How Much Does Insulin Cost and Why?

More than 37 million Americans have diabetes, a group of diseases with too much sugar in the blood. Of those patients, more than 7 million require some form of insulin, a naturally created hormone-based drug that helps regulate blood sugar levels. One of the biggest concerns for patients and healthcare providers is the rising price of insulin.

Over the past decade, the cost of insulin has tripled in the United States, with out-of-pocket costs also doubling. One in four patients say they eat insulin because they can’t afford it.

Stephanie Redmond, PharmD, CDE, BC-ADM, founder of Diabetes Doctor, told Verywell: “If someone has type 1 diabetes or if someone has already damaged their pancreas, those are the circumstances where their body does not produce any insulin. “There is no doubt that insulin is a lifesaver, and just a day or so without it, insulin would lead to hospitalization and possibly death for those patients.”

How has the government affected the price of insulin?

On July 24, 2020, former President Donald Trump signed an executive order that included language aimed at lowering the price of insulin and other drugs for Americans. This order goes into effect on January 22, 2021.

Robin Feldman, the Arthur J. Goldberg Distinguished Professor of Law at UC Hastings College of Law, San Francisco, told Verywell: “As with any legal imperative, detail is the devil. She also notes that we, “…will need some systemic changes to try to address the issues that are driving drug prices higher in general and prices for specific insulin higher.”

On June 16, 2021, under Biden’s administration, the Department of Health and Human Services announced in the Federal Register its plan to deregulate this 2020. They cite many reasons for doing so:

• It creates high administrative costs for the affected health centers.
• Affected medical centers have struggled to uphold the new rules to identify patients who are eligible to receive the drug at a lower price.
• The new regulations have resulted in a reduction in staff available to help with emergency and critical services.
• Covid-19 has put additional strain on these affected medical centers.

On March 1, 2022 during his State of the Union Address, President Biden discussed capping the price of insulin at $35 a month. He also mentioned the reduction in prescription drug prices.

What factors affect the cost of diabetes treatment?

People with diabetes have more than two times higher health care costs than Americans without the condition. On average, diabetes-related medical costs can add up to more than $9,500 per year.

One of the most influential factors for that difference is the cost of insulin. The amount people pay out-of-pocket for insulin depends on many different factors. This includes whether they have insurance, the type of plan they have, and coverage details such as the plan deductible. The dose and type of medication an individual needs can also affect the cost.

In his experience as a doctor and pharmacist, Redmond says most patients need about two vials of insulin per month or one to two packs of insulin pens. Each pack of pens is equivalent to about one and a half vials. As of March 2022, the price of a vial of insulin ranges from $50 to over $1,000, and a pack of pens ranges from $45 to over $600.

“The price is too high,” said Redmond. “Not just for insulin but for most diabetes medications. All that stuff is still insanely expensive.”

What is the Cost of Insured Insulin?

A report by the American Diabetes Association’s Insulin Affordability and Access Working Group found that nearly half of all Americans have employer-sponsored health insurance. About 20% are covered through Medicaid, and 14% are covered through Medicare. About 7% of Americans buy their own health insurance. About 9% of Americans are still uninsured.

Diabetes is considered a pre-existing condition, which is a condition you had before you signed up for health insurance. According to the study, about 1.9 million people with uninsured diabetes were covered after the Affordable Care Act (ACA) went into effect in 2010.

However, having insurance doesn’t mean insulin is affordable. Insured patients will often pay a copay or a percentage, instead of list price, for their insulin. Redmond says the cost can range from $30 to $50.

In the case of high-deductible health plans, patients must pay the list price for their insulin until their deductible is met. This means thousands of dollars out of pocket. “Many patients have a hard time paying that much,” says Redmond.

How have drug companies responded to the criticism?

Pharmaceutical companies have responded to criticism of high prices. For example, some companies offer discount cards. However, Redmond explains that it doesn’t help every patient. “You can’t use them if you have Medicare, and many of them cost $100-$150,” Redmond said of the rebates. “So if you have a high deductible in the thousands of dollars, these coupons aren’t very helpful, because that patient may still have to pay $300 out of pocket for their insulin or more for their insulin. until their deductible is met.”

Some drug companies have assistance programs for low-income individuals. “These are good options but take a lot of time, and a knowledgeable doctor is willing to take that time and help them with the forms,” says Redmond, social worker, or care coordinator. squirrels who can help.

Many insulin manufacturers have created programs in response to COVID-19. As of March 2022, these programs remain in effect:

• In April 2020, Novo Nordisk began providing free insulin for 90 days to patients who lost their health insurance during the pandemic.
• In May 2020, Sanofi began offering a temporary access program to financially challenged patients who were eligible to receive the drug for 30 days.
• In April 2020, Eli Lilly launched the Insulin Value Program offering a $35 copay card to uninsured individuals or those with commercial insurance.

Why is insulin more expensive in the US?

Three pharmaceutical companies – Novo Nordisk, Sanofi-Aventis and Eli Lilly – control the market. “Three major companies produce 90 percent of the global insulin supply and nearly 100 percent of the U.S. insulin supply,” Feldman said. “Observers have noticed that the big three tend to mirror each other’s increases in insulin prices. When one person raises the price, others quickly follow.”

Feldman says companies have become adept at what’s known as always-screening. “Screening involves different techniques to extend protection to a drug and prevent competition that could drive down prices.”

Many brand-name drugs have become more popular cheaper alternatives. However, the Food and Drug Administration (FDA) once considered insulin as a drug and biologically, there are different regulatory pathways.

Drugs that are considered similar to biologics or drugs made from living organisms, are called biosimilars, not generic drugs. Biosimilars must go through a specific approval route.

The brand-name liquids initially go through the pharmaceutical route, not the biological route. This means that competitors cannot introduce biosimilar insulin.

In March 2020, the FDA moved to label insulin as a biologic, which opened the door to new biosimilars. However, barriers remain. Feldman says the approval process is more complicated for biosimilars than for generic drugs, and the replacement process at the pharmacy is also more difficult.

State law allows pharmacists to automatically substitute a generic version for a drug, but such automatic substitution is not available for biosimilar ampoules unless certain conditions are met.

“It was a huge impact,” Feldman said. “Because auto-substitution is the way that traditional generic drugs enter the market and lower prices.”

The FDA approved a long-acting biologic insulin called Semglee in July 2021. However, patients and physicians must specifically request biosimilars because of the lack of automatic substitution. Historically, that hasn’t happened, Feldman says.

In addition, intermediaries along the insulin supply chain can drive up costs or keep new drugs out of reach. “Existing players with a large market share can use volume discounts to discourage [pharmacy benefits managers] and health plans from including new entrants,” Feldman said.

The bottom line is that the monopoly of the three companies is hurting people with diabetes. “Insulin is a very old drug,” says Feldman. “We have known about it for a long time. The patient shouldn’t pay through the nose for it now a hundred years from now. “

Summary

The price of insulin has increased dramatically over the past decade. However, the government has responded in an attempt to make the drug more accessible.

The cost of treatment for people with diabetes is greatly influenced by the price of insulin. This is largely driven by the big three companies that produce it. Plan details can also affect the price an individual pays for their drugs.