|MiniMed 640G continuous glucose monitor--Courtesy of Medtronic|
The notoriously tight-fisted National Institute for Health and Care Excellence (NICE), which makes healthcare product payment decisions for the U.K. on what can be used in the country's National Health Service (NHS), has come out with a recommendation in support of the use of the MiniMed Paradigm Veo system from Medtronic ($MDT). It's specifically for adults and children with Type 1 diabetes who have had disabling episodes of hypoglycemia even with continuous subcutaneous insulin infusion.
The MiniMed Paradigm Veo sensor system includes an automatic insulin shut-off feature as part of the MiniMed 640G CGM and insulin pump system, which was CE-marked more than a year ago in January 2015. Still, NICE cautioned that all of its physician commentators involved in compiling the report that the recommendation was based on had "difficulties in adopting and using the MiniMed 640G system." The system isn't yet approved in the U.S.
Specifically, the report noted concerns that the continuous glucose sensors used in the MiniMed 640G are not as accurate at those in a combination, competitive system made of a CGM from Dexcom ($DXCM) when used with an Animas Vibe insulin pump from Johnson & Johnson ($JNJ). But that Dexcom/J&J combo system lacks the insulin autoshutoff feature that Medtronic's MiniMed Paradigm Veo system offers.
As part of its recommendation, NICE specifically required that Medtronic collect, analyze and publish data on the use of the MiniMed Paradigm Veo including demonstrating that it improves patient outcomes, raises quality of life for patients and caregivers, reduces the number of hypoglycemic episodes, offers health economic benefits and can safely be used by young children and pregnant women.
The agency also advised that patients discontinue use of the MiniMed 640G system if they did not find that it reduced their number of hypoglycemic episodes. It also specifically declined to recommend the latest DexCom system due to "insufficient evidence to support its routine adoption."
All this came despite a steep price tag for a MiniMed 640G insulin pump: £2,995 ($4,330). Its reusable accompaniments are quite pricey as well: £525 for a 10-pack of Enlite glucose sensors, £109.50 for a 10-pack of Mio infusion sets, and £29.50 for a 10-pack of insulin reservoirs.
Medtronic countered with its own figures intended to justify the costs. It said that MiniMed 640G saves £1,500 per year in ongoing costs as compared to a standalone CGM/insulin pump used together and that each time a hospital admission for hypoglycemic disorders was avoided that resulted in a series of savings including £300 to £1,600 for the admission, £300 to £1,600 for emergency care, and £180 to £230 per ambulance call.
While the system does have this insulin autoshutoff feature, it does not venture into the fully automated territory of an artificial pancreas--the user must restart the insulin delivery manually or it will automatically restart after 120 minutes. Although, Medtronic is conducting clinical testing that includes a fully automated insulin restart feature.
"This guidance is a great step forward for ensuring that people with Type 1 diabetes have easier access to the latest technology, which will help those that meet the criteria manage their condition better," said Lesley Jordan, pump user and chief executive of UK Patient Advocacy Group Input, in a statement released by Medtronic.
- here is the NICE recommendation
- and here is the Medtronic announcement