The advocacy group said the type 1 diabetes community is concerned about the payer's decision because not every device works the same way for every person. After a 2016 policy change affecting adults, 2 pump makers pulled devices from the US market, although other innovation has continued.
Nearly 3 years after UnitedHealthcare set off a firestorm among the type 1 diabetes (T1D) community by naming Medtronic its preferred supplier of insulin pumps for adults, a fresh wave of protest has erupted after the payer extended the pact to youth starting at age 7. The change was announced in a UnitedHealthcare bulletin February 1, 2019.
The change follows FDA’s expanded approval for the Medtronic MiniMed 670G for people with T1D age 7 to 13 on June 21, 2018. The 670G, a hybrid closed-loop system, was previously approved for people with T1D aged 14 and older.
JDRF, the advocacy and research organization previously known as the Juvenile Diabetes Research Foundation, issued a statement last week calling on UnitedHealthcare to reverse its decision, saying insurance restrictions “are bad for people with T1D, bad for children and their caregivers, and bad for our healthcare system.” In 2017, JDRF launched a campaign, Coverage2Control, to highlight the need for people with T1D to have choices in insulin, diabetes technology, and supplies like test strips so that each person with T1D could select products that best meets his or her needs.
As was the case with the original policy change, the T1D community was taken by surprise, Cynthia Rice, vice president for advocacy and policy for JDRF, said in an interview with The American Journal of Managed Care® (AJMC®). Expanding the policy to include youth aged 7 and older happened despite extensive talks with the payer that took place after the May 2016 decision, she said.
“This really does matter to our community,” she said. “These technologies are important to managing type 1 diabetes. People feel strongly they want to use what works for them, and they should make this decision themselves with their doctor.”
In an email to AJMC®, a UnitedHealthcare spokeswoman said that patient safety and helping those with diabetes avoid dangerous high and low blood glucose levels were the key factors in the decision to make the MIniMed 670G system the preferred product for people with T1D age 7 and older. The policy applies to those prescribed an insulin pump for the first time and those whose pump must be replaced after an older pump is out of warranty, according to the policy.
“Pediatric patients who are currently using a non-Medtronic pump may remain on that pump in conjunction with the physician’s treatment plan,” UnitedHealthcare spokeswoman Tracey Lemper said.
A fact sheet from the payer states that there is no change in coverage for those using non-durable tubeless pumps. However, UnitedHealthcare declined to clarify what happens if a person temporarily stops using a non-durable pump and uses multiple daily injections instead. Some people with T1D occasionally switch back to injections if they cannot afford the cost-sharing to replace a pump or if they want to maintain the ability to manage their diabetes with insulin injections.
As it did in May 2016, UnitedHealthcare announced a clinical review policy that will allow physicians to appeal for their patients to use other pumps in special circumstances. However, Rice said successful appeals are rare, and UnitedHealthcare declined to release figures on the rate of successful appeals.
Information from United Healthcare states that 9 out of 10 enrollees who use an insulin pump already use a Medtronic pump. It is not clear how many youth with T1D will be affected by the new policy.
In July 2018, United Healthcare released results from 6000 participants who used Medtronic pumps over the first year of the preferred arrangement. The statement said there were 27% fewer preventable hospital admissions compared with United Healthcare beneficiaries using multiple daily injections.
However, JDRF’s Rice said told AJMC® that statistic only measures how Medtronic users compare with those who aren't using insulin pumps. A more meaningful analysis would examine how people fared after they were forced to switch once a warranty ran out, or how the outcomes of this group compared with those from a payer that allows people with T1D to use the insulin pump of their choice.
Rice said thus far, no one has released a study comparing outcomes for different insulin pump brands head-to-head. But advocates have been clear that the issue is not Medtronic’s technology—many leaders in the T1D community credit the company for pursuit of the 670G. The issue, they say, is that different products emphasize different features, such as alarms or alerts to family and caregivers, and features that matter greatly to one person may matter less to others.
In 2016, T1D advocates warned that the UnitedHealthcare—Medtronic relationship could affect competition and innovation in the diabetes technology marketplace. In 2017, both Roche and Johnson & Johnson stopped selling insulin pumps in the United States and handed their users over to Medtronic. However, in recent years Medicare has expanded coverage for continuous glucose monitors (CGM); first Dexcom, then Abbott’s Freestyle Libre received coverage after the product received FDA approval. Then, Medicare covered the Omnipod insulin pump after years of interpreting durable medical equipment rules in a way unfavorable to the tubeless pump.
Since the UnitedHealthcare decision, innovation has continued; there is considerable anticipation about the partnership between Insulet, maker of the Omnipod pump, and Tidepool, which is working to get an automated insulin delivery app through FDA, as well as Omnipod’s work with Dexcom.
Rice said it’s important that payers remain open to covering different technologies. “The reason why a doctor might choose one insulin pump over another depends on a lot of factors—how well the sensor works, the emergency alerts to let people know they’re about to have a severe low blood sugar,” she said. “United Healthcare is really an outlier here. … That’s why we’re advocating for them to join the rest of the industry.”