REPORT ON DIABETES CARE

What are pharma companies doing
to expand access to insulin – andhow can efforts be scaled up?
OCTOBER 2022

Millions of people with diabetes worldwide, but especially thosein low- and middle-income countries (LMICs), can neither accessnor afford the insulin that they need. Although pharmaceuticalcompanies are taking action to address affordability and have begun
scaling up initiatives deemed successful, efforts remain confined
to a few products, settings, and countries. As the rising burden of
diabetes becomes a pressing issue for many healthcare systems
in LMICs, and as new products and players enter the market, thebiggest challenge will be to make progress at scale so that a genuine
choice of insulin products is always available to people in thesecountries. This study examines companies' strategies to overcome
barriers to access, highlights areas where progress has been madeand identifies opportunities for future action.

Access to insulin in LMICs

ACKNOWLE DG E M E NTS

The Access to Medicine Foundation would like to thank the following
people and organisations for their contributions to this report.
FU N D E RS

The Leona M. and Harry B. Helmsley Charitable Trust
UK Foreign, Commonwealth and Development Office
The Dutch Ministry of Foreign Affairs
Bill & Melinda Gates Foundation
AXA Investment Managers

AUTH O RS

Claudia Martínez
Camille Romero
Natalia Sánchez Villalobos
E D ITO R IAL TE AM

Eleanor Bley Griffiths
E XPE RT R E VI E WE RS

Professor Hans Hogerzeil, Emeritus Professor Global Health, Groningen University; former Director for
Essential Medicines and Pharmaceutical Policies, World Health Organization
Charles Toomey, Co-Founder, Action4Diabetes
The Access to Medicine Foundation would like to thank the experts who provided their input throughinterviews during the development of this study.

ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent non-profit organisation that seeks to transform the healthcare ecosystem by motivating
and mobilising companies to expand access to their essential healthcare
products in low- and middle-income countries.
Naritaweg 227-A
1043 CB, Amsterdam
The Netherlands
For more information about this publication, please contact
Claudia Martínez, Research Programme Manager.
cmartinez@accesstomedicinefoundation.org+31 (0) 20 215 35 35
www.accesstomedicinefoundation.org

2

Access to Medicine Foundation

Table of contents

About this paper

4		
Executive summary

How this paper was developed		

Global insulin inequity is stark, and current

The content in this paper has been drawn from data available

access efforts fall short – but companies arein the public domain, peer-reviewed literature, and global

now seeking sustainable ways to scale up

health and policy reports. The paper was further informed byaccessdata collected for the 2022 Access to Medicine Index, as wellas additional data collected specifically for the purpose of

6

The challenge		
Lack of access to insulin is a devastatingproblem for diabetes patients globally

this publication and interviews held with partners and experts
in the diabetes field. The content was supplemented withinformation provided by industry and global health stakeholders during the Expert Session ‘Closing the gaps in access to12		Company profiles

diabetes care in low- and middle-income countries’ hosted by

How are companies addressing access to

the Foundation on 7 July 2022. A more detailed description

insulin?

of the methodology can be found in the appendix.

13

Eli Lilly

15

Novo Nordisk

18

Sanofi20

Biocon22

Industry analysis

This study specifically analyses the actions of the three

22

Lack of registration of essential insulins

main insulin manufacturers: Eli Lilly, Novo Nordisk andin LMICs is a barrier to expanding access

Sanofi. One major manufacturer of biosimilar insulins,

Companies are expanding access models, but

Biocon, is also in scope. The activities of other companies

system-level approaches to address chronic

and organisations are also considered to provide context

care are lacking

or support the information included in this study.

SCOPE OF THE RESEARCH
Companies

26

27
29

A patchwork of strategies to improveaffordability

Products

New strategies and partnership models areThis study is focused on insulins, which are essential

being used to tackle challenges in the insulin

products for many people living with diabetes mellitus.

supply chain and the delivery of diabetes care

Data collected and analysed specifically includes humaninsulin (regular and isophane) and analogues including

32
		Spotlight

aspart, degludec, detemir, glargine and lispro. A fullAccess to insulin for children andproduct list can be found in the appendix.

young people
Countries
34
		

Next steps

This study is focused on the context and actions taking

How to meet the challenge of expanding

place in 108 low- and middle-income countries (LMICs)

access to insulinthat are home to over 80% of the world’s population,using the same inclusion criteria as the 2022 Access to36

References

38

Appendix

Medicine Index. A full country list can be found in the
appendix.

3

Access to insulin in LMICs

EXECUTIVE SU M MARY

Global insulin inequity is stark, and current
access efforts fall short – but companies arenow seeking sustainable ways to scale up
accessf Companies carry out a variety of initiatives to expand the reach of their products
in LMICs, but often with limited scope, breadth and scale.
f By collaborating to solve access challenges, stakeholders in the global insulin
ecosystem can take action to systematically and sustainably address the insulin
access gap and increase treatment choice.
The number of people with diabetes worldwide is expected to reach 643 million by
2030, and 783 million by 2045, rising most rapidly in low- and middle-income
countries (LMICs) as the burden of non-communicable diseases grows.1 Yet, in
LMICs, many people who need insulin currently do not have access to this essential, life-saving drug – and many more do not have the choice of products that all
patients deserve. This is despite huge advances in diabetes treatments over recent
decades, including products such as analogue insulins, which have already become
well-established and preferred by patients and their healthcare practitioners inhigher-income countries.
Pharmaceutical companies can play a major role in reversing this inequity by
expanding access to their insulin products worldwide, including all the different
types of insulin products in their portfolios. This paper looks at what companies
are doing – or not doing – to address the core issues. Under the spotlight are thethree companies that dominate the global insulin market: Eli Lilly, Novo Nordisk andSanofi. Combined, these companies control over 90% of the global insulin market
by value.2 This paper also examines Biocon, a smaller company that markets biosimilar insulins, shedding light on the role played by such companies and their products(biosimilar insulins) in increasing access in LMICs.
Poorer populations miss out on access to insulin and treatment choice
No matter where they live in the world, every person deserves the medical treatment that would be best for them. The World Health Organization (WHO) recently
added several analogue insulins to its Model List of Essential Medicines, withanalogues joining the human insulins that were already listed – demonstrating an
increasing recognition by global health stakeholders that both types of insulin areneeded for patients in all countries.
Because registering a medicine is a necessary step that enables its sale in a country, data about registration can reveal a great deal about where a company is making a drug available (or has intentions to do so), and where it is not. Companies aretaking steps to make their products available in LMICs, yet analysis by the Accessto Medicine Foundation shows that poorer populations are being consistently overlooked when it comes to registration.
In some LMICs, the variety of types of insulins available is very limited. Only 29of the 108 countries in scope have all the insulins classified as “essential medicines”
by WHO registered, and only one of those is a low-income country. Worse, in 24
countries, no insulins were found to be registered at all. When even this initial step
towards access has not been taken for any insulin products, the situation for those
who need insulin to survive is very grave indeed.
4

Access to Medicine Foundation

Analogue insulins are widely registered in high-income countries, and mostupper-middle income countries have at least one analogue insulin registered.
However, at the bottom end of the country income scale, 15 of the 27 countries
classed as low-income do not have a single analogue insulin registered. When no
analogue insulins are registered, patients lose out on important treatment choices.
Addressing insulin affordability as a priority
The affordability of insulin remains a significant issue. Human insulins, while more
broadly available than analogue insulins in LMICs, are still out of the reach of many
people with diabetes. Analogue insulins are often priced significantly higher thanhuman insulins, especially in LMICs, creating further barriers to access. In general,pharmaceutical companies have previously focused their attention primarily on
expanding access to human insulins in LMICs, with analogues viewed as less of apriority – but this approach has started to shift, and could shift further in the future,as the importance of patients having access to both human and analogue insulins,
and the need for competition from biosimilar products, is acknowledged.
Tapping into the potential of biosimilars
Expanding the number and type of insulins on the market in LMICs will have a positive impact on both availability and affordability. For this reason, quality-assured
biosimilar insulins hold a great deal of potential, especially as several patents on
long-acting insulins have recently expired – meaning biosimilar versions can now belaunched as competitors. While the insulin market continues to be dominated by
global insulin manufacturers, several biosimilars companies do already produce andmarket a significant quantity of insulin products in LMICs. However, companies havesignificant hurdles to overcome before their products’ potential to expand accesscan be fully realised, including challenges in scaling up, competing with establishedbrands, and satisfying complex regulatory requirements.
Seeking sustainable strategies to expand accessOver the last decade, as laid out in the company profiles on pages 12-21, insulin
manufacturers have been building access programmes and exploring different strategies and initiatives in LMICs. They have tried a patchwork of approaches, often
focused on a small number of countries, or based around particular types of products (e.g. human insulins) or specific patient populations (e.g. children). Most strategies are project-based and limited in scope, and do not yet guarantee sustained
access for insulin-dependent patients requiring ongoing, life-long treatment.
However, companies are now starting to seek more sustainable, systemic
approaches to expanding access to insulin in LMICs. This includes developing targeted approaches to address the needs of specific populations lacking effective
access to healthcare, and engaging in partnerships to strengthen local health systems and supply chains. One particular consideration is that access to insulin mustbe paired with access to the monitoring devices (e.g. glucometers) and delivery
devices (e.g. needles) that are needed to use insulin effectively and keep diabetes
under control. As such, solving the major problems in access to insulin involves
looking at insulin within the broader picture of patients' needs, and considering
access to other essential products for managing diabetes.
To achieve long-term improvements and ensure that patients have access to thebest available treatments, companies must step up efforts to ensure that successful
access strategies are scaled up to reach more people, and strategies are expanded toinclude all insulin products. This paper identifies some of companies’ existing efforts
towards making sustainable access to insulin a reality in LMICs, as well as looking at
where action is not currently being taken, and where gaps remain. While the challenges
are complex, there is now real momentum towards overcoming those challenges
and pursuing opportunities to sustainably expand access to insulin products in LMICs.

5

Access to insulin in LMICs

TH E CHALLE NG E

Lack of access to insulin is a devastatingproblem for diabetes patients globally
Insulin was discovered 100 years ago, transforming type 1 diabetes from a certain

Diabetes by numbers:1,3

death sentence into a treatable long-term condition. Yet this transformation has

f Over half a billion adults worldwide

been far from universal. Huge numbers of people living in low- and middle-income
countries (LMICs) still do not have access to the diabetes products, including insulin, that they need to stay alive and healthy.
Daily access to insulin is essential for survival for patients with type 1 diabetes

currently have diabetes.
f Three out of four adults with diabetes
worldwide live in LMICs.
f Around 45% of people with diabetes

and many with type 2. Unfortunately, insulin products are often unavailable to thoseare undiagnosed and unaware of theirliving in LMICs – and when they are available, they are often unaffordable. The stark

condition.

reality is that without access to insulin, many more diabetic children and adults will
suffer and die from this life-long, chronic disease.
This is certainly not a new problem; global gaps in access to insulin have beenpresent ever since it was first discovered, manufactured and sold. But the problem

f Worldwide, 6.7 million deaths per year
were
attributed to diabetes in 2021.
f Insulin is estimated to be needed byis becoming more acute. The costs related to managing this condition represent

over 72 million people, including 9 mil-a concerning global burden, as total health expenditure due to diabetes in adults
amounted to USD 966 billion in 20211. The number of people with diabetes islion people living with type 1 diabetes.
f Approximately half of the people

expected to hit 643 million worldwide by 2030, and cases, mainly of type 2 diabe-

living with type 2 diabetes who needtes, are rising most rapidly in LMICs. The situation is worsened by poverty, conflictinsulin worldwide are actually receiving

and outbreaks of disease. Local and global disruptions threaten supply chains, damage fragile healthcare systems, and threaten both availability and affordability.

treatment.
f An estimated 94% of the global increasein diabetes by 2045 will occur in LMICs.

About diabetes

The number of people living with diabe-

Diabetes mellitus, also commonly known as diabetes, is a chronic condition in which

tes is projected to grow 129% in Africa

the body is unable to produce or properly use insulin, an essential hormone thatby 2045, in comparison to an estimatedhelps regulate blood glucose levels. When diabetes is left untreated, persistent highgrowth of 13% in the European region.

blood glucose levels cause devastating effects in body organs, including cardiovascular disease, kidney failure and nerve damage. Untreated or poorly controlled diabetes can lead to premature death in some cases and disabling conditions in others,
such as lower-limb amputations and partial or complete vision loss.1
The most common types of diabetes are known as type 1 and type 2 diabetes,with other types including gestational diabetes. Type 1 diabetes often has its onset
during childhood or young adulthood. Because of the body's non-existent or very
limited capacity to produce insulin, people living with type 1 diabetes need daily
injections of insulin to survive. Type 2 diabetes is the most common type of thedisease; it is generally diagnosed in adulthood, although onset in young people has
been increasing in the past decades. Treatment of type 2 diabetes includes diverse
interventions and medications, sometimes including insulin, which is an essential
treatment for about 15% (approximately 63 million) of people living with type 2 diabetes worldwide.3
Momentum for changeThis is a key moment to make a leap forward and address the chronic lack of equity
in access to diabetes treatment, because several developments have coalesced thatare potentially game-changing.
For one thing, the last three decades have seen significant innovation. Products
have been launched that can significantly improve the lives of people living withdiabetes, such as analogue insulins (see box, page 7), which can allow for improved6

Access to Medicine Foundation

control of blood sugar levels after meals and overnight - making patients' lives

Types of insulins

easier, cutting the risk of hypoglycaemia (low blood glucose levels), and potentially

Insulin production began in the 1920s

increasing adherence to treatment. Alongside this, some insulin products now allow

from animal pancreases. Currently,

more storage flexibility by decreasing the need for refrigeration – an advantage

biosynthetically produced insulin has

in many low-resource settings –, and more user-friendly delivery and monitoringalmost fully replaced the global use ofdevices have been developed, including pens and insulin pumps.

animal insulin. Two types are available on

For another thing, WHO recently made a landmark decision about analogue

the market: human insulins and analogue

insulins. Human insulins have been recognised as essential products and have been

insulins.

included in the WHO Model List of Essential Medicines (EML) since its very first

Human insulins have been available

edition in 1977; but in 2021, WHO made the landmark decision to add long-acting

for over 40 years. This type of insulin

analogue insulins degludec, detemir and glargine – and their biosimilars – to the list.

includes human regular insulin, which

The addition of several analogue insulins to the EML is a recognition of thehas a relatively short onset and dura-

importance of these products to diabetes patients in every country, and the needtion of action, and isophane or Neutral

for more competition in the market, and could be a catalyst that changes the way

Protamine Hagedorn (NPH) insulin, which

companies and governments consider the role of analogues in LMICs. However, as

has an intermediate range of action.

things stand, analogues are significantly more expensive than human insulin4 andAnalogue insulins are newer products

still represent the minority of overall insulin volumes used in LMICs. A concertedwith a targeted onset and duration of

approach is urgently needed to expand access to all types of insulins so that health-action, which facilitates a more spe-

care practitioners are able to offer their patients a genuine choice and prescribe thecific blood sugar control. Rapid-acting

best treatment for each person and their circumstances.

products include aspart and lispro, and5

The fact that patents on certain analogue insulins have recently expired could

long-acting products include glargine andalso have positive implications for access. This could lead to healthy competition

detemir. These were introduced in previ-from biosimilar versions (see page 9), and therefore more competitive prices inous decades, but recent years have seen

LMICs. Biosimilars face many challenges in the global diabetes market, as this paper

the introduction of products with ultra-

will explore – but there is a real opportunity to expand access to analogues now

long range of action, such as degludec.

that off-patent versions are possible.

In addition to insulin, patients some-With the launch of WHO’s Global Diabetes Compact in 2021, there is renewed

times need glucagon injections toimpetus towards bridging the gaps in access to diabetes care worldwide, as well as

increase blood sugar levels and counterclear goals and a framework for change (see box, page 8). The first-ever global tar-

the adverse effect of an excessive dosegets for diabetes were ratified by the World Health Assembly in 2022, including theof insulin.

TIMELINE : Innovations and developments in the
century after the discovery of insulin7-12

1978

2021

First recombinant DNA synthetic human insulin

Long-acting insulin

prepared. First portable insulin pumps developed.

analogues listed on
the WHO Model Lists

1921

1949

1996

Discovery of insulin

Production of first

Approval of lispro, firststandardised insulin syringes

analogue insulin (Eli Lilly)

1936

1963

1982

1999

Protamine utilised to

Design of firstFirst insulins using

Approval of first Continuous

produce slow- releaseinsulin pumprDNA technology
marketed, by Eli Lilly

insulin1920

of Essential Medicines

1930

1940

1950

1960

1923

1950

First production of insulin fromFirst sales

animal pancreas, by Eli Lilly,of NPHfollowed by production frominsulin, by

Nordisk Insulinlaboratorium

Nordisk

1970

1980

1990

Glucose Monitoring device

2000

2010

2020

1970

2000

First blood

Approval of insulin

EMA grants a positive

glucose meter

analogues aspart

opinion on two of

available(Novo Nordisk) and2022

Novo Nordisk’s humanglargine (Sanofi)(now Novo Nordisk) andinsulins, for flexible
storage outside

1985

Hoechst (now Sanofi)

refrigeration

Introduction of
insulin pens, by
1977
Human insulin listed on the first WHO
Model List of Essential Medicines

2015

Novo Nordisk

Approval of insulin analogue
2005

degludec (Novo Nordisk);

Approval of insulin

approval of first biosimilar

analogue detemir

insulin (glargine, by Eli Lilly)7

Access to insulin in LMICs

goal that 100% of people with type 1 diabetes have access to affordable insulin and

WHO Global Diabetes Compact

blood glucose self-monitoring by 2030.6

The Sustainable Development Goals, set

Given these advancements and the pressing need to address the global diabe-

in 2015 by the United Nations Generaltes burden, the momentum for change must not be lost. A century on from theAssembly, include the reduction of

discovery of insulin, efforts to expand access to insulin must be scaled up so thatpremature mortality from non-communi-

the millions of people living with diabetes worldwide can have full access to insulin,cable diseases (NCDs) by one third. The

including human and analogues, and all the long-term care they need to live full anddeadline for this goal is 2030, but thehealthy lives.

mortality figures for diabetes are one ofThis paper seeks to inform and inspire more collaborations and actions fromthe main factors making the goal difficultcompanies involved in the global insulin market, as well as from policymakers, inves-to attain. 23 In response to this, WHOtors, local governments and global organisations. It is published by the Access tolaunched the Global Diabetes Compact

Medicine Foundation, which has been tracking pharmaceutical companies’ actionsin 2021. ‘Key asks’ have been formulatedon access to their diabetes products in LMICs for more than a decade. By iden-

as priority areas for action for different

tifying opportunities for improvement, and by engaging with key stakeholders instakeholders, including the private sector,

access, the Foundation stimulates companies to improve access to their products

such as to “Improve access to diabe-

across the world.

tes diagnostics, medicines and health

The analysis in this report builds on data collected by the Foundation’s Accessto Medicine Index, which – since 2008 – has been measuring and analysing how

products, particularly insulin, in low- andmiddle-income countries”. 23

of some of the world’s largest pharmaceutical companies perform on access to
medicine. The main global insulin manufacturers – Eli Lilly, Novo Nordisk and Sanofi– were also given the opportunity to submit further data on their insulin products

WHO prequalification programme

for analysis in this report. Data was also collected from Biocon, an Indian company

To address the market concentration

which is one of the largest producers of biosimilar insulin.

issue, and to increase supply and affordability, it is critical for more manufactur-

The global insulin market is dominated by three companies

ers to enter the market and produce

The insulin market is currently dominated by three pharmaceutical manufacturers.

quality-assured insulin. In 2019, WHO

Together, Eli Lilly, Novo Nordisk and Sanofi control over 90% of the global insulin

launched a pilot programme for the pre-market by value.

qualification of biotherapeutic medicines,

2,13

These three manufacturers produce 83% of the insulin sold in

LMICs, where they also hold around 95% of the market share.5 In 2021, these threeincluding human insulin; and in 2022, thecompanies' yearly combined global revenue from insulin was approximately USD 18

programme was expanded to include

billion.14–16 *long-acting analogue insulins. 24 ProductYet, these companies – and the handful of smaller companies that make up theprequalification can reduce the regulatory

remaining share of the market – do not make all of their products available in every

burden on pharmaceutical companies –country in the world. Many people living in LMICs have access only to a limited

therefore making it more attractive toselection of insulin products, because – for example – a company may not see thelaunch their products in these countries.

commercial value of registering and launching its product in a particular market.

The overall prequalification programme

Even though companies have made commitments to increase insulin access, prod-

started in 2001 for HIV/AIDS medicines.

ucts remain out of the reach of health systems – and therefore patients – in many

WHO has since been expanding the scope

LMICs.

of the products, working in cooperation

While in some countries there is limited choice, in other countries there are nowith national regulatory agencies andoptions to choose from whatsoever. In these countries, which are among some ofinternational organisations to apply

the poorest in the world, none of these companies’ products are made available –standards of quality, safety and efficacy

meaning that diabetics simply cannot get the insulin they need.

of essential products. The inclusion ofhuman and long-acting analogue insulins

Affordability remains a barrier to accessing insulin

in the programme has the potential to

The challenges impacting affordable access to insulin are complex and multifaceted.

help create a secure supply of quali-

While the public sector covers the cost of insulin in some LMICs, either directly

ty-assured insulin, including of biosimilar

or via reimbursement, many patients in LMICs pay out-of-pocket.17 Overall, theproducts, in LMICs.

percentage of patients paying out-of-pocket for healthcare is 35% in LMICs,
compared to 13.6% in high-income countries, where the public sector is more likely
to be involved.18 Unfortunately, higher insulin prices are usually found in the private
market – further compounding the issue for patients living in LMICs.19
Individual buyers and governments across different LMICs pay highly variable
prices for insulins.5 The same insulin can cost ten times the price depending on* Uncorrected USD figures8

Access to Medicine Foundation

location, as one study found4 – and the highest median insulin prices have been

Share of the global insulin market (%) 13

found in low-income and lower-middle income countries.

20

The reasons for high costs are various; the manufacturer's selling price, whole-

Eli Lilly,

1sale and retail mark-ups, taxes and other tariffs also have an influence on insulin's

Novo Nordisk andfinal price.21 A lack of affordability can lead patients to not being able to access insu-

Sanofi control

lin at all, or to patients rationing their insulin if they cannot afford the quantity they

approximatelyneed. Indeed, discontinuation of insulin treatment has been identified as a common

99% of the global

issue in LMICs, with the cost of insulin and monitoring tools being one of the main99

insulin market

reasons.22

by value

People with diabetes in LMICs face persistent challenges in accessing a continuous, reliable, affordable supply of insulin – a problem that applies to all types of
insulins. Many people still struggle to access human insulin, as it is not always available and is often unaffordable, especially in low-resource settings. Access to insulin

Insulins sold in LMICs (%) 5

analogues is even more limited. Even when these products are available, they areoften unaffordable. Prices are two to six times higher than those of human insulins,

17

with affordability varying significantly between countries.4,20
While analogues are consistently priced higher than human insulin, the differencein production costs between these products does not reflect the price differential
at which they are sold. According to figures from 2018, the estimated cost of pro-Eli Lilly,
83

duction was only slightly higher for analogues compared to human insulins, primarily due to higher prices of Active Pharmaceutical Ingredients (APIs).25

Novo Nordisk andSanofi produce

Having access to analogue insulins can bring important advantages to people

83% of the insulin

living with diabetes. In terms of controlling blood glucose levels, analogue insu-

sold in LMIC

lins provide equal effectiveness in comparison to human insulins, while having themarkets

potential to decrease adverse effects.26,27 Analogues can also be administered moreconveniently and increase patients’ adherence to treatment.28,29
However, the current reality is that most people living in LMICs do not haveaccess to analogues or more convenient delivery methods. Analogues are still not
listed on many LMICs’ National Essential Medicines Lists, and consequently not supplied in the public sector, as is the case in countries including Senegal and Myanmar.
Even when analogue insulins are listed on a country’s National Essential Medicines

Biosimilar insulins

List, this does not always mean that patients have access to such products via theInsulin is classified as a biological drug,

public sector, as is the case in Kenya.

i.e., a complex molecule made from living

4,30,31

Nonetheless, the inclusion of analogues incountries’ National Essential Medicines Lists, alongside the entrance of more ana-cells or organisms. A ‘biosimilar’ is a drug

logue insulins in more LMIC markets and the resulting increase in competition, maythat is highly similar to a biological drug

soon lead to broader access to these products.32(the ‘reference product’ manufactured
by originator company) that is already on

Opportunity for biosimilars companies to expand access to insulins

the market.

Biosimilar insulins, products that are highly similar to reference insulins, have been

Because insulin is a biological product, itson the market since 2015*. Biosimilars companies, for example Biocon, Gan & Lee

structure is much more complex than thatand Wockhardt, focus specifically on manufacturing and marketing biosimilar ver-of simple chemical molecules which cansions of insulin products, both human and analogue.5 Though they are much smaller

be copied to create almost exact replicas

manufacturers than Eli Lily, Novo Nordisk and Sanofi, these biosimilars companiesof an originator product. Biosimilar drugs

could play a big role in access. While the main three insulin manufacturers still hold

are copies of a biopharmaceutical prod-

most of the market globally, several biosimilars manufacturers produce and market

uct; but because of the inherent naturea significant amount of insulin products in LMICs.5

of biological products, the process

Biosimilars have a meaningful share of the human insulin market in LMICs. Since

is more complex and while they areseveral patents on analogue insulins have recently lifted, they have also had the

produced in the same way and can have

option to manufacture biosimilars of analogue insulins. There is hope that analogue

a similar clinical effect, exact replicas

insulins can reach people in LMICs via biosimilar versions. However, this develop-

cannot be obtained.35

ment has yet to be fully realised. In one study of insulin use in 32 LMICs, biosimilar

Several biosimilar insulins have been

products (manufactured by all company types) accounted for 29% of the volume

launched in recent years, includingof human insulin used by patients, but a mere 8% of the analogue insulin used byregular and isophane human insulin

patients.

and analogues such as glargine.

5* Biosimilar products are manufactured
by both big global companies that
also manufacture originator products
and by smaller manufacturers. For
the purpose of this study, the term‘biosimilar insulin’ is used to define
all insulins produced by smaller
manufacturers (other than Eli Lilly,
Novo Nordisk or Sanofi).

9

Access to insulin in LMICs

The introduction of biosimilar insulins in LMICs has the potential to lower prices
for governments and patients. In general, biosimilar products can be introduced
at lower prices, which is particularly seen when several biosimilars of the same
medication exist in a certain market. For example, the availability of several insulin
biosimilar versions has led to significantly lower prices than for originator brands in
Bangladesh.32 After the introduction of biosimilars, originators companies typically
respond by lowering prices. Such price cuts of originator products have been seen
for the analogue lispro after the introduction of a biosimilar competitor.33
However, significant price changes have not always been noted after the introduction of a biosimilar into the market.5,34 If biosimilar products are not significantly
cheaper than the originator insulins in LMICs, patients may not see the case forchanging their treatment plan, making it difficult for biosimilars companies toincrease uptake of – and trust in – their products among prescribers and users.4,34
Reasons for the low availability of biosimilars may be related to various hurdles
that manufacturers of these products face, including regulatory challenges, lack oftrust from the government and prescribers and – in some cases – uncertainty about
the patent status of the originator product.35 Even though there is no evidence for
reduced efficacy or a higher rate of adverse events when using biosimilar insulin,
there is little knowledge and guidance available for prescribers and very often these
are not included in LMICs’ National Essential Medicines Lists.33,34

While the focus of this paper is primarily on access to insulin in LMICs, it is crucial to bear in mind that delivery methods andmonitoring tools are an integral part of diabetes care and also affect doctors’ and patients’ decisions about which insulin products to prescribe and use. However, for many people with diabetes in LMICs, most of these products remain unaffordable.36
Delivery methods

Monitoring tools

To control blood glucose levels, insulin needs to be injected

To keep diabetes under control and avoid complications,subcutaneously (under the skin), which can be done inpatients need to frequently monitor their blood sugar levels,

several ways:

using one of these devices:A needle and a syringe: Human insulin is mostly

Glucometers: These are small portable devices.

sold in vials, and the patient or their carer must

The patient uses a needle or a lancet to prickprepare the appropriate dose and inject it. This

their finger, and a test strip to capture a drop of

can be challenging for many people, including

blood, so that the device can measure the bloodchildren and the elderly.

sugar level. Even though the device itself can last
for a long time, needles or lancets and test strips

Insulin pens: This is the main delivery method forneed to be replaced for every measurement.

analogue insulins. Pens can be prefilled with insu-

These devices have been included by the WHO in

lin or fitted with a replaceable insulin cartridge.

its Model List of Essential In Vitro Diagnostics.37

Pens allow for a more convenient and accuratedelivery of the required insulin dose.

Continuous Glucose Monitoring devices (CGMs):
These are devices that track blood glucose con-Insulin pumps: These are small electronic devices

tinuously throughout the day. A CGM includes athat deliver insulin following a pre-programmed

disposable sensor that is placed under the skinschedule or automatically according to blood

which conducts readings every few minutes andsugar levels. Even though these are more conven-sends this information to an attached transmitter

ient, insulin pumps are still expensive and difficult

and, usually, to a separate receiving device, suchto access for many patients.

as a smartphone. CGMs provide a convenient way
of keeping oversight of one’s blood glucose levels, but remain largely out of reach in LMICs due
to various factors, including the reduced numberof manufacturers, the lack of reimbursement andthe cost of the sensors.38

10

Access to Medicine Foundation

Securing a sustainable supply of insulins
People living with diabetes require a secure and uninterrupted supply of insulin.
However, many LMICs lack an adequate infrastructure for the manufacture or
importation of insulin, or for its storage and distribution – impacting availability inboth the public and private sectors. Some countries also only import insulin fromone source, making them more vulnerable to shortages.20,39 The fragility of global
supply chains for essential health products has been made abundantly clear during
the COVID-19 pandemic,4 0 which also disproportionately affected people living withchronic conditions such as diabetes. There is now an opportunity to improve global
health security, including by strengthening health systems and supply chains, andto increase preparedness for other crises, such as future pandemics and climatechange-related disasters.
Under-importation of insulin appears to be an issue in many countries, as a mismatch has been identified between the amount of insulin supplied and the amountneeded to treat people living with diabetes, with health systems being often unaware of actual demand. Reasons for this might include weak forecasting systems
and systemic barriers preventing people from accessing treatment.39 For instance,
poor capacity to properly forecast insulin needs has led to countries such as
Mozambique and Kyrgyzstan not having the right quantity of insulin in local healthcare facilities.41
For insulin, one particular challenge is that it must be kept in continuous cold
storage until it is administered. Breaking the cold chain can have consequenceson safety and insulin potency, which, once lost, cannot be regained. Maintaining
a proper cold chain can be a challenge in many LMICs, particularly in rural areas,
which are more likely to lack infrastructure such as a continuous electricity supply,
cold chain transportation vehicles, or refrigerated storage.
This issue has gained more widespread attention since the launch of COVID-19
vaccines requiring cold or ultra-cold storage in late 2020. Those cold chain requirements posed a challenge for many countries, and affected procurement choices andthe speed of the vaccine roll-out in LMICs.42 However, investment in strengthening
countries’ cold chain infrastructure for COVID-19 vaccines could now have a positive benefit for insulin products (see page 29), while advancements in knowledge
about insulins’ heat-stability can also reduce the reliance on cold storage at the endof the supply chain.

11

Access to insulin in LMICs

CO M PAN Y PRO FI LESHow are companies addressing access toinsulin?
Eli Lilly, Novo Nordisk and Sanofi
The three largest manufacturers of insulin – Eli Lilly, Novo Nordisk and Sanofi– have been involved in the insulin market since its earliest days, with all threecompanies or their predecessors starting to produce and market insulins in 1923.
Over time, these companies have developed differing portfolios of diabetes
products, including different types of insulin products and other diabetes medicines.
While all three companies have both human and analogue insulins in their product portfolios, their approach to the insulin market in low- and middle-income
countries (LMICs) varies, including each company’s choice of which products toprioritise for patients in these countries. Over recent years, the companies havealso explored a range of access strategies targeted at expanding access to insulin in
LMICs, including paediatric diabetes programmes, training programmes, and pricing
strategies.
Details of the three companies’ approaches are laid out in the following pages.
These profiles, which are not comprehensive, set out some of the main examples ofeach company’s strategies to improve access in LMICs, and provide an overview ofwhat key actions are currently being taken.
BioconA number of smaller manufacturers of biosimilar insulins have entered the market
more recently and are starting to implement strategies to improve access to theirproducts in LMICs. Their portfolios can include biosimilar versions of human andanalogue insulins. One such company, Biocon, is profiled on page 20.

12Access to Medicine Foundation

CO M PAN Y PRO FI LE

Eli Lilly
Eli Lilly’s approach to expanding access to its insulins in LMICs sits within a wider

Eli Lilly & Co

access strategy covering healthcare more generally. As part of this, the company
has a significant paediatric programme for children and young people with diabe-

Headquarters

tes. Eli Lilly also pursues partnerships and takes part in initiatives at the country

Indianapolis, United Stateslevel. Of the other company initiatives to increase access to diabetes care, most arefocused within the United States, which is not in scope of this paper. (A full list ofCompany focus

countries in scope can be found in the appendix).

Research-based pharmaceuticalcompany with a focus on non-How diabetes products fit into Eli Lilly’s overall approach to access

communicable diseases.

Eli Lilly approaches access via its Lilly 30x30 programme, which aims to deliver
access to high-quality healthcare for 30 million people in resource-limited settings

Profileannually by 2030 – including, but not exclusively, people living in LMICs. This strat-

Eli Lilly was the first company to

egy covers diabetes, cancer and COVID-19 among other disease areas and includes

commercialise insulin worldwide. In

efforts to explore and expand alternative business models, access strategies andaddition to insulins, its portfolio includes

patient support programmes. In 2021, the estimated reach of the programme wasseveral other diabetes treatments, as

11.6 million people across all disease areas, an increase of approximately 6.6 million

well as oncology products and medicines

since 2015. This programme aims to cover a wide spectrum of treatment areas andto treat inflammatory diseases. Insulin

geographies. The company has not disclosed specific outcomes or the number oflispro (Humalog®) is one of thepatients reached through individual programmes within 30x30.

company’s blockbuster products andIn 1968, the company established Eli Lilly and Company Foundation, Inc., a U.S.based tax-exempt organisation commonly known as The Lilly Foundation. The

represents its second largest source ofrevenue.

Foundation’s grant activities are focused within the United States, but it also provides some financial grants to organisations working internationally.

Products for insulin-dependentpatients

Focus on paediatric programme

3 human insulins (vials)

The company has supported the Life for a Child programme since 2009, and this• Insulin human, rdna origin (Humulin®) 

now forms part of its approach to achieving the Lilly 30x30 goal. Life for a Child is• Isophane human insulin (Humulin N®) 

a collaborative initiative, established in 2000 and administered by the organisation• Isophane human insulin / human insulin

Diabetes NSW & ACT, that supports the delivery of healthcare to children and(recombinant) (Humulin 70/30®) 

youths with type 1 diabetes living in low-resource settings. It covers diagnosis,
monitoring, diabetes education and access to diabetes products including insulin.

3 analogue insulins (vials and pens)Through its support to the Life for a Child programme, the company donated over

• Insulin lispro (Humalog® and Lyumjev®)

3.2 million vials and cartridges of insulin, including insulin analogues such as glargine• Insulin lispro/insulin lispro protamine(Basaglar®), to children and youths in LMICs between 2009 and 2021. Notably, thisprogramme also provides delivery devices (e.g. syringes), blood glucose monitoring(Humalog Mix®)• Insulin glargine (Basaglar®) 

devices and test strips.
In 2022, Eli Lilly announced a commitment to support UNICEF's work with fund-2 glucagons*

ing of USD 14.4 million up until 2025. The contribution will be directed towards• Glucagon for injection (Glucagon) 

improving prevention, care and treatment of non-communicable diseases (NCDs),• Nasal glucagon (Baqsimi®)

including diabetes, at different levels of care. Focuses will include strengthening
data and health information systems and building capacity among local health careproviders. The initiative aims to improve health outcomes of 10 million children
and adolescents and will cover Bangladesh, Malawi, Nepal, the Philippines andThis product is on the WHO Model Listof Essential Medicines

Zimbabwe.
Donations of insulin via humanitarian partners
Eli Lilly provides donations of insulin via humanitarian partners. For example, in
2022 the company donated over 1.3 million insulin vials and pens through Direct
Relief and Project HOPE for hospitals and patients in Ukraine.
* Glucagon is used by insulin-dependent patients to counter the adverse effect of an excessive dose of insulin, i.e.
severe hypoglycaemia.

13

Access to insulin in LMICs

Country-specific strategies to improve access to insulin and diabetes care
The company participates in initiatives aimed at strengthening the continuum of
diabetes care. As an example, Eli Lilly has been collaborating with the global network Academic Model Providing Access to Healthcare (AMPATH) since 2002. In
western Kenya, working alongside the Ministry of Health, the partnership implemented a chronic disease management programme. Eli Lilly has made productdonations and provided financial support to several of AMPATH's initiatives. Since
the beginning of the programme, the company has reported donating over USD
215 million worth of medications, including insulin. With the support of Eli Lilly,
AMPATH has put in place a home glucose monitoring programme in Kenya. Over3,000 people living with diabetes are enrolled in the programme, which covers
care, education and medications, including insulin. Of these, 469 are enrolled in
the home glucose monitoring programme, through which they access facilities

Manuel, who lives in Bolivia and was diagnosed

for self-monitoring of their blood glucose, helping achieve better control of theirwith type 1 diabetes at two years old, measures his

condition. In February 2022, AMPATH announced new partnerships in Ghana andblood glucose levels - credit: Eli Lilly, Life for a Child

Mexico with the support of Eli Lilly and the Lilly Foundation, aiming to strengthen
more health systems.
Through the Lilly Global Health Partnership, a component of the company's Lilly
30x30 programme, the company is supporting the Tshwane Insulin Project (TIP).
TIP is a five-year research programme launched in 2019 in South Africa as a public-private partnership with academia and the government. The project consists ofa digital health intervention aiming to improve diabetes care through a variety ofactivities, including training for primary healthcare providers, patient education, andthe use of an app to assist with initiation of insulin treatment and its subsequent
management.
Eli Lilly has also partnered with Mexico's General Health Council and The UnitedStates-Mexico Foundation for Science (FUMEC) to develop and implement digital
health tools. By optimising public health information systems, the aim is to improveengagement between healthcare providers and users and foster a more effective
decision-making process for providers and policymakers and benefit more thanDr Nicholas Kirui and Dr Sonak D Pastakia take5.7 million people by 2030. As part of this partnership, Eli Lilly is taking part in thepart in a retrospective assessment of the quality

development of an epidemiological surveillance system, SANENT (National Systemof diabetes care in a rural diabetes clinic in

for Analysis of Non-Communicable Diseases), to support the treatment of people

Western Kenya - credit: Eli Lilly, AMPATH Kenyaliving with type 2 diabetes in Mexico, a country with one of the world's highest burdens of diabetes.
At present, Eli Lilly does not publicly disclose detailed information regarding
registration of products and access strategies for diabetes care in LMICs, and has
provided limited data to the Access to Medicine Foundation for this analysis

14

Access to Medicine Foundation

CO M PAN Y PRO FI LE

Novo Nordisk
Novo Nordisk takes a wide range of approaches to expanding access to diabetes

Novo Nordisk A/Scare, including a paediatric programme, pricing commitments, and taking steps toevaluate the heat stability of its insulin products in order to reduce cold storage

Headquarters

requirements. In LMICs, Novo Nordisk focuses its access strategies primarily on its

Bagsværd, Denmark

human insulin products.
Company focus

Diverse access strategies, with a focus on human insulins

Research-based pharmaceutical

Novo Nordisk has launched a social responsibility strategy, Defeat Diabetes, which

company with a primary business focus

sets long-term goals in the areas of prevention, provision of affordable care andon diabetes.

innovation in diabetes. To work toward these goals, the company has prioritised
three areas of work: reaching more children with type 1 diabetes, reducing the priceProfileof human insulin and committing to donations for relief efforts.

Novo Nordisk leads the insulin market,

The company has a range of strategies in place that tackle different areas ofholding almost half of the share of thehealthcare in line with its Defeat Diabetes strategy. Among Novo Nordisk’s various

total insulin market globally in 2021.

strategies are its Changing Diabetes in Children programme (CDiC), which works

In a smaller proportion, the company

to provide care for children with type 1 diabetes in LMICs; a programme focused on

portfolio also includes products

prevention of chronic disease, aiming to tackle the rise of diabetes type 2 in urban

targeting other endocrine disorders,settings; and the Novo Nordisk and Novo Nordisk Foundation co-funded Diabetes

haemophilia, and obesity, as well as

Compass initiative, run by the World Diabetes Foundation, which helps build health-hormone replacement therapies.

care capacity in LMICs. More recently, the company has started to roll out its new
iCARE model, described below.

Products for insulin-dependentpatients

Exploring a partnership-based model via Base of the Pyramid

3 human insulins (vials and pens)

In addition to these strategies, Novo Nordisk carries out multi-country strategies• Insulin human (rdna) (Actrapid®) 

to tackle different challenges across the continuum of diabetes care. In 2012, the• Isophane human insulin (Insulatard®) company established the Base of the Pyramid programme, a partnership model• Biphasic human insulin (Mixtard®) aiming to enhance access to diagnosis, treatment, and management of diabetes forpeople living with diabetes at the base of the economic pyramid. The programme

7 analogue insulins (vials and pens)covers capacity building, tackling supply challenges, patient education, and provision• Insulin aspart (l-arginine) (NovoRapid®)of human insulin at a lower price. For example, in collaboration with local partners• Insulin aspart (niacinamide) (Fiasp®)

in Kenya, gaps related to inadequate demand forecasting and insufficient capacity• Biphasic insulin aspart (NovoMix®)for storage and cold chain management were identified and addressed, achieving a• Insulin degludec (Tresiba®) regulation of cost structures and a more stable insulin supply.

• Insulin degludec/insulin aspart(Ryzodeg®)

Pursuing a comprehensive approach via iCARE• Insulin detemir (Levemir®) 

Novo Nordisk is now expanding its strategies through a comprehensive approach to• Insulin degludec/liraglutide (Xultophy®)access in LMICs. The iCARE initiative was launched in 2021 as a business-integrated
model aimed to improve access to diabetes treatment in 49 countries in sub-Saharan

1 glucagon* (injections)

Africa through four areas of work (Capacity, Affordability, Reach and Empowerment).

• Glucagon (GlucaGen HypoKit) 

The initiative aims to substantially increase the number of people with diabetes
accessing insulin in sub-Saharan Africa (excluding South Africa) by 2025. iCARE has
been launched in seven pilot countries so far: Ethiopia, Ghana, Côte d'Ivoire, Kenya,This product is on the WHO Model Listof Essential Medicines

Nigeria, Sudan and Tanzania. This initiative targets challenges such as affordability
barriers impeding access to care for vulnerable patients, hurdles in procurement andsupply chains (including last-mile distribution), mark-ups, inadequate forecasting,healthcare practitioners’ capacity, knowledge gaps in diabetes management, andpatient education. In these pilot countries, it has engaged with local governments andlocal partners to carry out localised strategies and track the impact of the approach.
The initiative also aims to achieve both affordability and financial sustainability, as* Glucagon is used by insulin-dependent patients to counter the adverse effect of an excessive dose of insulin, i.e.
severe hypoglycaemia.

15

Access to insulin in LMICs

increased sales volumes will enable lower costs and thereby lower prices.
Other company initiatives have focused on strengthening health systems to
improve diabetes care. For example, since 2021 Novo Nordisk has supported a programme for integrating type 1 diabetes care into the health systems of eight countries in eastern Africa and the Middle East, including six countries in scope: Ethiopia,
Kenya, Malawi, Mozambique, Rwanda and Tanzania. The Programme covers aspectsof health system planning, awareness-raising campaigns, diagnosis, treatment, provision of medical supplies, and patient support and education. The eight countries
were selected based on their level of commitment to strengthening diabetes careas part of their broader approach to non-communicable diseases. The programme iscarried out through a partnership between the Word Diabetes Foundation and local
partners, including the participating countries’ ministries of health and healthcare
institutions.
Healthcare workers at a clinic examine the footPricing and affordability strategies

of a man with diabetes - credit: Sala Lewis

Novo Nordisk has focused its affordability strategies primarily on its human insulin products, via such initiatives as Base of the Pyramid and iCARE, but also more
broadly. As part of the Defeat Diabetes strategy, the company has an “Access to
Insulin Commitment”, which includes a price ceiling commitment. Since 2020, theprice ceiling has been lowered to 3 USD per human insulin vial for 76 LMICs. These
include all Least Developed Countries, other low-income countries, and a selectionof middle-income countries where large low-income populations lack sufficient
health coverage. The Commitment is an offer to 76 governments (i.e. to the publichealth system), although it has not been taken up by all countries.
Concerning analogue insulins, Novo Nordisk has limited strategies in place. In
the private market, the company provides patient assistance programmes in countries including Mexico and Egypt, where insulin degludec (Tresiba©) is offered at
discounted prices for some patients. No information regarding access strategies
involving analogues in low-income countries has been provided by the company.
A child taking part in a Novo Nordisk programme

Paediatric programmein Kenya in 2019 has her blood sugar level tested

The Changing Diabetes in Children (CDiC) programme was established by Novoby a healthcare worker - credit: Sala Lewis

Nordisk in 2009 with the objective of improving access to care for children with
type 1 diabetes in LMICs. CDiC works to raise public awareness of diabetes,
strengthen healthcare capacity and increase access to human insulin through the
donation of these products and other necessary commodities. The company has
donated around 2.9 million vials and 245,000 pens of human insulin via the programme. More recently, CDiC has been making efforts to strengthen digital innovations and local data systems, aimed at increasing evidence-based policy making.
The programme is carried out through public-private partnerships in 24 countries,
including Cambodia, Guinea, Senegal and Peru, and has reached over 34,000 young
people since its start.
Strengthening the supply chain
Novo Nordisk has worked alongside various partners to tackle issues affecting theinsulin supply chain. For instance, it is part of the multisectoral Coalition for Accessto NCD Medicines & Products, which is working to implement a forecasting tool to
be used for estimating annual quantities and costs of products for diabetes care.
This initiative, carried out in collaboration with PATH and several local ministries ofhealth, is providing technical guidance to communicate with key country stakeholders and make better use of forecasting results to inform financing and procurement
processes. The programme currently covers Kenya and Uganda, and an evaluationof the initiative is taking place during 2022, with the aim of later expanding it to
Tanzania and the rest of the East Africa region.

16

Access to Medicine Foundation

To address issues affecting the cold chain for insulin, the company has also supported partners and institutions by providing fridges and training healthcare personnel in several countries in sub-Saharan Africa, as part of its iCARE model.
Donations of insulin in humanitarian and emergency settings
Novo Nordisk donates insulins and other products by partnering with humanitarianorganisations such as Direct Relief and the Red Cross. Through these programmes,
Novo Nordisk provided people living in conflict situations in Ethiopia, Yemen andUkraine with over 227,000 vials of human insulin between 2021 and 2022. To alleviate the impact of the COVID-19 pandemic, the company also donated approximately 1.3 million vials of human insulin to humanitarian organisations. Although inlower volume, the company has also included needles and different types of pens in
its donations.
Advances in heat-stable insulins
Following the EMA positive opinion, two of Novo Nordisk’s human insulins,
Actrapid® and Insulatard®, are undergoing national submissions to authorise anadditional flexible storage option outside of refrigeration at temperatures up to
30°C, for up to four weeks before opening .11,12 This has the potential to facilitate
insulin distribution and diabetes management in contexts with hot climates andwhere maintaining continuous cold storage represents a challenge, such as rural
areas without electricity.

17

Access to insulin in LMICs

CO M PAN Y PRO FI LE

Sanofi
Sanofi’s approach to expanding access to diabetes care and its insulins in LMICs

Sanofiincludes pricing strategies to increase the affordability of analogue insulins, programmes to train healthcare professionals, and multiple localised country-based

Headquarters

initiatives. The company has recently made new commitments and announced aParis, France

new approach aimed at improving access to prevention, treatment and care forpeople living with diabetes in many LMICs. The focus of Sanofi’s insulin portfolio is

Company focus

on analogue insulins.

Research-based pharmaceuticalcompany with a large and varied

New Global Health Unit aims at sustainable accessportfolio, including products for

In 2021, Sanofi launched its Global Health Unit, which will continue and expand

communicable and non-communicable

the company’s work with local governments and stakeholders, intergovernmental

diseases.

agencies and non-governmental organisations to increase access to its medicines.
Sanofi plans for this unit’s remit to cover 40 LMICs, which include countries that

Profilecurrently have severely limited access to insulin, such as Tuvalu, Haiti and Guinea-

Sanofi’s diabetes products sit

Bissau. The unit will seek to improve access to 30 medicines for communicable andwithin a wide-ranging portfolio that

non-communicable diseases (NCDs), most of them listed on the WHO Model List ofencompasses many different therapeutic

Essential Medicines (EML). The medicines will include insulin glargine, a long-acting

areas and product types, from antibiotics

analogue recently added to the EML, and glulisine, a rapid-acting analogue. Throughand vaccines to immunotherapy and

the Global Health Unit, Sanofi has shared a commitment to expand access to ana-

innovative oncology treatments. Insulin

logue insulins, with the target to reach 300,000 insulin-dependent patients byglargine (Lantus® and Toujeo®) is one

2030, in comparison to its 2021 reach of 15,000 patients. Sanofi aims for the unit toof the company’s best-selling products

be self-financed by charging just enough to cover the cost of treatment. This will beworldwide.

implemented through the sale of products under a new brand (‘Impact’) at a lower
price. The unit also aims to strengthen health systems by establishing an impact

Products for insulin-dependent

fund to support start-up companies and other innovators involved in the develop-

patients

ment of sustainable healthcare in the 40 LMICs within the unit’s remit.

1 human insulin (vials)• Human recombinant insulin

Analogues are central to Sanofi’s affordability initiatives(Insuman®) 

Before including analogue insulins within the scope of its Global Health Unit, Sanofi
had also put in place specific strategies to increase the affordability of these prod-

5 analogue insulins (vials and pens)

ucts. For example, since 2021, Sanofi has listed insulin glargine (Lantus©) in the• Insulin aspart (Insulin aspart Sanofi)

National Health Insurance Scheme and State Health Insurance Scheme of two of• Insulin glargine (Lantus® andNigeria’s 36 states at a price on par with human insulins. The company also plans

Toujeo®) 

an expansion of this strategy to two more states in 2022, aiming to reach 3,000• Insulin lispro (Admelog®)

patients.

• Insulin glulisin (Apidra®)

As another example, in Kenya, Sanofi tailors its pricing strategies to both the
public sector and private sector markets. The company offers a price for its insulin• Insulin glargine / lixisenatide (Suliqua® /Soliqua®)

glargine (Lantus®) in the public sector that is low enough to ensure it can be listed
for complete reimbursement. For patients paying out of pocket, there is a state
partnership and patient support programme which provides a free cartridge ofThis product is on the WHO Model Listof Essential Medicines

insulin glargine (Lantus®) for every two cartridges purchased by new patients. This
product is also available in Kenya via a private health insurance, which Sanofi madepossible by signing a commercial agreement.
For people paying out of pocket, Sanofi also pursues strategies such as patient
assistance programmes to provide discounts for certain products in different countries, as is the case in Brazil for insulin glargine (Lantus® and Toujeo®).

18

Access to Medicine Foundation

Building capacity for supply chain management
Sanofi has been tackling some long-term challenges related to the cold chain management of insulin. The company has a programme in place which aims to improve
the transport and cold chain management of vaccines and insulins. This programme
targets gaps in the capability of cold chain management and provides training topharmacists in hospitals and other key institutions in India to improve good pharmacy practice and cold chain monitoring and management. In 2021, approximately
150 pharmacists were trained through this initiative across 10 institutes in India.
Piloting new approaches to assess potential
To tackle challenges in the provision of care for NCDs, Sanofi launched a pilot project in Kenya in 2018 called ‘Ngao Ya Afya’. The initiative, which was implemented
in partnership with international and local stakeholders, encompassed digital andnon-digital interventions to improve access to care for patients with diabetes andA child takes part in Sanofi / International

hypertension. It included giving access to discounted consultations, medical tests

Diabetes Federation's KiDS programme in India

and discounted Sanofi medicines such as glargine (Lantus©), as well as some non-- credit: Govt High School, Fatorpa

Sanofi medicines. The initiative also provided tools for monitoring glucose,alongside a digital platform patients could use to aid self-management. In 2019,675 patients had access to discounted prices through the digital health wallet fordiabe-tes and/or hypertension treatments.
Youth programme with a focus on education
The KiDS project is an educational programme co-created by Sanofi and theInternational Diabetes Federation in 2013, in collaboration with the International
Society for Paediatric and Adolescent Diabetes and local partners such as
the Public Health Foundation of India, the Brazilian Diabetes Society and the
Associação de Diabetes Juvenil (ADJ) in Brazil. This programme targets schoolteachers, nurses, policymakers and families, and aims to provide education about
diabetes and decrease stigma and discrimination against children with this condition. The programme also aims to promote healthy lifestyles for the prevention of

A child takes part in Sanofi / International

type 2 diabetes among children. By the end of 2021, the trainings provided by the

Diabetes Federation's KiDS programme in India

programme had reached around 340,000 children, 19,800 school staff and more

- credit: Janta High School, Mapura

than 15,000 parents in 10 countries, including five of the countries in scope of thispaper.
Donations of insulin
Sanofi has engaged in short-term insulin donation initiatives. For instance, thecom-pany has donated around 30,000 units of insulin to people in Ukraine,
including not only human insulin but also the analogues aspart, glargine, lispro andglulisine.

19

Access to insulin in LMICs

CO M PAN Y PRO FI LE

BioconBiocon has ambitious goals to improve access to its insulins in LMICs by lowering

Biocon Limited

prices and boosting affordability, although the company is only in the early stages oftaking steps towards achieving these goals. Biocon has also recently begun pursuing

Headquarters

other strategies involving education and donations.

Bengaluru, India

The role of biosimilars in expanding accessCompany focus

Biosimilars companies could play a key role in expanding access to insulins in LMICs

Biopharmaceutical company with a(for more on biosimilars, see pages 9-10). As one of the world’s largest manufactur-

sizeable global footprint. Its biosimilarers of biosimilar insulins, Biocon was invited to contribute data for analysis in thisproducts, including oncological products

paper, which will look at what actions the company is taking – and what strategies it

and insulins, are manufactured by theis planning to pursue – to expand access to its insulin products.

company’s Biocon Biologics subsidiary.

Through its Biocon Biologics subsidiary, the company manufactures and sells
seven biosimilars and novel biologic products, including four insulin products (seeProfilebox, right). Since 2004, Biocon has supplied over 2.75 billion doses of human insu-

Biocon is dedicated to the manufacturing

lin globally. Its biosimilar insulins Semglee® (branded insulin glargine) and insulinof APIs, generic products and biosimilars

glargine (unbranded), co-developed alongside the US-based generic medicine man-across disease areas including

ufacturer Viatris, were approved by the US Food and Drug Administration (FDA)

immunology, oncology and diabetes.

in 2020 and, in 2021, Semglee® was given the first-ever interchangeable label for

The company was founded in 1978 anda biosimilar in the US, i.e., pharmacies are authorised to dispense Biocon’s insulin

has since expanded into biosimilars, withglargine (Semglee®) as a substitution for the reference product, Sanofi’s insulin

its biosimilars business now forming

glargine (Lantus®). In February 2022, Biocon announced it had entered into an

Biocon’s largest segment in terms ofagreement to fully acquire Viatris’s biosimilars business.

revenue.

Ambitious aims and small first steps on pricing and affordability

Products for insulin-dependent

Biocon's stated aim is that its biosimilar insulins should reach one in five insulin-de-patients

pendent people with diabetes globally, though no date has been publicly set for this3 human insulins (vials)

goal. As part of its approach to achieving this, in 2019 the company launched its• Rh-insulin (30% as soluble insulin

strategy ‘Mission 10 cents’, committing to offering its human insulins for less than
USD 10 cents per day from vials directly sourced from Biocon Biologics by governments in LMICs.
The programme has been launched in the Philippines, where the company signed

injection and 70% as isophane insulin
injection) • Rh-insulin (NPH / isophane insulin) • Rh-insulin (50% as soluble insulin

a memorandum of understanding (MoU) with two municipalities and the social

injection and 50% as isophane insulin

enterprise reach52, covering programme implementation and the logistics required

injection) to provide last-mile delivery of insulins at a price aligned to Biocon’s Mission 10
cents. In 2020, Biocon signed an agreement with the organisation Christian Social

2 analogue insulins (vials and pens)

Services Commission (CSSC) in Tanzania to help implement its Mission 10 cents ini-

• Insulin glargine 

tiative. Even though the company has reported that it has not yet received any firm

• Insulin aspart *orders from CSSC, in 2022, Biocon Biologics signed a procurement agreement with
the Tanzanian Ministry of Health to supply insulin for under USD 10 cents per day.
The company also reports that it has supplied its human insulin to the public sectors

This product is on the WHO Model Listof Essential Medicines

in Ghana since 2020 and in Mozambique since 2021, keeping the 10 cents mark as
the price ceiling for end users in these countries. So far, Biocon has not reported
specific outcomes or patient reach data for the implementation of this strategy inthe aforementioned countries.
Education initiative for healthcare providers, coupled with insulin donations
In 2021, Biocon entered a partnership with the Research Society for the Studyof Diabetes in India (RSSDI) to launch the Biocon & RSSDI Initiative for Diabetes
Knowledge in Type 1 Patients (BRIDGE-1). RSSDI will provide training for*This product has yet to be registered or marketed in countries in scope.

20

Access to Medicine Foundation

approximately 400 healthcare providers regarding the management of type 1 diabetes, with Biocon contributing educational materials and also providing free-ofcharge human (Rh-insulin) and analogue (insulin glargine) insulins for type 1 diabetes patients of these providers, for up to three years. This is expected to cover the
insulin needs of approximately 1,000 young patients.
Strengthening diabetes care services
The Biocon Foundation, the Corporate Social Responsibility arm of the company, isputting in place some initiatives to strengthen diabetes care services in India. The
Foundation operates NCD ‘specialist clinics’ that provide free-of-charge services inthree locations in India. The clinics address a range of issues, including screening,
diagnosis and management of type 2 diabetes. Biocon has reported that around
1,400 patients have benefited from services offered at these clinics.
A man has a blood sample taken to measure his
blood glucose level - credit: Biocon

A woman has her blood sugar levels checked ata clinic - credit: Biocon, reach52

21

Access to insulin in LMICsI N DUSTRY ANALYSIS

Lack of registration of essential insulins in
LMICs is a barrier to expanding access
Making sure insulins are registered in low- and middle-income countries (LMICs) is
an important step in securing access to these medicines for people with diabetes.
Outside of certain exceptional circumstances, registration with a country’s national
regulatory authority is the only way to enable distribution and marketing of a product in that country. It does not guarantee that the product will actually be madeavailable, but it is a precondition for ensuring access.
Human insulins are widely registered, but inconsistently
Human insulins* are the most widely registered** type of insulin in LMICs. For example, Novo Nordisk is the largest seller of human insulin worldwide, and has registered at least one of its human insulins in more than three quarters of the LMICs in
scope of this paper.***However, in several low-income countries, very few (or in some cases, none) of
Novo Nordisk’s human insulins have been registered – and nor have human insulins
from the other companies in scope, according to the data available. Biocon, anothercompany with an important footprint in LMICs, has registered at least one of its
human insulins in approximately two fifths of upper middle-income countries, but
only in approximately one fifth of low-income countries in scope.
Companies lag on registering analogue insulins, with wide gaps
Analogue insulins* are registered in a smaller number of LMICs overall, compared tohuman insulins. Registration of these products was not reported in almost one thirdof countries in scope.
Where analogues are registered, they are most likely to be insulin detemir(Levemir®) or insulin degludec (Tresiba®). These two long-acting analogue insulins, both from Novo Nordisk, were recently listed on the WHO's Model List of
Essential Medicines (EML) and are the most widely registered analogues in LMICs,
registered in 71 and 48 out of the 108 countries respectively.
Among LMICs, companies prioritise registration of their insulins in countries
classed as upper middle-income, which usually represent larger and more stable
markets compared to lower-middle and low-income countries. This is true for all
types of insulin, but the situation becomes particularly stark when looking at analogue insulins. While there is at least one analogue registered in the majority ofupper middle-income countries, this is the case for less than half of the low-income
countries in scope.
A prime example would be insulin glargine, a long-acting analogue insulin
recently included in the EML. Out of the countries included in this analysis, insulin glargine (from either Sanofi or Biocon) is registered in 57.7% of upper-middle
income countries, 41.8% of lower-middle income countries and only 7.4% of low-income countries. Biocon's insulin glargine is registered in 28 of the 108 countries inscope, while Eli Lilly and Sanofi do not publicly disclose individual registration data
for their insulin glargine (Basaglar® and Toujeo®, respectively).

* See page 39 for a full list of products
assessed for registration in thisanalysis.

** For this analysis, a product isconsidered to have been registered if it
has been either a) filed for registrationby the company, or b) has beenregistered by the regulatory authority.

*** See page 40-41 for more informationon the 108 countries in scope of thisanalysis.

22

Access to Medicine Foundation

FIGURE 1. Stark differences in insulin

FIGURE 2. 79 countries do not have all

registration between countries

essential insulins registered

Out of the 108 low- and middle-income countries

Out of the 108 low- and middle-income countries

analysed, 74 countries have at least one humananalysed, only 29 countries (27%) have all insulins

insulin and at least one analogue insulin

from WHO's Model List of Essential Medicinesregistered; 10 countries only have human insulin

registered – and as this figure shows, low-income

registered; and 24 countries have no insulins

countries are most likely to not have all essential

registered, according to the data available. This

medicines registered.

graph divides that data between upper-middle
income countries (UMICs), lower-middle income
countries (LMICs), and low-income countries(LICs).

60

60
15

50
40

20

3
23

10
0

40

1
39

30

30
6
9
12

UMICs LMICs

41

50

LICs

20

12

10

14

0

26
14

UMICs LMICs

1
LICs

No insulin registered

Not all insulins on the EML are registered

Only human insulin registered

All insulins on the EML are registered

Human insulin and at least one analogue
registered

The countries left furthest behind
While in some countries only human insulins are registered, there are 24 countries
in scope where none of the four companies examined by this paper are known
to have registered their insulins*. These include politically unstable countries andthose affected by conflict, e.g., Somalia and South Sudan, or countries with small
populations such as Kiribati and Tuvalu.
Lack of registration can have a severe impact on access and ultimately on thehealth outcomes of patients living in those countries. Lack of access can be particularly detrimental in those countries as many of the countries without reported
registration of insulin are also affected with a very high burden of diabetes.
Opportunities for expanding registration can be pursued more widely
Insulin manufacturers can pursue registration in countries where very few or no
insulins are registered (as highlighted above), as well as countries with a high burden of diabetes that struggle with availability of insulin, such as many in the West
Pacific region.
There are mechanisms that can facilitate registration of companies’ products
in LMICs, including insulins, and the main global insulin companies do pursue
some of these opportunities. Companies can register their products with National
Regulatory Authorities (NRAs) that are classed by the World Health Organization(WHO) as Stringent Regulatory Authorities (SRAs), such as NRAs in the US, UK or
Japan. Once the product is approved by an SRA, then countries with non-SRA drug
* As data may not be complete, thisdoes not necessarily represent
complete absence of insulin; however,it does indicate competition between
manufacturers and access to insulins
may be very limited in these countries.

23

Access to insulin in LMICs

FIGURE 3. In 24 countries, no insulins were found to be registered
Countries highlighted blue on the map do not have any insulins registered,according to the data available. No insulins were found to be registered in
10 of the top 15 countries with the highest burden of diabetes (by DALYrate),44 among the countries in scope. The Western Pacific region has thehighest estimated number of deaths related to diabetes among adults,
accounting for approximately 2.3 million deaths in 2021.1
Dem. People’s Rep. Korea

Tajikistan
Djibouti
SomaliaSouth Sudan
Comoros

BelizeGuinea-Bissau
Sierra Leone
Liberia
São Tomé and Príncipe
Equatorial Guinea

Kiribati

Swaziland/Eswatini
LesothoAngolaFederated States of Micronesia
Timor-Leste

TuvaluSolomon Islands
Tonga
Samoa
Papua New Guinea
Vanuatuauthorities can use an accelerated and streamlined regulatory process to facilitate
approval.
Recently, some companies have also taken steps towards using international
mechanisms such as the European Medicines Agency (EMA)’s ‘EU-Medicines for all’procedure (EU-M4all). In April 2022, the EMA, in cooperation with WHO, granted apositive scientific opinion for a proposed update to the storage conditions without
refrigeration of two human insulin products. The update is exclusively for non-EU
markets.11,12 In August 2022, Novo Nordisk received the first country approval, in
Lebanon (not in the scope of this paper), for the additional storage option.
Following the obtained positive opinion from the EMA, Novo Nordisk also submitted
applications to WHO for prequalification of the human insulin products Actrapid®
and Insulatard®, including the flexible storage options. A positive outcome frommechanisms such as WHO prequalification and EU-M4all can facilitate regional andnational approvals in LMICs.45​
In 2022, Sanofi made a public commitment to make its glargine the first analogue
insulin to be submitted for WHO prequalification (see page 8). This could represent
an important step in expanding access to this essential product and could encourage others to pursue this route with their analogue insulins.
Registering biosimilar insulins in LMICs
The registration of biosimilar insulins in more LMICs represents an opportunity toincrease access to these products, especially in settings where few or no insulins
are currently available.
There are specific challenges to overcome; the registration of biological products such as insulin can be complex due to complex regulatory requirements, which
often represent a high financial burden for smaller manufacturers.35,46 In addition,
registration of insulin may be more difficult in many LMICs due to limited local
expertise in regulatory evaluation processes for biological products.47

24

Access to Medicine Foundation

To tackle these challenges, a key strategy for biosimilar manufacturers is toengage in WHO’s prequalification procedure and in other collaborative procedures.
The WHO prequalification programme has potential to facilitate the work of regulatory authorities and increase trust among procurers, prescribers and patientsin LMICs. The programme can also facilitate the sale of insulin products via international non-profit procurement mechanisms and organisations. However, at thetime of publication, no biosimilar companies have applied to the prequalification
programme for insulin products.
Biosimilar manufacturers could also invest in more studies that assess the efficacy and safety of their products (also called 'switching’ studies) and help disseminate study results. This may help increase approval, uptake and trust for quality-assured biosimilar insulin.

25

Access to insulin in LMICsI N DUSTRY ANALYSIS

Companies are expanding access models,
but system-level approaches to address
chronic care are lacking
Building on insights from longer-term programmes and initiatives, the main global
insulin manufacturers are now exploring strategies to widen the reach of theirproducts in LMICs. A shift towards more systemic business approaches to expand
access to insulins can be observed, although this has not yet had a widespread
effect and is not supported by independently verified data. As the global demandfor insulin rises, all manufacturers will need to adapt and move towards global andsustainable approaches for access to all insulin products.
A higher-level public commitment to increase access to diabetes care can be an
important step in fostering integration of access strategies at every level of a company’s insulin business. As of today, only Novo Nordisk – a company with a portfolio
primarily focused on diabetes products – has established a global corporate strategy
targeted at improving access specifically to diabetes care, with its "Defeat Diabetes"
strategy. However, other companies, such as Sanofi, have now taken significant
steps to establish commitments for expanding access to insulin products in LMICs.
More generalised access strategies may also have an impact in advancing accessto diabetes care in LMICs. For example, Eli Lilly’s 30x30 encompasses diabetes andseeks to expand access to insulin and other diabetes products in low-resource settings. However, this strategy covers several disease areas, and outcomes specific fordiabetes-related activities have not been disclosed.
Some companies aim to integrate access, but impact evaluation needed forsustainability
Over the last few years, both Novo Nordisk and Sanofi have demonstrated a shift
towards more integrated business approaches to insulin. Novo Nordisk has begun
to implement its new business model iCARE in sub-Saharan Africa, and Sanofi
recently launched its Global Health Unit. An integrated approach involves centring
financial sustainability from the beginning and integrating initiatives into countries’
health systems, as well as other elements such as strengthening diabetes care.
Regular monitoring and evaluation and public disclosure of the impact of accessstrategies is necessary to make progress toward more integrated approaches toaccess. This should include tracking and sharing information about patient reach,volumes of insulin sold and impact on outcomes for patients in both the shortand long-term. This data can provide valuable insights that can improve ongoingprojects and inform future strategies. Companies can strengthen their evaluation
processes either by developing monitoring and evaluation frameworks in-house orworking with academic partners and other third parties.
For example, a 2017 assessment of the Base of the Pyramid programme by Novo
Nordisk’s academic partner University College London provided useful information
for the future. This assessment showed that the strategy had succeeded in lowering the final insulin price, but that many people still battled with the costs of traveland necessary commodities such as monitoring tools.48 Similarly, Sanofi's Ngao Ya
Afya initiative was co-led and assessed by its partner on the project, PharmAccess
Foundation, revealing challenges concerning patients’ adherence to care.49
To date, limited data exists on the impact and reach of companies’ access initiatives.
More systematic monitoring, evaluation and public sharing of learnings and progress
will be fundamental to advance and scale-up such strategies in a sustainable way. In
this way, successful factors to improve the availability and affordability of insulins canbe better understood and replicated to reach more people with diabetes in more LMICs.

26

Access to Medicine Foundation

I N DUSTRY ANALYSIS

A patchwork of strategies
to improve affordability
The data shows that companies vary their approach to affordability depending on
the type of insulin (e.g. human or analogue) and the context in particular countries(e.g. the role and structure of public sector healthcare, or the country’s income level).
Some of the companies’ access models analysed in this paper so far include
aspects that are intended to increase affordability of insulin. This section looks
more specifically at what actions companies are taking on pricing, whether they areparticipating in tenders, and the use of patient assistance programmes.
Affordability strategies for human insulins: opportunities to expand accessPrice ceilings are one approach companies are exploring as an affordability strategy,
with a specific focus on human insulins. For example, Novo Nordisk has established aprice ceiling in 76 countries (see page 16), and Biocon has launched Mission 10 cents(see page 20) – with both companies setting their price ceiling at a similar level.
These affordability strategies can reduce the costs for governments and patients.
However, implementing a price ceiling as a blanket approach may not consider
the diversity of contexts in different LMICs, and it is important for companies toconsider differences in how health systems function and what the ability to pay isfor the different payers and patients across different levels of the income pyramid.
Companies can also increase access by participating in public sector procurement,
via tenders and through international pooled procurement mechanisms, such as via
non-profit international medicine suppliers including by UNICEF and IDA Foundation.
When companies enter such contracts, the availability and affordability of insulin
can improve locally for a large number of patients at a time. Engaging in these strategies is key to expanding access to all types of insulin, but is especially vital toexpanding access to human insulin – which can generally be procured at a lower
price than analogue insulin – in countries where access to this essential product isstill limited, including many countries in which there is a high burden of diabetes.
Some strategies pursued for analogue insulins, but affordability a challenge
Most of companies’ affordability strategies are focused on human insulins. This isimportant, as due to their lower prices, human insulins continue to be the mostcost-effective option for many patients living in LMICs. However, this also contributes to the fact that analogue insulins remain much more expensive products thanhuman insulins in most countries. If prices are high, demand is likely to be lower –contributing to a self-perpetuating cycle.
Of the analogues assessed in this paper, equitable pricing access strategies were
only identified for Sanofi’s insulin glargine (Lantus® and Toujeo®). The company
implements pricing strategies targeted at different payers including public entities,
patients paying out of pocket, and those covered by private insurance. For instance,
the company offers a reduced price for its products in countries including Kenya
and Nigeria. However, the number of patients receiving analogues in the aforementioned countries seems to be limited. By incorporating analogues within the remitof its new Global Health Unit, Sanofi shows potential to increase access to theseproducts in LMICs. To understand the impact of this new strategy and the potential
increase in access to these products, tracking patient reach will be fundamental.
Other industry initiatives for analogue insulins have focused on providing discounts via patient assistance programmes for patients paying out of pocket. While27

Access to insulin in LMICs

these initiatives can be an effective tool for improving the affordability of theseproducts, they often do not result in sustained access and affordable pricing, as
they are usually limited in terms of eligibility criteria and cover a relatively small
number of individuals.
Analogue insulins remain out of reach for most patients accessing care throughboth public and private sectors. For example, in the second-largest hospital in
Kenya, long-acting analogues, now categorised as essential medicines on the EML,
represented less than 4% of total insulin utilisation in 2020.32 Furthermore, Sanofi
reported the number of patients reached with insulin glargine (Lantus®) in thewhole country in 2020 was less than 300.
The future of pricing and affordability
Insulin manufacturers, including biosimilars companies, can continue to expand
pricing and affordability strategies to cover more countries and more products.
One key way they can do this is by pursuing intra-country pricing strategies. This
involves setting different prices for different payers and population segments withina country, such as national health authorities, public and private institutions andindividual patients paying partially or totally out of pocket. It is important that companies share information about how and where pricing strategies are being applied,the criteria considered to establish price conditions, and the financial outcome forpatients accessing care through both public and private sectors.
In addition, companies can expand affordability strategies to include not only
human insulins, but also essential analogue insulins. This will help to expand accessto these products, so that people living with diabetes in LMICs have the same treatment options that people living in high-income countries have had for decades. This
could include, for example, engaging with local governments to establish demand,
participating in more tenders, and offering lower prices. In addition, biosimilars
manufacturers can increase the affordability of analogue insulins by launching quality-assured products in LMIC markets.
Reaching the most vulnerable patients via donations
For many years, companies have engaged in donations of their products, including
insulins, to people with diabetes living in low-resource and/or conflict areas. Some
donations are short-term, often in response to a natural disaster or crisis situation,
while other donation programmes are long-term. Such donations can be fundamental for the survival of people with diabetes who otherwise would not have any
options to access treatment.
The impact of insulin donations has previously been identified by international
stakeholders as beneficial, and in some cases, outcome studies have shown that
programmes correlate with reduction of related mortality and improvements inpatients’ blood glucose control.50 Nonetheless, concerns over the sustainability of
donation programmes have been raised, as access to treatment may become fully
dependent on industry presence.50 In some cases, long-term programmes do coverelements of addressing health system needs, but as companies move forward their
donation programmes should systematically incorporate plans for transitioning
towards sustainable strategies to ensure continued access.
In addition to insulin, patients need access to products including syringes, injection pens, monitoring devices and test strips. These are vital tools for administering insulin and for managing diabetes. As many countries still rely on donations toprovide access to these necessary commodities, it is essential for all companies tosystematically include these products in their donations and access strategies, forinstance by working in partnership with companies producing diagnostics and medical equipment. To increase the understanding of current global gaps, is importantthat companies disclose information regarding what products are being donatedand where.

28

Access to Medicine Foundation

I N DUSTRY ANALYSIS

New strategies and partnership models
are being used to tackle challenges in theinsulin supply chain and the delivery of
diabetes care
A range of challenges across the supply chain and within health systems canultimately affect the availability and affordability of insulin, as well impacting the
supply of other essential diabetes commodities, such as devices and diagnostics,
for people with diabetes. Pharmaceutical companies cannot solve these issues
alone, but they can play an important role by working with other global and local
stakeholders to address some of the problems that prevent people with diabetes
from getting access to the treatment they need.
Helping to solve issues in the supply chain
Securing a sustainable and affordable supply of insulin requires action across the
supply chain, from the manufacturing facility up to the last mile. But for many
LMICs with limited resources, the infrastructure required for the proper procurement, delivery, logistics and cold storage of medicine is often lacking.
Because pharmaceutical companies have extensive experience in product delivery, they can provide local governments and healthcare organisations with support
in terms of know-how, resources, models for efficient distribution networks andsupply practices, strategies to ensure continuous monitoring of demand levels, andcapacity building. Research-based pharmaceutical companies can also leverage
their expertise to innovate and create products that are more easily supplied andstored.
When cold storage issues are not addressed, this can fundamentally impede thesuccess of companies’ strategies to increase access to diabetes care. For example,
evaluations of Eli Lilly-supported programmes (AMPATH’s glucose management
programme in Kenya and the Tshwane Insulin Project in South Africa) showed thata lack of access to cold storage throughout the day, and a lack of knowledge about
the temperature at which insulin needs to be stored, contributed to participants’ongoing issues with controlling blood glucose levels.51,52

Looking for solutions to expand cold chain capacity for insulins
Opportunities regarding new advancements in cold chain capacity can be leveraged.
WHO and UNICEF stated in 2015 and reaffirmed in 2020 that it is permissible touse the Expanded Programme on Immunization (EPI) and vaccine cold chain capacity for the storage and transport of other temperature-sensitive pharmaceuticals
under certain conditions.53 Following the start of the pandemic and the need for asustainable cold chain to supply COVID-19 vaccines globally, there has been a great
push to build additional capacity in LMICs. This has, for example, been the case in
Malawi.54 Existing cold chain capacity could be used more frequently and effectively
to store and transport insulin. To make this successful, there is a need for collaboration between actors from the immunisation and NCD programmes at global andlocal levels.

29

Access to insulin in LMICs

Strengthening diabetes care at all levels
Diabetes is a chronic disease and requires uninterrupted access to healthcare services and all necessary treatments and commodities. Without adequate health facilities and trained healthcare practitioners in reachable locations, the continuum of
diabetes care breaks down. This includes preventative efforts (particularly for type2), as well as screening, diagnosis, referrals, lifelong daily treatment, and monitoring
for all people with diabetes at various levels of the healthcare system.
To improve the situation, there is an opportunity for companies to develop
and scale up integrated models, based on evidence of local needs and gaps.
Manufacturers of insulin can play a role in tackling system challenges, such as thoserelated to information systems, healthcare capacity, education and training. When
companies engage in such initiatives, they must implement robust strategies toensure that any potential conflict of interest is mitigated at all levels. This is notalways the case, as some companies currently fail to disclose if or how such strategies are put in place. In line with this, responsible promotional practices must be
adopted, including a public disclosure of value transfers to healthcare professionals
involved in diabetes capacity building programmes.
One significant challenge is that many people living in LMICs currently have limited access to commodities necessary for diabetes care. Currently, the situation isvery fragmented; for instance, a patient may have access to a vial of insulin but nosyringe, or may own a glucometer but be unable to obtain compatible test strips
due to lack of availability or high prices. A study performed in the LMICs covered by
the Life for a Child programme found that in many countries, injection devices weredifficult to access, and when available, there were prevailing limitations that led tomisuse.55 Affordability is a core part of the problem; in Mali and South Africa, forexample, the cost of syringes and glucose test strips represents the majority of thecost of diabetes care (also including insulin). For people living with type 1 diabetes
in Mali, test strips constitute almost 60% of the yearly cost of care.56
As insulin manufacturers make efforts to expand access to their insulin products,
partnerships with other stakeholders and companies can be essential to ensure theprovision of all necessary tools for ensuring appropriate management of diabetes,
whether as donations or at affordable prices.
To tackle the fragmentation of product provision, Novo Nordisk and Sanofi aretaking part in the Diabetes CarePak initiative, which is carried out by PATH (thenon-profit formerly known as Program for Appropriate Technology in Health). This
co-packaging solution aims to increase access to safe administration of insulin andself-care at the primary care level by bundling necessary commodities such as glucometers, test strips, needles and syringes, in line with the needs of people withdiabetes. CarePak has been rolled out in Kenya with the support of Novo Nordisk,
and in Uganda with the support of Sanofi. The initiative includes partnerships withlocal ministries of health, people living with diabetes and health care providers.

30

Access to Medicine Foundation

TABLE 1. Companies’ strategies along the supply chain and the continuum of care

Challenge to address

Examples of companies’ strategies to strengthen the supply chain
and continuum of care

Forecasting how much insulin will be needed
in a particular country, and in which areas andfacilities, can be complex.

Industry initiatives include important elements such as forecasting and information systems, which
require collaboration with other stakeholders. These have the potential to improve local supply systems
and create more sustainable provision of affordable insulin. For example, Novo Nordisk is working to
implement a forecasting tool to be used for estimating annual quantities and costs of products fordiabetes care, alongside PATH and the Coalition for Access to NCD Medicines & Products.

Procuring insulin can be expensive, especiallyfor countries purchasing insulin in smaller
quantities.

Discussions are in place to use existing mechanisms for international non-profit pooled procurementof insulins, specifically for LMICs. Such mechanisms are already in place for other essential medicines,
such as vaccines, antiretrovirals and antimalarial treatments, and have the proven benefit of reducing
the price of products for many countries.

Insulin needs continuous cold storage, which

Some localised efforts are being pursued to improve cold chain management, but expansion is needed.
can be a challenge for distributors and patients Recent progress in developing insulins that do not need continuous cold home-storage is a positivein many LMICs.
advancement, especially for patients in rural areas where storage capacity is limited.
Access challenges exist along the supply
chain and are difficult to tackle without
collaboration.
There are challenges in ensuring high-quality
diabetes training and education for healthcare
providers and patients alike, so that diabetes
can be successfully treated.

Companies are engaging in local partnerships with public and private entities to put access strategies
in place. Initiatives such as Novo Nordisk's Base of the Pyramid and Sanofi's Ngao Ya Afya have tackled
access challenges including continuity of supply, pricing, patients’ education and monitoring.
Initiatives focused on implementing digital information systems for the management of diabetes are
becoming more common. Companies including Eli Lilly and Sanofi are leveraging new technologies toimprove aspects of care such as clinical training, engagement between providers and users, patient
education and self-management.

31

Access to insulin in LMICs

SPOTLI G HT

Access to insulin for children and young
peopleAround 1.2 million children and adolescents are currently living with type 1 diabetes

Challenges faced by children and youngworldwide,1 and each of them requires access to multiple doses of insulin every day

people with diabetes

to stay alive. However, challenges with screening, diagnosis and access to treatmentf Lack of access to screening and diagnosis.

are prevalent in many LMICs, leading to children with this condition often dyingf Lack of access to appropriate

undiagnosed or misdiagnosed with malaria, gastroenteritis or other disorders.57
Global mortality due to diabetes (type 1 and 2) in under-25s has been estimated attreatment.
f Stigma, insufficient community

16,300 in just one year (2019), with 97.5% of deaths taking place in countries withawareness, and barriers to accessing

a low to high-middle socio-demographic index.58 Mortality due to diabetes in young

schooling.

people is estimated to be particularly high in sub-Saharan Africa, South-East Asiaand some countries in Latin America.57,58

f Difficulties with the types of delivery
and monitoring devices available, such

Insulin manufacturers have a range of programmes in place aiming to address

as higher perceived pain from injections

specific challenges in access to insulin and diabetes care for children and young

via a syringe or from finger-prick tests

people. Some examples are briefly outlined (see below).

for glucometers. Such difficulties can
reduce adherence to treatment.

Necessary steps to increase access to diabetes care for children and youth
Over the last 15 years, industry initiatives have made great strides and have helpedf Lack of regular access to healthcare

provide thousands of young people with insulin and necessary monitoring tools.

in diabetes management and insulin

There are now signs of longer-term commitment to these programmes; for exam-

dosing – which is especially key forple, Eli Lilly, through donations and financial support to Life For A Child, aims tochildren as they grow and their insulin

extend access to diabetes care to approximately 150,000 people annually by 2030

needs change.

workers with specific clinical expertiseand reach over 60 countries, including India, Ethiopia and Bolivia. In 2020, it wasannounced that Novo Nordisk’s CDiC was being expanded, with the aim of reaching
100,000 children by 2030.
Children and young people in LMICs continue to experience deep inequalities inaccess to diabetes care. For low-resource families with children with type 1 diabetes
living in countries where the public system does not provide treatment, the costs ofdiabetes management may take up all of the family's income.59 In such cases, industry programmes have brought valuable aid. However, concerns have been raised
about how to continue to provide long-term treatment once programmes end or
young people 'age out’ of these initiatives. Moving forward, industry programmes
must continue to work in partnership alongside local governments and stakeholders to ensure young people continue to have long-term access to all necessarycommodities for the management of their condition.

Eli Lilly - Life for a Child:

Novo Nordisk - Changing Diabetes

Sanofi - the KiDS projectThis programme provides insulin free

in Children:

This educational programme, co-createdof charge for people under the age of

Novo Nordisk's programme includes

by Sanofi, works with schoolteachers,

26 with type 1 diabetes in 44 countries

training of healthcare professionals,

nurses and policymakers and to foster(including 41 in scope). The programmeestablishing clinics, support for patient

safe environments for children between

includes the provision of monitoring tools,

education, and donations of human

6 and 13 years old. The programme aims

as well as education for health profes-

insulin for people up to 25 years old in 24

to promote education about diabetes,

sionals through the support of othercountries (including 22 in scope). The pro-raise awareness and reduce related

partners.

gramme also provides commodities suchstigma. KiDS programmes have been

For more, see page 13.

as glucometers and test strips through a

implemented in 10 countries (including 5

partnership with Roche.

in scope).

For more, see page 16.

For more, see page 19.

32

Access to Medicine Foundation

Partnerships and sustainable access

Newer monitoring and delivery methods

Even though some industry programmes have been in place for many years, many

bring benefits for children – when accessi-

local health systems in LMICs have not yet succeeded in being able to take on theble and affordable

mantle of diabetes care on a sustainable, long-term basis. Companies are attempt-

Insulin pens were introduced over 35 years

ing to find solutions to build sustainability and scale up access, so that more children

ago. In comparison to syringes, they arehave access to treatment, and so that people with diabetes are able to continueeasier for children and their carers to use,treatment after ageing out of paediatric programmes.

more convenient to administer during school

Pursuing partnerships is one key approach. For example, Novo Nordisk works

and outdoor activities, and less likely towith global partners such as the International Society for Paediatric and Adolescentattract stigma.60 Pens can also be used with

Diabetes and the World Diabetes Foundation, industry partners such as Roche

short, thin needles that minimise pain andDiabetes Care and local partners including ministries of health and national diabetes

discomfort during injection. Some pens areassociations. The activities developed in each context are based on priorities iden-

adapted to provide more specific dosing,tified by partner countries across workstreams such as data systems, research andwhich can benefit children who need theirinnovation. CDiC entered a partnership with Harvard University T.H. Chan School of

insulin dosage tailored as they grow.

Public Health to strengthen data systems and registries to identify cost-effective

Currently, insulin pens are only sometimes

interventions in LMICs. CDiC continues to seek local partners and governments toincluded within paediatric programmes.

look for ways to strengthen national health systems and create a financially sustain-

However, Novo Nordisk announced that,able model.

from 2022, its CDiC programme would

Sanofi seeks sustainable change through its KiDS project by pursuing local policy

upgrade from syringe and vial to pen devices

changes regarding the management of type 1 diabetes and prevention strategies“in a country-by-country phased approachfor type 2 diabetes in children. For this approach to be successful, local partner-

as appropriate”.61 Similarly, Eli Lilly recently

ships with a variety of stakeholders are necessary. KiDS was co-created with theannounced it is aiming to increase donations

International Diabetes Federation, in collaboration with the International Societyof reusable pens, as well as to cover costs

for Paediatric and Adolescent Diabetes – but with a key role for local partners such

associated with packaging and shipping.

as the Public Health Foundation of India, the Brazilian Diabetes Society and the
Associação de Diabetes Juvenil (ADJ) of Brazil.

In high-income countries, more recent
innovations in delivery methods have alreadyEli Lilly has also explored collaborative approaches, and in 2022 the company

revolutionised diabetes care. These include

entered a partnership with UNICEF to support care for children and adolescentssmart pens, which can connect with a smart-with non-communicable diseases in five LMICs. In the coming years, evaluation ofphone and track insulin dosing, and increas-

outcomes will be essential to assess the reach and impact of this initiative.

ingly sophisticated insulin pumps, which are

Indeed, evaluating outcomes can be a useful step in working towards sustainabil-

attached to the body and deliver continuous

ity. Novo Nordisk’s CDiC programme measures and reports outcomes via independ-and customised doses of insulin. Using insulin

ent evaluations (e.g. by University College London), which helps to build greater

pumps can significantly improve the man-understanding of the impact of the strategy. The company publicly discloses theagement of diabetes in children, decreasing

number of children reached and outcomes such as the number of educational ses-

adverse events and improving their quality

sions and professional trainings.

of life and psychosocial functioning.62,63

The global manufacturers of insulin have taken big steps in the 21st century to

However, these delivery devices are far lessset up paediatric programmes and reach more children in LMICs with diabetes.

likely to be available in LMICs. As technology

While most of these programmes are focused on insulin donations and local capac-

and science advances, a bigger gap in accessity building, companies are seeking ways to build long-term sustainability of accessis being observed between what is available

and have begun to explore different strategies to achieve this aim. However, chronic

for young people in high-income contexts

challenges remain and solutions must be found so that children with type 1 diabetes

and those living in lower-resource settings.

can access the treatment they need to live long, healthy lives.

In LMICs, many children and young people
do not have access to glucometers andnecessary test strips at home. Without theirown glucometer, a child will need to travel toa health facility for regular measurements,
or may have no choice but to skip testing
altogether. Paediatric programmes such as
Life for a Child and CDiC do provide thesetools to young people by engaging with
manufacturing partners. However, many
young people in LMICs not covered by these
programmes still have no access to theseessential diabetes products due to theirprohibitive cost.

33

Access to insulin in LMICs

N EX T STE PS

How to meet the challenge of expanding access to insulin

As the analysis in this paper has shown, there has been progress over the last decade, with insulin manufacturers starting to implement more strategies and initiatives focused on making insulin more accessible in contexts where access is limited.
However, to counteract the rising burden of diabetes, increase competition, andmake sure all people living with diabetes have a choice of insulins, efforts must be
increased.
This section sets out the key actions that insulin manufacturers, including manufacturers of biosimilar insulins, can take to expand access to their products in LMICs.
Critical priorities have been identified, in order to strengthen efforts to expand
access to insulin in LMICs and guide action towards achieving the targets and someof the key asks laid out in the WHO Global Diabetes Compact.

Expand registration of human and analogue insulins in LMICs to increase patients’ access and choice
Continue to expand the registration of

When seeking to expand access to their insulin products, companies can prioritise filing for registration

insulins, prioritising low-income countries andin the regions and countries where the need is most urgent. This includes regions with a high burden

lower-middle-income countries with a highof diabetes, such as the West Pacific, and regions with limited access to insulins, such as sub-Saharanburden of disease.

Africa (see map, page 24). Companies should prioritise registering the insulins – both analogue andhuman – that have been classed as ‘essential medicines’ by the World Health Organisation (WHO).

Submit products for WHO prequalification

These procedures can facilitate product registration in LMICs and expand the reach of new and existing

and collaborative procedures, as well as filingproducts, including quality-assured biosimilar insulins.

for registration with Stringent Regulatory
Authorities.
Register biosimilar insulin products in a

Manufacturers of biosimilar insulins can file their products for registration, both in countries where thegreater number of LMICs.

original insulin (the ‘reference product’) has been launched, and in countries it has not. Expanding theirfootprint in LMICs could increase access to affordable insulin in these countries.

Address affordability and accessibility challenges to promote sustainable access to insulin in the long term
Work towards the development of systematic

Manufacturers should expand efforts to increase access to affordable insulin for more people in more

approaches to access for LMICs.

LMICs by moving away from fragmented social responsibility models and towards a systematic accessapproach that addresses every payer's ability to pay (i.e. national authorities, public and private insurers
and people paying out-of-pocket). Such approaches should tackle barriers to access for vulnerable
groups such as children, young people, and all patients at the base of the economic pyramid.

Ensure that access strategies address

Manufacturers should work with local and national health authorities, diabetes patient groups andcontext-specific gaps and contribute to long-other local stakeholders to gain a better understanding of the local needs of different patient popula-term sustainability and integration into healthtions and align initiatives to regional and local government priorities. Strategies that prioritise meetingsystems.

local needs and working towards integration within the local health system can help achieve lifelong
sustainable access to chronic care for people with diabetes.

Increase efforts to monitor, measure and pub-Evaluating and publicly sharing the impact of strategies can reveal success factors and remaining gaps

licly disclose the impact of access strategies

and can also show what conditions are necessary to make a strategy sustainable in the long term –and initiatives.

potentially facilitating peer-to-peer learning between companies so that they can pursue successful
access strategies. Companies can strengthen their approaches to monitoring and evaluation either byimplementing robust evaluation plans in-house, or by partnering with third-party organisations andacademic institutions.

Pursue partnership approaches to address

Collaborations between insulin manufacturers, manufacturers of monitoring and diagnostic tools andchallenges that patients face in accessing

other sector partners can help increase access to essential commodities needed by many people living

both insulin and other essential products forwith diabetes, such as glucometers and syringes.

diabetes care.

34

Access to Medicine Foundation
Invest in optimising insulin supply and distribution
Support global efforts to develop digital tools

Such tools, developed by stakeholders including non-profit organisations, governments, and pharma-

to increase product traceability and forecast-ceutical companies, have the potential to improve the efficacy of the supply chain by ensuring greatering of insulin demand.

visibility of where products are. Digital tools can be used to help benchmark procurement prices andadequately meet product demand across different locations.

Participate in pooled procurement mech-

Manufacturers should enter international and/or regional mechanisms, such as those facilitated byanisms to support the supply of insulin in

UNICEF and IDA Foundation, to support the expansion of access to insulin for countries with limited

regions where access is limited.

access and purchasing capacity.

Collaborate with local distributors and logis-

When local stakeholders in LMICs request assistance from companies and seek to work in partnership,tics providers to identify bottlenecks in the

manufacturers can work together with these local stakeholders to facilitate last-mile delivery of insulin

supply chain and strengthen last-mile delivery

and necessary diabetes supplies for people living in hard-to-reach areas. Key steps can include decen-of essential products.

tralising insulin supply and building healthcare providers’ capacity at the primary care level.

Continue to invest in, and accelerate access to, adapted and novel diabetes treatments or delivery methods
Prioritise and invest in the development ofPeople living in resource-poor settings, and patients facing particular challenges such as children andadapted and/or novel insulin products to meetyoung people (see page 32), benefit from products that have been designed or adapted to meet their

the needs of people living in LMICs, and planneeds. This includes insulin products that reduce the need for continuous cold chain storage of insulin,ahead to ensure that products reach patients

as well as insulin products that provide more flexibility around frequency of administration. Whenin these countries.

developing or adapting products, companies should establish detailed plans during product development and ahead of launch to ensure that, after they are approved, these products reach the people
who need them the most.

Catalysers for expanding access to insulin

f Strategies to address unnecessary mark-ups to the price ofAside from companies, other stakeholders with essential roles

insulin. Reviewing, optimising and enforcing national regula-to play in facilitating the expansion of access to diabetes caretions related to taxes, import tariffs and wholesale and retailinclude national and local health authorities, national regulatory

mark-ups can help reduce the magnitude of mark-ups alongauthorities, global health organisations, manufacturers of essen-

the insulin supply chain and ensure the lowest possible local

tial commodities, and local partners.

insulin price for patients.

Here, in the context of the broader healthcare ecosystem, thef Optimisation of local supply chains for insulins. Investment

Foundation highlights how challenges can be tackled by otherin local distribution and forecasting technologies can leadstakeholders in order to ‘catalyse’ the expansion of access toto more effective management of the supply chain in LMICs,

insulin and speed up companies’ progress.

reducing the risk of disruptions and ensuring better continuity

Catalysers include:of supply. Similarly, action to strengthen and expand coldf Continued progress toward strengthening local regulatory

chain capacity, for instance by promoting the integration of

capacity in LMICs. Current efforts to support more effective

insulin within the cold chain system for vaccines, can help

regulatory systems, such as by the WHO’s Regulatory System
Strengthening programme, will be essential to facilitate theensure access in resource-limited settings.
f Prioritisation of diabetes in LMIC governments' policy

registration and availability of quality-assured products inand funding. Adopting national diabetes targets, in line with

LMICs, including of biologic products.

international agreements (e.g., World Health Assembly reso-

f Global and regional harmonisation of regulation for medical

lutions), and taking steps to meet these targets, for example

products. If countries’ or regions’ regulatory requirements andby improving access to screening at the primary care level, areregistration procedures are streamlined and/or aligned withessential to strengthen diabetes care. Such efforts must beother countries’, this can expedite registration and also encour-

supported by increased investment in diabetes care.

age more companies to file their products for registration. Thiscan include streamlining technical requirements for marketing
authorisation of products, such as legislation, technical guidelines, and regulatory documentation.
f Improved knowledge and awareness of biosimilars. Initiatives
such as evidence-based training for healthcare providers andpatient education programmes, guided by health authorities
and patient and clinicians' associations, can help inform the use
and role of biosimilar insulins. These initiatives can also encourage the adoption of guidelines regarding interchangeability andincrease the use of biosimilar insulins whenever they are themost affordable option.

35

Access to insulin in LMICs

RE FE RE NCES
1.

International Diabetes Federation.
IDF Diabetes Atlas 10th Edition.; 2021.
www.diabetesatlas.org
2. World Health Organization. Keeping
the 100-Year-Old Promise: Making
Insulin Access Universal.; 2021. http://
apps.who.int/bookorders.
3. Basu S, Yudkin JS, Kehlenbrink S,
et al. Estimation of global insulin
use for type 2 diabetes, 2018–30:
a microsimulation analysis. Lancet
Diabetes Endocrinol. 2019;7(1):25-33.
doi:10.1016/S2213-8587(18)30303-6
4. Ewen M, Joosse HJ, Beran D, Laing
R. Insulin prices, availability andaffordability in 13 low-income andmiddle-income countries. BMJ
Glob Health. 2019;4(3). doi:10.1136/
bmjgh-2019-001410
5. IQVIA Institute. Understanding Insulin
Market Dynamics in Low-and MiddleIncome Countries. Producers, Supply
and Costs.; 2021.
6. World Health Organization. First-everglobal coverage targets for diabetes
adopted at the 75th World Health
Assembly. Published May 28, 2022.
Accessed June 13, 2022. https://www.
who.int/news-room/feature-stories/
detail/first-ever-global-coverage-targets-for-diabetes-adopted-at-the-75th-world-health-assembly
7. Quianzon CC, Cheikh I. History of
insulin. J Community Hosp Intern
Med Perspect. 2012;2(2):18701.
doi:10.3402/jchimp.v2i2.18701
8. Clarke SF, Foster JR. A history ofblood glucose meters. Br J Biomed
Sci. 2012;69(2):83-93.
9. Vecchio I, Tornali C, Bragazzi NL,
Martini M. The discovery of insulin:
An important milestone in the history of medicine. Front Endocrinol(Lausanne). 2018;9. doi:10.3389/
fendo.2018.00613
10. Lee SH, Yoon KH. A century of progress in diabetes care with insulin: A
history of innovations and foundation
for the future. Diabetes Metab J.
2021;45(5):629-640. doi:10.4093/
DMJ.2021.0163
11. European Medicines Agency.
Committee for Medicinal Productsfor Human Use (CHMP). Summaryof Opinion. Actrapid, Insulin Human.;
2022. www.ema.europa.eu/contact
12. European Medicines Agency.
Committee for Medicinal Productsfor Human Use (CHMP). Summary ofOpinion. Insulatard, Insulin Human.;
2022. www.ema.europa.eu/contact
13. Schultz K. The Global Diabetes Care
Market.; 2011. Accessed September
15, 2022. https://www.yumpu.com/
en/document/read/3266542/
the-global-diabetes-care-market-kare-schultz-novo-nordisk
14. Eli Lilly and Company. Eli Lilly andCompany 2021 Annual Report on
Form 10-K.; 2021.
15. Novo Nordisk. Financial Report for the
Period 1 January 2021 to 31 December
2021.; 2022.
16. Sanofi. Annual Report on Form 20-F.;
2021.
17. Beran D, Pedersen HB, Robertson J.
Noncommunicable diseases, accessto essential medicines and universal

health coverage. Glob Health Action.
2019;12(1). doi:10.1080/16549716.201
9.1670014
18. The World Bank. Out-of-pocket
expenditure (% of current healthexpenditure) | Data. Published 2022.
Accessed August 22, 2022. https://data.worldbank.org/indicator/SH.XPD.
OOPC.CH.ZS
19. Beran D, Lazo-Porras M, Mba CM,
Mbanya JC. A global perspectiveon the issue of access to insulin.
Diabetologia. 2021;64:954-962.
doi:10.1007/s00125-020-05375-2/
Published
20. Beran D, Laing RO, Kaplan W, et al. A
perspective on global access to insulin:a descriptive study of the market,
trade flows and prices. Diabetic
Medicine. 2019;36(6):726-733.
doi:10.1111/dme.13947
21. Ball D, Ewen M, Laing R, Beran D.
Insulin price components: Casestudies in six low/middle-income
countries. BMJ Glob Health. 2019;4(5).
doi:10.1136/bmjgh-2019-001705
22. Chan JCN, Gagliardino JJ, Ilkova H,
et al. One in Seven Insulin-Treated
Patients in Developing Countries
Reported Poor Persistence with
Insulin Therapy: Real World
Evidence from the Cross-Sectional
International Diabetes Management
Practices Study (IDMPS). Adv Ther.
2021;38(6):3281-3298. doi:10.1007/
s12325-021-01736-4
23. World Health Organization. The Global
Diabetes Compact.; 2021.
24. World Health Organization.
WHO - Prequalification of Medical
Products (IVDs, Medicines, Vaccines
and Immunization Devices,
Vector Control). Published May
17, 2022. Accessed July 13, 2022.
https://extranet.who.int/pqweb/
news/2nd-eoi-human-insulin
25. Gotham D, Barber MJ, Hill A.
Production costs and potential prices
for biosimilars of human insulin andinsulin analogues. BMJ Glob Health.
2018;3(5):e000850. doi:10.1136/
bmjgh-2018-000850
26. Cheng AYY, Wong J, Freemantle N,
Acharya SH, Ekinci E. The Safety andEfficacy of Second-Generation Basal
Insulin Analogues in Adults with Type
2 Diabetes at Risk of Hypoglycemia
and Use in Other Special Populations:
A Narrative Review. Diabetes Ther.
2020;11:2555-2593. doi:10.6084/
m9.figshare.12906755
27. Semlitsch T, Engler J, Siebenhofer A,
Jeitler K, Berghold A, Horvath K.
(Ultra-)long-acting insulin analogues
versus NPH insulin (human isophaneinsulin) for adults with type 2 diabetes
mellitus. Cochrane Database of Syste­matic
Reviews. 2020;2020(11 doi:10.1002/
14651858.CD005613.pub4
28. He X, Chen L, Wang K, Wu H, Wu J.
Insulin adherence and persistence
among chinese patients with type 2
diabetes: A retrospective database
analysis. Patient Prefer Adherence.
2017;11:237-245. doi:10.2147/PPA.
S123389
29. McGovern A, Tippu Z, Hinton W,
Munro N, Whyte M, de Lusignan S.

Comparison of medication adherence and persistence in type 2
diabetes: A systematic review andmeta-analysis. Diabetes Obes Metab.
2018;20(4):1040-1043. doi:10.1111/
dom.13160
30. Opanga S, Wangeci Njeri L, Kimonge
D, Godman B, Oluka M. Assessing
Utilisation and Expenditure on LongActing Insulin Analogues in Kenya;
Findings and Implications for the
Future. Scholars Academic Journalof Pharmacy. 2021;10(4):63-70.
doi:10.36347/sajp.2021.v10i04.002
31. Ministry of Health Republic of Kenya.
Kenya Essential Medicines List -2019.
Published 2019. Accessed July 5,2022. https://www.health.go.ke/
wp-content/uploads/2020/07/KenyaEssential-Medicines-List-2019.pdf
32. Haque M, Islam S, Abubakar AR, etal. Utilization and expenditure on
long-acting insulin analogs among
selected middle-income countries
with high patient co-payment
levels: Findings and implications
for the future. J Appl Pharm Sci.
2021;11(7):172-182. doi:10.7324/
JAPS.2021.110720
33. Chaplin S. Biosimilar insulins: willswitching soon be the norm? Practical
Diabetes. 2021;38(4):17-20.
34. Godman B, Haque M, Leong T, etal. The Current Situation Regarding
Long-Acting Insulin Analogues
Including Biosimilars Among
African, Asian, European, and SouthAmerican Countries; Findings and
Implications for the Future. Front
Public Health. 2021;9. doi:10.3389/
fpubh.2021.671961
35. Llano A, Fisher M, McKay G. Biosimilar
insulin: the current landscape.
Practical Diabetes. 2017;34(2):51-54.
36. Klatman EL, Jenkins AJ, Ahmedani
MY, Ogle GD. Blood glucose meters
and test strips: global market andchallenges to access in low-resource
settings. Lancet Diabetes Endocrinol.
2019;7(2):150-160. doi:10.1016/
S2213-8587(18)30074-3
37. World Health Organization. The selection and use of essential in vitro diagnostics - TRS 1031. Published January
29, 2021. Accessed July 25, 2022.
https://www.who.int/publications/i/
item/9789240019102
38. Clinton Health Access Initiative (CHAI).
Diabetes Self-Monitoring Devices in
Low- and Middle-Income Countries.
Market Report.; 2021.
39. Sharma A, Kaplan WA. Insulin imports
fail to meet many countries’ needs.
Science (1979). 2021;373(6554).
40. Access to Medicine Foundation. What
Can Be Learned from COVID-19 to
Solve Chronic Issues in access to
Health Care in Low- and MiddleIncome Countries?; 2021. Accessed
August 22, 2022. https://accesstomedicinefoundation.org/news/7-lessons-from-covid-19-for-pharma-companies
41. Beran D, Mirza Z, Dong J. Access toinsulin: Applying the concept of security of supply to medicines. Bull World
Health Organ. 2019;97(5):358-364.
doi:10.2471/BLT.18.217612

42. World Health Organization. From vaccines to vaccinations: seventh meetingof the Multilateral Leaders Task Forceon COVID-19 Vaccines, Therapeutics
and Diagnostics. Published December
22, 2021. Accessed July 21, 2022.
https://www.who.int/news/item/2212-2021-from-vaccines-to-vaccinations-seventh-meeting-of-the-multilateral-leaders-task-force-on-covid-19vaccines-therapeutics-and-diagnostics
43. The World Bank. Population, total- Angola, Belize, Comoros, Djibouti,
Equatorial Guinea, Eswatini, GuineaBissau, Kiribati, Lesotho, Liberia,
Micronesia, Fed. Sts., Korea, Dem.
People’s Rep., Papua New Guinea,
Samoa, Sao Tome and Principe, Sierra
Leone, Solomon Islands, Somalia,
South Sudan, Tajikistan, TimorLeste, Tonga, Tuvalu, Vanuatu | Data.
Published 2022. Accessed September
19, 2022. https://data.worldbank.org/
indicator/SP.POP.TOTL?contextual=default&end=2021&locations=AO-BZKM-DJ-GQ-SZ-GW-KI-LS-LR-FM-KPPG-WS-ST-SL-SB-SO-SS-TJ-TL-TOTV-VU&start=2013
44. Global Burden of Disease
Collaborative Network. Global
Burden of Disease Study 2019
(GBD 2019) Results. Published
online 2021. doi:https://doi.
org/10.6069/1D4Y-YQ37
45. Cavaller Bellaubi M, Harvey Allchurch
M, Lagalice C, Saint-Raymond A. The
European Medicines Agency facilitatesaccess to medicines in low- and middle-income countries. Expert Rev Clin
Pharmacol. 2020;13(3):321-325. doi:10.
1080/17512433.2020.1724782
46. Perrin C, Ewen M, Beran D. The roleof biosimilar manufacturers in improving access to insulin globally. Lancet
Diabetes Endocrinol. 2017;5(8):578.
doi:10.1016/S2213-8587(17)30218-8
47. Roth L, Bempong D, Babigumira JB, etal. Expanding global access to essential medicines: Investment priorities
for sustainably strengthening medical
product regulatory systems. Global
Health. 2018;14(1):1-12. doi:10.1186/
S12992-018-0421-2/TABLES/5
48. Shannon GD, Haghparast-Bidgoli
H, Chelagat W, Kibachio J, SkordisWorrall J. Innovating to increase
access to diabetes care in Kenya: anevaluation of Novo Nordisk’s baseof the pyramid project. Glob Health
Action. 2019;12(1). doi:10.1080/165497
16.2019.1605704
49. Somasundaram S, Lefort T, Lamory
G, et al. Using Mobile Technology
to Break Access and Awareness
Barriers for the Benefit of Patientswith Diabetes and Hypertension. An
Innovative and Dynamic Partnershipof Pharmaccess, Carepay and Sanofi.;2020. Accessed July 5, 2022. https://www.thelancet.com/journals/langlo/
article/PIIS2214-109X
50. Hogerzeil H v, Recourt S. Company
and company-supported programmeswith a component of donated insulin
in LMICs. Published online 2018. www.
haiweb.org
51. Pastakia SD, Cheng SY, Kirui NK,
Kamano JH. Dynamics, impact, and36

Access to Medicine Foundation

feasibility of self-monitoring of blood
glucose in the rural, resource-constrained setting of western Kenya.
Clinical Diabetes. 2015;33(3):136-143.
doi:10.2337/diaclin.33.3.136
52. Ngassa Piotie P, Wood P, Muchiri
JW, Webb EM, Rheeder P. Attitudes
and beliefs of South African primary
healthcare practitioners on initiating
insulin in people with type 2 diabetes:
Findings from the Tshwane Insulin
Project (TIP). Prim Care Diabetes.
2021;15(5):865-870. doi:10.1016/j.
pcd.2021.06.005
53. World Health Organization.
Temperature-sensitive health products in the Expanded Programme on
Immunization cold chain. Published
November 19, 2020. Accessed June17, 2022. https://www.who.int/
publications/i/item/WHO-2019-nCovImmunization-Cold_Chain-2020.1
54. UNICEF. Improved cold chain keeps
COVID-19 jabs cool | UNICEF Malawi.
Published 2022. Accessed June17, 2022. https://www.unicef.org/
malawi/stories/improved-cold-chainkeeps-covid-19-jabs-cool
55. Klatman EL, Ogle GD. Access to insulin delivery devices and glycated haemoglobin in lower-income countries.
World J Diabetes. 2020;11(8):358369. doi:10.4239/wjd.v11.i8.358
56. Médecins Sans Frontières, SantéDiabète. Towards Insulin for All:
Operationalising the WHA74
Resolution on Diabetes.; 2022.
57. Patterson C, Guariguata L, Dahlquist
G, Soltész G, Ogle G, Silink M.
Diabetes in the young - a global
view and worldwide estimates ofnumbers of children with type 1
diabetes. Diabetes Res Clin Pract.
2014;103(2):161-175. doi:10.1016/j.
diabres.2013.11.005
58. Cousin E, Duncan BB, Stein C, etal. Diabetes mortality and trends
before 25 years of age: an analysis of
the Global Burden of Disease Study
2019. Lancet Diabetes Endocrinol.
2022;10(3):177-192. doi:10.1016/
S2213-8587(21)00349-1
59. Ogle GD, Kim H, Middlehurst AC,
Silink M, Jenkins AJ. Financial costs
for families of children with Type 1
diabetes in lower-income countries.
Diabetic Medicine. 2016;33(6):820826. doi:10.1111/dme.12997
60. Spollett GR. Improved Disposable
Insulin Pen Devices Provide an
Alternative to Vials and Syringes
for Insulin Administration. Diabetes
Spectrum. 2012;25(2):117-122.
doi:10.2337/DIASPECT.25.2.117
61. Novo Nordisk, Roche Diabetes Care,
International Society for Pediatric andAdolescent Diabetes, World Diabetes
Foundation. Changing Diabetes inChildren. Year in Review 2021.; 2021.
62. Woerner S. The benefits of insulin pump therapy in children andadolescents with type 1 diabetes. J
Pediatr Nurs. 2014;29(6):712-713.
doi:10.1016/j.pedn.2014.08.010
63. Franklin V. Influences on Technology
Use and Efficacy in Type 1 Diabetes. J
Diabetes Sci Technol. 2016;10(3):647655. doi:10.1177/1932296816639315

37Access to insulin in LMICs

APPENDIX
I . M ETHO DO LOGY
This paper was developed through direct data collection from the insulin manufacturers in scope, as well as a review ofpublic sources and interviews with stakeholders, as detailed below.

Data collection

Data collected on a diversity of topics, including• Data submitted to the 2022 Access to Medicine

registration of insulin products, company governance,

Index• Supplementary data requests to companies

access strategies and supply and manufacturing
related to diabetes in LMICs.

• Publicly available information (including annual
reports, peer-reviewed literature, and other

The following companies were invited to provide

publications)information: Biocon, Eli Lilly, Novo Nordisk, Sanofi.

Stakeholder consultations• Targeted consultation process including 16 experts
from 14 different affiliations. This included 6 experts

Insights used to define current challenges, practices

from 6 LMICs in scope.

and priorities in expanding access to insulin, as well

• Included in-country clinicians, academic researchers

as broader diabetes care, in LMICs.

and implementing partners, as well as representatives from local ministries of health, global healthorganisations and patient groups.
Expert representatives from industry, public sector
Expert session

partners and global health organisations met to‘Closing the gaps in access to diabetes care indiscuss practices and solutions for closing the gaps

low- and middle-income countries’, 7 July 2022.

in access to diabetes care in LMICs.

38

Access to Medicine Foundation

I I . PRO DUCT SCOPETABLE 1. Products in scope of this study
Yes
No
Product name (International

ATC code*

Manufacturer

On-patent?**

Nonproprietary Name)

Registration data
available? ***Human insulins
Insulin human (rdna)

A10AB01

BioconInsulin human (rdna)

A10AB01

Eli Lilly

Insulin human (rdna)

A10AB01

Novo Nordisk

Insulin human (rdna)

A10AB01

Sanofi

Isophane human insulin

A10AC01

BioconIsophane human insulin

A10AC01

Eli Lilly

Isophane human insulin

A10AC01

Novo Nordisk

Isophane human insulin; human insulin

A10AD01

BioconIsophane human insulin; human insulin

A10AD01

Eli Lilly

Isophane human insulin; human insulin

A10AD01

Novo Nordisk

Insulin aspart

A10AB05

BioconInsulin aspart (l-arginine)

A10AB05

Novo Nordisk

Insulin aspart (niacinamide)

A10AB05

Novo Nordisk

Biphasic insulin aspart

A10AD05

Novo Nordisk

Insulin aspart

A10AD05

Sanofi

Insulin degludec

A10AE06

Novo Nordisk

Insulin degludec/ insulin aspart

A10AD06

Novo Nordisk

Insulin degludec/ liraglutide

A10AE56

Novo Nordisk

Insulin detemir

A10AE05

Novo Nordisk

Insulin glargine

A10AE04

BioconInsulin glargine

A10AE04

Eli Lilly

Insulin glargine

A10AE04

Sanofi

Insulin glargine/ lixisenatide

A10AE54

Sanofi

Insulin glulisin

A10AB06

Sanofi

Insulin lispro

A10AB04

Eli Lilly

Insulin lispro

A10AB04

Sanofi

Insulin lispro; insulin lispro protamine

A10AD30

Eli Lilly

Analogue insulins* The Anatomical Therapeutic**The patent status reported is not

Orange Book, Health Canada) and/*** ‘Registration data’ represents

Chemical (ATC) classification

intended to be a presentation ofor patent databases (MedsPaL4 anddata provided by companies

system is the gold standard forpatent rights worldwide nor does it

Pat-INFORMED5). Where possible,

regarding whether the product has

international drug utilisation

capture all patents that might apply

patent status was verified with

been registered– or filed formonitoring and research. ATC codes

to a product. It should only be usedcompanies. It cannot be used as anregistration – in any of the countries

can be consulted at the WHO

as a proxy description, which wasindication of patent status outsidein scope. Registration data available

Collaborating Centre for Drugbased on information fromof South Africa and/ or the US andfor analysis in this paper included 15

Statistics Methodology website

regulatory authority websites (i.e.,

Canada.

insulin products (6 human insulins(https://www.whocc.no/atc_ddd_

South-African CIPC Intellectualindex/).

Property database, the US FDA

and 9 insulin analogues).

39

Access to insulin in LMICsI I I . G EOG R APH IC SCO PE
TABLE 2. The 108 low- and middle-income countries in scope of this paper
Key for this list:
LIC

Low-income country, based on World Bank income classifications

LMIC

Lower-middle income country, based on World Bank income classifications

LDC

Least Developed Country, based on ECOSOC LDC List

LHDC Low Human Development Country, based on UN Human Development Index
MHDC Medium Human Development Country, based on UN Human Development Index
HiHDIHigh Human Development Country with high inequality, based on UN Inequality-Adjusted Human Development Index

East Asia & Pacific

Honduras

LMIC

Dem. Rep. Congo

LIC

Cambodia

LMIC

Mexico

HiHDI

Rep. Congo

LMIC

China

HiHDI

Nicaragua

LMIC

Côte d’Ivoire

LMIC

Indonesia

LMIC

Paraguay

MHDC

Equatorial Guinea

MHDC

Kiribati

LMIC

Peru

HiHDI

Eritrea

LIC

Dem. People’s Rep. Korea

LIC

Suriname

HiHDI

Ethiopia

LIC

Lao PDR

LMIC

Venezuela

HiHDI

Gabon

MHDC

Micronesia, Fed. Sts.

LMIC

The Gambia

LIC

Mongolia

LMIC

Middle East & North Africa

Ghana

LMIC

Myanmar

LMIC

Algeria

LMIC

GuineaLIC

Papua New Guinea

LMIC

Djibouti L

MIC

Guinea-Bissau

LIC

Philippines

LMIC

Arab Rep. Egypt

LMIC

Kenya

LMIC

Samoa

LMIC

Iran

HiHDI

Lesotho

LMIC

Solomon Islands

LMIC

Iraq

MHDC

Liberia

LIC

Thailand

HiHDI

MoroccoLMIC

Madagascar

LIC

Timor-Leste

LMIC

Palestine, State of /Malawi

LIC

Tonga

LMIC

West Bank Gaza

LMIC

Mali

LIC

TuvaluLDC

Syrian Arab Republic

LMIC

Mauritania

LMIC

Vanuatu

LMIC

Tunisia

LMIC

Mozambique

LIC

Vietnam

LMIC

Rep. Yemen

LMIC

Namibia

MHDC

Niger

LIC

Nigeria

LMIC

Europe & Central Asia

South Asia

Armenia

LMIC

Afghanistan

LIC

RwandaLIC

KosovoLMIC

Bangladesh

LMIC

São Tomé and Principe

LMIC

Kyrgyz Republic

LMIC

BhutanLMIC

Senegal

LIC

Moldova

LMIC

India

LMIC

Sierra Leone

LIC

Tajikistan

LMIC

Maldives

HiHDI

Somalia

LIC

Turkmenistan

MHDC

Nepal

LIC

South Africa

MHDC

UkraineLMIC

Pakistan

LMIC

South Sudan

LIC

Uzbekistan

LMIC

Sri Lanka

LMIC

Sudan

LMIC

Swaziland/Eswatini

LMIC

Tanzania

LIC

Latin America & Caribbean

Sub-Saharan Africa

Belize

HiHDI

Angola

LHDC

Togo

LIC

Bolivia

LMIC

Benin

LIC

UgandaLIC

BrazilHiHDI

Botswana

MHDC

ZambiaLMIC

Colombia

HiHDI

Burkina Faso

LIC

Zimbabwe

LIC

Dominican Republic

HiHDI

BurundiLIC

Ecuador

HiHDI

Cabo VerdeLMICEl Salvador

LMIC

Cameroon

LMIC

Guatemala

LMIC

Central African Republic

LIC

Guyana

MHDC

Chad

LIC

Haiti

LIC

Comoros

LIC

40

106 countries, the Index can draw on the benefits of consistency and capacity in tracking the progress of pharmaceutical

Step 4: Include all Least Developed Countries (LDCs) as

companies and their impacts in countries that face develop-

defined by ECOSOC.9

Access to Medicine Foundation

ment and inequality-related constraints in access to medicine.

FIGURE
1. Countries
in scopeof thisinpaper– 108Access
Countries
FIGURE
7Countries
includedthe 2022
to Medicine Index – 108 Countries

Legend: Basis for inclusion*● World Bank income classification● UN Human Development Index● UN Inequality-Adjusted Human
Development Index● ECOSOC LDC List
● New inclusion* The latest country income and developmentclassifications are available through the World Bank and
UNDP data.
Due to scaling, countries may not be visible on the map(e.g., Tuvalu)

24

41

Access to insulin in LMICs

Report Design

Copyright and sharing parts of thisCO3 [Irma Bannenberg]

reportYou are free to:

Photo Disclaimer

Share — copy and redistribute the material in

The Access to Medicine Foundation gratefully

any medium or format.

respects the permission granted to reproduce

The licensor cannot revoke these freedoms as

the copyright material in this report. Every rea-long as you follow the license terms.

sonable effort has been made to trace copyright holders and to obtain their permission for

Under the following terms:

the use of copyright material. Should you believe

Attribution — You must give appropriate credit,that any content in this report does infringe any

provide a link to the license, and indicate ifrights you may possess, please contact us atchanges were made. You may do so in any rea-

info@accesstomedicinefoundation.org or

sonable manner, but not in any way that sug-+ 31 (0) 20 21 53 535.

gests the licensor endorses you or your use.
NonCommercial — You may not use the material

Disclaimer

for commercial purposes.

As a multi-stakeholder and collaborative pro-

NoDerivatives — If you remix, transform, or build

ject, the findings, interpretations and conclu-

upon the material, you may not distribute thesions expressed herein may not necessarily

modified material.

reflect the views of all members of the stake-No additional restrictions — You may not apply

holder groups or the organisations they repre-

legal terms or technological measures that

sent. The report is intended to be for informa-

legally restrict others from doing anything thetion purposes only and is not intended as pro-license permits.

motional material in any respect. The material is not intended as an offer or solicitation for

Notices:

the purchase or sale of any financial instrument.

No warranties are given. The license may not

The report is not intended to provide account-give you all of the permissions necessary for youring, legal or tax advice or investment recommen-

intended use. For example, other rights such as

dations. Whilst based on information believed to

publicity, privacy, or moral rights may limit how

be reliable, no guarantee can be given that it is

you use the material. For more information on

accurate or complete.

how you can use this report, please contact us
at info@accesstomedicinefoundation.org or+ 31 (0) 20 21 53 535.

Access to Medicine Foundation
Naritaweg 227A
1043 CB Amsterdam
The Netherlands
www.accesstomedicinefoundation.org
info@accesstomedicinefoundation.org+31 (0)20 21 53 535

42