More than 1.6 million New Yorkers are diagnosed with diabetes, and some 11 percent of the State’s almost 20 million residents may already have prediabetes. Diagnosis and intervention are complicated by the fact that only 20 percent of the population is aware that without a lifestyle change and medical oversight, they will “graduate” to a Type 2 diagnosis.

This crisis is hidden in plain sight, waiting to overwhelm the health system.

Diabetes and New York, Imperfect Together

Prediabetes is among the more worrisome health comorbidities. Consider that:

• Diabetes disproportionately affects racial/ethnic minority populations. Compared with white adults, the risk of having a diabetes diagnosis is 77 percent higher among African Americans, 66 percent higher among Latinos/Hispanics, and 18 percent higher among Asian Americans. New York’s diverse population positions the State as an epicenter for diabetes risks.

• Diabetes prevalence is approximately 17% higher in rural areas than in urban areas, with studies showing that adults in rural America were more likely to report a diagnosis of diabetes than their urban counterparts. Approximately 21.5 percent of New Yorkers live in rural regions, with about 4.2 million residents.

• Type 2 diabetes is a pressing public health concern in New York State, affecting individuals of all ages and backgrounds. According to the New York State Department of Health, approximately 10.3% of adults in the State have been diagnosed with diabetes, with Type 2 accounting for most cases. This prevalence translates to over 1.6 million adults living with diabetes, a figure that continues to rise.

• There are 5,228,000 people in New York, 33.5% of the adult population, who have prediabetes. Their blood glucose levels are higher than usual but not yet high enough for them to be diagnosed with diabetes.

• Some 33% of adults aged 65 or older have Type 2 or prediabetes. This age group is at higher risk than younger people of developing diabetes-related complications such as nerve damage, kidney failure, or heart disease. In New York, nearly one in six people are 65 and older, and this population is growing faster than in any other State.

Raising awareness of prediabetes is one challenge; preventing diabetes is another. Addressing the urgent needs of people unable to afford essential treatment is yet another.

Without consistent treatment, blood sugar levels in individuals with diabetes fluctuate uncontrollably, risking hyperglycemia or hypoglycemia, both life-threatening conditions. Prolonged neglect escalates health complications, including cardiovascular diseases, kidney failure, blindness, and nerve damage, significantly reducing life expectancy. The emotional toll of diabetes is also profound; diabetes burnout is real, resulting from the stress and anxiety of constant monitoring every day, all year long, which often leads to depression.

Tackling Access to Care Saves Costs and Lives

The already considerable healthcare costs of diabetes also continue to mount, causing intensifying economic strain as emergency treatment, hospitalizations and repeat hospitalizations climb due to the disease. According to the National Institutes of Health, care for people with diabetes accounts for 1 in 4 healthcare dollars in the U.S. On average, people with diabetes shoulder annual medical expenditures of $19,736, of which approximately $12,022 is specific to diabetes management.

When people require insulin, the price can be a significant obstacle, and failure to access therapy has downstream costs. According to the American Diabetes Association (ADA), people with diabetes have medical expenses that are 2.3 times higher than people who do not have diabetes, and the impact is even more significant for communities of color, which face disproportionately high diagnosis rates.

To fight the disease and its costs in reduced health and mental well-being, as well as runaway treatment and hospitalization costs, addressing the barriers to accessing insulin is paramount. For decades, data has demonstrated that tighter control of insulin blood glucose levels corresponds to fewer medical complications, keeping people out of the hospital and helping to prevent amputations.

People with Medicare Part B and D have a one-month supply of each Part D- and Part B-covered insulin, capped at $35, and do not pay a deductible. However, for the economically challenged, the cost of insulin often means that they are skipping or limiting doses. The impact on their long-term health can be disastrous.

New York State’s Governor Tackles Insulin Access

Governor Kathy Hochul has proposed eliminating insulin cost-sharing through legislation to tackle this public health challenge. The policy would cap an insured person’s cost at $100 out-of-pocket for each 30-day prescription supply.

This public policy effort is the most expansive stopgap against insulin cost-sharing in the nation, providing financial relief to New Yorkers and improving adherence to a life-saving medication that can prevent severe kidney disease that can even cascade to necessary dialysis. This proposal is estimated to save New Yorkers $14 million in 2025 alone.

By removing cost barriers, the program empowers individuals to manage their diabetes effectively. It tackles a key social determinant of health – the cost barrier to access medicine – potentially improving health outcomes. Since the insulin cap proposal was introduced in New York, other States have seen Governor Hochul’s program as a model to address their patient-care challenges.

“Access to affordable insulin is an essential need for those who require this life saving medication,” states Dr. Leon Igel, an endocrinologist and obesity medicine specialist at Weill Cornell and Chief Medical Officer for Intellihealth. Dr. Igel will be honored in May 2024 by the New York Metro Region of the American Diabetes Association for his equal commitment to patient care and research.

Insulin dependency and consistent access to diabetes care is a New York State priority.  Through public health Initiatives such as the Governor’s insulin program, progress is being made in addressing this escalating crisis. Addressing social determinants of health and ensuring that people can affordably access healthy food will also help reduce risks – these steps can address obesity, a critical preventive measure.

Relationship Between Obesity and Health Inequities

Obesity is among the primary risk factors for Type 2 diabetes, and its prevalence in New York reflects the national trend. The Centers for Disease Control and Prevention (CDC) reports that nearly 30% of adults in New York have obesity, with specific communities showing disproportionate risk. Minority populations, low-income individuals, and those residing in underserved neighborhoods are particularly vulnerable to obesity. Limited access to nutritious foods, inadequate healthcare services, and socioeconomic disparities contribute to the heightened risk faced by these groups.

Obesity also leads to prediabetes, a stepping-stone to Type 2 diabetes. Alarmingly, more than 35% of adults in New York have prediabetes, placing them at an increased risk of developing the full-blown disease if left unchecked. State health officials note that 15-30 percent of people with prediabetes without intervention will develop Type 2 diabetes within five years, leaving them vulnerable to heart disease and stroke.

The trajectory from prediabetes to Type 2 diabetes underscores the importance of early detection and comprehensive management strategies – including, if necessary – access to insulin. Moreover, addressing the underlying factors driving prediabetes, such as obesity and health inequities, is essential in stemming the tide of diabetes-related complications.

 “Treating obesity to prevent progression to Type 2 diabetes is critical” according to Dr. Katherine Saunders, an obesity medicine expert at Weill Cornell Medicine in New York City and co-founder of Intellihealth. “Once individuals develop Type 2 diabetes, it can be harder to treat their obesity and the other weight-related comorbidities they likely have as well.”

Government Action Can Save Lives

With access programs like the Governor suggests, New York State is taking bold, preemptive steps toward a future where diabetes no longer casts a dark shadow on the health and well-being of its citizens. Being insulin-dependent and having consistent access reduces a pivotal barrier to care.  As patients, care providers and insurers struggle to navigate the complexities of diabetes management, Governor Hochul’s policy efforts are paramount in shaping a healthier tomorrow for Empire State residents. This proposed legislation, if passed, may encourage other States to follow her lead.

Now, if States also recognize that preventive care – addressing access to healthy food and keeping waistlines down is a public health priority issue, our healthcare system might begin to shift from sick care to well-care.  That would be a significant cost- and life-saving advance.

The post New York Tackles Insulin Access Hurdles as Governor Hochul Takes on Therapy Costs appeared first on Medika Life.

People with commercial insurance and the uninsured can access the copay card by calling the Lilly Diabetes Solution Center at (833) 808-1234

Date of Release: Sept. 10, 2020 

INDIANAPOLIS, /PRNewswire/ — Eli Lilly and Company (NYSE: LLY), which introduced the Lilly Insulin Value Program $35 copay card in April 2020 to help people struggling financially during the COVID-19 crisis, today announced the program has been added to the company’s comprehensive suite of insulin affordability solutions. Anyone with commercial insurance, and those without insurance at all, can continue filling their monthly prescription of Lilly insulins for $35 through this program.

The copay card is being added to Lilly’s suite of solutions to help people with high-deductible insurance plans who otherwise face challenging out-of-pocket costs and those who don’t have insurance because of their income or job status.

“No one should ever have to ration their insulin. That’s why we are committed to including the copay card in our ongoing suite of solutions,” said Mike Mason, president, Lilly Diabetes. “Making insulin affordable at pharmacies through programs like the Lilly Insulin Value Program helps reduce the financial burden some people face at the pharmacy counter.”

The copay card can be accessed immediately through the Lilly Diabetes Solution Center. Numerous programs – such as help for people with immediate needs, automatic caps at retail pharmacies and donations to nonprofit organizations such as Lilly Cares – are helping up to 20,000 people each month access Lilly insulins at lower costs. The $35 copay card can be accessed by calling the Solution Center at (833) 808-1234 or by downloading the copay card at insulinaffordability.com.

Earlier this year, Lilly announced plans to make its insulins available through the Medicare Part D Senior Savings Model, allowing seniors to purchase their monthly prescriptions for $35. Collectively, the Lilly Insulin Value Program and Medicare Part D Senior Savings Model provide options for anyone using Lilly insulin to purchase their monthly prescription at retail pharmacies for $35 starting in January 2021.

“Shifting costs from healthy people to those with chronic conditions such as diabetes is a persistent trend that must be reversed,” Mason said. “The Part D Senior Savings Model is a solution-oriented approach to a problem that has affected seniors for a long time. This program will help people living with diabetes who use insulin.”

Lilly also provides penny-priced insulin to all 340B covered entities. Additionally, following the Administration’s recent executive order requiring Federally Qualified Health Centers to pass 340B discount pricing for insulin onto patients, Lilly announced last week it will continue selling insulin at 340B prices to only those contract pharmacies that agree to pass discounts onto patients with no mark-ups, dispensing fees or duplicate billing.

Awareness Campaign
Today’s announcement ties to the start of a new awareness program launched by Lilly. Throughout the program – Insulin Affordability: Learn, Act, Share – Lilly will collaborate with numerous national, state and local organizations to educate people using Lilly insulin how to take action and save money at the pharmacy.

“We’ve launched this awareness initiative as part of our ongoing commitment to help people using Lilly insulin access it at an affordable out-of-pocket cost,” said Adrienne Brown, vice president, U.S. Connected Care & Insulins. “Although we offer several affordability programs, we know there are people who have not taken action to get help. Our goal is to encourage people who use Lilly insulin and need help to take actions that may lower their out-of-pocket costs at the pharmacy.”

“Everyone in the health care community must work together to help patients understand their options if they use insulin,” added Elena Rios, M.D., President and CEO of the National Hispanic Medical Association. “Too many people continue to face high costs because they don’t have insurance, or because they have inadequate insurance. Making our communities aware of the $35 copay card and other programs available – and how to access them – will help ensure people can afford their insulin.”

Other Savings Options for Patients
A separate copay card for Humulin^® R U-500 (insulin human injection, 500 units/mL) allows for a monthly prescription fill for as little as $25 for people with commercial insurance and can be accessed at Humulin.com. Additionally, people with commercial insurance who use Baqsimi^® (glucagon) nasal powder 3 mg can pay as little as $25 for up to two devices with a copay card, which was first made available in August 2019.

Terms, conditions, and limitations apply to the Lilly copay cards. Not available to those patients with government insurance such as Medicaid, Medicare, Medicare Part D, TRICARE^®/CHAMPUS, Medigap, DoD, or any State Patient or Pharmaceutical Assistance Program.

PURPOSE and SAFETY SUMMARY
Important Facts About BAQSIMIä(BAK-see-mee). It is also known as glucagon nasal powder.
BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.
It is not known if BAQSIMI is safe and effective in children under 4 years of age.
Warnings
Do not use BAQSIMI if:

• you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
• you have a tumor in your pancreas called insulinoma.
• you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:
High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.
Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.
Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

• rash
• difficulty breathing
• low blood pressure

Common side effects
The most common side effects of BAQSIMI include:

• nausea
• vomiting
• headache
• runny nose
• discomfort in your nose
• stuffy nose
• redness in your eyes
• itchy nose, throat, and eyes
• watery eyes

These are not all the possible side effects of BAQSIMI. For more information, ask your doctor.
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using
Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

• have a tumor in your pancreas.
• have not had food or water for a long time (prolonged fasting or starvation).
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

• Read the detailed Instructions for Use that comes with BAQSIMI.
• Use BAQSIMI exactly how your doctor tells you to use it.
• Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
• Your doctor will tell you how and when to use BAQSIMI.
• BAQSIMI contains only 1 dose of medicine and cannot be reused.
• BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
• BAQSIMI will work even if you have a cold or are taking cold medicine.
• After giving BAQSIMI, the caregiver should call for emergency medical help right away.
• If the person does not respond after 15 minutes, another dose may be given, if available.
• Tell your doctor each time you use BAQSIMI.
• Store BAQSIMI at temperatures up to 86°F (30°C).
• Keep BAQSIMI in the shrink wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.
Learn more
For more information, call 1-800-545-5979 or go to www.baqsimi.com.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine.  You can ask your pharmacist or doctor for information about BAQSIMI that is written for health professionals. This information does not take the place of talking with your doctor.  Be sure to talk to your doctor or other health care provider about BAQSIMI and how to take it.  Your doctor is the best person to help you decide if BAQSIMI is right for you.

Please click to access the Baqsimi full Prescribing Information and Patient Information.

GN CON BS 24JUL19

PURPOSE and SAFETY SUMMARY

Important Facts About Humulin^® (HUE-mu-lin) R U-500. It is also known as insulin human injection (500 units/mL).

Humulin R U-500 is a prescription insulin used in adults and children who need more than 200 units of insulin a day to control high blood sugar for their diabetes mellitus. It is more concentrated than standard insulin. It has 5 times as much insulin in each mL as standard insulin.

It is not known if Humulin R U-500 is safe and effective when used with other insulins, when used in an insulin pump, or in children. There were no studies done in children, so your doctor will give you special instructions for use in children.

Warnings

Humulin R U-500 may cause serious side effects, including:

• Severe low blood sugar, which can lead to seizures, unconsciousness, and death.
• Severe allergic reactions. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
• Swelling of your hands and feet. Tell your doctor if you are short of breath, have swelling in your ankles, or have gained weight suddenly.
• Heart failure when taking a medication from a class of drugs called thiazolidinediones (TZDs) with Humulin R U-500. This may occur in some people even if they have not had heart problems before.
• Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.

Do not share your Humulin R U-500 KwikPen^®  or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.

When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.

When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the “U-500 insulin syringe.” Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.  

Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.

Do not use Humulin R U-500 in an insulin pump or inject it into your vein or muscle.

Do not take this medicine if you have low blood sugar.

Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.

Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.

Common side effects

The most common side effects of Humulin R U-500 include:

• Low blood sugar (hypoglycemia). Talk to your doctor about low blood sugar symptoms and treatment. Symptoms may be different for each person.
• Allergic reactions, such as redness and swelling at the site where you inject.
• Skin thickening or pits at the injection site (lipodystrophy).
• Itching and rash.

These are not all the possible side effects of Humulin R U-500.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:

• Any allergies you have. Your doctor can check if the medicine has ingredients that may cause a reaction.
• Any medical conditions, including problems with your liver, kidney, or heart.
• All the medicines you take, especially a class of drugs called thiazolidinediones, or TZDs. Be sure to include the over-the-counter medicines, vitamins, and herbal supplements you take.

How to take

• Read the instructions that come with your Humulin R U-500 carefully. Take it exactly the way your doctor tells you.
• Know how much Humulin R U-500 you are supposed to take. Do not change your dose unless your doctor tells you to.
• Check the label of your insulin each time you use it. This will help you make sure you are using the right one.
• Test your blood sugar before you take Humulin R U-500. Do not take it if your blood sugar is too low.
• Do not mix Humulin R U-500 with any other insulin.
• Always use a new needle when injecting Humulin R U-500. This will help you avoid infection.
• Inject Humulin R U-500 under your skin. Change (rotate) where you inject your insulin with each dose. Do not inject your insulin into the exact same spot. Avoid injecting your insulin into areas where the skin has pits or lumps, or is thickened, tender, bruised, scaly, hard, scarred, or damaged. This will help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.

Learn more

For more information, call 1-800-545-5979 or go to humulin.com.

This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.

Please click to access the Humulin R U-500 full Prescribing Information and Patient Information.

HM CON BS 15NOV2019

Humulin^®, KwikPen^®, and BAQSIMI^® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates.

About Diabetes
Approximately 34 million Americans¹ (just over 1 in 10) and an estimated 463 million adults worldwide² have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone¹. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

This press release contains forward-looking statements about the Lilly Insulin Value Program and other insulin and glucagon affordability programs, and reflects Lilly’s current beliefs. There is no guarantee that our insulin and/or glucagon affordability programs will significantly lower or cap monthly out-of-pocket costs for people who use these medicines. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

PP-LD-US-2219 09/2020 ©Lilly USA, LLC 2020. All rights reserved.

References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.
2. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.

Greg Kueterman;kueterman_gregory_andrew@lilly.com; +1 (317)432-5195 (Media)

Kevin Hern; hern_kevin_r@lilly.com; +1 (317)277-1838 (Investors)

The post Lilly commits Insulin Value Program, With $35 Copay Card appeared first on Medika Life.

We are inviting commentary, suggestions and workable solutions to address the imbalances of the current system. Professionals can also submit articles for consideration and inclusion on this page. We accept a broad range of materials and ideally we would entertain opinions from across the industry, incorporating practitioners, pharmacists, pharma, distribution and the health insurance sector to enable a fair and balanced discussion.

A number of resources and external links are available oductionthe toolbar on the right (desktop users) or page down if you’re on mobile.

Introduction

Diabetes is now the costliest chronic condition in the United States, with one fourth of health care expenditures in the United States spent on patients with diabetes. The insulin costs for the estimated 8.3 million Americans who require prescription insulin accounts for roughly 20 percent of the overall cost of treating diabetes before rebates and discounts are factored in—although after rebates are accounted for, insulin is responsible for 6.3 percent of overall costs. If current trends continue, gross annual insulin costs could reach $121.2 billion by 2024 – Source:American Action Forum

The average list price of insulin increased 11 percent annually from 2001 to 2018, with average annual per capita insulin costs now nearing $6,000. Because patients’ out-of-pocket costs are typically based on list price, their expenses have risen substantially despite the decrease in net price for many of the most commonly used insulin products over the past several years.
If the trends of the past decade continue, gross insulin costs in the United States could reach $121.2 billion in total spending (or $12,446 per insulin patient) by 2024, but if more recent trends of much slower price growth prevail, insulin spending could total $60.7 billion in 2024 (or $6,263 per patient)

The article below is drawn with thanks from the American Diabetes Association. It was produced by the Insulin Access and Affordability Working Group and provides an in-depth and succinct overview of the problems faced by Americans dependent on Insulin. It is, in our opinion, the most robust analysis of the manufacturer controlled market of insulins in America.

For references please refer to the original article.

There are more than 30 million Americans with diabetes, a disease that costs the U.S. more than $327 billion per year. Achieving glycemic control and controlling cardiovascular risk factors have been conclusively shown to reduce diabetes complications, comorbidities, and mortality. To achieve these desired outcomes, the medical community now has available many classes of medications and many formulations of insulin to effectively manage the metabolic abnormalities for people with diabetes.

However, the affordability of medications in general, and for insulin specifically, is currently of great concern to people with diabetes, their families, health care providers, insurers, and employers. For millions of people living with diabetes, including all individuals with type 1 diabetes, access to insulin is literally a matter of life and death. The average list price of insulin has skyrocketed in recent years, nearly tripling between 2002 and 2013. The reasons for this increase are not entirely clear but are due in part to the complexity of drug pricing in general and of insulin pricing in particular.

As the price of insulin continues to rise, individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to serious short- and long-term health consequences. To find solutions to the issue of insulin affordability, there must be a better understanding of the transactions throughout the insulin supply chain, the impact each stakeholder has on what people with diabetes pay for insulin, and the relative efficacy of therapeutic options.

Thus, as the nation’s leading voluntary health organization whose mission is “to prevent and cure diabetes and to improve the lives of all people affected by diabetes,” the American Diabetes Association (ADA) is committed to finding ways to provide relief for individuals and families who lack affordable access to insulin.

Scope of the Problem

Approximately 7.4 million Americans with diabetes use one or more formulations of insulin. People with diabetes using insulin come from varied economic, racial, and ethnic backgrounds. Almost 20% of African Americans with diabetes use insulin, either alone or with oral medications, as do 14% of Caucasians and 17% of Hispanics with diabetes. Of adults with diabetes earning below the poverty level, approximately 24% use insulin, either alone or with oral medications.

Currently, there are only three insulin manufacturers serving the U.S. market: Eli Lilly, Novo Nordisk, and Sanofi. Almost 100 years ago, the discovery of insulin, derived from animal sources, literally began to save human lives. The advent of genetic engineering brought human insulin formulations to patients with diabetes in the 1980s. Rapid-acting and long-acting human insulin analogs were introduced in the 1990s. The patents for many of the human insulin and human insulin analog formulations in current clinical use have expired.

Working Group members from the USC Schaeffer Center for Health Policy & Economics have significant experience in studying medication pricing. Using Centers for Medicare & Medicaid Services data on National Average Drug Acquisition Cost (NADAC), they identified 30 insulin products with NADAC data available between October 2012 and December 2016 and categorized them by product type: short-acting insulin vials, rapid-acting insulin vials, rapid-acting insulin pens, and long-acting insulin pens/vials.

For each product, they collected monthly Wholesale Acquisition Cost (WAC) from First Databank and calculated average monthly WAC and NADAC for each category by averaging across products in each category. They used Medicare Part D claims from 2006 to 2013 to calculate the average insulin expenditure and out-of-pocket spending per insulin user and the Medicare spending by utilization (i.e., the total spending divided by the number of insulin users times mean annual day supply).

The average U.S. list price (WAC) of the four insulin categories increased by 15% to 17% per year from 2012 to 2016. Over the same period, the price pharmacies paid to purchase insulins (NADAC) increased at similar rates. Spending on insulins by Medicare Part D has also shown an increasing and accelerating trend.

For example, Medicare spending by utilization on rapid-acting insulin in vials had a compound annual growth rate (CAGR) of 10% per year between 2006 and 2013 but a CAGR of 13% between 2011 and 2013. As spending on insulin has increased, so too have patient out-of-pocket costs. Between 2006 and 2013, average out-of-pocket costs per insulin user among Medicare Part D enrollees increased by 10% per year for all insulin types. Comparatively, overall inflation during this time was 2.2%, medical care service costs increased by 3.8%, and spending for all prescription drugs increased by an average of 2.8%

Insulin affordability and accessibility issues, however, are not restricted to the U.S. Data from the global ACCISS (Addressing the Challenges and Constraints of Insulin Sources and Supply) study found several overarching trends. First, even for the same insulin product, there is a wide range of prices across the world. Second, there is a large price differential between the lower prices of human insulin formulations and the higher prices of human insulin analog formulations on a global level.

Third, there has been increasing use of human insulin analogs compared with normal human insulin over the recent past, which is greater in more developed parts of the world. This study also reported that the global insulin market is dominated by the same three large multinational corporations that manufacture and sell insulin in the U.S. Those companies represent 99% of the total insulin by value, 96% by total market volume, and 88% of global product registrations.

Complexity of the Insulin Supply Chain and Pricing Mechanisms

Pricing of drugs in general, and for insulin specifically, is very complex. Numerous stakeholders (i.e., manufacturers, wholesalers, PBMs, pharmacies, health plans, and employers) are involved in the insulin supply chain, and the distribution and payment systems involve multiple transactions among these stakeholders. With this system, there is no one agreed-upon price for any insulin formulation. The price ultimately paid by the person with diabetes at the point of sale results from the prices, rebates, and fees negotiated among the stakeholders.

Stakeholders in the insulin supply chain have varying degrees of negotiating power, which adds to the complexity. The following narrative represents the Working Group’s understanding of the U.S. insulin delivery system as obtained by research and in specific interviews with the stakeholders.

Overview of Insulin Supply Chain Dynamics

The complexity of the insulin supply chain is outlined schematically in the diagram above. The insulin supply chain mirrors that of many other prescription drugs. As outlined, manufacturers set the list price for each insulin product. Manufacturers typically sell their medications to wholesalers, who handle distribution to individual pharmacies. But sometimes a pharmacy chain will deal directly with the manufacturer. Wholesalers typically purchase the medications for close to the list price, often receiving a handling fee from the manufacturer that is calculated as a fixed percentage of the list price. Wholesalers then sell the medications to pharmacies, with little to no markup.

They may, however, charge the higher list price. Pharmacies dispense the medication to individual patients and collect cost-sharing required by the patient’s health plan (if any). Pharmacies then submit a bill to the individual’s health insurance plan (if any) to be reimbursed for the cost of the medication dispensed to the patient, less any cost-sharing collected, plus a dispensing fee. If a patient does not have or use health insurance for the medication, the pharmacy typically charges the patient a price relatively close to its purchase price, with a markup.

While the medication itself takes a rather direct path from manufacturer to wholesaler to pharmacy to patient, the flow of money is far less direct and transparent. Furthermore, PBMs often manage the pharmacy benefit portion of a health plan on behalf of their clients. Their clients are the payers for health care, such as large employers, health insurers providing pharmacy benefits to Medicare enrollees, health insurers covering state Medicaid program enrollees, or health insurance plans sold directly to individuals. It is important to note, therefore, that PBMs’ primary customers are health plans and employers, not patients.

The Increasing List Prices of Insulin Formulations

Much of the public discussion regarding insulin affordability and accessibility has focused on the rapidly increasing average list prices of insulin over the past two decades, which nearly tripled between 2002 and 2013. The list price is defined as the price manufacturers set for their medication. Along with yearly increases, the published data also suggest that when one insulin manufacturer increases the price for a given insulin formulation, the other insulin manufacturers often increase their prices by a similar amount shortly thereafter

The Increasing Use of Higher-Priced Insulins

Another important trend affecting overall costs for insulin in the last decade is the shift in insulin utilization from the less expensive human insulins to more expensive human insulin analogs. While the prices of both types of insulin have increased, the difference in pricing between them has substantially added to insulin costs—both to the health care system and to many patients (human insulins are available at the pharmacy for $25 to $100 per vial compared with human insulin analogs at $174 to $300 per vial]). This is further discussed below in formulary decisions and patient financial burden.

The Growing Gap Between the List Price and Net Price

While the list price is defined as the price manufacturers set for their medication, the list price is not ultimately what is paid for the medication (with some exceptions), nor is it what manufacturers receive for their products. The net price manufacturers receive for their medications is the list price less any fees paid to wholesalers, and/or discounts paid to pharmacies, and any rebates paid to PBMs or health plans.

The Working Group found a number of examples from public sources showing that the net price to the insulin manufacturers has grown at a slower rate, or has gone down, compared to list prices. For example, the net price of the insulin formulation Lantus (glargine) increased more or less in parallel with the list price from 2007 to 2013. However, the net price has decreased in recent years (2014–2016). As a result, the net price increased by 57% between 2007 and 2016, increasing 23% as fast as the list price reported as a 252% increase over the same period.

This finding of greater increases in list prices than net prices raises the following questions. Who else has benefited or lost from the substantial increase in insulin list prices over the last decade? And why has the financial burden for people with diabetes who use insulin continued to increase—especially for those without insurance who may have to pay the full list price?

Role of Rebates and Discounts in the Pricing of Insulin

The widening gap between the net and list price of insulin in recent years appears to be the result of increasing rebates and discounts negotiated between stakeholders. Manufacturers negotiate with a PBM for discounts from the list price to have their medications placed on a lower cost-sharing tier and/or to avoid constraints on utilization on the PBM’s client formulary. In this process, manufacturers agree to fees and price concessions, typically paid to the PBM after health plan enrollees receive the manufacturer’s medication. These retroactive discounts or rebates are in addition to the fees paid to PBMs by the payers to provide the pharmacy benefit management services. The rate of increase in these rebates has accelerated to approach approximately half of the list price of insulin. PBMs also negotiate with pharmacies to determine how much participating pharmacies will be paid for medications dispensed to enrollees in the PBM client’s health plan.

Because PBMs design the formulary for their clients, some stakeholders believe PBMs have significant input into which medications are on the formulary and at which tier, setting the parameters for patient access to and cost-sharing for insulins. Nationally, PBMs administer the prescription medication benefit for more than 266 million Americans, and the three major PBMs (CVS Caremark, Express Scripts, and OptumRx) manage about 70% of all prescription claims. Arguably, this gives PBMs considerable leverage in any rebate/discount negotiation with stakeholders.

Transparency and Flow of Dollars

A consistent observation made to the Working Group was the lack of transparency throughout the insulin supply chain. Many interviewed stakeholders recommended increased transparency from entities across the insulin supply chain. Manufacturers reported that without knowledge of the negotiations that take place between PBMs and health plans, they are at a disadvantage in determining pricing for their insulin products. Manufacturers state that the need to provide a higher rebate to achieve preferred formulary positioning impacts the list price of insulin. However, manufacturers do not know where the dollars from increased rebates flow.

Health plans, pharmacists, and people with diabetes also called for increased transparency, including shedding a light on how the list price is set by the manufacturer. Health plans stated that while there is no requirement to report factors that determine increasing list prices, private and public payers are paying for the majority of the costs as list prices continue to rise. Payers would like more transparency in pharmacy acquisition prices and want more information on the therapeutic benefits of more expensive analog insulins. Pharmacists, patients, and providers also would like formulary decisions to be more transparent.

After research and stakeholder discussions, it is still unclear to the Working Group precisely how the dollars flow and how much each intermediary profits. In the vast majority of cases, discounts and rebates negotiated between PBMs and manufacturers and between PBMs and pharmacies, which affect the cost of insulin for people with diabetes, are confidential. Even PBM clients are not privy to many of these negotiations, nor do they know the net price obtained by the PBM for insulins.

How rebates and discounts are distributed is also unclear. To lower patient costs for insulin, the rebates would need to be passed through to individuals with diabetes at the point of sale. Health plan representatives who met with the Working Group pointed out that this would minimize the incentive for PBMs to select for their formulary medications with higher rebates. On the other hand, representatives of the PBMs told the Working Group that when they offer part of the rebates to their customers, it is more common for their customers to use the rebates to lower overall premiums for the plan than to use them to reduce patients’ cost-sharing for insulin at the point of sale. The Working Group could not confirm these claims.

An additional argument presented to the Working Group was that the current system appears to transfer profits from one stakeholder to another. So, it is not clear who really benefits from the rebates and discounts provided to the various stakeholders.

Formulary Decisions and Incentives

Based on the Working Group’s review of the insulin supply chain, it is clear that the insulin manufacturers still control the list price of insulin, but a meaningful share of the negotiating power has shifted from manufacturers to the PBMs. PBMs attempt to keep medication costs down by moving market share between competing products, and their market power is directly related to their ability to provide exclusive formulary coverage for particular brands of medications.

The PBMs told the Working Group that formulary determinations are first and foremost based on clinical considerations. However, when the PBM’s clinical experts determine that one type of medication is necessary on a given formulary tier but there is no clinical preference for one brand or formulation over another, the PBM will approach manufacturers to seek rebates in exchange for preferential formulary tiering. These types of negotiations help to determine whether a particular insulin will be available at all to insured individuals with diabetes under a given health plan, and on which cost-sharing tier an insulin formulation will be placed.

Sometimes a PBM will exclude a medication from its national formulary if the PBM’s net cost for the medication is higher than a competitive or similar product. In addition to formulary placement, PBMs determine which and how many medications on the formulary are subject to utilization management, such as prior authorization, step therapy, or quantity limits to steer prescribers and patients to medications with better safety or efficacy profiles and/or lower net costs. PBMs may also develop a list of preventive or essential medications, recommending the health plan cover medications on the list without patient cost-sharing. Some types or brands of insulins may be included on these lists, but it varies from PBM to PBM and health plan to health plan.

The Working Group was informed that the PBMs generally pass a portion of the rebates received from manufacturers back to the employer or health plan and that in some cases, less than 10% of the rebate is retained by the PBM. These statements were not confirmed by the Working Group. In addition to negotiating rebates with manufacturers, PBMs charge employers, plans, and pharmacies administrative fees for a variety of services. Specifically, health plans and employers pay PBMs a fee for utilization management, such as prior authorization requests for plan enrollees. To ensure the PBM does not have a financial incentive tied to the number of medications requiring utilization management, some employers or plans outsource the processing of utilization management requests and approvals to another company.

The insulin manufacturers told the Working Group that they are not privy to the negotiations that take place between PBMs and health plans. Further, employers and health plans that work with PBMs noted that they are not privy to the net prices the PBM negotiates with manufacturers on their behalf. Instead, the PBM guarantees at the beginning of the plan year the total dollar amount of rebates it will pay to the employer or health plan.

The health plans the Working Group interviewed reported that plans and PBMs have an incentive to select medications for their formularies that offer a higher rebate. It was also suggested to the Working Group that the need to offer higher rebates in order to achieve preferential formulary positioning from PBMs creates an incentive for manufacturers to raise the list price. In addition, wholesalers are paid for their distribution services as a percentage of the list price of the medications they handle, even though their handling costs may not differ from one product to another. Thus, there are incentives throughout the insulin supply chain for high list prices.

In contrast, stakeholders have noted that the current structure of the Medicaid best price requirements limit the amount of discounts or rebates manufacturers provide in the commercial market. If a manufacturer agrees to provide specific rebates to the Medicaid program, all of its medications will be covered (with some exceptions). The basic Medicaid rebate calculation defined in federal law is the larger of a standard percentage of the medication’s average net price, or the average net price minus the “best price” the manufacturer provided to another payer. In addition, if a medication’s average net price increased by more than inflation, the manufacturer must pay an additional rebate to Medicaid.

If a manufacturer’s rebate agreement with a non-Medicaid PBM or health plan results in a net price lower than the net price Medicaid would receive using the standard percentage rebate calculation, the manufacturer must use that rebate agreement amount to calculate the medication’s rebate for all Medicaid enrollees. Stakeholders shared that the Medicaid best price requirement essentially sets a floor for negotiations with PBMs and health plans since manufacturers are hesitant to provide a very large rebate to non-Medicaid plans that will also have to be paid to Medicaid.

Formulary Decisions and Patient Health

It is clear that decisions made from negotiations between stakeholders that affect formulary choice may not be in the best financial or medical interest of the patient. People with diabetes informed the Working Group that they have little choice in medication coverage, particularly for those enrolled in employer-sponsored plans. PBMs often exclude from formularies the insulins made by the manufacturer who offers the lowest rebate. As a result of these negotiations, rules for coverage differ from plan to plan and year to year, or even within the same plan year. When insulins are excluded from the formulary, moved to a different cost-sharing tier, or removed during the plan year (sometimes called “nonmedical switching”), providers and people with diabetes can be inconvenienced and patients’ health may be adversely affected. For example, patients with high cost-sharing may be less adherent to recommended medication dosing and administration, resulting in harm to their health. In addition, formulary exclusions and frequent formulary changes cause uncertainty, increase financial costs for patients, increase work required by providers, and could be undermining patient health.

The Working Group noted concern about the increased burden on people with diabetes and reduced adherence to effective management strategies. The ADA was provided with numerous stories and complaints from constituents regarding this concern. One such example comes from Kathy Sego, who signed the ADA’s Make Insulin Affordable petition and whose son, Hunter, has type 1 diabetes. Hunter requires approximately four vials of insulin per month to properly manage his diabetes, at a monthly out-of-pocket cost of $1,948 until the family meets the health plan deductible. Knowing the impact of this cost on his family, Hunter, a college student in 2016, began skipping insulin doses, which can lead to serious and even deadly complications (33). Hunter Sego is one example of the many individuals who struggle to obtain the insulin they need to survive. When people are unable to afford their cost-sharing, many resort to rationing or skipping doses in order to make their insulin supply last longer, risking their health and their lives.

Formulary Decisions and Patient Financial Burden

Formulary exclusions and frequent formulary changes increase financial costs for patients. In addition, patients are bearing more of the cost of medications because of high-deductible plans, increased use of coinsurance, growing number of formulary tiers, and fewer medications covered per tier. Since negotiated discounts or rebates are usually not passed directly to people with diabetes, their financial obligations for purchasing insulin are often based on the list price. Clearly, this varies depending on the type of insurance the person has and the type of insulin purchased (see below) but specifically impacts those with a high deductible, those who have to pay coinsurance, or those who are in the Medicare Part D coverage gap. People without insurance are often required to pay list price for insulins.

Health plans noted that out-of-pocket insulin costs could be lower for some people with diabetes if health savings account–eligible high-deductible health plans could exempt insulin from the deductible. Manufacturers agree that exempting insulin from the plan’s deductible is a critical step in lowering out-of-pocket insulin costs. Until there is a systematic plan that addresses a change in benefit design to lower out-of-pocket insulin costs for people with diabetes, human insulin may be a valid alternative to more expensive analog insulins for some patients. In this regard, there would need to be significant education of people with diabetes and health care providers on the appropriate use of human and analog insulins, and careful selection of people who may benefit from analog insulin.

While data on average patient out-of-pocket spending for insulin are not widely available, one study found that patient out-of-pocket expenses for insulin doubled over a 10-year period. Using a private insurance administrative claims database for all insulin prescriptions filled at least once, the median out-of-pocket cost to patients went from $19 per vial of insulin in 2000 to $36 per vial of insulin in 2010. In addition, Working Group members with the USC Schaeffer Center found that average Medicare Part D beneficiary out-of-pocket costs for all insulin types doubled between 2006 and 2013, from $27 per month to $65 per month. However, it should be noted that these results are average costs and do not capture fluctuations in cost-sharing that patients experience throughout the year (such as during the deductible phase), and they do not capture patient costs when their insulin is not on their health plan’s formulary. In addition, these studies do not include people who are uninsured. More information is needed to better quantify insulin costs for people with diabetes.

Biosimilar Insulins

Another issue raised by stakeholders was the lack of competition in the insulin manufacturing sector and whether introduction of biosimilar insulins will lead to lower prices. The Working Group spoke with manufacturers who want to introduce a biosimilar insulin into the U.S. market who said the increased regulatory burden associated with the development, as well as U.S. Food and Drug Administration (FDA) approval, of biosimilars is deterring manufacturers from producing biosimilar insulins.

Insulin is a biologic medication made from living cells and far more complex to manufacture than small-molecule medications, which are made by combining different chemical ingredients. Before 2010, a regulatory path was not in place to allow for the development of biosimilar medications, as there has been for decades for small-molecule drugs. If a biologic medication no longer had patent protection, another company could manufacture its own version. In order to obtain FDA approval, the company would not be able to rely exclusively on safety and efficacy data from the original manufacturer’s research, as is the case with small-molecule generic drugs.

To address this problem, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act in 2010. Under the BPCIA, companies developing alternatives to biologic medications (called “biosimilar” medications) must prove that their medication is “highly similar” to the original biologic and that there are no “clinically meaningful” differences from the original biologic. According to the FDA, “this generally means that biosimilar manufacturers do not need to conduct as many expensive and lengthy clinical trials, potentially leading to faster access to these products, additional therapeutic options, and reduced costs for patients”. The manufacturer of a biosimilar medication can submit additional data to the FDA to be deemed “interchangeable” with the original biologic medication.

These data must show that the biosimilar is “expected to produce the same clinical result” as the original biologic medication and that “switching between the proposed interchangeable product and the reference product does not increase safety risks or decrease effectiveness compared to using the reference product without such switching”. Depending on state laws, if a biosimilar is deemed interchangeable by the FDA, a pharmacist may fill a prescription written for the original version with the biosimilar version, much like they currently do for other types of medications with so-called generic medications. Prior to passage of BPCIA, alternative versions of original biologic medications were referred to as “follow-on biologics.” As of this writing, there are no biosimilar insulins on the market, but to date, three follow-on biologic human insulin analogs have been approved by the FDA. Discussion with stakeholders revealed differing opinions on how much biosimilars would lower the price of insulin. Currently, the only follow-on biologic insulin on the market was introduced with a list price approximately 15% less than the original version.

Patient Assistance Programs

The Working Group also reviewed information regarding the value of pharmaceutical patient assistance programs as a solution to help people with diabetes afford their insulin. However, it is beyond the scope of this current report to provide details, benefits, and value of all the available programs. People with diabetes will need to discuss this option with their physician and health plan (if applicable) to determine what, if any, benefit these patient assistance programs could provide to them individually. Although the Working Group did not address this option in detail, it was not deemed to be a long-term or comprehensive answer to the rising cost of insulin for the vast majority of people with diabetes.

Continued Innovation for Diabetes Therapies

One issue of importance to people with diabetes is the need for continued innovation in diabetes management and prevention. New technologies, pharmacotherapies, and strategies continue to be needed to prevent the disease, to diminish adverse side effects like hypoglycemia and weight gain, to promote adherence, and to prevent complications. Such innovation would generate substantial value to people with diabetes both now and in the future (45). One of the best ways to encourage innovation is to better link reimbursement to value (46). With value-based insurance design, the amount of cost-sharing for a medical treatment or service is set according to its value rather than its cost. Value-based insurance design provides coverage for evidence-based treatments that improve health by lowering or eliminating patient cost-sharing. Efforts to encourage value-based insurance design, wherein cost-sharing is linked to population health outcomes, may improve adherence and lower patient financial burden (47).

Patient Cost-Sharing: Insurance Type Matters

There are many factors that impact how much people with diabetes pay for insulin, including the amount and type of insulin and delivery system they use. Another major factor is whether the person has insurance and, if so, what type. Whether the person’s health insurance plan or its PBM has negotiated rebates with insulin manufacturers also impacts the cost to people with diabetes. In the U.S., there are many different types of health insurance.

Almost half of Americans have health insurance provided through their employer or a family member’s employer. Employer coverage is generally regulated by federal law, but employers have leeway in determining which benefits to cover and how much to charge enrollees. Medicaid, a health insurance program for low-income individuals, covers more than 68 million Americans (20% of the population). Each state manages and administers the Medicaid programs for their residents; however, they are required to follow federal guidelines, which include limits to the out-of-pocket costs to beneficiaries.

Medicare, the federal health care program for Americans over age 65 years, people with disabilities under age 65 years, and people with end-stage renal disease, covers about 14% of Americans. Federal rules dictate the benefits covered under Medicare and how much enrollees pay, including Medicare Part D, the program’s prescription drug benefit. Approximately 7% of Americans purchase insurance on their own directly from an insurer or through state health insurance exchanges (called individual market insurance). Federal and state laws dictate which benefits are covered in individual market insurance plans as well as enrollees’ annual spending on care. Roughly 2% of Americans are covered under other government programs like military or Veterans Administration coverage, and 9% have no health insurance coverage.

The Uninsured Person

An uninsured person with diabetes will pay the full $480 for the insulin, regardless of any rebates offered by the manufacturer. He or she could directly receive payment assistance from the manufacturer or a pharmaceutical patient assistance program, but eligibility for those programs varies based on the individual’s income, state, and medication.

The Person With Commercial Insurance

A person with diabetes who has commercial insurance may pay less than the $480 list price, but the amount paid depends upon the person’s insurance contract. If the person is required to pay an annual deductible that has not yet been reached (for example, if this is the patient’s first expenditure in the new year), the person with diabetes will pay the full $480 list price for the insulin until the person spends enough to meet the deductible. Once the deductible is met, if the person’s insurance contract specifies a fixed co-payment, he or she will pay a flat amount, for example, $50 per prescription, even if the person with diabetes uses multiple vials of the same insulin product per month.

However, if the insurance plan requires coinsurance, the person with diabetes will pay a percentage, for example, 20% of the cost of each vial of insulin. Importantly, the coinsurance is based on the list price of the insulin, not the net cost after any rebates or discounts negotiated by the PBM. In this case, the out-of-pocket cost by the person with diabetes for the insulin is $96 per vial (20% of the $480 list price).

The Person With Medicare

A Medicare beneficiary with Part D prescription drug coverage could face an array of different benefit designs and out-of-pocket expenditures, depending on the type of plan in which the person with diabetes enrolls, where the prescription is filled, and the phase of coverage. For example, in 2018 under the standard benefit, beneficiaries face a deductible of $405 and a coinsurance rate of 25%. Thus, on the first fill, the first $405 is paid out-of-pocket, plus 25% of the remaining cost of the drug (25% of $75) for a total of $423.75. The 25% coinsurance rate applies to additional fills until the person reaches the plan’s initial coverage limit ($3,750 in most plans in 2018) and enters the coverage gap, commonly known as the “donut hole.”

Historically, beneficiaries paid 100% of the Part D plan’s brand-name drug costs in the donut hole, but the Affordable Care Act has reduced some of that burden. In 2018, beneficiaries pay 35% of the Part D plan’s brand-name drug costs (or $168 per prescription in this example) in the coverage gap until their annual out-of-pocket expense reaches $5,000. After that, beneficiaries pay 5% of a drug’s list price ($24) for the remainder of the calendar year. Beginning in 2019, beneficiaries in the standard plan will pay 25% (or $120 per vial in this example) of the cost of their brand-name prescription drugs once they meet their deductible until they reach the out-of-pocket maximum.

The Person With Medicaid

For a person with diabetes with Medicaid drug coverage, co-payments are generally limited to a nominal amount ($1–$5) for drugs on the preferred drug list. Medicaid drug coverage varies from state to state, however, all states include some insulins on their preferred drug lists. If a Medicaid enrollee needs a medication not on the state’s preferred drug list, the prescriber can submit a request on his or her behalf stating the medical need for the drug.

Conclusions and Recommendations

After discussions with more than 20 stakeholders in the insulin supply chain, the Working Group remains concerned by the complexity of the system. As outlined, there are numerous stakeholders involved in the delivery of insulin, with multiple opaque transactions between and among these stakeholders. It was also the consensus of the Working Group that incentives throughout the insulin supply chain facilitate and may even promote high list prices. The following sections provide the conclusions and recommendations of the Working Group.

Conclusions

• List prices of insulin have risen precipitously in recent years. Between 2002 and 2013, the average price of insulin nearly tripled.
• The current pricing and rebate system encourages high list prices.
  • ∘ As list prices increase, the profits of the intermediaries in the insulin supply chain (wholesalers, PBMs, pharmacies) increase since each may receive a rebate, discount, or fee calculated as a percentage of the list price.
• There is a lack of transparency throughout the insulin supply chain. It is unclear precisely how the dollars flow and how much each intermediary profits.
  • ∘ Manufacturers are rarely paid the list price for insulin. The so-called net price—which reflects what the manufacturers receive—is much lower; however, in most cases, the data are not available.
  • ∘ In the vast majority of cases, discounts and rebates negotiated between PBMs and manufacturers and between PBMs and pharmacies, which affect the cost of insulin for the person with diabetes, are confidential.
    •  ▪ PBM clients (often large employers in most cases) are not privy to these negotiations, nor do they know the net price obtained by the PBM for insulins.
  • ∘ Formulary considerations and decisions are not transparent.
• PBMs have substantial market power.
  • ∘ PBMs’ primary customers are health plans and employers, not patients.
  • ∘ PBMs negotiate rebates from manufacturers using formulary placement as leverage.
    •  ▪ PBMs often exclude from formularies the insulins made by the manufacturer who offers the lowest rebate.
    •  ▪ As a result of negotiation, rules for coverage differ from plan to plan and year to year, or even within the same plan year.
    •  ▪ When insulins are excluded from the formulary, moved to a different cost-sharing tier, or removed during the plan year, it places a burden on people with diabetes and providers and may have a negative health impact.
  • ∘ PBMs receive administrative fees from their clients (health insurance plans) for utilization management services (prior authorization, etc.). Often it is the PBM that determines which and how many drugs on the formulary are subject to utilization management.
• People with diabetes are financially harmed by high list prices and high out-of-pocket costs.
  • ∘ Regardless of the negotiated net price, the cost of insulin for people with diabetes is greatly influenced by the list price for insulins.
    •  ▪ Out-of-pocket costs vary depending upon the type of health insurance each individual has and the type of insulin prescribed. The costs can be significantly higher for people who are uninsured, who have an insurance plan with a high deductible, or who are in the Medicare Part D donut hole.
  • ∘ Manufacturer rebates often are not directly passed on to people with diabetes.
• Patients’ medical care can be adversely affected by formulary decisions.
  • ∘ People with high cost-sharing are less adherent to recommended dosing, which results in short- and long-term harm to their health.
  • ∘ Formulary exclusions and frequent formulary changes cause uncertainty, increase financial costs for people with diabetes, and could have serious negative consequences on the health of people with diabetes.
• The regulatory framework for development and approval of biosimilar insulins is burdensome for manufacturers.
  • ∘ There are not enough biosimilar insulins on the market.
  • ∘ Prices for biosimilar insulins are not likely to be lower unless there are multiple biosimilars that can be subsituted for the brand-name analog insulin, rather than only one.
• Prescribing patterns have favored newer, more expensive insulins.
  • ∘ Newer insulins, including analogs, are more expensive than older insulins including human insulins.
  • ∘ Human insulin may be an appropriate alternative to more expensive analog insulins for some people with diabetes.

Recommendations

• Providers, pharmacies, and health plans should discuss the cost of insulin preparations with people with diabetes to help understand the advantages, disadvantages, and financial implications of potential insulin preparations.
• Providers should prescribe the lowest-priced insulin required to effectively and safely achieve treatment goals.
  • ∘ This may include using human insulin in appropriately selected patients.
  • ∘ Providers should be aware of the rising cost of insulin preparations and how this negatively impacts adherence to the clinical treatment by people with diabetes.
  • ∘ Providers should be trained to appropriately prescribe all forms of insulin preparations based on evidence-based medicine.
• Cost-sharing for insured people with diabetes should be based on the lowest price available.
• Uninsured people with diabetes should have access to high-quality, low-cost insulins.
• Researchers should study the comparative effectiveness and cost-effectiveness of the various insulins.
• List price for insulins should more closely reflect net price, and rebates based on list price should be minimized. The current payment system should rely less on rebates, discounts, and fees based on list price.
• Health plans should ensure that people with diabetes can access their insulin without undue administrative burden or excessive cost.
  • ∘ Payers, insurers, manufacturers, and PBMs should design pharmacy formularies that include a full range of insulin preparations, including human insulin and insulin analogs, in the lowest cost-sharing tier.
• PBMs and payers should use rebates to lower costs for insulin at the point of sale for people with diabetes.
• There needs to be more transparency throughout the insulin supply chain.
• Payers, insurers, manufacturers, PBMs, and people with diabetes should encourage innovation in the development of more effective insulin preparations.
• The FDA should continue to streamline the process to bring biosimilar insulins to market.
• Organizations such as the ADA should do the following:
  • ∘ Advocate for access to affordable and evidence-based insulin preparations for all people with diabetes.
  • ∘ Ensure that health providers receive ongoing medical education on how to prescribe all insulin preparations, including human insulins, based on scientific and medical evidence.
  • ∘ Develop and regularly update clinical guidelines or standards of care based on scientific evidence for prescribing all forms of insulins and make these guidelines easily available to health care providers.
  • ∘ Make information about the advantages, disadvantages, and financial implications of all insulin preparations easily available to people with diabetes.

Document Reference: Insulin Access and Affordability Working Group: Conclusions and Recommendations

William T. Cefalu¹⇑, Daniel E. Dawes², Gina Gavlak³, Dana Goldman⁴, William H. Herman⁵, Karen Van Nuys⁴, Alvin C. Powers⁶, Simeon I. Taylor⁷ and Alan L. Yatvin⁸, on behalf of the Insulin Access and Affordability Working Group

Author Affiliations

1. American Diabetes Association, Arlington, VA
2. Morehouse School of Medicine, Atlanta, GA
3. North Coast Health, Lakewood, OH
4. USC Schaeffer Center for Health Policy & Economics, Los Angeles, CA
5. University of Michigan, Ann Arbor, MI
6. Vanderbilt University Medical Center, Nashville, TN
7. University of Maryland School of Medicine, Baltimore, MD
8. Popper & Yatvin, Philadelphia, PA

Corresponding author: William T. Cefalu, wcefalu@diabetes.org.

Diabetes Care 2018 Jun; 41(6): 1299-1311.https://doi.org/10.2337/dci18-0019

The post Addressing The Unregulated Costs of Insulin in America appeared first on Medika Life.

What is insulin?

Insulin is a hormone made by the pancreas that helps glucose in your blood enter cells in your muscle, fat, and liver, where it’s used for energy. Glucose comes from the food you eat. The liver also makes glucose in times of need, such as when you’re fasting. When blood glucose, also called blood sugar, levels rise after you eat, your pancreas releases insulin into the blood. Insulin then lowers blood glucose to keep it in the normal range.

What is insulin resistance?

Insulin resistance is when cells in your muscles, fat, and liver don’t respond well to insulin and can’t easily take up glucose from your blood. As a result, your pancreas makes more insulin to help glucose enter your cells. As long as your pancreas can make enough insulin to overcome your cells’ weak response to insulin, your blood glucose levels will stay in the healthy range.

What is prediabetes?

Prediabetes means your blood glucose levels are higher than normal but not high enough to be diagnosed as diabetes. Prediabetes usually occurs in people who already have some insulin resistance or whose beta cells in the pancreas aren’t making enough insulin to keep blood glucose in the normal range. Without enough insulin, extra glucose stays in your bloodstream rather than entering your cells. Over time, you could develop type 2 diabetes.

How common is prediabetes?

More than 84 million people ages 18 and older have prediabetes in the United States. That’s about 1 out of every 3 adults.

Who is more likely to develop insulin resistance or prediabetes?

People who have genetic or lifestyle risk factors are more likely to develop insulin resistance or prediabetes. Risk factors include

• overweight or obesity
• age 45 or older
• a parent, brother, or sister with diabetes
• African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, Native Hawaiian, or Pacific Islander American ethnicity
• physical inactivity
• health conditions such as high blood pressure and abnormal cholesterol levels
• a history of gestational diabetes
• a history of heart disease or stroke
• polycystic ovary syndrome, also called PCOS

People who have metabolic syndrome—a combination of high blood pressure, abnormal cholesterol levels, and large waist size—are more likely to have prediabetes.

Along with these risk factors, other things that may contribute to insulin resistance include

• certain medicines, such as glucocorticoids , some antipsychotics, and some medicines for HIV
• hormonal disorders, such as Cushing’s syndrome and acromegaly
• sleep problems, especially sleep apnea

Although you can’t change risk factors such as family history, age, or ethnicity, you can change lifestyle risk factors around eating, physical activity, and weight. These lifestyle changes can lower your chances of developing insulin resistance or prediabetes.

What causes insulin resistance and prediabetes?

Researchers don’t fully understand what causes insulin resistance and prediabetes, but they think excess weight and lack of physical activity are major factors.

Excess weight

Experts believe obesity, especially too much fat in the abdomen and around the organs, called visceral fat, is a main cause of insulin resistance. A waist measurement of 40 inches or more for men and 35 inches or more for women is linked to insulin resistance. This is true even if your body mass index (BMI) falls within the normal range. However, research has shown that Asian Americans may have an increased risk for insulin resistance even without a high BMI.

Researchers used to think that fat tissue was only for energy storage. However, studies have shown that belly fat makes hormones and other substances that can contribute to chronic, or long-lasting, inflammation in the body. Inflammation may play a role in insulin resistance, type 2 diabetes, and cardiovascular disease.

Excess weight may lead to insulin resistance, which in turn may play a part in the development of fatty liver disease.

Physical inactivity

Not getting enough physical activity is linked to insulin resistance and prediabetes. Regular physical activity causes changes in your body that make it better able to keep your blood glucose levels in balance.

What are the symptoms of insulin resistance and prediabetes?

Insulin resistance and prediabetes usually have no symptoms. Some people with prediabetes may have darkened skin in the armpit or on the back and sides of the neck, a condition called acanthosis nigricans. Many small skin growths called skin tags often appear in these same areas.

Even though blood glucose levels are not high enough to cause symptoms for most people, a few research studies have shown that some people with prediabetes may already have early changes in their eyes that can lead to retinopathy. This problem more often occurs in people with diabetes.

How do doctors diagnose insulin resistance and prediabetes?

Doctors use blood tests to find out if someone has prediabetes, but they don’t usually test for insulin resistance. The most accurate test for insulin resistance is complicated and used mostly for research.

Doctors most often use the fasting plasma glucose (FPG) test or the A1C test to diagnose prediabetes. Less often, doctors use the oral glucose tolerance test (OGTT), which is more expensive and not as easy to give.

The A1C test reflects your average blood glucose over the past 3 months. The FPG and OGTT show your blood glucose level at the time of the test. The A1C test is not as sensitive as the other tests. In some people, it may miss prediabetes that the OGTT could catch. The OGTT can identify how your body handles glucose after a meal—often before your fasting blood glucose level becomes abnormal. Often doctors use the OGTT to check for gestational diabetes, a type of diabetes that develops during pregnancy.

People with prediabetes have up to a 50 percent chance of developing diabetes over the next 5 to 10 years. You can take steps to manage your prediabetes and prevent type 2 diabetes.

The following test results show Prediabetes

• A1C—5.7 to 6.4 percent
• FPG—100 to 125 mg/dL (milligrams per deciliter)
• OGTT—140 to 199 mg/dL

You should be tested for prediabetes if you are overweight or have obesity and have one or more other risk factors for diabetes, or if your parents, siblings, or children have type 2 diabetes. Even if you don’t have risk factors, you should start getting tested once you reach age 45.

If the results are normal but you have other risk factors for diabetes, you should be retested at least every 3 years.

How can I prevent or reverse insulin resistance and prediabetes?

Physical activity and losing weight if you need to may help your body respond better to insulin. Taking small steps, such as eating healthier foods and moving more to lose weight, can help reverse insulin resistance and prevent or delay type 2 diabetes in people with prediabetes.

The National Institutes of Health-funded research study, the Diabetes Prevention Program (DPP), showed that for people at high risk of developing diabetes, losing 5 to 7 percent of their starting weight helped reduce their chance of developing the disease.³ That’s 10 to 14 pounds for someone who weighs 200 pounds. People in the study lost weight by changing their diet and being more physically active.

The DPP also showed that taking metformin, a medicine used to treat diabetes, could delay diabetes. Metformin worked best for women with a history of gestational diabetes, younger adults, and people with obesity. Ask your doctor if metformin might be right for you.

Making a plan, tracking your progress, and getting support from your health care professional, family, and friends can help you make lifestyle changes that may prevent or reverse insulin resistance and prediabetes. You may be able to take part in a lifestyle change program as part of the National Diabetes Prevention Program [External link].

Clinical Trials

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and other components of the National Institutes of Health (NIH) conduct and support research into many diseases and conditions.

What are clinical trials, and are they right for you?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Researchers also use clinical trials to look at other aspects of care, such as improving the quality of life for people with chronic illnesses. Find out if clinical trials are right for you [External Link]

What clinical trials are open?

Clinical trials that are currently open and are recruiting can be viewed at www.ClinicalTrials.gov [External Link].

This article has been reproduced in part from the National Institute of Diabetes and Digestive and Kidney Diseases. Visit their site for more detailed information on assistance with Diabetes within the U.S.

The post Prediabetes and Insulin Resistance appeared first on Medika Life.

Gestational diabetes is usually diagnosed in the 24th to 28th week of pregnancy. Managing your gestational diabetes can help you and your baby stay healthy. You can protect your own and your baby’s health by taking action right away to manage your blood glucose levels.

How can gestational diabetes affect my baby?

High blood glucose levels during pregnancy can cause problems for your baby, such as

• being born too early
• weighing too much, which can make delivery difficult and injure your baby
• having low blood glucose, also called hypoglycemia, right after birth
• having breathing problems

High blood glucose also can increase the chance that you will have a miscarriage or a stillborn baby. Stillborn means the baby dies in the womb during the second half of pregnancy.

Your baby also will be more likely to become overweight and develop type 2 diabetes as he or she gets older.

How can gestational diabetes affect me?

If you have gestational diabetes, you are more likely to develop preeclampsia, which is when you develop high blood pressure and too much protein in your urine during the second half of pregnancy.

Preeclampsia can cause serious or life-threatening problems for you and your baby. The only cure for preeclampsia is to give birth. If you have preeclampsia and have reached 37 weeks of pregnancy, your doctor may want to deliver your baby early. Before 37 weeks, you and your doctor may consider other options to help your baby develop as much as possible before he or she is born.

Gestational diabetes may increase your chance of having a cesarean section, also called a C-section, because your baby may be large. A C-section is major surgery.

If you have gestational diabetes, you are more likely to develop type 2 diabetes later in life. Over time, having too much glucose in your blood can cause health problems such as diabetic retinopathy, heart disease, kidney disease, and nerve damage. You can take steps to help prevent or delay type 2 diabetes.

What are the symptoms of gestational diabetes?

Usually, gestational diabetes has no symptoms. If you do have symptoms, they may be mild, such as being thirstier than normal or having to urinate more often.

What causes gestational diabetes?

Gestational diabetes occurs when your body can’t make the extra insulin needed during pregnancy. Insulin, a hormone made in your pancreas, helps your body use glucose for energy and helps control your blood glucose levels.

During pregnancy, your body makes special hormones and goes through other changes, such as weight gain. Because of these changes, your body’s cells don’t use insulin well, a condition called insulin resistance. All pregnant women have some insulin resistance during late pregnancy. Most pregnant women can produce enough insulin to overcome insulin resistance, but some cannot. These women develop gestational diabetes.

Being overweight or obese is linked to gestational diabetes. Women who are overweight or obese may already have insulin resistance when they become pregnant. Gaining too much weight during pregnancy may also be a factor.

Having a family history of diabetes makes it more likely that a woman will develop gestational diabetes, which suggests that genes play a role.

When will I be tested for gestational diabetes?

Testing for gestational diabetes usually occurs between 24 and 28 weeks of pregnancy. If you have an increased chance of developing gestational diabetes, your doctor may test for diabetes during the first visit after you become pregnant.

How do doctors diagnose gestational diabetes?

Doctors use blood tests to diagnose gestational diabetes. You may have the glucose challenge test, the oral glucose tolerance test, or both. These tests show how well your body uses glucose.

Glucose Challenge Test

You may have the glucose challenge test first. Another name for this blood test is the glucose screening test. In this test, a health care professional will draw your blood 1 hour after you drink a sweet liquid containing glucose. You do not need to fast for this test. Fasting means having nothing to eat or drink except water. If your blood glucose is too high—140 or more—you may need to return for an oral glucose tolerance test while fasting. If your blood glucose is 200 or more, you may have type 2 diabetes.

Oral Glucose Tolerance Test (OGTT)

The OGTT measures blood glucose after you fast for at least 8 hours. First, a health care professional will draw your blood. Then you will drink the liquid containing glucose. You will need your blood drawn every hour for 2 to 3 hours for a doctor to diagnose gestational diabetes.

High blood glucose levels at any two or more blood test times—fasting, 1 hour, 2 hours, or 3 hours—mean you have gestational diabetes. Your health care team will explain what your OGTT results mean.

Your health care professional may recommend an OGTT without first having the glucose challenge test.

How can I manage my gestational diabetes?

Many women with gestational diabetes can manage their blood glucose levels by following a healthy eating plan and being physically active. Some women also may need diabetes medicine.

Follow a healthy eating plan

Your health care team will help you make a healthy eating plan with food choices that are good for you and your baby. The plan will help you know which foods to eat, how much to eat, and when to eat. Food choices, amounts, and timing are all important in keeping your blood glucose levels in your target range.

If you’re not eating enough or your blood glucose is too high, your body might make ketones. Ketones in your urine or blood mean your body is using fat for energy instead of glucose. Burning large amounts of fat instead of glucose can be harmful to your health and your baby’s health.

Your doctor might recommend you test your urine or blood daily for ketones or when your blood glucose is above a certain level, such as 200. If your ketone levels are high, your doctor may suggest that you change the type or amount of food you eat. Or, you may need to change your meal or snack times.

Be physically active

Physical activity can help you reach your target blood glucose levels. If your blood pressure or cholesterol levels are too high, being physically active can help you reach healthy levels. Physical activity can also relieve stress, strengthen your heart and bones, improve muscle strength, and keep your joints flexible. Being physically active will also help lower your chances of having type 2 diabetes in the future.

Talk with your health care team about what activities are best for you during your pregnancy. Aim for 30 minutes of activity 5 days of the week, even if you weren’t active before your pregnancy.² If you are already active, tell your doctor what you do. Ask your doctor if you may continue some higher intensity activities, such as lifting weights or jogging.

How will I know whether my blood glucose levels are on target?

Your health care team may ask you to use a blood glucose meter to check your blood glucose levels. This device uses a small drop of blood from your finger to measure your blood glucose level. Your health care team can show you how to use your meter.

Recommended daily target blood glucose levels for most women with gestational diabetes are 

• Before meals, at bedtime, and overnight: 95 or less
• 1 hour after eating: 140 or less
• 2 hours after eating: 120 or less³

Ask your doctor what targets are right for you.

You can also use an electronic blood glucose tracking system on your computer or mobile device. Record the results every time you check your blood glucose. Your blood glucose records can help you and your health care team decide whether your diabetes care plan is working. Take your tracker with you when you visit your health care team.

How is gestational diabetes treated if diet and physical activity aren’t enough?

If following your eating plan and being physically active aren’t enough to keep your blood glucose levels in your target range, you may need insulin.

If you need to use insulin, your health care team will show you how to give yourself insulin shots. Insulin will not harm your baby and is usually the first choice of diabetes medicine for gestational diabetes. Researchers are studying the safety of the diabetes pills metformin and glyburide during pregnancy, but more long-term studies are needed. Talk with your health care professional about what treatment is right for you.

This article has been reproduced in part from the National Institute of Diabetes and Digestive and Kidney Diseases. Visit their site for more detailed information on assistance with Diabetes within the U.S.

The post Gestational Diabetes, Risks and Treatment appeared first on Medika Life.

The good news is that you can take steps to prevent or delay the development of type 2 diabetes.

Who is more likely to develop type 2 diabetes?

You can develop type 2 diabetes at any age, even during childhood. However, type 2 diabetes occurs most often in middle-aged and older people. You are more likely to develop type 2 diabetes if you are age 45 or older, have a family history of diabetes, or are overweight or obese.

As in type 1 diabetes, certain genes may make you more likely to develop type 2 diabetes. The disease tends to run in families and occurs more often in these racial/ethnic groups:

• African Americans
• Alaska Natives
• American Indians
• Asian Americans
• Hispanics/Latinos
• Native Hawaiians
• Pacific Islanders

Genes also can increase the risk of type 2 diabetes by increasing a person’s tendency to become overweight or obese.

Additional Risk factors

You are more likely to develop type 2 diabetes if you

• are overweight or obese
• are age 45 or older
• have a family history of diabetes
• are African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, Native Hawaiian, or Pacific Islander
• have high blood pressure
• have a low level of HDL (“good”) cholesterol, or a high level of triglycerides
• have a history of gestational diabetes or gave birth to a baby weighing 9 pounds or more
• are not physically active
• have a history of heart disease or stroke
• have depression
• have polycystic ovary syndrome, also called PCOS
• have acanthosis nigricans—dark, thick, and velvety skin around your neck or armpits

What are the symptoms of diabetes?

Symptoms of diabetes include

• increased thirst and urination
• increased hunger
• feeling tired
• blurred vision
• numbness or tingling in the feet or hands
• sores that do not heal
• unexplained weight loss

Symptoms of type 2 diabetes often develop slowly—over the course of several years—and can be so mild that you might not even notice them. Many people have no symptoms. Some people do not find out they have the disease until they have diabetes-related health problems, such as blurred vision or heart disease.

What causes type 2 diabetes?

Type 2 diabetes is caused by several factors, including

• overweight and obesity
• not being physically active
• insulin resistance
• genes

Overweight, obesity, and physical inactivity

You are more likely to develop type 2 diabetes if you are not physically active and are overweight or obese. Extra weight sometimes causes insulin resistance and is common in people with type 2 diabetes. The location of body fat also makes a difference. Extra belly fat is linked to insulin resistance, type 2 diabetes, and heart and blood vessel disease.

Insulin resistance

Type 2 diabetes usually begins with insulin resistance, a condition in which muscle, liver, and fat cells do not use insulin well. As a result, your body needs more insulin to help glucose enter cells. At first, the pancreas makes more insulin to keep up with the added demand. Over time, the pancreas can’t make enough insulin, and blood glucose levels rise.

What causes gestational diabetes?

Scientists believe gestational diabetes, a type of diabetes that develops during pregnancy, is caused by the hormonal changes of pregnancy along with genetic and lifestyle factors.

Insulin resistance

Hormones produced by the placenta contribute to insulin resistance, which occurs in all women during late pregnancy. Most pregnant women can produce enough insulin to overcome insulin resistance, but some cannot. Gestational diabetes occurs when the pancreas can’t make enough insulin.

As with type 2 diabetes, extra weight is linked to gestational diabetes. Women who are overweight or obese may already have insulin resistance when they become pregnant. Gaining too much weight during pregnancy may also be a factor.

Genetic mutations

• Monogenic diabetes is caused by mutations, or changes, in a single gene. These changes are usually passed through families, but sometimes the gene mutation happens on its own. Most of these gene mutations cause diabetes by making the pancreas less able to make insulin. The most common types of monogenic diabetes are neonatal diabetes and maturity-onset diabetes of the young (MODY). Neonatal diabetes occurs in the first 6 months of life. Doctors usually diagnose MODY during adolescence or early adulthood, but sometimes the disease is not diagnosed until later in life.
• Cystic fibrosis produces thick mucus that causes scarring in the pancreas. This scarring can prevent the pancreas from making enough insulin.
• Hemochromatosis causes the body to store too much iron. If the disease is not treated, iron can build up in and damage the pancreas and other organs.

Hormonal diseases

Some hormonal diseases cause the body to produce too much of certain hormones, which sometimes cause insulin resistance and diabetes.

• Cushing’s syndrome occurs when the body produces too much cortisol—often called the “stress hormone.”
• Acromegaly occurs when the body produces too much growth hormone.
• Hyperthyroidism occurs when the thyroid gland produces too much thyroid hormone.

Damage to or removal of the pancreas

Pancreatitis, pancreatic cancer, and trauma can all harm the beta cells or make them less able to produce insulin, resulting in diabetes. If the damaged pancreas is removed, diabetes will occur due to the loss of the beta cells.

Medicines

Sometimes certain medicines can harm beta cells or disrupt the way insulin works. These include

• niacin, a type of vitamin B3
• certain types of diuretics, also called water pills
• anti-seizure drugs
• psychiatric drugs
• drugs to treat human immunodeficiency virus (HIV)
• pentamidine, a drug used to treat a type of pneumonia 
• glucocorticoids—medicines used to treat inflammatory illnesses such as rheumatoid arthritis, asthma, lupus, and ulcerative colitis
• anti-rejection medicines, used to help stop the body from rejecting a transplanted organ

Statins, which are medicines to reduce LDL (“bad”) cholesterol levels, can slightly increase the chance that you’ll develop diabetes. However, statins help protect you from heart disease and stroke. For this reason, the strong benefits of taking statins outweigh the small chance that you could develop diabetes.

If you take any of these medicines and are concerned about their side effects, talk with your doctor.

How do health care professionals diagnose type 2 diabetes?

Your health care professional can diagnose type 2 diabetes based on blood tests. You can learn more about testing for diabetes here.

How can I manage my type 2 diabetes?

Managing your blood glucose, blood pressure, and cholesterol, and quitting smoking if you smoke, are important ways to manage your type 2 diabetes. Lifestyle changes that include planning healthy meals, limiting calories if you are overweight, and being physically active are also part of managing your diabetes. So is taking any prescribed medicines. Work with your health care team to create a diabetes care plan that works for you.

What medicines do I need to treat my type 2 diabetes?

Along with following your diabetes care plan, you may need diabetes medicines, which may include pills or medicines you inject under your skin, such as insulin. Over time, you may need more than one diabetes medicine to manage your blood glucose. Even if you don’t take insulin, you may need it at special times, such as during pregnancy or if you are in the hospital. You also may need medicines for high blood pressure, high cholesterol, or other conditions.

Learn more about medicines, insulin, and other diabetes treatments.

What health problems can people with diabetes develop?

Following a good diabetes care plan can help protect against many diabetes-related health problems. However, if not managed, diabetes can lead to problems such as

• heart disease and stroke
• nerve damage
• kidney disease
• foot problems
• eye disease
• gum disease and other dental problems
• sexual and bladder problems

Many people with type 2 diabetes also have nonalcoholic fatty liver disease (NAFLD). Losing weight if you are overweight or obese can improve NAFLD. Diabetes is also linked to other health problems such as sleep apnea, depression, some types of cancer, and dementia 

How can I lower my chances of developing type 2 diabetes?

Research such as the Diabetes Prevention Program [External link], sponsored by the National Institutes of Health, has shown that you can take steps to reduce your chances of developing type 2 diabetes if you have risk factors for the disease. Here are some things you can do to lower your risk:

• Lose weight if you are overweight, and keep it off. You may be able to prevent or delay diabetes by losing 5 to 7 percent of your current weight. For instance, if you weigh 200 pounds, your goal would be to lose about 10 to 14 pounds.
• Move more. Get at least 30 minutes of physical activity, such as walking, at least 5 days a week. If you have not been active, talk with your health care professional about which activities are best. Start slowly and build up to your goal.
• Eat healthy foods. Eat smaller portions to reduce the amount of calories you eat each day and help you lose weight. Choosing foods with less fat is another way to reduce calories. Drink water instead of sweetened beverages.

Ask your health care team what other changes you can make to prevent or delay type 2 diabetes.

This article has been reproduced in part from the National Institute of Diabetes and Digestive and Kidney Diseases. Visit their site for more detailed information on assistance with Diabetes within the U.S.

The post Type 2 Diabetes, Risks and Treatment appeared first on Medika Life.

Diabetes occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes mainly from the food you eat. Insulin, a hormone made by the pancreas, helps the glucose in your blood get into your cells to be used for energy. Another hormone, glucagon, works with insulin to control blood glucose levels.

In most people with type 1 diabetes, the body’s immune system, which normally fights infection, attacks and destroys the cells in the pancreas that make insulin. As a result, your pancreas stops making insulin. Without insulin, glucose can’t get into your cells and your blood glucose rises above normal. People with type 1 diabetes need to take insulin every day to stay alive.

Who is more likely to develop type 1 diabetes?

Type 1 diabetes typically occurs in children and young adults, although it can appear at any age. Having a parent or sibling with the disease may increase your chance of developing type 1 diabetes. In the United States, about 5 percent of people with diabetes have type 1.¹

What are the symptoms of type 1 diabetes?

Symptoms of type 1 diabetes are serious and usually happen quickly, over a few days to weeks. Symptoms can include

• increased thirst and urination
• increased hunger
• blurred vision
• fatigue
• unexplained weight loss

Sometimes the first symptoms of type 1 diabetes are signs of a life-threatening condition called diabetic ketoacidosis (DKA). Some symptoms of DKA include

• breath that smells fruity
• dry or flushed skin
• nausea or vomiting
• stomach pain
• trouble breathing
• trouble paying attention or feeling confused

DKA is serious and dangerous. If you or your child have symptoms of DKA, contact your health care professional right away, or go to the nearest hospital emergency room.

What causes type 1 diabetes?

Experts think type 1 diabetes is caused by genes and factors in the environment, such as viruses, that might trigger the disease. Researchers are working to pinpoint the causes of type 1 diabetes through studies such as TrialNet [External Link]

How do health care professionals diagnose type 1 diabetes?

Health care professionals usually test people for type 1 diabetes if they have clear-cut diabetes symptoms. Health care professionals most often use the random plasma glucose (RPG) test to diagnose type 1 diabetes. This blood test measures your blood glucose level at a single point in time. Sometimes health professionals also use the A1C blood test to find out how long someone has had high blood glucose.

Even though these tests can confirm that you have diabetes, they can’t identify what type you have. Treatment depends on the type of diabetes, so knowing whether you have type 1 or type 2 is important.

To find out if your diabetes is type 1, your health care professional may test your blood for certain autoantibodies. Autoantibodies are antibodies that attack your healthy tissues and cells by mistake. The presence of certain types of autoantibodies is common in type 1 but not in type 2 diabetes.

Because type 1 diabetes can run in families, your health care professional can test your family members for autoantibodies. Type 1 diabetes TrialNet, an international research network, also offers autoantibody testing to family members of people diagnosed with the disease. The presence of autoantibodies, even without diabetes symptoms, means the family member is more likely to develop type 1 diabetes.

If you have a brother or sister, child, or parent with type 1 diabetes, you may want to get an autoantibody test. People age 20 or younger who have a cousin, aunt, uncle, niece, nephew, grandparent, or half-sibling with type 1 diabetes also may want to get tested.

What medicines do I need to treat my type 1 diabetes?

If you have type 1 diabetes, you must take insulin because your body no longer makes this hormone. Different types of insulin start to work at different speeds, and the effects of each last a different length of time. You may need to use more than one type. You can take insulin a number of ways. Common options include a needle and syringe, insulin pen, or insulin pump.

Some people who have trouble reaching their blood glucose targets with insulin alone also might need to take another type of diabetes medicine that works with insulin, such as pramlintide. Pramlintide, given by injection, helps keep blood glucose levels from going too high after eating. Few people with type 1 diabetes take pramlintide, however.

The NIH has recently funded a large research study to test use of pramlintide along with insulin and glucagon in people with type 1 diabetes. Another diabetes medicine, metformin, may help decrease the amount of insulin you need to take, but more studies are needed to confirm this. Reseachers are also studying other diabetes pills that people with type 1 diabetes might take along with insulin.

Hypoglycemia, or low blood sugar, can occur if you take insulin but don’t match your dose with your food or physical activity. Severe hypoglycemia can be dangerous and needs to be treated right away. 

How else can I manage type 1 diabetes?

Along with insulin and any other medicines you use, you can manage your diabetes by taking care of yourself each day. Following your diabetes meal plan, being physically active, and checking your blood glucose often are some of the ways you can take care of yourself. Work with your health care team to come up with a diabetes care plan that works for you. If you are planning a pregnancy with diabetes, try to get your blood glucose levels in your target range before you get pregnant.

Do I have other treatment options for my type 1 diabetes?

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has played an important role in developing “artificial pancreas” technology. An artificial pancreas replaces manual blood glucose testing and the use of insulin shots. A single system monitors blood glucose levels around the clock and provides insulin or a combination of insulin and glucagon automatically. The system can also be monitored remotely, for example by parents or medical staff.

In 2016, the U.S. Food and Drug Administration approved a type of artificial pancreas system called a hybrid closed-loop system. This system tests your glucose level every 5 minutes throughout the day and night through a continuous glucose monitor, and automatically gives you the right amount of basal insulin, a long-acting insulin, through a separate insulin pump.

You still need to manually adjust the amount of insulin the pump delivers at mealtimes and when you need a correction dose. You also will need to test your blood with a glucose meter several times a day. Talk with your health care provider about whether this system might be right for you.

The illustration below shows the parts of a type of artificial pancreas system.

The continuous glucose monitor sends information through a software program called a control algorithm. Based on your glucose level, the algorithm tells the insulin pump how much insulin to deliver. The software program could be installed on the pump or another device such as a cell phone or computer.

Starting in late 2016 and early 2017, the NIDDK has funded several important studies on different types of artificial pancreas devices to better help people with type 1 diabetes manage their disease. The devices may also help people with type 2 diabetes and gestational diabetes.

NIDDK is also supporting research into pancreatic islet transplantation—an experimental treatment for hard-to-control type 1 diabetes. Pancreatic islets are clusters of cells in the pancreas that make insulin. Type 1 diabetes attacks these cells. A pancreatic islet transplant replaces destroyed islets with new ones that make and release insulin.

This procedure takes islets from the pancreas of an organ donor and transfers them to a person with type 1 diabetes. Because researchers are still studying pancreatic islet transplantation, the procedure is only available to people enrolled in a study.

What health problems can people with type 1 diabetes develop?

Over time, high blood glucose leads to problems such as

• heart disease
• stroke
• kidney disease
• eye problems
• dental disease
• nerve damage
• foot problems
• depression
• sleep apnea

If you have type 1 diabetes, you can help prevent or delay the health problems of diabetes by managing your blood glucose, blood pressure, and cholesterol, and following your self-care plan.

Can I lower my chance of developing type 1 diabetes?

At this time, type 1 diabetes can’t be prevented. However, through studies such as TrialNet, researchers are working to identify possible ways to prevent or slow down the disease.

This article has been reproduced in part from the National Institute of Diabetes and Digestive and Kidney Diseases. Visit their site for more detailed information on assistance with Diabetes within the U.S.

The post Type 1 Diabetes, Risks and Treatment appeared first on Medika Life.

Over time, having too much glucose in your blood can cause health problems. Although diabetes has no cure, you can take steps to manage it and stay healthy.

Sometimes people call diabetes “a touch of sugar” or “borderline diabetes.” These terms suggest that someone doesn’t really have diabetes or has a less serious case, but every case of diabetes is serious.

What are the different types of diabetes?

The most common types of are type 1, type 2, and gestational diabetes.

Type 1 diabetes

If you have type 1 diabetes, your body does not make insulin. Your immune system attacks and destroys the cells in your pancreas that make insulin. Type 1 diabetes is usually diagnosed in children and young adults, although it can appear at any age. People with type 1 diabetes need to take insulin every day to stay alive.

Type 2 diabetes

If you have type 2 diabetes, your body does not make or use insulin well. You can develop type 2 diabetes at any age, even during childhood. However, this type of diabetes occurs most often in middle-aged and older people. Type 2 is the most common type of diabetes.

Gestational diabetes

Gestational diabetes develops in some women when they are pregnant. Most of the time, this type of diabetes goes away after the baby is born. However, if you’ve had gestational diabetes, you have a greater chance of developing type 2 diabetes later in life. Sometimes diabetes diagnosed during pregnancy is actually type 2 diabetes.

Other types of diabetes

Less common types include monogenic diabetes, which is an inherited form of diabetes, and cystic fibrosis-related diabetes

How common is diabetes?

As of 2015, 30.3 million people in the United States, or 9.4 percent of the population, had diabetes. More than 1 in 4 of them didn’t know they had the disease. It affects 1 in 4 people over the age of 65. About 90-95 percent of cases in adults are type 2 diabetes.1

Who is more likely to develop type 2 diabetes?

You are more likely to develop type 2 diabetes if you are age 45 or older, have a family history of diabetes, or are overweight. Physical inactivity, race, and certain health problems such as high blood pressure also affect your chance of developing type 2 diabetes. You are also more likely to develop type 2 diabetes if you have prediabetes or had gestational diabetes when you were pregnant. Learn more about type 2 diabetes.

What health problems can people with diabetes develop?

Over time, high blood glucose leads to problems such as

• heart disease
• stroke
• kidney disease
• eye problems
• dental disease
• nerve damage
• foot problems

This article has been reproduced in part from the National Institute of Diabetes and Digestive and Kidney Diseases. Visit their site for more detailed information on assistance within the U.S.

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