Exclusivity deals in managed care to hold down the cost of drug therapy are not new. But requiring persons with type 1 diabetes to use insulin pumps from a single manufacturer has brought out a whole different reaction.
On May 3, 2016, UnitedHealthcare (UHC) announced a first for the insurer: an exclusive agreement with Medtronic to provide insulin pumps for its enrollees with diabetes. Come July 1, 2016, the medical device giant would be the sole source for any new durable medical equipment (DME) for those in commercial and community plans.
Despite several caveats, and the fact that non-Medtronic pump users will not be affected right away, reaction has been swift. First, the stock price for a smaller pump maker, Tandem Diabetes Care, dropped 20% on the news. Responses from the diabetes online community—including several influential writers with type 1 diabetes—were equally pointed.
Among them were diaTribe’s Kelly Close, who wondered whether the move will stifle innovation, and SixUntilMe’s Kerri Sparling, who described the “intimate” relationship that users have with a device that is with them 24/7. Sparling wrote she has used different brands over time—including Medtronic—as her needs have changed.
The UHC policy includes several exemptions, according to a bulletin from the insurer. Anyone with a non-Medtronic pump still under warranty will have supplies covered as long the device is working. Children under 18 are exempt, as are those in Medicare Advantage and UHC Sierra Health or Life Commercial plans.
There will also be a clinical exemption process, according to UHC spokeswoman Kristen Hellmer. In an email to The American Journal of Managed Care, Hellmer said, “If a patient and his/her doctor feel there is a medical need to use a non-Medtronic pump, we will work directly with the prescribing physician on the request.” Approved requests would be covered as an in-network benefit, she said.
In the bulletin, UHC said the move was “part of our ongoing efforts to provide a better member experience, while increasing quality and lowering the overall cost of diabetes care in the United States.”
UHC specifically mentioned that covered pumps will include Medtronic’s MiniMed 530G, introduced more than 2 years ago with great fanfare for its integrated pump and continuous glucose monitoring system with Threshold Suspend, a feature that temporarily shuts off insulin delivery if sensors show glucose levels falling below a preset level. (This was the device first touted as an “artificial pancreas” before T1D commentators pushed back on that description.)
Close and others who responded to the news noted that exclusivity contracts in healthcare are nothing new. For years now, pharmacy benefit managers in particular have sought to hold down costs for employers when an expensive new drug class is introduced by negotiating with drug manufacturers; if all refuse to lower lists prices sufficiently, one may get an exclusive deal.
Well-known examples involve the direct acting antivirals to treat hepatitis C virus, where AbbVie reached such an arrangement with Express Scripts for its therapy Viekira Pak, and in the race among the rival cholesterol drugs, the PCKS9 inhibitors, where Amgen’s Repatha won exclusive deals with CVS Health and Harvard Pilgrim.
Both T1D advocates and an official with Tandem said an insulin pump can’t be compared with a drug. “Insulin pumps are not a one-size-fits-all solution,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care, in a statement. “Selecting which pump is the best fit for a person to manage their therapy needs should be decision made between a person and their healthcare provider.”
Members of the T1D community who have commented over the past week did not find fault with Medtronic products per se, and, in fact, many praised the company’s work on the investigational MiniMed 670G and the just-completed pivotal trial of its closed loop system. The issue, Close, Sparling, and others say, is limiting options for a medical product that for persons with T1D is a highly personal choice.
“We’re not talking about T-shirts here; this is a medical device that is part of every moment of every day, and you’d better believe that access to have a choice matters,” Sparling wrote.
The move comes at the precise moment when multiple, competing projects are closing in on the “artificial pancreas,” a technical feat that would allow those with diabetes to go about their daily lives with algorithm-driven technology to monitor blood glucose levels and dose insulin accordingly. Advocates for those with T1D have noted that the presence of multiple projects would likely offer many choices in AP technology and perhaps lower prices.
Criteria for selection. Asked what the criteria were used in selecting Medtronic as the exclusive provider, Hellmer said patient safety was a key criterion, and cited the Threshold Suspend feature on the MiniMed 530G. She also cited the ASPIRE study, which found patients using the device with the suspend feature spent less time below the preset shut-off level of 70 mg/dL, and patients who needed the feature did not experience rebound hyperglycemia.
Patient consultation. Hellmer did not specify how patients were consulted for this particular decision, but cited UHC’s ongoing engagement efforts including a 2009 plan to reimburse those who actively managed their condition for out-of-pocket costs up to $500.
As for the concerns that UHC’s move will limit innovation by smaller companies, she responded, “Pushing for additional innovation in diabetes care is at the heart of this relationship. That is why we plan to bring our extensive experience creating value-based programs with hospitals and physicians to our agreement with Medtronic and hope to expand the industry’s innovation on both technology and clinical programs.”