Presentations by Kasia Lipska, MD, Alan Carter, PharmD, David Robbins, MD, and Robert Ratner, MD, with Commentary by Scott Isaacs, MD
A panel of experts talked about the challenges given skyrocketing prices and what physicians can do when prescribing needed medications to ease the cost for patients at the American Diabetes Association (ADA) 77th Scientific Session, Dealing with the Rising Costs of Insulin—An Active Dialogue.1
It may be hard to imagine but when insulin was discovered in 1921, it was very affordable, supporting the scientists desire to share the method of preparation so everyone would be free to make produce it, and could not secure a ''profitable monopoly."
Times have changed, as four experts addressed the current state of prescription medication costs. While the approaches the panelists offered to the problem were different, with so many patients priced out of necessary medications, the one area of agreement was a critical need to find a solution.1
To better understand the price jumps, knowing the history of insulin can help,1 said Kasia Lipska, MD, assistant professor of medicine at Yale University School of Medicine in New Haven, Connecticut.
''The discovery of insulin was an unbelievable achievement," Dr. Kipska said. The early products weren't perfect as they had a short duration, ''so patients had to do a lot of injections."
“Neither was early insulin pure. There were people who died from anaphylactic reactions," she said.
Then, improvements were achieved,1,2 such as:
With these advances, however, came new patents, and ''these patents now extend well into the 21st century," Dr. Lipska said. "The term is generally 20 years."
As insulin analogs came onto the market, the proportion of insulin users with type 2 diabetes (T2D) using human versus analog reversed.2 In 2000, insulin analog users were in the minority, and by 2010, they were the majority.
That led to ''the big three" sharing the market space, said Dr. Lipska, with:
Biosimilar formulations often provide an expectation for price relief, Dr. Lipska said but has not always born out. For example, a lower price was not seen with the introduction of Basaglar (glargine), which was approved by the Food and Drug Administration (FDA) in 2015 (and didn’t enter the US market until Dec. 2016, due to delay in entry because of patent infringement litigation).
However, Basaglar was approved not as a biosimilar but as a ''follow-on'' biologic, meaning it was deemed safe and effective based on some evidence from previous studies allowing it to qualify for 3, 5, or 7 years of market exclusivity.
This approval scenario did not drive down costs—its best list price in New Haven, Dr. Lipska said, was $332.50 for 5 kwikpens.
She called this the ''paradox of incremental innovation,'' noting that older insulin products did not generate a market for generic, lower-priced competition given that many of the older formulations became obsolete or were removed from the market.
Prices of some insulins have gone up more than 350%. A vial of Humalog, for instance, cost $21 in 1996. By July 2016, it was $255, which is 700% higher, said Dr. Lipska, when adjusted for inflation.
Yet, Novolin at Walmart is only $25, as many speakers pointed out.1
“Multiple players have an affect on insulin costs,” said Alan Carter, PharmD, principal investigator at MRI Global, a non-profit research organization and adjunct professor of pharmacy at the Kansas City School of Pharmacy at the University of Missouri, Kansas City.
Among the contributing parties:
Behind the scenes, there is also Medicare Part D, the Affordable Care Act, and pharmacy benefit managers (PBM).
Dr. Carter took issue not only with the rising costs but also with the insulin monitoring for quality post-FDA approval. As it stands, manufacturers perform internal quality monitoring, with the FDA inspecting manufacturing records and facilities, and adverse event reports serving as an early warning for the FDA.
The bigger problem is the lack of clarity on adverse events for insulin, with Dr. Carter asking "What is an adverse event with insulin— Is it hypoglycemia, hyperglycemia, HbA1C?”1
With cost a growing challenge for many patients, clinicians need to think of alternatives, said David Robbins, MD, professor of medicine and director of the KU Diabetes Institute at the University of Kansas Medical Center in Kansas City.
“When interpreting studies, for instance, it's important to differentiate statistically significant from clinically significant,” said Dr. Robbins.
He offered a few more suggestions:1
"It's not the technique of monitoring, it’s the education and motivation given the patient," he said.
“Human insulin is a less expensive option and could relieve the financial pressure for many patients,” Dr. Liska said and the others agreed.
In a viewpoint published in Journal of the American Medical Association,2 Dr. Liska and her coauthors suggested that practitioners consider recommending human insulin for the patient who might need financial relief, along with instructions on how to best use it.
Clinicians need to examine our own behaviors, Dr. Robbins said. "We are part of the problem,” he said, “That sample in the drug cabinet, for instance, may sometimes sway prescribing practices.” Free now, expensive later.
The FDA could raise the bar for new drug testing, Dr. Robbins said. "The FDA often allows new drugs to be tested against placebo rather than older drugs."
"The opportunity for the ADA is to be more transparent about their funding," Dr. Robbins said, offering knowledge of an estimated annual revenue of more than $31 million received by the ADA from drug companies.” The ADA should also consider changing its practice of accepting advertising from pharmaceutical companies in its journals,1 Dr. Robbins said.
In covering all bases, pharma could provide real and accurate expenditures to ''make us aware of what it costs to bring a new drug to market," he said.
The ADA has asked for a congressional hearing into insulin prices, said Robert Ratner, MD, formerly chief medical and scientific officer for the ADA and now at Medstar Health Research Institute in Hyattsville, Maryland.
The association launched a public petition on insulin pricing as part of its initiative—Stand Up for Affordable Insulin—to encourage greater patient participation in demanding that lifesaving insulin to be affordable,3 said Dr. Ratner, "As of this week, it has 250,000 signatories."
“The main triggers for soaring insulin costs cited by the speakers rings true,” said Scott Isaacs, MD, FACP, FACE, told Endocrine Web. Dr. Isaacs is the medical director at the Atlanta Endocrine Associates, and on the faculty at the Emory University School of Medicine, in Atlanta, Georgia.
In Dr. Isaacs' opinion, ''the major cause for the rise in insulin prices are the pharmacy benefit managers."
His shared four actions with EndocrineWeb that colleagues can consider taking to help keep costs down for patients is:
Dr. Liska reports no relevant disclosures. Dr. Carter is a scientific advisory board member for Epinex Diagnostics. Dr. Isaacs is a consultant for Novo Nordisk and is on the speakers' bureaus for Novo, Takeda Pharmaceutical Company, and Orexigen Therapeutics Inc.