Federal Intervention Needed on Insulin Prices

Marcia Frellick

June 18, 2018

CHICAGO — Insulin prices have nearly tripled in a decade and the American Medical Association (AMA) is calling on the Federal Trade Commission and the Justice Department to take action.

"It is shocking and unconscionable that our patients struggle to secure a basic medicine like insulin," William McDade, MD, PhD, an AMA board member, said in a news release. "The federal government needs to step in and help make sure patients aren't being exploited with exorbitant costs. The AMA also plans to educate physicians and policymakers on ways to tackle this problem, and transparency from manufacturers and [pharmacy benefit managers] is a good place to start."

The average price of insulin — for which there is no generic equivalent — increased from $4.34/mL in 2002 to $12.92/mL in 2013, according to one study (JAMA. 2016;315:1400-1402). The cost of insulin per patient in the United States is "greater than all other antihyperglycemic medications combined," the authors point out.

Eli Lilly & Co.'s best-selling insulin, Humalog, cost $21 per vial in 1996, but that had increased to $275 per vial by 2017, according to a recent report in Bloomberg.

Lilly, Denmark-based Novo Nordisk, and France-based Sanofi dominate the market. In 2015, the three companies earned 93% of the revenue in the insulin market and produced 92% of the product, as reported by Medscape Medical News.

Insulin costs six times as much in the United States as it does in much of Europe, according to the American Diabetes Association. Of the more than 30 million Americans who have diabetes, about 7.4 million depend on insulin, the association reports.

At a "Breaking Point"

David Tridgell, MD, an endocrinologist from Park Nicollet in St. Louis Park, Minnesota, said he agrees that change must start with transparency.

Virtually every endocrinologist I've spoken with has had one or more patients end up in the hospital with diabetic ketoacidosis because they can't afford their insulin.

"It doesn't do anything to directly affect price, which is why I think, politically, Congress might be more willing to start with transparency," he told Medscape Medical News. "At the very least, you'll see who the really bad players are, and that might shame them into cleaning up their act. That's step 1 in a very long list of things that need to happen to bring prices down."

Current patient experiences show that we are "at a breaking point, or beyond," said Tridgell. He reported that a 65-year-old patient with type 1 diabetes, new to Medicare, told him recently, and gave him permission to share, that, "in 2017, I had to decide between food, rent, and insulin. I couldn't do it, so I had to move back in with my daughter.

"Virtually every endocrinologist I've spoken with has had one or more patients end up in the hospital with diabetic ketoacidosis because they can't afford their insulin," Tridgell said.

Working with patients in a compassionate manner to determine whether they are having trouble paying for their insulin and then leading them to resources that can help takes a significant amount of time, he added.

In December 2017, the US Food and Drug Administration (FDA) announced that it would add insulin to its campaign to encourage generic competition for brand-name products that the agency believes are causing excessive burden to the health system, according to a Bloomberg report.

FDA Adds Insulin to List Needing Generics

The campaign is meant to highlight opportunities for manufacturers of generics, and the FDA expedites review of any application for a product on the list.

The AMA is calling for more physician education on price and transparency. If information systems can integrate data on prices, physicians will be in a better position to help patients who have trouble paying for insulin.

In Los Angeles, there is a strong black market for insulin, said Mayer Davidson, MD, from the Charles R. Drew University of Medicine and Science and the David Geffen School of Medicine at UCLA in Los Angeles.

Often, people who are prescribed more expensive analog versions of insulin will sell those online and then buy $25 vials of ReliOn human insulin at Walmart for their own use, he explained. Walmart and Novo Nordisk have a partnership to sell the human insulin vials at reduced prices.

This is a small example of the intricate web of buyers and sellers and negotiators that make solutions monumentally complex.

Some of the recommendations in a new comprehensive report that outlines the problem (Diabetes Care. 2018;41:1299-1311) match those voted into policy here at the AMA 2018 Annual Meeting, Davidson explained.

What needs to change is something very fundamental.

Tridgell said he would like to see the AMA join with other societies and associations that are making similar calls to action and present a united slate of recommendations to Congress.

Davidson said he agrees. "It has to be done in a systemic way. You can't have different guidelines coming from different directions. What needs to change is something very fundamental. We have to find out exactly how the system works before you can suggest ways to change it."

McDade, Tridgell, and Davidson have disclosed no relevant financial relationships.

American Medical Association (AMA) 2018 Annual Meeting. Presented June 15, 2018.

Follow Medscape on Twitter @Medscape and Marcia Frellick @mfrellick

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