The current issue of Evidence-Based Diabetes Management explores studies and patient access issues surrounding this closely watched inhaled insulin.
The current issue of Evidence-Based Diabetes Management (EBDM) includes a 2-part feature on Afrezza, the inhaled prandial insulin from MannKind that was approved by the FDA in June 2014. Afrezza is a closely watched therapy in both the diabetes advocacy and the investor communities, who don’t necessarily view its prospects the same way.
Here are 5 things to know about Afrezza:
1. It’s not the first inhaled insulin
Pfizer brought a product called Exubera to the market in 2006, but it failed a year later despite sales projections in excess of $2 billion. Critics and patients alike largely blamed the design of the inhaler, which was quite large and was compared to a bong. Afrezza’s inhaler, which resembles a whistle, has had better reviews, although it reportedly does make a noise.
2. Evidence shows Afrezza acts quickly
An abstract presented in June at the American Diabetes Association showed that Afrezza acts in 12 to 15 minutes; the profile is described in EBDM by R. Keith Campbell, MBA, BPharm, CDE, as much closer to what the body secretes when it consumes food; Campbell describes the action as moving quickly and getting “out of the way.”
3. Many reports on social media are positive
For many patients, Afrezza has been a phenomenon; social media users often post copies of A1C results, accompanied by comments like “best ever,” along with comments about improvements in quality of life due to fewer hassles with injections or adjustments during the day.
4. But there are many barriers to access
Because the drug is inhaled, the FDA requires spirometry before a prescription and at intervals afterward to weed out patients with lung problems. Some physicians won’t prescribe it as health plans have put the drug in costly, non-preferred tiers and prior authorization is required.
5. As a result, the first launch of Afrezza failed
MannKind, the maker of Afrezza, had a marketing agreement with Sanofi that was canceled in January 2016. MannKind regained control of the product and is in the midst of a relaunch that is being closely scrutinized by Wall Street. The company is trying to get more favorable formulary treatment—especially in Medicare—based on recent studies and its lack of price increases. The company plans different pricing strategies and a label update.