Biosimilar Insulin Could Offer Patients Cost-Saving Options

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 received her diabetes diagnosis at age 25 and has depended on insulin for the past 20 or so years: Humalog (insulin lispro), which is manufactured by Eli Lilly, and Levemir (insulin detemir), which is manufactured by Novo Nordisk. She is enrolled in Medicare and has an AARP supplement health plan.

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

Tiedemann is lucky. Her son picks up the cost of her 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 with The Center for Biosimilars®. "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 increased by nearly $3000 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,¹ 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.²

“The fact that type 1 diabetes has gone from a death sentence to a survival condition [and] back to a death sentence in the United States is shameful,” James Elliott, a T1International trustee, wrote in an email to The Center for Biosimilars®. “We know of at least 4 young Americans with type 1 who have died since June.”

A bipartisan bill has been introduced that could reduce the price of insulin by 75%, bringing it back down to 2006 levels.³ Caps on the price increase of insulin would be set as one way to help keep the cost of insulin in check. But biosimilars insulins are increasingly being seen as a solution to the problem.

Insulin has traditionally been regulated as a drug, not as a biologic. Newer versions of insulins are therefore follow-on products, rather than biosimilars, and are not subject to the biosimilar approval pathway’s interchangeability provision. However, 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,” Norman Sharpless, MD, acting FDA commissioner, said in a May 2019 speech. “So, this means that insulin and insulin analogues 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.”⁴

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 depend on insulin, and the introduction of a biosimilar insulin could be revolutionary to their healthcare needs. The policy changes cannot come fast enough: Follow-on insulins available to date, including Admelog,⁵ 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 [of] 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 [United States[ needs to head toward 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,⁶ and the Senate Finance Committee has asked CMS for insulin information as part of its own investigation.⁷

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-a-year insulin market would cause money to be redirected.”

For people living with diabetes, rising insulin costs means less money for daily necessities and become too expensive even with health insurance. 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?”

References

1. Biniek JF, Johnson W. Spending on individuals with type 1 diabetes and the role of rapidly increasing insulin prices. Health Care Cost Institute website. healthcostinstitute.org/research/publications/entry/spending-on-individuals-with-type-1-diabetes-and-the-role-of-rapidly-increasing-insulin-prices. Published January 21, 2019. Accessed August 20, 2019.
2. Life with diabetes is complicated. T1International website. t1international.com/about/. Accessed August 20, 2019.
3. Summary of the Insulin Price Reduction Act. Shawebsite. shaheen.senate.gov/imo/media/doc/Insulin%20Price%20Reduction%20Act%20Summary.pdf. Published July 22, 2019. Accessed August 19, 2019.
4. Sharpless NE. Remarks by Acting Commissioner Ned Sharpless at the FDA public hearing on the future of biosimilar insulin. FDA website. www.fda.gov/news-events/speeches-fda-officials/remarks-acting-commissioner-ned-sharpless-fda-public-hearing-future-biosimilar-insulin-05132019. Published May 13, 2019. Accessed August 10, 2019.
5. FDA approves Admelog, first short-acting follow-on insulin product to treat diabetes [press release]. Silver Spring, MD: FDA; December 11, 2017. www.fda.gov/news-events/press-announcements/fda-approves-admelog-first-short-acting-follow-insulin-product-treat-diabetes. Accessed August 21, 2019.
6. Silverman E. New York attorney general probes big three insulin makers over their pricing. STAT website. statnews.com/pharmalot/2019/07/30/insulin-sanofi-novo-lilly-ny-probe/. Published July 30, 2019. Accessed August 20, 2019.
7. Grassley, Wyden seek insulin cost data from CMS [press release]. Washington, DC: US Senate Committee on Finance; May 21, 2019. finance.senate.gov/chairmans-news/grassley-wyden-seek-insulin-cost-data-from-cms. August 21, 2019.