More than 60 cystic fibrosis experts strongly support Relizorb being made available to CF patients on tube feeding, pushing in a commentary for the insurance coverage that’s generally denied this digestive enzyme cartridge, and inviting “the CF community” to become advocates of better patient access to the device.
Their opinion piece included a comprehensive analysis of Relizorb’s benefits, based on studies, reviews, and these experts own real-world evidence, collected from about 450 of their patients using the Alcresta Therapeutics‘ device.
“[T]he signatories of this communication … view this as a valuable therapeutic option for their CF patients who require tube feedings,” the group wrote.
“Its use has the potential to improve health for people with CF, and its cost may be mitigated by the real possibility of reduced pulmonary decline in a well-nourished person with CF.”
Signed by 20 gastroenterologists, 23 CF physicians, 17 CF dietitians, and 1 PharmD, the commentary was published in the Journal of Cystic Fibrosis and titled “Challenging barriers to an option for improved provision of enteral nutrition.”
Achieving and maintaining a healthy weight is crucial to CF patients, but some need nutritional support — in the form of gastrointestinal, or enteral, tubes — because they are not able to absorb necessary nutrients from the foods they eat. These people often do not produce enough lipase, a digestive enzyme that catalyzes the breakdown of fats, resulting in insufficient absorption of fats. Poor fat absorption hinders weight gain and leads to other gastrointestinal problems.
Relizorb is an in-line digestive enzyme cartridge containing lipase immobilized on beads (iLipase) that is connected to the end of a feeding tube.
The device delivers lipase directly to the gut to help break down fats, enabling their proper digestion and absorption. Relizorb can break down 90 percent of the fats present in most tube-feeding formulas, Alcresta reports on a Relizorb webpage.
Relizorb’s safety and efficacy has been demonstrated in clinical trials (NCT02750501 and NCT02598128), both in adult and pediatric populations. Results showed it can triple the levels of healthy fats in the bloodstream. Safety was further supported in real-world use, the experts noted. The technology was approved by the U.S. Food and Drug Administration (FDA) for use in adults in 2015, and for children age 5 and up in 2017.
But, as the care providers noted, the device is “frequently unavailable to patients due to the vicissitudes of insurance approvals in the US.” Specifically, CF patients get “these devices … primarily through a fund established by the manufacturer since insurers have argued that this is an experimental device. This is despite the fact that the FDA has cleared its use.”
Insurers base their opposition on the lack of a series of “randomized, placebo-controlled” clinical trials detailing benefit, the commentary said. It then noted that Relizorb is not a drug, and its approval was based on the more limited evidence needed for a device.
“While we agree that additional data needs to be generated,” the experts wrote, “our obligation as advocates for our patients is to support access to this innovation.” They also called Relizorb “unique,” noting that pancreatic enzyme replacement therapy (PERT) is the option available to improve absorption. But use of PERT capsules was not approved for CF patients on feeding tubes, although these care providers said they are sometimes given.
“Use of an immobilized lipase cartridge to support enteral feedings is making a positive difference for many patients with CF and is a rational alternative to the historical but illogical current standard of care,” they wrote.
“A new, effective tool is tantalizingly within reach and we call on insurance providers to make it possible for us to use it,” the group concluded, calling on the CF community “to advocate with insurance providers to reimburse for this device.”
Added Alcresta in a press release: “The passion and commitment of these healthcare providers and the Cystic Fibrosis Foundation to ensure that effective treatments are made available to patients reinforces our ongoing efforts to work with payers to increase access to Relizorb by ensuring that medical coverage policies reflect the clinical value of Relizorb,” said Eric First, the company’s chief medical officer.