Artificial Pancreas in Limbo for Diabetics Covered by Anthem

[dropcap]H[/dropcap]ealth insurer Anthem Inc. will reconsider its decision not to cover an artificial pancreas for diabetics sold by Medtronic Plc, one of the medical company’s most promising new products.(Source: Family handout)

It would be a welcome change for Medtronic, but one that comes too late for many patients who paid thousands of dollars out of pocket months ago to get access to the breakthrough insulin-pump system.

“They have my device and are sitting on it,” said Faith Cohen Schoenfeld from Tarzana, California, who’s anxious for her 17-year-old diabetic son to get the system before he departs for college next year.

“I’m scared and I’m frustrated.”

Anthem patients who enrolled in Medtronic’s priority-access program for its new device were caught in the crossfire after the insurer deemed the system “investigational

and not medically necessary,” making it the sole holdout among major U.S. insurance companies.

Medtronic, which didn’t anticipate the rejection, won’t ship those patients the product, MiniMed 670G, until they get proof that Anthem will cover the supplies needed to run it.

“For me to know that somebody out there is sitting in an office and making decisions that are life-changing, and they decide you don’t get this, you don’t get to feel better, you lose;

I think there is something wrong with that,” said Katzap-Nackman, who’s also diabetic.

When contacted by Bloomberg News, Anthem defended its May decision, saying its medical policy

and technology assessment committee found that there wasn’t enough evidence to justify coverage.

Only 300 patients with well-controlled diabetes took part in studies of the 670G, an insufficient number, the Indianapolis-based company said in an emailed statement.

But the committee requested more input from specialists including the JDRF diabetes research group and Medtronic,

and will consider the additional information at a November meeting, Anthem said, leaving open the possibility it might change its policy.

That won’t be soon enough for patients. Medtronic’s priority access program ends Oct. 27.

Glucose Spikes

Medtronic said it provided Anthem with data that clearly demonstrate the clinical benefits of the 670G, showing that patients are less likely to have glucose spikes that can cause long-term damage to the heart and other organs, or lead to blindness and amputations.

The insurer’s decision impacts thousands of diabetics, the device maker said by email.

The coverage snag is compounding a supply constraint that’s been crimping sales of the new device, after Medtronic was caught unprepared when the U.S. Food

and Drug Administration approved the 670G in September 2016, earlier than anybody expected.

It wasn’t supposed to be that complicated for patients. The arrival of the world’s first artificial pancreas promised a drastic improvement in the quality of life

and health of people with type 1 diabetes, who don’t naturally produce insulin that’s needed to convert blood sugar to energy.

While older devices automate some of the endless tasks of monitoring and adjusting glucose via an insulin pump, the 670G removes most human involvement, providing 24-hour assistance to smooth the dangerous swings in blood sugar levels.

To improve distribution while also using excess inventory from an earlier version, the 630G, Medtronic got creative.

Its priority-access program lets patients buy the 630G, at their own expense or with insurance help if available, to be first to upgrade to the 670G for a small additional fee, when it became available.

Daily Struggles

Katzap-Nackman, who lives in Marina del Rey, California, decided to enroll after getting multiple calls from Medtronic and hearing her children’s pediatrician sing the praises of the artificial pancreas.

She knows first-hand the daily struggle of controlling diabetes.

Her 12-year-old daughter Mikayla, who has had type 1 diabetes since the age of two, checks her blood sugar a half-dozen times a day, gives herself extra injections when she eats and changes the infusion site for her pump every three to four days.

The seventh grader still struggles to keep her blood-sugar goals.

Months passed until Katzap-Nackman got a letter from Medtronic, saying Anthem wouldn’t cover the new device, and encouraging her to “reach out to Anthem to share why the MiniMed 670G system is medically necessary for you.”

“It was a heart-breaking moment,” Katzap-Nackman said. Her family’s shot at getting to the artificial pancreas quickly will be gone by November.

Adam Schoenfeld, whose mother paid $3,800 out of pocket to priority access the 670G, is also stuck with an older device.

A high school senior, Schoenfeld plans to apply to colleges close to home in Los Angeles and as far away as Colorado and Oregon.

He’s able to maintain tight control of his sugar levels during the day, but suffers from dramatic and unpredictable swings at night.

“I’m definitely worried,” he said. “I don’t let diabetes bring me down, but I don’t want to have to constantly monitor it, every minute of the day.

What I really want the system for is the middle of the night, so I’ll get a good night’s sleep.”

By Bloomberg.com – https://bloom.bg/2yKh2sJ