V-Go Insulin Device a Solution to Insulin Underuse

A new way to lower medical costs for patients with diabetes

With Pablo Mora MD and Irl Hirsch MD

Data presented on V-Go suggests that the system can reduce diabetic related costs and improve glycemic control.

Over 9% of the world’s population is diabetic, with an annual cost in the United States of $327 billion USD. The American Diabetes Association estimates that the medical costs carried by diabetic patients are 2.3 times more than non-diabetic patients. The individual “cost” of diabetes can be broken down into three factors: direct costs, cost of diabetic complications, and lost work productivity. In patients already at an economic disadvantage, these factors can combine to exacerbate each other, creating a downward health and economic spiral.

Cost-related insulin underuse

In 2018, researchers from the Yale School of Medicine and Harvard Medical School asked diabetics visiting the Yale Diabetic Center six questions: In the last 12 months, have you done one or more of these, because of cost?

  • Used less insulin than prescribed?
  • Tried to stretch your insulin?
  • Taken smaller doses of insulin than prescribed?
  • Stopped using insulin?
  • Not filled an insulin prescription?
  • Not started insulin?

They found that nearly 1 in 4 patients in their urban center answered yes to at least one of the questions. Furthermore, those patients with cost-related insulin underuse were 2.9 times more likely to have poor glycemic control, as indicated by A1c levels. This lack of control can lead to diabetic-induced complications such as diabetic retinopathy, neuropathy, and nephropathy. Reduced control can also aggravate comorbidities.

Adherence to diabetic treatment regimens improves glycemic control, but when patients are underusing their insulin medication due to the cost of insulin and diabetic supplies, then they are no longer controlling it.

In an abstract by presenter Pablo Mora, MD, endocrinologist at Dallas Diabetes and Endocrine Center at Medical City Dallas, data was presented at this year's virtual conference of The Endocrine Society that type 2 diabetic patients could use regular human insulin in the novel automate insulin delivery device, V-Go, with similar results as rapid-acting insulin.

What does this mean for diabetes patients? 

V-Go (Zealand Pharma) is a 24-hour wearable patch-like insulin delivery device. It is programmed with a preset continuous basal delivery rate with on-demand bolus (mealtime) dosing. Earlier studies showed that, compared to multiple daily injections, patients on the V-Go system maintained good glycemic control, keeping A1c levels under 9%. Patients also used less insulin. Furthermore, when a patient switched to the V-Go device, their diabetic monthly costs dropped $119 compared to their costs on multiple daily injections.

Regarding these earlier studies, Dr. Mora, author of the ENDO2020 conference study, told EndocrineWeb:

“Keep in mind that for patients using V-Go, the alternative is usually an insulin regimen consisting of multiple daily injections (MDI). These regimens are complex, painful, require two different insulins (basal and bolus) and greatly impact daily living. V-Go can remove the complexities of insulin therapy, making it more acceptable to patients. This prior data has supported the cost-effectiveness of V-Go compared to multiple daily regimens when insulin analogs were prescribed.”

The ENDO2020 research, then, explored the diversity of the V-Go system using other, less expensive, insulin options. Dr. Mora said, “This study takes it one step further to demonstrate that the use of a regular human insulin offers a similar efficacy and safety profile compared to rapid acting analogues and result in an insulin cost savings."

In the 14-week multicenter prospective non-inferiority study, patients were assigned in a 1:1 ratio randomly to either Rapid Acting Insulin (RAI, n=54) or the less expensive, Regular Human Insulin (RHI, n=59). All patients were experienced with the V-Go system using RAI. Both groups had significant but similar reductions in A1c from baseline, down 0.60% for RHI and 0.38% for RAI. Severe hypoglycemia was not reported. The authors concluded that regular human insulin could be used as effectively and safely as synthetic insulins in the V-Go system.

The financial implications of this study are addressed in an abstract to be presented at the conference of the Academy of Managed Care Pharmacy (AMPC2020). During the 14-week study period, they found that the average 30-day cost of using RHI in the V-Go system was $250 less than the costs they incurred in the period prior to the study, when RAI was used in the system. The RAI group, those that used synthetic insulin before and during the 14-week period, actually had a $15 monthly increase in costs during the study period.

What is the expected impact of V-Go?

The overall data regarding V-Go suggests that the system can reduce diabetic-related costs and maintain glycemic control, potentially preventing the downward spiral of cost-related insulin underuse. When asked about the impact of these studies, Irl Hirsch, MD, Professor in the Division of Metabolism, Endocrinology and Nutrition at the University of Washington, told EndocrineWeb:

“I wish we had this when the pump came out! The results are not a surprise, but what was needed was an approval using regular insulin for the company to do the study. On top of that, we will likely see over the next 12 months or so our first biosimilar insulins which potentially could disrupt the US insulin market. We don't know yet if that will happen, but it seems likely. This is the reason the regular insulin in the V-Go may not be as important now as it could have been 5 or 10 years ago.”

Considering the potential role of biosimilar insulins, the V-Go system has already shown versatility in using different insulin options. In advance of the shift, the FDA drafted guides to facilitate the licensure of biosimilar insulin. These guides would inherently facilitate approval of such compounds in automated delivery devices such as V-Go.

Dr. Bjugstad reports no competing conflicts with regard to her involvement in conducting or discussing this study. Dr. Mora has associations as a consultant with Novo Nordisk, Sanofi Aventis, and Valeritas. His research is funded by Vareritas. Dr. Hirsch conducts research with Medtronic Diabetes and Insulet.

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