Latest Results on Intarcia's Mini-Pump Show "Clear Value to Payers," Says Study Author

While waiting for the FDA's decision on its novel mini-pump to treat type 2 diabetes (T2D),¹ Intarcia Therapeutics has presented a fresh round of evidence aimed at a different audience: payers.

The results of a pair of studies presented in June at the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, California, showed that patients with T2D who used Intarcia’s ITCA 650, a matchstick-size pump that delivers microscopic doses of exenatide, were less likely than patients taking sitagliptin to need an additional drug to control their diabetes.^2,3

The author of one of these studies, Robert R. Henry, MD, professor of medicine at the University of California, San Diego, said in an e-mail to Evidence-Based Diabetes Management™ that the findings add to the evidence that show “clear value” for payers. Not only can payers avoid the cost of additional medication, but by ensuring compliance, he said, they can also reduce the likelihood of complications that send patients to the hospital.

Results from other studies presented at ADA in June showed that ITCA 650 was safe to take alongside common drugs such as birth control pills, acetaminophen, and statins.^4,5 These results are important because the ITCA 650 is designed to be inserted under the skin and left in place for up to 6 months.

By the time the FDA accepted Intarcia’s new drug application in February, the company had presented results showing twice the reduction in glycated hemoglobin (A1C) as sitagliptin, 3 times the weight loss, as well as top-line results that showed ITCA 650 met end points of a cardiovascular (CV) safety study.^1,6,7 What sets ITCA 650 apart in the market is the possibility of tamper-proof persistence for patients whose T2D was not controlled with metformin. For those unwilling or unable to take a pill or injectable on schedule, this “is one of the major features of ITCA 650 [that] make it so valuable,” said Henry, who is also the chief of section, Diabetes, Endocrinology & Metabolism, and director at the Center for Metabolic Research, VA San Diego Healthcare System.

As Henry noted, compliance has vexed every drug on the market—both oral and injectable—and in the real world, no therapy has been able to overcome the problem of certain patients who simply don’t stick with a regimen and develop costly complications. (For similar reasons, Proteus Digital Health is working on a pill with a digestible sensor to monitor compliance.⁸)

Henry has studied the ITCA 650 for some time and was the lead author of an abstract that pooled data from 39-week and 52-week studies to compare patients on ITCA 650, sitagliptin, and placebo. Patients began with an average A1C of 8.6%, and there were predefined protocols for including additional oral antidiabetic therapies if patients’ A1C was not maintained below 8%. Most patients on ITCA 650 maintained glycemic control below this threshold, the abstract said (FIGURE).²

“An increase in [antidiabetic therapy] occurred in all groups at week 26, but 88% of ITCA 650 patients remained on assigned therapy at week 39,” the authors wrote. “In contrast, there was a progressive increase in the need for [antidiabetic therapy] in the placebo and sitagliptin groups at week 26.”²

In the e-mail, Henry said the ability to ensure constant delivery of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, stands apart from the normal delivery method for this powerful drug class. “All other GLP-1 agonists are given by subcutaneous injection and are frequently associated with noncompliance for numerous reasons, despite the fact that aside from insulin, they are the most efficacious glucose-lowering agents,” Henry said.

Compliance issues cause patients to miss out on weight-loss benefits and, in some cases, CV-risk benefits, he said. Ensuring persistence, Henry said, offers “clear value to payers—not only the immediate cost of not having to use other medications, many of which may be less effective or also associated with noncompliance.”

Just as important, or perhaps more so, “ITCA 650 use translates to overall better glycemic control compared [with] noncompliant use of medications, with lower risks of complications, mainly microvascular and perhaps macrovascular disease,” he said. “I believe these features make ITCA 650 very attractive to payers.” References

1. Intarcia announces FDA filing acceptance of new drug application (NDA) for ITCA 650 for the treatment of type 2 diabetes [press release]. Boston, MA: Intarcia Therapeutics; February 3, 2017. intarcia.com/media/press-releases/2017-feb-3-intarcia-announces-fda-filing-acceptance.html. Accessed August 11, 2017.

2. Henry RR, Schwartz B, Kjems L Huang H, Baron M. ITCA 650 improves glycemic control and reduces the need to advance antidiabetes therapy. Presented at: 77th Scientific Sessions of the American Diabetes Association; June 11, 2017; San Diego, CA. Abstract 1078-P. abstractsonline.com/ pp8/#!/4297/presentation/44313.

3. Rosenstock J, Prabhakar P, Kjems L, Baron M. ITCA 650 significantly reduces the need to advance antidiabetes therapy compared to sitagliptin. Presented at: 77th Scientific Sessions of the American Diabetes Association; June 11, 2017; San Diego, CA. Abstract 1110-P. abstractsonline.com/pp8/#!/4297/ presentation/44314.

4. Lathia C, Kjems L, Yarmaloff L, Huang H, Baron M. Effect of ITCA 650 on the PK of acetaminophen (APAP) and other commonly coadministered drugs. Presented at: 77th Scientific Sessions of the American Diabetes Association; June 11, 2017; San Diego, CA. Abstract 1108-P. abstractsonline.com/ pp8/#!/4297/presentation/44311.

5. Kjems L, Lathia C, Yarmaloff L, Huang H, Baron M. Treatment with ITCA 650 does not affect the pharmacokinetics (PK) and pharmacodynamics of a combination oral contraceptive (OC). Presented at: 77th Scientific Sessions of the American Diabetes Association; June 11, 2017; San Diego, CA. Abstract 1109-P. abstractsonline.com/pp8/#!/4297/presentation/44312.

6. Intarcia presents FREEDOM-2 trial results in type 2 diabetes demonstrating clinically meaningful superiority and sustained glucose control and weight reduction for ITCA 650 vs Januvia oral presentation at ADA 76th Scientific Sessions [press release]. New Orleans, LA: Intarcia Therapeutics; June 12, 2016. intarcia.com/media/press-releases/2016-june-12-freedom-2-trial-results-in-type-2- diabetes.html. Accessed August 13, 2017.

7. Intarcia announces successful cardiovascular safety results in phase 3 FREEDOM-CVO trial for ITCA 650, an investigational therapy for type 2 diabetes [press release]. Boston, MA: Intarcia Therapeutics; May 6, 2016. intarcia.com/media/press-releases/2016-may-6-cardiovascular-safety.html. Accessed August 13, 2017.

8. Proteus Digital Health website. www.proteus.com/. Accessed August 8, 2017.

Download PDF: Latest Results on Intarcia's Mini-Pump Show "Clear Value to Payers," Says Study Author