Generics And Biosimilars Are Driving Down The Overall Price Of Insulins
Since 2019, the overall retail price of insulins has declined by about 5%. Most of this decline can be seen as a result of recent approvals of generics and biosimilars.
In 2019, Eli Lilly released the first generic insulin, insulin lispro, the counterpart to the popular rapid-acting insulin Humalog. Since then, the FDA has approved generic versions of Humalog 75/25 , , , and most recently, Lantus .
Retail prices for generic insulin lispro and insulin aspart are currently about half that of Humalog and Novolog, respectively. The same goes for the generic mixed insulins, insulin lispro 75/25 and insulin aspart 70/30, compared to Humalog 75/25 and Novolog 70/30, respectively.
Generics have been instrumental in bringing down costs for some patients. Instead of paying a retail price of over $700 for a package of 5 Humalog KwikPens, for example, patients can now pay closer to $300 for a package of 5 generic insulin lispro KwikPens. However, weve seen that limited insurance coverage can prevent some patients from accessing these savings.
Like generics, follow-on products have also helped to bring down insulin prices overall. Generics contain the exact replicas of the active ingredients in a brand-name medication. But biologic drugs like insulin are nearly impossible to recreate. So sometimes, manufacturers make close copies of them instead, known as follow-ons or biosimilars. Biosimilars tend to be more expensive than generics but less expensive than brands.
How To Save On Insulin
In order to save on insulin, you must be a savvy medical shopper:
- Always use a manufacturer savings card or patient assistance program when paying to save money.
- Do your research before choosing an insulin. Search to find out which brand is best for you financially, as well as medically.
- Ask your doctor to appeal your coverage if insurance does not automatically accept and cover the insulin you may need.
Whats Fueling The Rapid Increase In Insulin Prices
There is no doubt that the prices of insulin have reached a tipping point where some people cant afford their medication. In a presentation for the ADA, Irl B. Hirsch, MD, explains that from 2013 to 2016, a vial of glargine insulin had a price increase of 593%, and a box of five insulin lispro pens rose 522%. During that time, inflation rose by only 8.3%. In 2014, drugmakers increased the price of insulin twice, each time for approximately 16%. That means insulin prices rose by over 30% in one year.
There isnt just one reason for the high cost of insulin. Pharmaceutical companies complain that pharmacy benefit managers administering prescription benefits for commercial insurance companies drive the cost up by requiring rebates to have their brand of insulin included in the insurance formulary. They claim their net price is lower than the list price. But the PBMs say its the pharmaceutical companies who set the list price.
Several factors keep insulin prices high:
Higher levels of competition would lower prices, increasing the affordability of insulin.
The rising cost of insulin has real-world consequences. A group in Minneapolis reportedly take a bus to Canada to purchase insulin at a fraction of the price as it sells for in the United States.
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How Does The Uk Compare
T1International is a non-profit advocating for affordable, accessible diabetes care worldwide. Founder Elizabeth Rowley is an American who now lives in the UK.
As a T1 diabetic herself, Ms Rowley has first-hand experience navigating both health systems. She describes the US system as “convoluted”, with profits happening at all levels in between.
“People spend most of their life in fear of losing their insurance, of running out of insulin and the cost going up, or of having to stay in terrible jobs or relationships to ensure they keep their health insurance coverage,” Ms Rowley tells me. “That’s the best case scenario.
“Worst case, folks are rationing insulin which has led to many reported deaths and excruciating complications. People are buying and sharing insulin from people online they have never met, having to choose between buying food, paying rent, or taking their medicine.”
Diabetics in the US pay on average over $210 each month for insulin, according to a T1International 2016 survey, compared to less than $50 in India or nothing at all in some European countries.
“In the UK, I walked into the pharmacy, and with my medical exemption card, picked up my essential medicines. While the NHS is still overpaying for insulin, the cost it pays is miniscule compared to what people in the US must pay.”
Ms Rowley acknowledges these other systems aren’t perfect – but to her, they are still far better for patients.
Why Insulin Relief Was Limited To Medicare Patients
Democrats pursued the Inflation Reduction Act through a process called budget reconciliation, or a simple party majority.
In that process, the Senate Parliamentarian ruled broader insulin reform for non-Medicare patients could not be included in the legislation. Senate lawmakers then sought 60 votes in order to keep it in the bill. But they fell short with just 57 votes, as 43 lawmakers opposed it.
The result was a disappointment, Gabbay said. Legislation capping the cost of insulin, or the cost of care to people with diabetes, has already been passed in 23 states and Washington, D.C.
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“We were hoping that now is the time to go national and really have a comprehensive law that would protect all people with diabetes in the U.S.,” Gabbay said.
The American Diabetes Association plans to continue to advocate for relief for more patients, including the INSULIN Act, which calls for capping monthly insulin costs for a broader patient population.
“We hope that that can come to Congress this fall,” Gabbay said.
Senate Majority Leader Chuck Schumer, D-N.Y., also expressed his intention to bring the proposal up for a vote again in the coming months.
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Lantus Holds The Highest Market Share In 2021
Lantus was approved by the US Food and Drug Administration in April 2000. Lantus is a man-made form of hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Lantus is for use in adults with type 1 or types 2 diabetes, and in children at least 6 years old with type -1 Diabetes. For type 1 diabetes, Lantus is used together with short-acting insulin given before meals. Lantus and Januvia, two treatments for diabetes are some of the highest-selling drugs of all time and represent some of the greatest breakthroughs in diabetes control.
The United States was the largest market for Lantus in 2021, accounting for more than 58% of the market revenues. However, the biosimilars for Lantus may not present it with competitive challenges currently. The loss of exclusivity for Lantus may not result in the near-term disruption of the market for it. However, there will be additional pricing pressure and some loss of market share that would continue and may increase over time.
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Insulin Prices: How Much Does Insulin Cost
Diabetes is no small issue in the United States. There are approximately 30.3 million people with diabetes in the U.S., according to the Diabetes Research Institute. Five percent of themor about 1.5 million peoplehave type 1 diabetes and require insulin to survive. Some people with type 2 diabetes can control blood sugar with diet and activity. Still, many need insulin, especially as the condition progresses.
And, unfortunately, insulin prices have risen dramatically over the past 10 years. Between 2012 and 2016, the price almost doubled, according to the Health Care Cost Institute. In 2012, the average cost of insulin per diabetes patient was $2,864 per year. By 2016, it had risen to $5,705. Today, one vial of insulin can cost $250, and some people need six vials per month.
In addition to that, there are other diabetes supplies, such as a glucose monitor, test strips, lancets, and a safe place to store used syringes or pens. It could easily cost someone without insurance $1,300 per month to care for the condition. Even with insurance, copayments and supplies can eat away at your monthly budget. Luckily, there are savings options.
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What Medicare Beneficiaries On Insulin Can Expect
For patients age 65 and up who rely on insulin, the Inflation Reduction Act is a “game changer,” Gabbay said.
More than 8 million people in the U.S. rely on insulin to manage their blood glucose levels, and if they stop taking the medication for a few days, they could die. “It’s deadly serious,” Gabbay said.
Yet as the year progresses, some Medicare patients tend to get nervous about a coverage gap known as a “donut hole” and may try to ration their insulin, he said.
The high costs of insulin result in 14% of patients having “catastrophic” levels of spending on the treatment, according to recent research from Yale University. For Medicare patients on insulin, catastrophic spending affects one in five patients, the research found.
Starting in 2023, the Inflation Reduction Act will cap the cost of insulin for Medicare beneficiaries at $35 per month and will include those who use insulin pumps.
Medicare beneficiaries who pay more than $35 per month after the legislation is initially enacted will be reimbursed, according to the American Diabetes Association.
For patients struggling to cover insulin, the American Diabetes Association provides resources that may help curb those costs at Insulinhelp.org.
Cost Of Insulin By Country 2022
Insulin is a hormone, made by the pancreas, which enables the body’s cells to absorb sugar from the bloodstream and consume it for energy. However, in roughly 10% of the world’s population (see Diabetes Rates by Country, the body’s ability to produce and utilize insulin is disrupted, resulting in a chronic condition known as diabetes. There are two main forms of diabetes: Type 1, in which the pancreas fails to produce enough insulin and type 2, in which the pancreas makes enough insulin but the cells can’t process it effectively. Diabetes is a serious condition. Without adequate insulin, the body becomes unable to manage its blood sugar level, which can lead to a host of medical complicationsin fact, according to the International Diabetes Foundation, diabetes caused 6.7 million deaths in 2021.
Fortunately, type 1 diabetes is usually treatable with the use of man-made insulin, which can be administered via a syringe or pen, an inhaler, or a surgically attached pump. Unfortunately, insulin prices have skyrocketed in the United States over the past two decades and continue to rise. For example, the American Journal of Managed Care pointed out that the cost of a one-month supply of the insulin Humalog cost $21 in 1996, but $275 in 2019a 1200% increasebut actual inflation during that same period was only 63.67%.
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How The Inflation Reduction Act Will Affect Insulin Prices
For the 1 in 3 Medicare beneficiaries who use insulin, the Inflation Reduction Act will mean a decrease in the out-of-pocket price of insulin, with co-pays capped at $35 a month. And while they wont directly impact insulin prices, other provisions in the law, such as allowing Medicare to negotiate prices and placing a $2,000 annual cap on out-of-pocket costs, will provide further relief for Americans on Medicare who use insulin.
However, the bill will not impact the overall price of the drugjust the copay amountmeaning that insulin will continue to be a financial burden for those not covered by Medicare. Its reducing the patient out of pocket , but were not actually reducing the price that manufacturers charge and receive for their product, says Chandra.
For One Patient A Three
When Michelle Fenner signed up to run this years Los Angeles Marathon, it got her thinking: Tijuana, Mexico, is only a 2½-hour drive from L.A. Why not take a trip across the border and buy some insulin for her son?
Its so easy to just go across the border, mused Fenner.
This idea had been in the back of Fenners mind for a while. Her son was diagnosed with Type 1 diabetes nine years ago, meaning he needs daily injections of insulin to live. The list price of the modern generation of insulin has skyrocketed since his diagnosis. On one trip to the pharmacy last year, Fenner was told that a three-month supply of insulin would cost her $3,700.
That same supply would cost only about $600 in Mexico.
So, when she booked her trip to Los Angeles, Fenner said, I decided we need to update our passports and go and get more insulin.
Fenner is not the only one thinking like this. The U.S. government estimates that close to 1 million people in California alone cross to Mexico annually for health care, including to buy prescription drugs. And between 150,000 and 320,000 Americans list health care as a reason for traveling abroad each year. Cost savings is the most commonly cited reason.
Right To Shop Legislation
But, Thurston said, he expects that in the next six months, savings will likely be in the ballpark of $1 million.
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Why Insulin Remains Unaffordable
But why does insulin a medication thats been around for more than 100 years remain unaffordable for many people in the U.S.?
The high cost can be attributed in part to evergreening, a process in which drug companies make incremental improvements to their products that can extend the life of their patents, said Dr. Kevin Riggs, a physician at the University of Alabama at Birmingham Heersink School of Medicine. He co-wrote a study published in the New England Journal of Medicine in 2015 that described the century-long history of the drug.
The improvements may include tinkering with a molecule or changing the delivery system, such as using insulin pens instead of vials.
Extending patentscan discouragegeneric drugs from being developed, Riggs said, allowing drugmakers with exclusive rights to their insulin to charge whatever the market will bear. And as supply chains have become more complicated over the years, costs have ballooned.
And so that means those prices have gone up crazy, he said.
And even when the patents do expire as many have Riggs said that the large investment it takes to get insulin manufactured and approved by U.S. regulators may make the venture less appealing to generic drugmakers.
Eric Tichy, division chair of pharmacy supply solutions for the Mayo Clinic in Rochester, Minnesota, agreed, saying the barrier to entry to produce insulin is pretty high.
No one should be “forced to make the decision between life or death,” she said.
How Do I Calculate How Much Insulin To Take
In people who do not have diabetes, their bodies release insulin in response to the foods they eat. This is because many foods contain carbohydrates. Some examples include bread, sweets, fruits, and even vegetables.
Your body breaks carbohydrates down into smaller building blocks, like glucose. You need insulin to use this glucose for energy. If your body cannot make or use insulin effectively, youll need to inject it to process your food for energy.
Calculating how much insulin to take is usually based on two considerations:
- Basal insulin dose. A basal insulin dose is an amount that you give yourself daily regardless of the foods you eat.
- Bolus insulin dose. A bolus insulin dose helps correct or anticipate the carbohydrates you eat throughout the day. You will usually correct this with a bolus dose of rapid-acting insulin.
Anticipating a bolus dose is where insulin administration can get tricky. When you give yourself insulin, you are estimating how many units of insulin it will take to process the carbohydrates you eat.
The University of California, San Francisco states that, as a general rule, 1 unit of insulin will process anywhere from 12 to 15 grams of carbohydrates and lower your blood sugar by about 50 milligrams per deciliter .
Since the human body is so complex, not all people will process insulin the same way. Factors like time of day, stress levels, and physical activity can make these numbers more difficult to predict.
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Ways To Save On Insulin
Its difficult to predict where drug prices will be in the future, but if you take insulin, we hope our analysis gives you some ideas for how to talk to your provider about affordable options. Here are more ways you can save:
1) Use a manufacturer savings card or patient assistance program. Major insulin manufacturers Eli Lilly, Novo Nordisk, Sanofi-Aventis, and MannKind offer copay cards and patient assistance programs for patients with and without insurance coverage. In many cases, these programs can reduce out-of-pocket costs to as little as $0 per month. For more information, just search for your drug on goodrx.com, and click on Savings Tips for details.
2) Shop around. GoodRx offers discounts on insulin drugs, which can save you as much as 50% off the full retail price. At goodrx.com, you can also compare insulin prices at different pharmacies in your area and find information about discount programs at specific pharmacies.
3) Appeal your coverage. If you have insurance and your plan doesnt cover the insulin you need, ask your doctor about submitting an appeal. Your insurance company may require a prior authorization or step therapy before you can fill your prescription, but its worth trying if you want to get your insulin covered.
A note about insulin use