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Evidence-Based Diabetes Management September 2016
Afrezza: Treating Diabetes in a Physiologic Manner
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Patients Report Barriers to Getting Afrezza, but A1C Results Are Worth It

Mary Caffrey
Gaining access to Afrezza can mean battling with an insurer to cover it. Sometimes the first hurdle is getting a doctor to write a prescription, according to those who've been through the process.
In January 2016, an endocrinologist told his new patient that MannKind Corporation was “going out of business,” before he rambled on about having shorted the stock. The doctor said he didn’t want to write a prior authorization (PA) letter for Afrezza because it might damage his reputation with the insurer.

But the patient, Hillard Saveth, didn’t give up. As he relayed in an e-mail to Evidence-Based Diabetes Management (EBDM), Saveth had obtained Afrezza through his former primary care physician (PCP) before a policy change by his pharmacy benefit manager sent him looking for a “letter of medical necessity.” With Afrezza, he’d attained glycated hemoglobin (A1C) levels of 5.7%, his lowest ever. As a person with type 2 diabetes (T2D) and an aversion to needles, Saveth saw Afrezza as a godsend, and he was determined to continue.

By May, the endocrinologist had changed his mind on the fast-acting, prandial inhaled insulin. In the meantime, Saveth spent money out of pocket to stay on Afrezza and keep his A1C at 5.7%. During this period, Saveth even asked for a letter that said he could get Afrezza if he switched to metformin and experienced side effects. He never filled the prescription for metformin that his endocrinologist recommended.

“The long and short of it is, you need to have a plan,” Saveth said. 

Saveth was one of several people who shared with EBDM their stories of trying to gain access to Afrezza, which the FDA approved in June 2014 to treat both T2D and type 1 diabetes (T1D), the latter in combination with a long-acting basal insulin.1 When EBDM asked patients like Saveth to discuss problems with payer coverage, they volunteered stories about doctors reluctant to prescribe the drug, nurses who championed their cause, and a marketing decision by Sanofi that 1 patient found hard to fathom—and that MannKind is still working to undo.

Afrezza’s odyssey, both before and after FDA approval, seems like something from a novel. On one side sits a small core of devoted patients; on the other, there’s an equally active band of analysts who watch MannKind’s every move, tracking its cash position and Afrezza’s weekly script count. Through MannKind’s severed marketing relationship with Sanofi to Afrezza’s closely watched relaunch, one of the drug’s bright spots has been patient reports on social media, often complete with documentation of “lowest ever” A1C levels.2-4

MannKind’s fortunes could rise or fall based on decisions by formulary managers who, so far, have put Afrezza outside the preferred tier in Tier 3, reserved for higher-cost branded drugs. Not only do physicians have to order spirometry tests to weed out patients with underlying lung problems (an FDA requirement),1 but they also must navigate the PA process. Depending on the plan, some patients may not be able to get Afrezza through a PCP, only an endocrinologist. Patients also report having to justify why they haven’t tried older therapies first.

Michael Castagna, MannKind’s chief commercial officer, told EBDM in an interview that it’s frustrating to see a product that is “completely differentiated” from other insulins being treated like an injected product; he said it’s also frustrating that there’s been no recognition that Afrezza has not taken a price increase in 2 years while other insulins have. (Patients who spoke with EBDM reported paying between $180 and $300 out of pocket for Afrezza; a check of GoodRx in early September showed pricing between $272 and $300.)5

Among commercial plans, Castagna said, “we have 71% national coverage.” In Medicare, restrictions are still severe, but where coverage exists, he said 50% of the PAs go through.

This fall, Castagna embarks on the toughest of tasks: a second chance to make a first impression. He and his team must reintroduce Afrezza to patients, payers, and endocrinologists in the wake of Sanofi’s unsuccessful launch, which was abandoned in January 2016.4 MannKind has made new hires, is revamping its speaker program, and will concentrate on endocrinologists, not PCPs. MannKind does have some new tools: evidence presented this summer at the 76th Scientific Sessions of the American Diabetes Association (ADA) shows the drug works much faster than other insulins and leaves the body quickly relative to its rivals. It acts in 16 to 21 minutes compared with 45 to 52 minutes for insulin lispro, and its duration of action was shorter by 2 to 3 hours.6

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