden of accessing these necessary therapies and technologies is clearly needed. Currently, a small number of companies control the majority of both the insulin and BGM market – we’d like to see more health economist focus on this area to understand what might expand the market or further contract it. Companies like Biocon are looking to reduce prices to those in LMICs and we’d like to better understand how more stakeholders might develop more ability to pursue this end. While market pressures may be able to reduce prices in LMICs and thus increase access to affordable therapies and technology for people living with diabetes, we would also suggest investment in approaches that include a broader set of stakeholders.
2. Innovation and Increased Funding
Long-term, sustainable diabetes management requires a strong health system that is able to provide supplies, education, and therapies to people living with diabetes. In LMICs, much of the focus surrounding strengthening health systems has historically been related to infectious and communicable diseases such as malaria, HIV, and tuberculosis, which has ultimately translated to increased funding for infectious disease management and extremely limited resources for managing non-communicable diseases like diabetes. While there is certainly growing attention for non-communicable diseases, increased international funding has the potential to dramatically alter and improve the landscape of non-communicable disease care in LMICs. As Ms. Kaltman noted, “the world listens to the funding narratives and tropes of big agencies like the Gates Foundation, USAID, The Department for International Development in the UK, and I don’t know of any of these programs that have projects that have been diabetes-related.”
In addition to providing increased funding for diabetes in LMICs, international attention has the ability to shed light on the need for LMIC-specific diabetes innovations. Access to insulin is often limited by its temperature sensitivity, and temperature can also damage BGM meters and strips. This 2020 study also provided guidance on what the authors considered the ideal A1c testing device in LMICs, stating the system would be “an accurate, easy-to-use, battery power option that uses inexpensive testing supplies that have a long shelf-life and do not require refrigeration.” While such technology may seem out of reach currently, it is entirely possible that LMIC-specific technologies could be designed and made available with enough attention devoted to the issue. Despite the significant population of people with diabetes living in LMICs, very little innovation has focused on addressing their specific needs. Local populations are often not consulted on their needs, meaning that when innovations do arrive, they may not fill the specific needs of people with diabetes in LMICs. Moving forward with a goal of improving outcomes, centering the needs and ideas of local people with diabetes in LMICs should be a central tenant of innovation and change – as should acquiring data on where prevalence of diabetes and serious diabetes complications is most acute. While community involvement has been largely fragmented historically, this is addressable.
Dr. Beran on community involvement: “I think the approach [to innovation] has to look at how do you go to communities and say, look, this is what we as researchers have identified as your problems. Are we right or are we wrong? If we’re wrong, tell us why we’re wrong, and then how do we solve this? How do we solve this together in terms of saying, okay, we as a group of researchers and people who are going to benefit from this have identified the core problem – how are we going to address this and how can we help you address this?”
Dr. Beran on LMIC-specific technology: “We need a blood glucose meter that can work in 40°C heat [104°F] in 80% humidity. And rather than have numbers, can it have colors, or can it do something else? Or can we have a meter that doesn’t need strips or something else that would address some of these problems and fill a real gap? Because the majority of people who need a blood glucose meter can’t access it, and among those who have it, many of them don’t use it to its full potential.”
3. Education and Peer Support
Building capacity of health care professionals and health literacy of people with diabetes in LMICs is fundamental to improving diabetes care. At the provider level, more robust, realistic, and context-specific guidelines can help providers understand best practices in treatment. More relevant guidelines can also provide patients with direction and specific instructions to help manage their diabetes and reduce complications. Specifically, according to Dr. Beran, guidelines aimed at simplifying data interpretation and dosing calculations for patients have great potential to improve treatment adherence and reduce complications.
In addition to guidelines, improved peer support and reduced stigma are key factors for improving diabetes care and management in LMICs. While the internet has made connecting to people with diabetes easier than ever, and we have seen significant growth in diabetes support communities in the US and other high-income countries, people with diabetes in LMICs sometimes lack diabetes role models in their communities. Peer and community support for people with diabetes is important not only for relieving some of the emotional burden of managing diabetes, but also because it provides an additional avenue for people to learn diabetes management skills and context-relevant management advice that may be otherwise inaccessible. As stakeholders and LMICs work to grow health system capacity, efforts centered around community support should play an integral role in any proposed system.
Ms. Lepeska on diabetes education: “If the ultimate goal is to help everybody to be empowered to manage their own care then, other than access to insulin and supplies which, of course, is essential, I think the education element is really important. Because I think not only does it teach you how to manage your condition, but also it’s starting to empower people to advocate for themselves in terms of what they might need with their government or with their doctor. It’s giving them more education, more tools to understand ‘this is what we need to make this work in our context.’”
Dr. Beran on peer support: “I think peer support needs to be a bigger priority, I’ll always remember this time in Vietnam where a mother with a young child with diabetes met someone from abroad who came in and was there to present, and the mother realized, wait a minute, this is a young woman with diabetes, looks fine, is going to university and has a future. Therefore, my son can have a future as well. I think that’s a big part of the problem where, unfortunately, you have parents who see the generation above their children getting complications and dying and that’s the future they’re then looking at for their own children. Whereas, if you can have peer support groups, I think it serves two purposes: one is it shows that type 1 diabetes is not a death sentence and two, it breaks down this barrier of the interaction… These groups can then help a mother with a young child who’s just been diagnosed, who’s six years old, to meet someone who can say, ‘I’m 26 years old, I’ve had diabetes for 20 years, and yes it’s hard, but here’s how I’ve done it.’”
4. Transitioning Away from Insulin Donation Programs
While insulin donation programs provide necessary support and services in LMICs, long-term sustainability is best achieved by transitioning toward increasing health system capacity and improving national health care resources. For donation programs looking to support a transition toward nationally supported insulin accessibility initiatives, the ACCISS study authors recommend the following ten-step process:
Donor agencies should support a program with a free basic package of education, diagnosis, and treatment for as many children with type 1 diabetes as possible, thereby preventing the almost certain death these children would otherwise face, and create a national patient register for follow-up and reporting;
Donor agencies should collaborate with the national government, diabetes associations, people living with diabetes, and other donors to create a national continuum of care for type 1 diabetes from childhood to adulthood;
Donor agencies should work with national authorities to create systems to prevent, diagnose, and treat acute and chronic complications of type 1 diabetes in children and adults;
Donor agencies should provide detailed information on key aspects of the support program including the number of recipients, type and value of diagnostics used and medicines donated, total program costs, etc;
Donor agencies should present to national authorities, other donation programs, and national health insurance systems about the proof of concept that type 1 diabetes can be successfully and cost-effectively diagnosed and treated in LMICs;
Donor agencies should encourage national authorities to develop and implement a national diabetes policy as a commitment and a guide for action to achieve universal access to decentralized health services for the prevention, diagnosis and treatment of diabetes;
Donor agencies should encourage national authorities to create systems whereby young adults are empowered to procure affordable standard diabetes care after their eligibility for donation programs ends;
Donor agencies should work with the national government toward inclusion of standard diagnosis, care, and treatment of diabetes in national health insurance programs;
Donor agencies should encourage the national government to integrate the prevention, diagnosis, and treatment of diabetes and its complications with the delivery of nutritional advice and other services for the prevention and treatment of other chronic conditions such as HIV, tuberculosis, leprosy, and hypertension: and
Donor agencies should phase out their involvement as soon as the above objectives have been achieved.
-- by Hanna Gutow, June Dong, and Kelly Close