Afrezza, Medicare CGM Struggles Top Stories for 2016 in Evidence-Based Diabetes Managementâ„¢

Afrezza, the inhaled, fast-acting mealtime insulin from MannKind Corporation, remains a curious topic in diabetes care: despite weekly reports from Wall Street about low prescription counts, reader interest is enormous.

Three articles about Afrezza are among the 5 articles in Evidence-Based Diabetes Management (EBDM)™ that generated the greatest online reader interest during 2016. There was no shortage of news about Afrezza over the past year, starting with Sanofi's January announcement that it would end its agreement with MannKind to market the drug. Over the course of the year, MannKind built its own sales force, relaunched the product, and worked with payers to improve access for patients with diabetes.

Michael Castagna, who joined the company as its chief commercial officer, said in an interview that there’s been significant progress on patient access. The most noteworthy milestone came October 1, 2016, when ExpressScripts added Afrezza to its national and Part D formularies, without prior authorization. However, in the quarterly earnings call in November, Castagna said that besides cost, efficacy continues to be an issue with some patients who don’t stay on the drug. He attributed this to the need “to reinforce appropriate titration early on in treatment.” The novelty of the drug’s mechanism of action and the need for an individualized dosing strategy are discussed in EBDM™’s most-read article of the year.

Most-read EBDM™ articles of 2016:

5. Measuring the Quality of Diabetes Care, March 2016

Authors from the Joslin Diabetes Center, Joanna Mitri, MD, MS; and EBDM™ editor-in-chief Robert A. Gabbay, MD, PhD, FACP, who is Joslin’s chief medical officer, outlined the development of the Joslin Clinical Analytic Tool, or JCAT. This method of measuring quality in diabetes care was a cover story in the theme issue, “All About Measurement.”

4. MannKind Path to Afrezza Survival Involves Lower Prices to Woo Payers, March 2016

This update about Sanofi’s decision in January 2016 to sever its marketing agreement with MannKind featured speculation from analysts who follow the company on how it might survive. MannKind has resisted calls to simply cut the price of Afrezza, saying it has not taken a price increase since the launch, and increases in other fast-acting insulins have closed the price gap with those products.

3. A Medicare Appeal for CGM Coverage: One Patient’s Never-Ending Story, May 2016

For the issue on seniors and diabetes, distributed at the 76th Scientific Sessions of the American Diabetes Association, EBDM™ featured a first-person account from Dan Patrick who has lived with type 1 diabetes for more than 50 years. Patrick shared how he gathered data and worked through a complex, multi-level appeal to get coverage for his Dexcom G4 continuous glucose monitor (CGM). Lack of routine Medicare coverage for these devices is one of the thorniest issues on the diabetes advocacy agenda. This week, Patrick said he’s bracing for another round of problems in a new coverage year, but there’s also some hope. FDA granted just a new indication to the Dexcom G5 Mobile, which patients will be allowed to use for dosing. Some believe this will pave the way to more routine Medicare coverage for CGM.

For more on the policy challenge of Medicare CGM payment, read coverage from the FDA advisory panel in July.

2. Patients Report Barriers to Getting Afrezza, but A1C Results Are Worth It, September 2016

For our fall issue on therapeutics, EBDM™ invited followers of our Twitter account @EBDiabetes to share their tales of jumping through hoops with payers to get coverage for Afrezza. The surprise? Stories of having to overcome doctors’ misconceptions about the drug just to get a prescription. In this week’s interview, Castagna said that he gets calls from patients with insurance problems, “All day long. It’s the number one issue I deal with.”

Said Castagna, "The weekly script counts don't reflect the underlying noise." He promised that the "noise" will translate into sales in 2017.

1. Afrezza: Treating Diabetes in a Physiologic Manner, September 2016

The commentary from R. Keith Campbell, MBA, BPharm, CDE, professor emeritus of pharmacotherapy at Washington State University, offered readers both an overview of how the inhaled insulin does its job and a patient’s perspective on using the product correctly. Campbell’s explanation of how titrating Afrezza doses differs from that of other insulins is a must-read for physicians who treat people with diabetes, and for patients considering the drug.