Ultra Rapid-Acting Inhaled Insulin Afrezza Now Available in US Pharmacies Nationwide

Twitter Summary: Sanofi + MannKind Afrezza now available in some US pharmacies; prices comparable to Novolog/Humalog, @afrezzauser gives patient perspective!

Update (2/3/15): Today, Sanofi and MannKind announced the official launch of the ultra rapid-acting inhaled-insulin Afrezza. The insulin is now available at pharmacies nationwide. The diaTribe team got an exclusive call with Sanofi executives (Andrew Purcell, Vice President and Head of Sanofi’s US Diabetes Business Unit and Stefan Schwarz, Sanofi’s Head of US Marketing for Afrezza) to discuss the details of the launch and plans moving forward. Below are a few key pieces of information in regards to this official launch:

• The Afrezza “Patient Savings Card” indicates that “depending on your insurance coverage,” the first prescription of Afrezza will cost $0, followed by no more than $30 for each additional refill (each refill supplies two inhalers and a month’s supply of cartridges). We are curious what insurance plans will qualify for this savings plan, but as of now details about Afrezza’s insurance coverage are not available. We have heard anecdotally that Humana insurance will likely make a decision about covering Afrezza within 3-6 months.

• Before receiving a prescription for Afrezza, patients will be required to undergo a breathing test (“spirometry”) to verify their lung health (Afrezza is not approved for people with chronic lung disease, including asthma and COPD). Afrezza is also not recommended in patients who smoke or who have recently stopped smoking. Spirometry is a simple and common examination used to measure how much air the lungs can inhale and exhale, as well as how fast they can exhale. From our understanding, primary care physicians (PCPs) may be more familiar with spirometry testing than endocrinologists (as PCPs use it for patients with asthma and other breathing problems).

• In our call with Sanofi management, we discussed how Afrezza compares to Exubera – the first approved inhaled insulin in the US that was later taken off the market due to issues with its design, cost, dosing complications, and long-term safety concerns. Sanofi management pointed to three main differences between Afrezza and Exubera: (i) the Afrezza device is very small and portable; (ii) the Afrezza device doesn’t require any additional cleaning or maintenance (users simply dispose of the Afrezza device after 15 days of use and replace with a new one); and (iii) Afrezza’s insulin dosing is much simpler as cartridges are labeled in subcutaneous insulin units, so no conversion factor is needed when health care providers prescribe it.

• There are no concrete plans to submit Afrezza for approval outside of the US yet, though Sanofi is currently assessing the possibility of entering Afrezza into a global market.

Original Article (1/29/15):

Sanofi and MannKind's ultra rapid-acting inhaled-insulin Afrezza for type 1 and type 2 diabetes is now available in some US pharmacies! Though Sanofi has not officially announced its availability, Afrezza can now be picked up at retail outlets like CVS and Walgreens – for now, a special pharmacy order may be required, meaning you can pick it ~1-2 days after you turn in the prescription. If interested, please call your doctor to find out the steps necessary to get access to Afrezza.

From speaking with pharmacists, it seems that Afrezza’s cash price costs are comparable to those of Novolog and Humalog insulin pens. While it’s still unclear exactly how much patients with insurance will need to pay for Afrezza, we expect most patients with insurance to have co-pays of around $30. There will be a discount for those paying out-of-pocket, but it will still be expensive (similar to other insulins). Many insurance companies probably won’t make final decisions about Afrezza for some time, but as we understand it, the first month of Afrezza will be free to patients (through coupons that will be on Afrezza.com) and as noted, co-pays will be around $30.

We’ve been monitoring the twitter feed of Sam Finta (@afrezzauser), a type 1 patient took part in Afrezza’s clinical trials and participated in the FDA Advisory Committee hearing for Afrezza, to hear his experience in these early days. Kelly also got the chance to interview Sam in a panel this week for those working with managed care officials and pharmacy leaders. The word so far is certainly very positive (from the other patients she interviewed too!) and we expect the product’s ease of use will appeal to doctors and nurses as well – “ease of use” means it’s more likely that patients will take insulin when they should! Of course, the ultimate goal is that patients have better outcomes while also saving money for the healthcare system, and that will take some time. 

Afrezza could be an especially good option for type 2 patients that are not achieving their goals on pills, as well as any patient that dislikes injections, those struggling to manage mealtime blood sugars, and those who experience lots of hyperglycemia after meals. The inhaled insulin only comes in two sizes right now: equivalent to 4- or 8-units of injected rapid-acting insulin – it will be interesting to see how it is used in type 1. Some may choose to use it for particularly high carb meals or to correct a very high blood sugar; others may want to move to it for more of their insulin needs, especially if they do not experience hypoglycemia, which anecdotally we hear is pretty rare with Afrezza (though this is not on the label). We also hear that Afrezza works pretty quickly – this also is not on the label and is again more anecdotal. For more on Afrezza, please see our coverage of its FDA approval and partnership with Sanofi; we’ll have a Test Drive on it soon!

Kelly Close has been on the scene covering the Afrezza news, check out this video below of Sam Finta using Afrezza!

-AB/KC