Patients Say They Are Ready for Cost-Saving Biosimilar Insulin

Winnie Tiedemann, 73, of New Jersey lives with her son and his 5 children. She worked for years as a secretary for her husband and son’s company, John Tiedemann, Inc. Which specializes in church paintings and historic restorations.

Tiedemann was diagnosed with diabetes at age 25 and has been insulin-dependent for the past 20 or so years. She has insurance, Medicare and AARP health insurance. Tiedemann is currently dependent on Humalog (insulin lispro), which is manufactured by Eli Lilly, and Levemir (insulin detemir), which is manufactured by Novo Nordisk.

Her out of pocket costs? Around $3600 a year.

Tiedemann is lucky. Her son picks up the cost of insulin.

“I don't get much money. I didn't work that many years, so I get very little in social security” Tiedemann said in an interview. "He just picks it up for me. And if he didn't, I wouldn't be able to use it.”

The gross amount spent on insulin per person has increased by nearly $3000 dollars between 2012 and 2016 despite daily insulin use by people with type 1 diabetes increasingly only 3%, according to a 2019 study conducted by the nonprofit Health Care Cost Institute, which receives data contributions from Humana, Aetna, Kaiser Permanente, and UnitedHealthcare.

According to the nonprofit T1International, this price hike can be deadly as people try to ration their insulin and bring down costs.

“The fact that type 1 diabetes has gone from a death sentence to a survival condition [and] back to a death sentence in the US is shameful,” James Elliott, a T1International trustee, wrote in an email to The Center for Biosimilars®. “We know of at least four young Americans with type 1 who have died since June.”

A bipartisan bill has been introduced that could potentially reduce the price of insulin by 75%, bringing it back down to 2006 levels. Caps on the price increase of insulin would be set as one way to help bring down the type of insulin. But biosimilars insulins are also increasingly seen as a solution to the problem.

Insulin has traditionally been regulated as a drug, not as a biologic. Subsequent-entry versions of insulins are therefore follow-on products, rather than biosimilars, and are not subject to the biosimilar approval pathway’s interchangeability provision. Insulins, along with some other products, will transition to regulation as biologics and biosimilars in 2020, in keeping with a date set out in the Biologics Price Competition and Innovation Act.

“By moving insulin and other applicable products to be under the [Public Health Service Act], Congress has promoted a pathway for follow-on insulin products to become available” acting FDA administer Norman Sharpless, MD said in a May 2019 speech. “So, this means that insulin and insulin analogs will now be open to biosimilar competition. Which in turn can lead to development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness.”

The increased competition biosimilars provide will hopefully drive down the cost of insulin, according to the FDA. Six million people in the United States alone are insulin-dependent, and the introduction of a biosimilar insulin could be revolutionary to their healthcare needs-and policy changes cannot come fast enough; follow-on insulins available to date, including Admelog, which is manufactured by Sanofi and references Eli Lilly’s Humalog, has a list price of only approximately 15% less than Humalog.

According to Elliott, shallow cost savings are because the US insulin market is dominated by just 3 major companies, and competition is not robust.

“So long as the US market is dominated by the Big 3 entities; Eli Lilly, Sanofi, Novo Nordisk, all of whom are under multiple investigations for collusion, I don't see the market changing significantly” Elliott said in his email. “Ultimately, insulin in the US needs to head towards commodity status, and I don't see this happening until there are more than a handful of supplies, or a public or non-for-profit manufacturer.”

The 3 major insulin manufacturers have received subpoenas from the New York attorney general regarding their pricing practices, and the Senate Finance Committee has asked CMS for insulin information as part of its own investigation.

For Elliott, biosimilar insulin and reducing the cost of insulin as a whole will affect everyone—not just insulin dependent people.

“Patients who need insulin to live, their families, government-funded drug programs, tax-payers, shareholders of new entrants, the economy as a whole—the sheer scale of the $30-billion-dollar-a-year insulin market would cause money to be redirected.”

For people living with diabetes, rising costs means less money for daily necessities and can even get too expensive for health insurance to cover. For Tiedemann, her insurance has already switched her medication once because it got too expensive. She’s up to try anything that can help reduce costs.

“I mean, if it's going to do the same thing, why not?”