Harvard Study Finds Older, Cheaper Insulins Are Safe

Patient Hilda Kaelber (68) from Munich injects herself with an insulin pen in Munich, Germany, Friday, Feb. 2, 2007. Photographer: Guido Krzikowski/Bloomberg News

With little fanfare, a private Medicare delivery system owned by insurer Anthem Inc. moved thousands of elderly patients with diabetes from costly new insulin drugs such as Sanofi's Lantus to older and cheaper insulin products.

The health system saved millions. But many of the patients ended up better off financially, too: Fewer of them hit the Medicare coverage gap, where patients pay a significant portion of the costs. While blood sugar increased slightly on average, there was no rise in emergency-room visits or hospitalizations from dangerously low or high blood sugar.

That's the conclusion of a new study from Harvard Medical School researchers that could change how diabetics are treated and change the fortunes of drugmakers.

For years, even as insulin prices rose sharply, doctors continued to put patients on some of the mostly costly new versions. But increasingly, top researchers are questioning whether drugs such as Lantus from Sanofi, Levemir and Novolog from Novo Nordisk A/S, and Humalog from Eli Lilly & Co. are really needed for many patients.

The results, published on Tuesday in the Journal of the American Medical Association, suggest it is safe to switch most type-2 diabetes patients away from newer, more expensive drugs, especially if cost is an issue.

"Quite simply, it means that switching many or most patients with type-2 diabetes from analog to human insulin is probably safe and effective and in addition, it could be very much cost-saving," said Jing Luo, the Harvard Medical School researcher and internist who is the lead author of the study.

The insulin switch was conducted by CareMore Health, a doctor-led health care delivery arm of Anthem Inc. that treats patients in private Medicare and Medicaid plans in a number of states. It features neighborhood care centers within three to five miles of where patients live.

Drug Switch

The care organization had historically provided the most costly insulin drugs to Medicare patients without any copayment. But as prices for the drugs soared, it reconsidered its approach in 2014. It decided it would switch patients en masse to older insulin drugs that cost less. Copayments on the newer drugs were raised for some patients after the switch, while patients prescribed the older insulin drugs didn't have a copay, according to the study.

"There had never been a large scale effort like ours to migrate an entire population from analog insulin to human insulin," said Sachin Jain, chief executive officer of CareMore Health and a co-author of the study. "We did this with some trepidation." But it worked out well, he said.

The health system's monthly insulin expenditures plummeted from $3.4 million in late 2014 to $1.4 million at the end of 2016, according to the results in the Journal of the American Medical Association. While blood-sugar levels on average increased slightly, this small difference may not be clinically important, the study concluded.

More importantly, many patients saved money, too. Prior to the switch, 80.4% of the insulin patients reached the Medicare coverage gap, or so-called donut hole, Harvard's Luo said. In 2016, after patients were switched, only 52.7% of the patients had spending that was high enough to put them in the coverage gap, Luo said.

Contested Conclusions

In an email, Sanofi said that the study was unable to detect rates of minor low blood sugar episodes or nighttime low blood sugar episodes that can be potentially life-threatening.

"This, among other limitations, make it difficult to draw any conclusions," spokeswoman Ashleigh Koss said in an email. Some 85% of people who use Sanofi's insulin products pay less than $50 a month out of pocket, she said.

Eli Lilly, which makes both new analog insulin products as well as older human insulins, said it believed that treatment choice should be between a patient and his or her doctor.

"Analogs and human insulin both have revolutionized the way diabetes is treated and both continue to have a place in today's treatment regimen," spokesman Gregory Kueterman said in an email.

While older human insulin products are an important option, "insulin analogs continue to play a critical role in overall diabetes management," said Ken Inchausti of Novo Nordisk, in a statement. Novo's human insulin is available at many retail pharmacies for $25 a vial, he said.

In an editorial accompanying the study in JAMA, Yale School of Medicine professor Kasia Lipska said that the new insulin products "do not offer major advantages," although the may modestly reduce nighttime low blood sugar episodes.

"These findings should prompt physicians and patients to reconsider which type of insulin is best," she wrote.

Overall, 14,635 CareMore plan members took insulin during the study period, according to the study. The vast majority had type-2 diabetes, in which the body still produces insulin but is resistant to its effects.

— Read Drug Prices Drive Many Americans to Black Market for Medicines, on ThinkAdvisor.

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