Insulin Access Among Uninsured Type 1 Diabetes Patients in the

United States
Sean Moss

Summary
Insulin is a hormone that regulates blood sugar levels and is vital for people with diabetes to
manage their condition. However, the rising cost of insulin has made it increasingly
inaccessible, particularly for vulnerable groups such as low-income individuals, the uninsured or
underinsured, the elderly, and rural communities in the US. The lack of competition in the insulin
market due to dominant players with patents and regulatory barriers to entry has resulted in
limited incentive to compete on price, leading to excessively high prices for life-saving
medication. The lack of transparency in insulin prices and the specialized nature of the market
further exacerbates the problem. Pharmaceutical companies use pricing strategies, including
price gouging and regularly increasing prices, which contribute to the high cost of insulin. The
complex supply chain involved in the production of insulin, including the procurement of raw
materials and testing and purification processes, results in higher costs for manufacturers that
are passed on to consumers, contributing to the high cost of insulin. High insulin costs force
patients to ration doses, leading to life-threatening consequences and long-term health
complications, resulting in financial burdens for individuals, families, and the healthcare system,
resulting in a negative cycle of rising costs for all parties. Government policy changes, including
price controls, greater transparency, direct negotiation with pharmaceutical companies, and
promoting competition, can help solve the problem of high insulin prices, as demonstrated by
successful approaches in other countries. However, careful consideration must be given to
potential drawbacks such as stifling innovation and potential shortages of supply.

Key Terms
Type 1 diabetes mellitus - A disease where the pancreas produces little to no insulin, which
prevents blood sugar from entering cells and thus builds up blood sugar in the bloodstream,
which causes damage to the body.1
Insulin - Insulin is a hormone that is produced in the pancreas, and it regulates the level of
sugar in the blood.2
Healthcare system - An organization of people, institutions, and resources that deliver
healthcare services to meet the health needs of their target populations. 3
Diabetic Ketoacidosis - DKA develops when your body does not have enough insulin to break
down blood sugars to use for fuel. Instead, your liver breaks down fat for fuel, a process that

1
“What Is Type 1 Diabetes?” Centers for Disease Control and Prevention (Centers for Disease Control and
Prevention, March 11, 2022), https://www.cdc.gov/diabetes/basics/what-is-type-1-diabetes.html.
2
“Insulin,” Encyclopædia Britannica (Encyclopædia Britannica, inc., December 21, 2022),
https://www.britannica.com/science/insulin.
3
“Defining Health Systems,” AHRQ, accessed February 12, 2023, https://www.ahrq.gov/chsp/defining-health-
systems/index.html.
produces acids called ketones. When too many ketones are produced rapidly, they will build up
to dangerous levels in your body, usually causing heart and nerve damage. 4
Patents - Patents are property rights granted by the government to an inventor. This gives the
inventor exclusive rights to the process, design, or invention for a designated time in exchange
for disclosure of the invention. In the United States, the US Patent and Trademark Office gives
patents.5
Blood Glucose Level - Your BGL is a measurement of the amount of glucose, or sugar, in your
bloodstream. Glucose comes from carbohydrates in food, and they are the body’s main source
of energy.6 Insulin regulates this and keeps it at a stable level of 100 mg/dL.7
List Price - The price at which a manufacturer sells a drug to wholesalers, pharmacies, and
other intermediaries before any discounts or rebates are applied.8
Net price - The price a manufacturer receives after accounting for discounts and rebates
negotiated with insurers, pharmacy benefit managers, and other payers. 9
Copay - The amount a patient is required to pay out-of-pocket for a prescription drug, usually a
fixed dollar amount or a percentage of the drug's cost.10
Deductible - The amount a patient must pay out-of-pocket for healthcare expenses before
insurance coverage kicks in.11
Formulary - A list of prescription drugs covered by an insurance plan, usually organized into
tiers based on cost and coverage level.12
Pharmacy benefit manager (PBM) - A third-party administrator that negotiates drug prices and
manages prescription drug benefits for insurers and employers.13
Rebate - A discount provided by a drug manufacturer to a PBM, insurer, or other payers in
exchange for including their drug on a formulary or providing favorable coverage.14

4
“Diabetic Ketoacidosis,” Centers for Disease Control and Prevention (Centers for Disease Control and Prevention,
December 30, 2022), https://www.cdc.gov/diabetes/basics/diabetic-ketoacidosis.html.
5
Will Kenton, “What Is a Patent in Simple Terms? with Examples,” Investopedia (Investopedia, January 20, 2023),
https://www.investopedia.com/terms/p/patent.asp.
6
“Blood Glucose (Sugar) Test: Levels & What They Mean.,” Cleveland Clinic, accessed February 12, 2023,
https://my.clevelandclinic.org/health/diagnostics/12363-blood-glucose-test.
7
“Manage Blood Sugar,” Centers for Disease Control and Prevention (Centers for Disease Control and Prevention,
September 30, 2022), https://www.cdc.gov/diabetes/managing/manage-blood-sugar.html.
8
James Chen, “What Is a List Price,” Investopedia (Investopedia, November 10, 2022),
https://www.investopedia.com/terms/l/list-price.asp.
9
Katie Terrell Hanna, “What Is Net Price?” WhatIs.com (TechTarget, April 29, 2022),
https://www.techtarget.com/whatis/definition/net-price.
10
Julia Kagan, “What Is a Copay? Definition in Health Insurance and Example,” Investopedia (Investopedia,
November 7, 2022), https://www.investopedia.com/terms/c/copay.asp.
11
“Deductible - Glossary,” Glossary | HealthCare.gov, accessed March 11, 2023,
https://www.healthcare.gov/glossary/deductible/.
12
“Formulary - Glossary,” Glossary | HealthCare.gov, accessed March 11, 2023,
https://www.healthcare.gov/glossary/formulary/.
13
“Pharmacy Benefit Managers and Their Role in Drug Spending,” Commonwealth Fund, April 22, 2019,
https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug-
spending.
14
Adam Hayes, “Rebate: Definition, Types, Examples, vs. Discount,” Investopedia (Investopedia, December 19,
2022), https://www.investopedia.com/terms/r/rebate.asp.
Supply chain - The sequence of events and businesses involved in bringing a drug from the
manufacturer to the patient, including wholesalers, distributors, pharmacies, and insurers. 15
Out-of-pocket costs - The expenses paid by the patient for healthcare services and
prescription drugs that are not covered by insurance.16

Context
Q: What are diabetes and insulin, and what are their impacts?
A: Insulin is a hormone produced by the pancreas that helps regulate the body’s blood sugar
levels. In a healthy body, the pancreas produces insulin to move the sugars from food into cells,
where they can be used to fuel the body after eating.17 When someone is diabetic, their body
either does not produce enough insulin or is inefficiently used, causing massive swings in blood
glucose levels and many health problems. If unregulated, blood glucose levels can cause
damage to blood levels and nerves. This damage can cause problems like heart disease,
strokes, kidney disease, and extensive nerve damage in the eyes, feet, and skin. 18 To manage
diabetes, those affected need to regulate their BGL, make lifestyle changes, and take
medications or insulin.19
Diabetes is a chronic medical condition that causes elevated levels of blood sugar. There are
two kinds: Type 1 and Type 2. In Type 1 Diabetes, the body’s immune system attacks the beta
cells of the pancreas, which produce insulin.20 Insulin is a hormone that regulates blood glucose
levels. When these attacks end, the body cannot produce its insulin and requires daily insulin
injections or the use of an insulin pump.21 Type 2 Diabetes, rather than an autoimmune disease,
is a metabolic disorder where the body becomes resistant to insulin or does not produce enough
on its own. This type is associated with obesity, sedentary lifestyles, and an unhealthy diet. 22

Q: What are the various kinds of insulin, and how are they used?
A: There are two main types of insulin available: human insulin and analog insulin. Both human
and analog insulin serves the same purpose, but there are some key differences between the
two that may affect the effectiveness depending on the person.
Human insulin is a naturally occurring form of insulin that is produced using DNA technology. 23 It
is structurally identical to the insulin produced by the human body and takes longer to start

15
Adam Hayes, “The Supply Chain: From Raw Materials to Order Fulfillment,” Investopedia (Investopedia, January
11, 2023), https://www.investopedia.com/terms/s/supplychain.asp.
16
Julia Kagan, “Out-of-Pocket Expenses: Definition, How They Work, and Examples,” Investopedia (Investopedia,
February 5, 2023), https://www.investopedia.com/terms/o/outofpocket.asp.
17
“Insulin,” Encyclopædia Britannica (Encyclopædia Britannica, inc.), accessed March 11, 2023,
https://www.britannica.com/science/insulin.
18
Encyclopædia Britannica, Insulin
19
Encyclopædia Britannica, Insulin
20
Centers for Disease Control and Prevention, What Is Type 1 Diabetes?
21
Encyclopædia Britannica, Insulin
22
“Type 2 Diabetes,” Mayo Clinic (Mayo Foundation for Medical Education and Research, November 19, 2022),
https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/symptoms-causes/syc-20351193.
23
“Human Insulin vs. Insulin Analogs, Pros, Cons, More,” Healthline (Healthline Media, October 27, 2021),
https://www.healthline.com/health/diabetes/human-insulin.
working and has a slower onset of action compared to analog insulin. 24 However, it is also
longer lasting, making it a good option for individuals who need to maintain stable blood sugar
levels throughout the day.
In comparison, analog insulin is a modified form of human insulin that has been engineered to
work more quickly or last longer than regular human insulin.25 For example, rapid-acting analog
insulin is designed to start working quickly and reach its peak effect in a short amount of time,
making it a good option for individuals who need to address rapid spikes in blood sugar levels
like type 1 diabetics.26 Long-acting analog insulin, on the other hand, provides a slower, more
prolonged insulin release to help maintain stable blood sugar levels over a longer period. 27
Bring in prices concerning insulin types here
Q: What are insulin’s impacts?
A: Insulin has revolutionized the management of diabetes and has improved the lives of millions
of people with the condition. Insulin has been particularly effective in improving health
outcomes. Insulin allows people with diabetes to regulate their blood sugar levels, reducing their
risk of developing complications such as heart disease, stroke, kidney disease, nerve damage,
and eye, foot, and skin problems discussed above. 28 By controlling blood sugar levels, people
with diabetes can live longer, healthier lives.29 It has also improved the quality of life of diabetics
and has made it possible for people with diabetes to live more active, normal lives. 30 With the
availability of insulin, people with diabetes can manage their condition and participate in
activities and hobbies that they may have otherwise been unable to do. It has also increased the
life expectancy of diabetics. Before the discovery of insulin, diabetes was a death sentence for
many people and people would die of diabetic ketoacidosis.31 Today, with the availability of
insulin and improved diabetes management, people with diabetes can expect to live as long as
those without the condition.32 Overall, insulin has been a lifesaving treatment for people with
diabetes and has changed the course of the disease for millions of people around the world.
Q: Why is insulin inaccessible today?
A: Insulin has become increasingly inaccessible due to its rising cost. 33 The price of insulin has
increased significantly in many countries, particularly in the United States, making it difficult for
diabetics to afford the treatment they need.34 The reasons for the rising cost of insulin are
complex and include factors such as increased production costs, a lack of competition in the

24
Healthline, Human Insulin vs. Insulin Analogs, Pros, Cons, More
25
Mike Watts, “Analogue Insulin Is a Sub-Group of Human Insulin. Analogue Insulin Is Laboratory Grown but
Genetically Altered to Create Either a More Rapid Acting or More Uniformly Acting Form of the Insulin.,” Diabetes,
November 8, 2022, https://www.diabetes.co.uk/insulin/analogue-insulin.html.
26
Mike Watts, Analogue Insulin Is a Sub-Group of Human Insulin. Analogue Insulin Is Laboratory Grown but
Genetically Altered to Create Either a More Rapid Acting or More Uniformly Acting Form of the Insulin
27
Mike Watts, Analogue Insulin Is a Sub-Group of Human Insulin. Analogue Insulin Is Laboratory Grown but
Genetically Altered to Create Either a More Rapid Acting or More Uniformly Acting Form of the Insulin
28
“The History of a Wonderful Thing We Call Insulin,” The History of a Wonderful Thing We Call Insulin | ADA,
accessed February 12, 2023, https://diabetes.org/blog/history-wonderful-thing-we-call-insulin.
29
American Diabetes Association, The History of a Wonderful Thing We Call Insulin
30
American Diabetes Association, The History of a Wonderful Thing We Call Insulin
31
American Diabetes Association, The History of a Wonderful Thing We Call Insulin
32
American Diabetes Association, The History of a Wonderful Thing We Call Insulin
33
Julia Belluz, “The Absurdly High Cost of Insulin, Explained,” Vox (Vox, April 3, 2019),
https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive.
34
Julia Belluz, The Absurdly High Cost of Insulin, Explained
market, and changes in the healthcare system and insurance coverage.35 According to one
Department of Health and Human Services analysis, the average wholesale price of insulin has
risen by 15% to 17% annually between 2012 and 2016.36 To put this into perspective, in the US
currently, a month’s supply of insulin can cost up to $900 a month.37 Insulin prices in the US are
about eight times higher than in all non-U.S. OECD countries combined.38
Q: Who is most vulnerable to insulin access barriers?
A: The most vulnerable people to insulin access barriers include people who have limited
financial resources and those with little to no insurance coverage. 39 This group is primarily
composed of low-income individuals and families, uninsured or underinsured individuals, the
elderly, rural communities, children and young adults with diabetes, and minorities within the
United States.40 The first 3 groups often cannot afford insulin due to its excessive costs, either
due to its lack of coverage in insurance plans or high out-of-pocket costs.41 Rural communities
are particularly affected as rural areas already have limited healthcare services and may have to
cross large distances to access care.42 Children and young people are also in vulnerable
positions as they may not have the financial means to access insulin by themselves and must
rely on their caregivers to provide the treatment that they need. 43 It is important to note that any
diabetic can face insulin access barriers, regardless of age, race, or socio-economic status.
However, the groups of people listed above are particularly at risk and may face additional
challenges in accessing insulin due to limited financial resources and limited insurance
coverage in the United States.44
Q: Why is insulin access a uniquely American problem?
A: The high cost of insulin in the United States is the primary reason why insulin access is a
uniquely American problem. According to the US Department of Health and Human Services,
the average price of insulin quadrupled between 2002 and 2020, and it has continued to rise

35
Ritu Prasad, “The Human Cost of Insulin in America,” BBC News (BBC, March 14, 2019),
https://www.bbc.com/news/world-us-canada-47491964.
36
(Peer-reviewed) Mulcahy, Andrew W., Daniel Schwam, and Nathaniel Edenfield, Comparing Insulin Prices in the
United States to Other Countries: Results from a Price Index Analysis. Santa Monica, CA: RAND Corporation, 2020.
https://www.rand.org/pubs/research_reports/RRA788-1.html.
37
Katie Thomas, “Drug Makers Accused of Fixing Prices on Insulin,” The New York Times (The New York Times,
January 30, 2017), https://www.nytimes.com/2017/01/30/health/drugmakers-lawsuit-insulin-drugs.html.
38
Mulcahy et. al., Comparing Insulin Prices in the United States to Other Countries: Results from a Price Index
Analysis
39
(Peer-reviewed) “Keeping the 100-Year-Old Promise: Making Insulin Access Universal,” World Health Organization
(World Health Organization, November 12, 2021), https://www.who.int/publications/i/item/9789240039100.
40
World Health Organization, Keeping the 100-Year-Old Promise: Making Insulin Access Universal
41
(Peer-reviewed) Scott A; O'Cathain A; Goyder E; “Socioeconomic Disparities in Access to Intensive Insulin
Regimens for Adults with Type 1 Diabetes: A Qualitative Study of Patient and Healthcare Professional Perspectives,”
International journal for equity in health (U.S. National Library of Medicine, October 11, 2019),
https://pubmed.ncbi.nlm.nih.gov/31604437/.
42
(Peer-reviewed) Cynthia N. Massey, Susan J. Appel, Kyrel L. Buchanan, Andrea L. Cherrington; Improving
Diabetes Care in Rural Communities: An Overview of Current Initiatives and a Call for Renewed Efforts. Clin
Diabetes 1 January 2010; 28 (1): 20–27.
43
Massey et. al., Improving Diabetes Care in Rural Communities: An Overview of Current Initiatives and a Call for
Renewed Efforts
44
Massey et. al., Improving Diabetes Care in Rural Communities: An Overview of Current Initiatives and a Call for
Renewed Efforts
since then in the US.45 Insulin is significantly more expensive in the United States than it is in
other countries. For example, a 10 ml vial of insulin costs approximately $300 in the United
States, while the same vial costs less than $30 in Canada.46 According to another study, the
average US manufacturer price per standard unit across all insulins was $98.70, compared to
$6.94 in Australia, $12.00 in Canada, and $7.52 in the UK. 47 That price for a standard unit of
insulin is more than ten times the price in nearly 32 countries, many of which are OECD
members.48 The issue of insulin access in the United States is compounded by the lack of a
universal healthcare system. Unlike many other developed countries, the United States does
not have a government-run healthcare system that provides affordable access to healthcare for
all citizens.49 Instead, Americans rely on private insurance companies to cover their medical
expenses. However, many insurance plans do not cover the full cost of insulin, or they require
high deductibles and copays, making the medication unaffordable for many people. Many
people with diabetes cannot afford to pay for their insulin, which can lead to serious health
complications, such as blindness, kidney failure, and even death. In some cases, people have
been forced to ration their insulin or switch to cheaper, less effective forms of medication. These
actions can have severe consequences for people living with diabetes and can result in
hospitalizations, amputations, and other health complications and these impacts are uniquely
American.50

Contributing Factors
#1 - The Lack of Competition
The lack of competition in the insulin market is one of the main reasons for the high prices of
insulin, making it difficult for many individuals with diabetes to afford the life-saving medication
they need.51 When there is limited competition in a market, the dominant players have more
control over prices, and there is little incentive for them to lower prices. 52 This is exactly what
has happened in the insulin market, where a few dominant players control much of the market
share, and prices have exploded over the years. These companies have been able to maintain

45
Tara O'Neill Hayes et al., “Research: Understanding the Insulin Market,” AAF, March 18, 2020,
https://www.americanactionforum.org/research/understanding-the-insulin-market/.
46
Tara O'Neill Hayes et al., “Research: Understanding the Insulin Market,”
47
PharmaNewsIntelligence, “Insulin Prices 8x Higher in the US Compared to Similar Nations,”
PharmaNewsIntelligence, October 9, 2020, https://pharmanewsintel.com/news/insulin-prices-8x-higher-in-the-us-
compared-to-similar-nations.
48
PharmaNewsIntelligence, “Insulin Prices 8x Higher in the US Compared to Similar Nations”
49
Max Fisher, “Here's a Map of the Countries That Provide Universal Health Care (America's Still Not on It),” The
Atlantic (Atlantic Media Company, June 28, 2012),
https://www.theatlantic.com/international/archive/2012/06/heres-a-map-of-the-countries-that-provide-
universal-health-care-americas-still-not-on-it/259153/.
50
Max Fisher, “Here's a Map of the Countries That Provide Universal Health Care (America's Still Not on It)”
51
(Peer-reviewed) Dzintars Gotham, Melissa J Barber, and Andrew Hill, “Production Costs and Potential Prices for
Biosimilars of Human Insulin and Insulin Analogues,” BMJ Global Health (BMJ Specialist Journals, September 1,
2018), https://gh.bmj.com/content/3/5/e000850.
52
(Peer-reviewed) Adam Hayes, “What Is a Monopoly? Types, Regulations, and Impact on Markets,” Investopedia
(Investopedia, January 18, 2023), https://www.investopedia.com/terms/m/monopoly.asp.
their dominant position by obtaining patents for their products and using their extensive
resources to engage in aggressive lobbying tactics. 53
Due to the limited competition in this market, there is little incentive for these companies to
compete on price, as they know that people with diabetes will continue to need insulin
regardless of the cost.54 This lack of competition can result in higher prices for insulin, as
companies have less incentive to keep prices low.
Another factor that contributes to the lack of competition in the insulin market is the patents held
by the dominant players. These patents prevent other companies from producing the same
insulin treatments and allow the dominant players to control the prices of insulin and make it
difficult for new entrants to enter the market and offer a cheaper alternative. The excessive
costs of developing new insulin treatments, combined with the regulatory barriers to entry, make
it difficult for competition to offer a lower-priced alternative.55
Regulatory barriers also contribute to the lack of competition in the insulin market. The approval
process for new insulin treatments is lengthy and expensive, which discourages new entrants
from entering the market.56 Additionally, the requirements for clinical trials and the prohibitive
costs associated with these trials are also a barrier to entry for new competitors. 57 This,
combined with the patents held by the dominant players, makes it increasingly difficult for new
competitors to offer a cheaper alternative to existing insulin treatments.
The lack of transparency also affects the lack of competition in insulin production. The prices of
insulin are not easily accessible, and patients often have no way of knowing the actual cost of
the insulin they are taking.58 The market price for insulin varies constantly between
manufacturers and individual prescriptions.59 There are also variations in the cost of production
to the market price. This lack of transparency makes it difficult for patients to compare prices
and make informed decisions about which insulin treatments to use. 60
Additionally, the prohibitive cost of insulin research and development, regulatory requirements,
and the specialized nature of the insulin market can make it difficult for new companies to enter
the market and compete with established players.61 This lack of competition further contributes
to the excessive cost of insulin and makes it difficult for people with diabetes to access the
treatment they need.

53
“Insulin Prices Are Soaring, Patients Are Dying and Pharma Is Fighting Price Caps,” Yahoo! News (Yahoo!),
accessed February 12, 2023, https://news.yahoo.com/pharma-lobby-co-opting-state-110006214.html.
54
Ritu Prasad, The Human Cost of Insulin in America
55
(Peer-reviewed) Tara O'Neill Hayes et al., “Research: Understanding the Insulin Market,” AAF, March 18, 2020,
https://www.americanactionforum.org/research/understanding-the-insulin-market/.
56
(Peer-reviewed) Ryan Knox, “Insulin Insulated: Barriers to Competition and Affordability in the United States Insulin
Market,” Journal of Law and the Biosciences 7, no. 1 (2020), https://doi.org/10.1093/jlb/lsaa061.
57
Ryan Knox, Insulin Insulated: Barriers to Competition and Affordability in the United States Insulin Market
58
“Insulin Supply Chain Transparency Needed to Prevent Price Hikes.,” European Pharmaceutical Review,
November 9, 2018, https://www.europeanpharmaceuticalreview.com/news/80887/insulin-supply-chain/.
59
European Pharmaceutical Review, Insulin Supply Chain Transparency Needed to Prevent Price Hikes
60
(Peer-reviewed) “Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” The
Journal of Clinical Endocrinology & Amp; Metabolism 106, no. 4 (December 2021): pp. 935-941,
https://doi.org/10.1210/clinem/dgaa817.
61
(Peer-reviewed) Insulin Products and the Cost of Diabetes Treatment.” Congressional Research Service. Accessed
February 13, 2023. https://sgp.fas.org/crs/misc/IF11026.pdf.
Note that the lack of competition in the insulin market is not unique to insulin. 62 Many other
markets, including markets for other treatments for chronic conditions, face similar challenges.
However, the excessive cost of insulin is a particular concern, as insulin is a critical treatment
for people with diabetes, and access to the treatment is essential for their survival.
Add numbers and go into depth on each paragraph
#2 - Pricing strategies
Pricing strategies used by pharmaceutical companies are one of the primary factors contributing
to the soaring prices of the treatment. They use pricing strategies, such as setting high list
prices for insulin and offering discounts through rebates, which can result in soaring prices for
consumers.63 Insulin is a critical treatment for people with diabetes, and access to affordable
insulin is essential for their health and well-being. However, the pricing strategies used by
pharmaceutical companies make it difficult for many to access the insulin they need.
One of the pricing strategies used by pharmaceutical companies is the practice of price
gouging, where prices are artificially inflated to increase profits. 64 This is a widespread practice
in markets with limited competition, and the insulin market is no exception. When there is limited
competition, pharmaceutical companies have more control over the prices they charge, and
they may choose to increase prices to maximize their profits. 65 They also regularly increase
prices. This is a widespread practice in the pharmaceutical industry, and it is particularly
common for treatments for chronic conditions, like diabetes.66 The practice of regularly
increasing prices contributes to the prohibitive cost of insulin and makes it difficult for people
with diabetes to access the treatment they need.
It is also important to note that the excessive cost of insulin is not just a result of the pricing
strategies used by pharmaceutical companies. It is a multifaceted problem and there are many
other factors at play here, including the inflated cost of insulin research and development,
regulatory requirements, and the specialized nature of the insulin market. 67 However, the pricing
strategies used by pharmaceutical companies are a major contributor to the excessive cost of
insulin and make it difficult for many people to access treatment.
Expand on pricing strategies and prices rising in lockstep
#3 - Complex Supply Chain
The procurement of raw materials for insulin production is a crucial step in the manufacturing
process and can be expensive. The production of insulin requires the use of recombinant DNA
technology and amino acids, which are sourced from specialized suppliers. 68 These raw
materials must meet strict quality standards, and the procurement process must adhere to

62
(Peer-reviewed) “Research and Development in the Pharmaceutical Industry.” Congressional Budget Office.
Accessed February 12, 2023. https://www.cbo.gov/publication/57126.
63
Rachel Gillett, “One Chart Reveals How the Cost of Insulin Has Skyrocketed in the US, Even Though Nothing
about It Has Changed,” Business Insider (Business Insider), accessed February 12, 2023,
https://www.businessinsider.com/insulin-price-increased-last-decade-chart-2019-9?op=1.
64
Julia Belluz, The Absurdly High Cost of Insulin, Explained
65
Cydni, “Price Gouging - Definition, Examples, Cases,” Legal Dictionary, January 14, 2016,
https://legaldictionary.net/price-gouging/.
66
Cydni, Price Gouging – Definition, Examples, Cases
67
Congressional Budget Office, Research and Development in the Pharmaceutical Industry.
68
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment
regulations and guidelines set by regulatory agencies.69 This added complexity results in higher
costs for manufacturers, which are passed on to consumers.
Testing and purification are also critical steps in the insulin manufacturing process. To ensure
the safety and effectiveness of the drug, manufacturers must perform extensive quality control
measures throughout the production process.70 This includes testing of raw materials,
intermediate products, and the final product.71 The purification process involves the removal of
impurities and contaminants to ensure the product meets quality standards. 72 The added
complexity of these steps also contributes to the prohibitive cost of insulin.
In addition to the direct costs of procurement and testing, the complexity of the insulin supply
chain also contributes to higher costs due to inefficiencies in the production process. For
example, production issues, such as contamination or batch failures, can result in significant
waste and reduced efficiency, driving up the cost of insulin.73 The cost of developing new insulin
treatments and improving existing treatments is also high, and these costs are often passed on
to consumers in the form of higher prices.74 The process of developing new drugs and
treatments is complex, time-consuming, and expensive, and these costs are reflected in the
price of insulin and other treatments.75
Pharmaceutical companies invest significant resources into R&D to develop new drugs and
treatments for various conditions. The process of developing new drugs, including insulin, is
expensive and requires a significant investment of time and resources. 76 This investment
includes the cost of researching new treatments, conducting clinical trials, and obtaining
regulatory approval for new drugs. The prohibitive cost of R&D is reflected in the price of insulin
and other treatments, and it is a significant contributor to the excessive cost of insulin. The
prohibitive cost of R&D also affects the accessibility of insulin, as people with diabetes may
have difficulty affording the treatment they need.
Use this to reiterate important points and combine them effectively
Note that these factors interact in complex ways, and addressing the prohibitive cost of insulin
will require a multi-faceted approach that considers the unique challenges of the healthcare
system and the insulin market. However, reducing the excessive cost of insulin and making the
treatment more accessible and affordable for everyone is an important goal for governments,
healthcare providers, and advocacy groups.
The steps taken in insulin production from producers to consumers are extremely complex, and
at each stage of production, intermediaries increase the price.

69
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment
70
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment
71
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment
72
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment
73
“Insulin Production - Genetic Engineering (CCEA) - GCSE Biology (Single Science) Revision - CCEA - BBC
Bitesize,” BBC News (BBC), accessed February 12, 2023, https://www.bbc.co.uk/bitesize/guides/zp3gy4j/revision/2.
74
“Celebrating the Discovery and Development of Insulin,” National Institute of Diabetes and Digestive and Kidney
Diseases (U.S. Department of Health and Human Services), accessed February 12, 2023,
https://www.niddk.nih.gov/news/archive/2021/celebrating-discovery-development-insulin.
75
National Institute of Diabetes and Digestive and Kidney Diseases (U.S. Department of Health and Human
Services), Celebrating the Discovery and Development of Insulin
76
Congressional Research Service, Insulin Products and the Cost of Diabetes Treatment.
The involvement of intermediaries, such as PBMs, in the distribution of insulin, can also
contribute to the excessive cost of insulin, as they often negotiate discounts with pharmaceutical
companies, and this can result in higher costs for consumers.
These intermediaries, involved in the distribution of insulin, can significantly impact the cost of
the treatment and access to the insulin people need. Intermediaries are companies that
purchase drugs from pharmaceutical companies and sell them to hospitals, pharmacies, and
other healthcare providers. They play a significant role in the distribution of insulin and can
affect insulin prices by negotiating discounts from pharmaceutical companies and marking up
the price of insulin when they sell it to healthcare providers. These markups can result in higher
costs for people with diabetes, making it more difficult for them to access the insulin they need.
Break into two paragraphs and go into depth in each, DATA
Difference between intermediaries and PBMs
PBMs are companies that manage prescription drug benefits for insurance companies and
employers. They play a critical role in the distribution of insulin by negotiating prices with
pharmaceutical companies and determining which drugs will be covered by insurance plans.
PBMs can affect insulin prices by negotiating discounts from pharmaceutical companies, but
they also make money by marking up the price of drugs when they sell them to insurance
companies and employers. These markups can result in higher costs for people with diabetes,
making it more difficult for them to access the insulin they need.

Negative Consequences
#1 - Insulin Rationing and Health Costs for Patients
The rising costs of insulin have forced many people to be unable to afford the medication. The
situation has become so dire that some people are forced to ration their insulin doses, skip
doses, or not take enough insulin to manage their condition. 77 This is especially true for those
who do not have health insurance or those who have high deductibles or copays. 78 The
consequences of not taking enough insulin can be life-threatening. People with diabetes who do
not receive the necessary doses of insulin can experience severe symptoms such as dizziness,
confusion, fatigue, and even coma.79 In some cases, people may even die from complications
related to their diabetes. Furthermore, rationing insulin can lead to long-term health
complications.80 High blood sugar levels can cause damage to vital organs such as the heart,
kidneys, and eyes.81 This can lead to a range of health problems such as heart disease, kidney
failure, and blindness.82 High blood sugar levels can cause a range of health problems,
including damage to vital organs such as the heart, kidneys, and eyes.83 Over time, high blood

77
Naomi Thomas, “1.3 million Americans with Diabetes Rationed Insulin in the Past Year, Study Finds,” CNN (Cable
News Network, October 17, 2022), https://edition.cnn.com/2022/10/17/health/insulin-rationing-diabetes-
study/index.html.
78
Naomi Thomas, 1.3 million Americans with Diabetes Rationed Insulin in the Past Year, Study Finds
79
(Peer-reviewed) Adam Gaffney, David U. Himmelstein, and Steffie Woolhandler, “Prevalence and Correlates of
Patient Rationing of Insulin in the United States: A National Survey,” Annals of Internal Medicine, 2022,
https://doi.org/10.7326/m22-2477.
80
Adam Gaffney, Prevalence and Correlates of Patient Rationing of Insulin in the United States: A National Survey
81
Adam Gaffney, Prevalence and Correlates of Patient Rationing of Insulin in the United States: A National Survey
82
Adam Gaffney, Prevalence and Correlates of Patient Rationing of Insulin in the United States: A National Survey
83
“High Blood Sugar: Complications That Can Happen,” WebMD (WebMD), accessed March 11, 2023,
https://www.webmd.com/diabetes/uncontrolled-blood-sugar-risks.
sugar levels can increase the risk of complications such as heart disease, kidney failure,
blindness, and nerve damage.84 This can result in significant financial burdens for individuals
and families, as well as the healthcare system as a whole
#2 - Increased Healthcare Costs
The high cost of insulin is not only a concern for people with diabetes, but it can also result in
increased healthcare costs for both individuals and the healthcare system. When individuals
with diabetes are unable to access or afford the necessary doses of insulin to manage their
condition, it can lead to serious health consequences, including complications that require
medical care.85 These complications can be more expensive to treat than managing the
condition effectively with insulin. Complications related to high blood sugar levels, such as
cardiovascular disease, kidney failure, and nerve damage, can require hospitalization and
specialized medical care.86 This can result in significant healthcare costs for individuals with
diabetes and their families. For example, hospitalization for diabetic ketoacidosis can cost
thousands of dollars.87
In addition to increased healthcare costs for individuals with diabetes, the healthcare system
also bears the burden of higher costs when individuals are unable to manage their condition
effectively due to high insulin prices.88 The healthcare system may have to bear the cost of
emergency room visits, hospitalization, and ongoing medical care for individuals with diabetes
who experience complications related to their condition.89 Furthermore, the increased
healthcare costs associated with high insulin prices can result in a negative cycle. As the cost of
insulin continues to rise, people with diabetes may be unable to afford the medication they need
to manage their condition effectively, resulting in increased healthcare costs for themselves and
the healthcare system.90 This can lead to further strain on the healthcare system, which can
result in higher costs for all parties.91

Best Practices
To solve a problem as gargantuan as the insulin market, government policy changes will be
needed to correct the problem.
There are several different forms that government regulation of insulin prices could take. One
option is to implement price controls, which would set a cap on the price that pharmaceutical

84
WebMD, High Blood Sugar: Complications That Can Happen
85
(Peer-reviewed) “The High Cost of Insulin in the United States: An Urgent Call to Action,” accessed March 12,
2023, https://www.mayoclinicproceedings.org/article/S0025-6196(19)31008-0/fulltext.
86
Mayo Clinic, The High Cost of Insulin in the United States: An Urgent Call to Action
87
Mayo Clinic, The High Cost of Insulin in the United States: An Urgent Call to Action
88
(Peer-reviewed) “Health and Economic Benefits of Diabetes Interventions,” Centers for Disease Control and
Prevention (Centers for Disease Control and Prevention, December 21, 2022),
https://www.cdc.gov/chronicdisease/programs-impact/pop/diabetes.htm.
89
(Peer-reviewed) McEwen LN; Herman WH; “Health Care Utilization and Costs of Diabetes,” National Center for
Biotechnology Information (U.S. National Library of Medicine), accessed March 11, 2023,
https://pubmed.ncbi.nlm.nih.gov/33651541/.
90
McEwen and Herman, Health Care Utilization and Costs of Diabetes
91
Centers for Disease Control and Prevention, Health and Economic Benefits of Diabetes Interventions
companies can charge for insulin.92 Another option is to allow the government to negotiate the
price of insulin directly with pharmaceutical companies, like how the government negotiates
prices with healthcare providers in other countries.93 A third option is to create a public option for
insulin, where the government would produce and distribute the medication directly to
consumers.94
Another way that government regulation can improve insulin prices is by introducing greater
transparency into the pricing process. Currently, there is a lack of transparency around drug
pricing in the United States, which makes it difficult for consumers to understand why
medications like insulin are so expensive.95 Consumers would be able to see the markup at
each step of the production process and be more informed on which insulin product to buy that
best meets their needs.96 By introducing greater transparency, the government could help to
ensure that the prices of insulin and other medications are fair and reasonable. 97
In addition to price controls and greater transparency, the government can also negotiate
directly with pharmaceutical companies to lower the cost of insulin. This is a common practice in
other countries, where governments negotiate directly with healthcare providers and
pharmaceutical companies to ensure that medications are affordable for everyone. 98 By
negotiating with pharmaceutical companies, the government can help to ensure that people with
diabetes have access to the insulin they need without having to pay exorbitant prices. 99
Another way that government regulation can improve insulin prices is by supporting research
and development of alternative insulin formulations. 100 While traditional insulin formulations have
been around for decades, newer formulations, such as long-acting insulin analogs, can be more
effective and easier to use.101 By supporting research and development in this area, the
government can help to bring down the cost of insulin while also improving its effectiveness. 102
Finally, the government can play a role in improving access to insulin by promoting competition
in the market.103 Currently, a small number of pharmaceutical companies dominate the insulin
market, which limits competition and allows these companies to charge high prices for their
products. Policy changes can modify the process of pharmaceutical drug review to maintain
safety while reducing costs, provide grants and subsidies for low-cost insulin manufacturers,

92
Barbara Sprunt, “House Passes Bill to Cap Insulin Prices,” NPR (NPR, March 31, 2022),
https://www.npr.org/2022/03/31/1090085513/house-passes-bill-to-cap-insulin-prices.
93
Barbara Sprunt, “House Passes Bill to Cap Insulin Prices”
94
Barbara Sprunt, “House Passes Bill to Cap Insulin Prices”
95
NCHC Staff, “Policy Solutions to Address the Rising Cost of Insulin,” National Coalition on Health Care, March 8,
2023, https://nchc.org/policy-solutions-to-address-the-rising-cost-of-insulin/.
96
NCHC Staff, “Policy Solutions to Address the Rising Cost of Insulin”
97
NCHC Staff, “Policy Solutions to Address the Rising Cost of Insulin”
98
(Peer-reviewed) Irl B Hirsch, “Insulin Pricing in the USA: The Saga Continues,” The Lancet Diabetes & Amp;
Endocrinology 10, no. 10 (2022): p. 695, https://doi.org/10.1016/s2213-8587(22)00251-0.
99
Irl B Hirsch, “Insulin Pricing in the USA”
100
“Federal Advocacy,” Federal Advocacy | ADA, accessed April 1, 2023, https://diabetes.org/get-
involved/advocacy/connected-congress.
101
American Diabetes Association, “Federal Advocacy”
102
American Diabetes Association, “Federal Advocacy”
103
Ryan Knox, “Insulin Insulated”
and many more ways to grow competition.104 By promoting competition, the government can
help to bring down prices and improve access to insulin for people living with diabetes.
Impact
Government regulation of drug prices (especially insulin) has been successful in other nations
with the methods described above, particularly in countries with universal healthcare systems.
For example, in Canada, the Patented Medicine Prices Review Board (PMPRB) regulates the
prices of patented drugs, including insulin, to ensure that they are not excessive. 105 The PMPRB
uses a range of factors, including the prices of comparable drugs in other countries, to
determine the maximum price that pharmaceutical companies can charge for their products. 106
Similarly, in the United Kingdom, the National Institute for Health and Care Excellence (NICE)
assesses the cost-effectiveness of new drugs and determines whether they should be made
available to the National Health Service (NHS).107 This includes assessing the cost-
effectiveness of insulin formulations and other medications used to manage diabetes. 108
Other countries, such as Australia, Germany, and Japan, also use a variety of regulatory
approaches to manage drug prices and ensure that medications are affordable for
consumers.109 These approaches include price controls, direct negotiation with pharmaceutical
companies, and greater transparency around drug pricing.110
Overall, the evidence shows that government regulation of drug prices can be effective in
controlling the cost of medications, including insulin. However, there are also challenges
associated with this approach, including the need to balance affordability with innovation and
the potential for shortages of supply. As such, any regulatory approach must be carefully
designed to ensure that it achieves its intended outcomes without creating unintended negative
consequences.
Gaps
However, there are also potential drawbacks to government regulation of insulin prices. One
concern is that regulation could stifle innovation in the pharmaceutical industry. The excessive
cost of insulin in the United States is partly due to the significant research and development
costs associated with creating new medications.111 If government regulation limits the profits

104
Steven Ross Johnson, “FDA Says New Rules Should Increase Competition for Insulin, but Others Aren't as Sure,”
Modern Healthcare, December 12, 2018,
https://www.modernhealthcare.com/article/20181211/NEWS/181219975/fda-says-new-rules-should-increase-
competition-for-insulin-but-others-aren-t-as-sure.
105
Patented Medicine Prices Review Board Canada, “Government of Canada,” Canada.ca (/ Gouvernement du
Canada, February 10, 2023), https://www.canada.ca/en/patented-medicine-prices-review.html.
106
Government of Canada, “Patented Medicine Prices Review Board”
107
“Nice,” NICE, accessed April 1, 2023, https://www.nice.org.uk/.
108
NICE, “Nice”
109
Jo-Anne Mae Roales, “Regulatory, Pricing, and Reimbursement: Japan,” PharmaBoardroom, August 24, 2022,
https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-japan/.
110
Jo-Anne Mae Roales, “Regulatory, Pricing, and Reimbursement”
111
“The Insulin Act,” Paragon Institute, accessed April 2, 2023, https://paragoninstitute.org/wp-
content/uploads/2022/07/INSULIN-Act-Policy-Brief-Paragon-Health-Institute-20220718.pdf.
that pharmaceutical companies can make, it could discourage them from investing in new
treatments and cures.112
Another concern is that government regulation could lead to shortages of insulin. If the
government sets the price of insulin too low, pharmaceutical companies may choose to stop
producing the medication, leading to a shortage of supply.113 This could result in people with
diabetes being unable to access the medication they need, which could have serious health
consequences.114

Key Takeaways
• Insulin is crucial for managing diabetes, but its rising cost makes it inaccessible for
vulnerable groups like low-income individuals, uninsured/underinsured, elderly, and rural
communities in the US
• Limited competition due to dominant players with patents and regulatory barriers to entry
leads to soaring prices for insulin, while the lack of transparency in prices and the
specialized market worsens the issue
• Pharmaceutical companies use pricing strategies like price gouging and regularly
increasing prices, and the complex supply chain results in higher costs for
manufacturers, which contribute to high insulin prices with high health and financial
impacts on consumers
• Government policy changes such as price controls, greater transparency, direct
negotiation with pharmaceutical companies, and promoting competition can help solve
the problem, but potential drawbacks such as stifling innovation and supply shortages
must be considered

112
Paragon Institute, “The Insulin Act”
113
Center for Drug Evaluation and Research, “Drug Shortages,” U.S. Food and Drug Administration (FDA), accessed
April 1, 2023, https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.
114
Center for Drug Evaluation and Research, “Drug Shortages”