Evidence-Based Diabetes Management December 2017
Evidence-Based Diabetes Management December 2017
Evidence-Based Diabetes Management
“Sprint to Zero“: A Strategy to Address High Rates of Nontraumatic Amputations in Minority Communities
Jeffrey Carr, MD, FACC, FSCAI
Eldrin F. Lewis, MD, MPH, on Heart Failure's Place in Diabetes Drug Trials, and the Promise of SGLT2s in Prevention
Robert A. Gabbay, MD, PhD, FACP
Thomas R. Graf, MD
Medical World News: Business Updates
Medical World News: Business Updates
Animas Leaves the Insulin Pump Market Amid Competitive PressuresEBDMTM Staff
ANIMAS CORPORATION, part of Johnson & Johnson Diabetes Care, has left the insulin pump market amid market pressures and emerging technology trends.
“We are incredibly grateful to our patients and healthcare partners for the trust, cofidence, and loyalty they have placed in Animas products over the last 12 years,” said Valerie Asbury, Animas general manager, in statement released October 5, 2017.1 “With rapidly changing needs of customers, rapidly evolving market dynamics, and increased competitive pressures, it proved too difficult to sustain the insulin pump business, and we decided to pursue an exit of the business.”
Animas ended sales of its Vibe and OneTouch Ping pumps in the United States and Canada but said it would honor warranties. Thus, a patient who needs a replacement pump will be able to get one, said Bridget Kimmel, senior manager for communications and public a airs for Johnson & Johnson Diabetes Solutions, in an interview with The American Journal of Managed Care®. Decisions about the exit in other countries require consultation with work councils, she said.
Kimmel said the majority of Amimas’ 90,000 pump users are within the 4-year warranty period, and most will be within warranty through September 30, 2019.
As previously reported in Evidence-Based Diabetes ManagementTM, the insulin pump market faces multiple pressures. First, an exclusivity agreement between market leader Medtronic and the nation’s largest payer, United Healthcare, was seen by analysts as a threat to at least 1 of the smaller players in the market.2 Kimmel said the Medtronic exclusivity agreement with United Healthcare was among many factors that contributed to the decision.
Second, emerging technology such as smart insulin pens and smaller sensors will pair with smarter apps to allow most of the heavy lifting to be done by a patient’s smartphone.3 This could make traditional insulin pumps obsolete. Steven R. Pacelli, executive vice president for Strategy & Corporate Development at Dexcom, which makes popular continuous glucose monitoring systems, told attendees at a Wall Street healthcare conference in September this is a key reason why his company does not want to be in the pump business.4
Nonetheless, Dexcom had a relationship with Animas, which received FDA approval less than a year ago for its Vibe pump to integrate with Dexcom’s G5.5 Back in 2010, Animas announced a major initiative with JDRF, formerly the Juvenile Diabetes Research Foundation, to work with Dexcom on artificial pancreas technology. JDRF has decried payer exclusivity deals, saying they would lead to a loss of patient choice. The group released a statement, which read in part:
“JDRF is extremely concerned that Animas Corporation will be closing op- erations and ending the sale of its insulin pumps, as it means fewer treatment options for people with type 1 diabetes,” the statement said. “Pump choice is critical, and people with type 1 diabetes need the ability to choose the devices that work best for them. Innovation and competition are essential to the development of next-generation therapies, and until there’s a cure, JDRF will continue to drive e orts that will improve health outcomes for people facing the daily burdens and dangers of this disease.”6
Earlier this year, Roche left the market and turned its patients over to Medtronic, and Animas announced a similar arrangement. “Patients using an Animas insulin pump will be offered the option to transfer to a Medtronic pump,” the Animas statement said.1,2
Johnson & Johnson had announced in January it was considering a sale of all its diabetes businesses, which include Animas and LifeScan, which makes blood glucose monitoring systems and a disease management app.7 Disease management tools are making their way into larger shares of the population with type 2 diabetes (T2D), which in the United states accounts for all but 1.25 million of the 30.3 million people who have the disease.
While the statement said, “Johnson & Johnson is continuing to evaluate potential strategic options for LifeScan, Inc,” Kimmel said that for now, it’s “business as usual” for the company.
LifeScan, which has a partnership with WellDoc, created the BlueStar technology to provide 24/7 coaching for people with T2D. Also, LifeScan is moving ahead with plans to expand its OneTouch Reveal app across several countries, including India, through the end of 2017, and to promote data-sharing relationships with physicians and managed care companies.7 Kimmel said a new population health venture with Express Scripts is up and running.
1. Animas Corporaton to close operations and exist insulin pump market [press release]. Chesterbrook, PA: Johnson & Johnson; October 5, 2017. www.jnj.com/media-center/press-releases/animas-corporation-to-close-operations-and-ex- it-insulin-pump-market. Accessed October 17, 2017.
2. Smith A. UnitedHealthcare’s Medtronic deal sparks furor, but a year later, innovation continues. Am J Manag Care®. 2017;23(SP11):SP455-SP456.
3. Smith A. After 20 years of watching diabetes tech, Kliff eyes smart insulin pens, CGM for patients with type 2 diabetes. Am J Manag Care®. 2017;23(SP11):SP453-SP454.
4. Caffrey M. Fitbit, Dexcom to put CGM on the wrists of people with diabetes. Am J Manag Care ®. www.ajmc.com/ newsroom/fitbit-dexcom-to-put-cgm-data-on-wrists-of-people-with-diabetes. Published September 11, 2017. Accessed October 17, 2017.
5. OneTouch Vibe pump earns FDA approval and Health Canada license and is first pump integrated with the Dexcom G5 mobile continuous glucose monitor [press release]. Chesterbrook, PA: PR Newswire; December 20, 2016. www.prnewswire. com/news-releases/onetouch-vibe-plus-insulin-pump-earns-fda-approval-andhealth-canada-license-and-is-first-pump- integrated-with-the-dexcom-g5-mobilecontinuous-glucose-monitor-300381728.html. Accessed August 20, 2017.
6. JDRF statement: Animas exits the insulin pump business. New York, NY: JDRF; October 5, 2017. www.jdrf.org/ blog/2017/10/05/jdrf-statement-animas-exits-the-insulin-pump-business/. Accessed October 17, 2017.
7. Caffrey M. J&J’s OneTouch Reveal: connecting diabetes patients with physicians, managed care. Am J Manag Care. 2017;23(SP11):SP444.
FDA Approves Continuous Glucose Monitor That Doesn't Require Finger SticksMary Caffrey
PEOPLE WITH DIABETES who live in the United States can finally monitor blood glucose levels without routine finger sticks. The FDA approved Abbott’s Freestyle Libre Flash Glucose Monitoring System on September 27, 2017—a decision considered a breakthrough by diabetes advocates long awaiting the approval. The device is already on the market in more than 40 countries.1
When first approved, continuous glucose monitoring (CGM) systems required patients to conduct a blood glucose test with each insulin dose and to use blood testing to calibrate the system. But as accuracy improved, patients began dosing their insulin based on CGM information without a separate blood test, even though the FDA had not approved the systems for this purpose. That changed earlier this year, when the Dexcom G5 was approved for insulin dosing with calibration twice daily, paving the way for Medicare reimbursement.2
The Abbott device, by contrast, is factory calibrated; a sensor wire inserted beneath the skin surface constantly monitors glucose levels. Patients can wave a mobile reader over the device to determine if their blood glucose levels are in range, too high, or too low and check their status over the past 8 hours.
Not only do many patients find frequent finger-stick tests painful and a hassle, but payers often limit the number of test strips they will cover, putting patients in a bind if they need to do a test with every insulin dose or to calibrate the CGM. This newest option cuts down on blood glucose tests and can save patients money.
“We are celebrating a breakthrough moment for people with diabetes in the US—an end to the worry and hassles associated with routine finger sticks, which have been the standard of glucose testing for more than 40 years,” Jared Watkin, senior vice president of Abbott Diabetes Care, said in a statement. “At Abbott, we believe that FreeStyle Libre will transform diabetes management, and we’re proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives.”3
The FDA stressed that people with diabetes must still test their blood sugar regularly; they simply do not need to use a blood test to calibrate the Abbott device. A press release announcing the approval stated, “Risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions, as well as mild skin irritations around the insertion site.1
“It does not provide real-time alerts or alarms in the absence of a user-initiated action; for example, it cannot alert users to low blood glucose levels while they are asleep,” the FDA statement continued.
The FDA approved the Abbott device for adults only and the sensor for 10 days1; in Europe, the sensor is approved for 14 days.4 The device is waterproof, and readings are not disrupted if a patient takes acetaminophen. While pricing was not disclosed, the Chicago Tribune reported that it is expected to be comparable to the cost of the device in Europe, where the reader and each sensor cost the equivalent of $69.5
“Diabetes management requires active participation by the patient. Regular monitoring of glucose levels is especially crucial among patients being treated with insulin,” Maria Tulpan, MD, an endocrinologist at Lenox Hill Hospital in New York, New York, said in Abbott’s announcement. “What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise, and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.”
The FDA’s reluctance to approve the Flash CGM system had long frustrated the company and diabetes advocates, who noted that the product was not only in use around the world but also eligible for reimbursement in countries with strict standards, including the United Kingdom and Japan.
The decision came after Abbott published 2 clinical trials involving 50,000 patients, which found that patients who used the scanner frequently had improved glycemic control and less hypoglycemia.
1. FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration [press release]. Silver Spring, MD: US Food and Drug Administration; September 27, 2017. www.fda.gov/NewsEvents/News- room/PressAnnouncements/ucm577890.htm. Accessed September 27, 2017.
2. FDA approval of Dexcom’s non-adjunctive indication triggers a new era in diabetes management [press release]. San Diego, CA: Dexcom, Inc; December 20, 2016. www.businesswire.com/news/home/20161220005992/en/FDA-Ap- proval-Dexcom%E2%80%99s-Non-Adjunctive-Indication-Triggers-Era. Accessed October 28, 2017.