Commerce Impacts Access to 'Artificial Pancreas' for US Patients

Miriam E Tucker

October 12, 2017

A major insulin-pump manufacturer has withdrawn from the US and Canadian markets, while another is experiencing supply and reimbursement problems.

While technology certainly represents the new frontier in diabetes management and there is much positive news, such as the recent US approval of Abbott's novel FreeStyle Libre Flash Glucose Monitoring System, the field is not without its setbacks.

This latest involves the departure of Animas Corporation (a division of Johnson & Johnson) from the North American insulin-pump market, with the firm directing their 90,000 customers over to Medtronic.

At the same time, Medtronic itself is experiencing a supply problem, preventing shipment of the sensor component of its hybrid closed-loop 670G insulin-delivery system (dubbed the first "artificial pancreas") to new customers, as well as a major insurer's refusal to cover the system.

And of course, this is all happening against a backdrop of uncertainty regarding the whole US healthcare system and the extent to which people with diabetes and other chronic diseases will be able to obtain sufficient insurance coverage to provide access to advances for treatment in both the near and longer term.

Animas Exits the United States and Canada

Animas announced its decision to discontinue manufacture and sale of both its Vibe and OneTouch Ping insulin pumps in the United States and Canada last week.

"This decision was extremely difficult and comes following an extensive exploration of all viable other options for the Animas business," the company said in a statement.

JDRF (formerly the Juvenile Diabetes Research Foundation), decried the move, saying in a statement "JDRF is extremely concerned that Animas Corporation will be closing operations and ending the sale of its insulin pumps, as it means fewer treatment options for people with type 1 diabetes....Innovation and competition are essential to the development of next-generation therapies."

Patients currently using Animas pumps and supplies will continue to receive support and supplies through a transition period, and warranties will be honored through September 30, 2019.

Those with pump warranties expiring on or after that date will be contacted by Medtronic and offered the option to transfer to that company's 630G sensor-augmented pump system (not the 670G hybrid closed-loop system) at no cost.

Patients and providers can also check the Animas website for more information.

Of course, patients aren't obligated to switch to Medtronic, and competitors including Tandem Diabetes and Insulet are both offering special arrangements to draw in current Animas users. In the case of the latter, Insulet is offering a no-cost trial of its tubeless insulin-pump Omnipod System.

Artificial-Pancreas Sensor Supplies Not Meeting Current Demand

Demand has been so high for the Medtronic 670G, dubbed the first "artificial pancreas" when it was approved by Food and Drug Administration in September 2016, that Medtronic was already struggling to keep up with supply of the system's continuous glucose monitor (CGM) component when Hurricane Maria hit Puerto Rico, damaging a key Medtronic plant located there, Mike Hill, vice president, marketing, global integrations, said in a statement provided to Medscape Medical News.

"Our main priority is the safety of our employees who live on the island as well as our customers who rely on our therapies for the management of their diabetes….Our facility is returning to full production, and our teams are working around the clock to produce new products as quickly as possible," Mr. Hill said.

In the meantime, the full 670G system — algorithm-enabled pump plus CGM — is being shipped only to patients enrolled in Medtronic's Priority Access Program, which was created to allow those who were using the 630G to be the first to switch to the 670G, while new users are receiving just the pump.

One Insurer Says No to the Artificial Pancreas/670G

Adding to frustrations, one major US insurance company, Anthem Blue Cross/Blue Shield, has said it will not cover the Medtronic 670G because it "considers the device to be investigational and not medically necessary."

In a statement provided to Medscape Medical News, Anthem said that after extensive review, its Medical Policy & Technology Assessment Committee (MTPAC) "concluded that there is not yet enough data on the longer-term safety and efficacy of hybrid closed-loop devices based on review of limited available published studies. These studies involved fewer than 300 people, all of whom had well-controlled diabetes."

Anthem's medical policy team will continue to monitor the evidence for the 670G "as more user data/experience and clinical literature become available to better understand the risks and benefits of hybrid closed-loop therapy. Updated information will be presented to the MTPAC at least once a year or sooner if appropriate."

Medtronic's Mr Hill told Medscape Medical News that Anthem is the only major commercial payer in the US that has decided not to cover the 670G/artificial pancreas.

"This decision impacts thousands of patients with diabetes who are not able to access this important therapy," he said, noting that this decision was made despite Medtronic providing Anthem with data from JAMA showing that "patients on the system experienced less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia, and reduced A1c when compared with those not on the therapy."

"We are hopeful Anthem will reevaluate the data we presented and move their decision more in line with the rest of the major payers in the country," he stressed.

In addition to the commercial space, 16 State Medicaid plans "have published CGM policy that does not limit access to the MiniMed 670G system," he added.

JDRF has just launched a new phase of its "Coverage2Control" campaign urging insurers not to restrict patient choice regarding diabetes technologies.

"Through these and other efforts, it's our goal to ensure that people with type 1 diabetes continue to have treatment options, as we work toward our ultimate vision of a world without type 1 diabetes," the organization notes in a statement. 

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