More than 36 million people in the United States have Type 2 diabetes, and roughly 22 percent of them — or about 8 million — require daily insulin injections to control their blood glucose levels.
Starting this week, that grueling regimen can be reduced to just one shot a week.
Novo Nordisk announced Tuesday that it is rolling out a weekly insulin injection for Type 2 diabetes called Awiqli. It is the first-of-its-kind weekly dose to reach the market, after approval by the Food and Drug Administration in March.
The appeal of reducing 365 shots a year to 52 is obvious: greater convenience, less pain. Novo Nordisk says removing the daily requirement can create “a routine that feels more manageable.”
But there are other issues to keep in mind — most importantly, the risk of hypoglycemia, or low blood sugar, which Novo Nordisk said was a common adverse reaction in Awiqli clinical trials. Hypoglycemia can make people feel shaky, irritable, and, if the blood sugar gets very low, confused. It can be dangerous and can even cause death if it gets excessively low.
Another factor is access: It is not yet clear which insurance plans will cover Awiqli and whether they will require patients to jump through hoops to qualify for coverage.
Two prominent doctors who specialize in treating diabetes discuss what patients need to keep in mind.
Is this drug for everyone who requires insulin for Type 2 diabetes? Who could benefit most?
Some of the most obvious candidates for a once-weekly jab are people with disabilities, elderly people in assisted-living facilities, people with memory problems, or others who have trouble keeping track of their blood sugar and insulin needs on their own, said Rozalina McCoy, an endocrinologist at the University of Maryland School of Medicine.
“It would be very helpful for them to have somebody come to the home once a week to give them an injection. That is a huge advantage,” said McCoy, who was not involved in the drug’s development.
For people in nursing homes where low staffing is a constant issue, she added, reducing insulin to a once-a-week dose would ease the burden on nurses.
Yet extra caution is required to guard against hypoglycemia in the elderly, which may cause doctors to hesitate before prescribing Awiqli, said Kasia Lipska, a Yale School of Medicine endocrinologist.
“I think this will be a niche type of insulin and not widely adopted,” she said. “Its main advantage — the long duration of action — is also its central limitation.”
Novo Nordisk said in an email that Awiqli, as the only weekly insulin available, offers patients an option, “recognizing the importance of personalized care and the need for treatments that fit different routines and preferences for adults living with type 2 diabetes.”
What are the potential problems? What are considerations for glucose monitoring throughout the week?
Patients should still monitor their glucose every day, McCoy said, so doctors will know the size of the weekly Awiqli dose that is required.
Patients should start with a conservative dose, so their blood sugar is not pushed down too low with a drug that will be in their system all week, she said.
If a patient is already doing well on a daily insulin dose, doctors can multiply it by seven to calculate the Awiqli dose, McCoy said, citing the FDA-approved label. If they are new to insulin, they should start with the lowest dose, she said, and work their way up.
What is the cost, and will insurance cover it?
Novo Nordisk said the list price of Awiqli — before insurance and discounts — will be $99 for a box containing a single, multi-dose injector pen. How long the pen lasts depends on the dose each patient requires; some patients could use less than a whole pen in a month, others more. Novo Nordisk defines a monthly supply as two pens.
Novo Nordisk said the weekly drug will cost $35 for a monthly supply for people with Medicare Part D plans or commercial insurance. For people without insurance, Novo Nordisk has a discount program that will set the price at $55 for a monthly supply.
But whether Medicare Part D plans and commercial insurance plans treat Awiqli differently from other insulins remains to be seen. Drug coverage tiers are called formularies.
“They don’t have to place it on the formulary, or could place restrictions on it,” Lipska said. “Prior authorization or step therapy is quite plausible, particularly early on.”
CVS Health, which is the umbrella for Aetna health insurance and CVS Caremark pharmacy benefit management, said it was reviewing the new drug and had not made any determinations. UnitedHealth Group, the nation’s largest insurer, declined to comment.
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