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  • Novo Nordisk is introducing an "authorized generic" version of its main mealtime insulins starting Jan 2, 2020.
  • The new "Insulin Aspart" and "Insulin Aspart Mix" products will cost 50% less than brand name Novolog insulins.
  • Novo becomes the second insulin manufacturer to take this route: Eli Lilly launched a half-price version of its mealtime Humalog insulin earlier in 2019.
  • Novo is also introducing a new $99 cash card that can be used for monthly supplies of its brand name insulins (not the generics).

Novo Nordisk has announced that it will launch a new so-called “authorized generic” version of its Novolog and 70/30 Mix insulins, that will sell at 50% off the high list price of those products. This is the second of the "big three" insulin manufacturers to take this step, after Eli Lilly did the same earlier in the year.

Announced Sept. 6, the Denmark-based Pharma giant with US headquarters in New Jersey said this newly-approved “insulin aspart” and “insulin aspart mix” will be available in pharmacies starting on Jan. 2, 2020. In addition, Novo Nordisk US will be offering patients a new flat-rate savings card for its non-generic insulins.

“We have to do this,” said Ken Inchausti, Senior Director of Corporate Communications for Novo Nordisk US, who has been monitoring the affordability issue dating back to his time working for the American Diabetes Association in the 1990s. “People are running into issues getting their insulin or finding it unaffordable... it’s an acute moment, a crisis moment, and we’ve seen too many stories of what happens sometimes. We’re trying to ensure that we can have something that can be easily accessible in a moment when someone needs help.”

The current Insulin Pricing Crisis in America is clearly a huge systematic failure that’s been created over decades. Today, the level of public outcry and media coverage has brought this to the forefront of public discourse.

From talking with Inchausti and other company sources, here's what we learned about Novo’s new move to address the issue:

 

What's an "authorized generic" insulin? 

This is a specific FDA-regulated category, referring to a drug that’s identical to the original analogue insulin and therefore doesn't need additional FDA approval; the manufacturer can simply slap on a new label and let the federal agency know it’s done that. For detail on the regulatory side of this, here's the official FDA page on "authorized generic" medication.

 

Is it really the same insulin? 

Yes, it is. Novolog was first approved by the FDA in 2000 (following Lilly’s Humalog as the first mealtime analogue insulin in 1996). Now, nearly two decades later, this “Insulin Aspart” is kind of like water coming out of the same tap, but going into two bottles with different labels. The chemical makeup of the insulins is exactly the same.

When it comes to insulin types, there's a lot of confusing language -- "analogues," "biosimilars," "follow-ons," and "generics."

Learn all about it by reading: WHY ISN'T THERE MORE AFFORDABLE GENERIC INSULIN?

 

What will the actual price be?

Here’s the breakdown, per Novo Nordisk sources:

  • Insulin Aspart 10mL vial: $144.68 (compared to $289.36 for Novolog)
  • Insulin Aspart penfills (box of five 3mL pen cartridges): $268.73 (vs $537.47)
  • Insulin Aspart FlexPens (box of five 3mL pens): $279.41 (vs $558.83)
  • Insulin Aspart 70/30 mix (10mL vial): $150.06 (vs of Novolog 70/30 mix $300.12)
  • Insulin Aspart 70/30 mix FlexPens (box of five 3mL pens: $279.41 (vs $558.83)

 

How did Novo decide on the 50% off price point? 

“In line with our affordability offerings, we thought it would help people in High Deductible Health Plans (HDHP) reduce their out-of-pocket costs," Inchausti says. "We know that it’s a major concern for those people... so this product will be useful in that context. One solution isn’t going to fit every situation. For some, this follow-on brand may be applicable to their situation. The cash card or other programs may be applicable to someone else. We want to make sure that there’s diversity in the offerings we have."

 

How can people use the new Novo insulin cash savings card?

The new $99 Cash Card Program is for the company's main analog insulins (not for the new authorized generic insulins):

  • Allows purchase of up to three vials or two packs of FlexPen/FlexTouch pens of any combination of Novo Nordisk analog insulins (3000-3600 units total per month depending on the brand) for a flat cost of $99. Novo points to clinical study data suggesting that is the max amount needed to cover the monthly needs of most people with diabetes. Should someone have a medical requirement for more, they can obtain a second $99 Savings Card for the same amount of insulin.
  • Eligibility specifics are still being determined, but it will be for the uninsured and those with commercial insurance; it is not allowed for people on Medicare and Medicaid.

To learn more about other Novo savings options, the company encourages people to visit their NovoCare site or call (800) 727-6500.

 

Why wasn't Novo's generic offered sooner, especially in response to Lilly's half-price Lispro insulin?

“I would not say it’s in response to someone else. These are not meant to be competitive, at all," Inchausti says.

"It’s about (us) working on affordability programs for quite some time... We’ve had Patient Assistance Programs for 15+ years. But we’ve seen changes in health coverage, changes in benefit design and deductibles, and you’re seeing the trend line go up on high deductible health plans, and sometimes it’s all that's offered… So we want to see what more we can be doing to provide people support in the context of those changes. We’re always trying to find solutions within this healthcare system we have now.”

 

Why not just reduce the price of existing Novolog insulins? 

Like Lilly before them, Novo cites the complex U.S. drug pricing system. This includes existing contracts for those analogue insulins that if changed, could potentially endanger broader access.

(While it seems like a straightforward option, it’s not as simple as flicking a light switch, we're told -- at least not without blowing the fuse box circuits attached to the big electrical system that is currently how insulin and drug pricing works.)

 

What if insurance companies and PBMs (Pharmacy Benefit Managers) choose not cover the new low-cost insulins?

Nothing forces them to. As we’ve seen with Lilly’s Insulin Lispro, big players like Express Scripts (owned by Cigna) can opt not to cover this and continue collecting rebates for the higher-priced analogue versions.

Inchausti says Novo is "having conversations with payers" in advance of the launch in January 2020. He points to “misaligned incentives” that often drive decision-making on insurance coverage and formulary inclusion, and notes that Novo (and others) have raised that issue publicly and before Congress. The value of these new type of medications to patients needs to be made clear, and payers need to have an incentive to care about that.

“It’s a conversation that needs to be happening within the community, as to why these medications aren’t being put on a formulary," he says.

 

What other lessons has Novo learned by watching its competitor Lilly do this before?

While Inchausti says he doesn't want to make comparisons, he notes that "one of the things we are doing... is working with our stakeholders and supply chain -- with wholesalers, pharmacy benefit managers, within the system." He says the Jan. 2 launch date was selected to allow time for those negotiations, to "make sure these options are available and easy to access.”

 

The bottom line

With skyrocketing insulin prices now becoming a political hot button, the big insulin makers have certainly been under increasing pressure -- especially with heart-breaking stories surfacing about insulin rationing leading to patient deaths. Grassroots #insulin4all advocates are currently holding a series of vigils and protests nationwide to raise the public profile on this issue.

While this is a good step forward, it can be seen as too little, awfully late. Still, with two out of three big insulin manufacturers taking steps to lower prices, it seems there is light at the end of the tunnel for improving insulin access and affordability.

No doubt that more could’ve been done sooner, but this can still help people who need it. Here’s to improving access and affordability in whatever ways possible, while continuing to push for bigger systematic changes.