Relizorb Will Be Covered by Medicare

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The Centers for Medicare and Medicaid Services (CMS) has published a local coverage determination confirming that Relizorb — an enzyme cartridge to help in digestion for cystic fibrosis (CF) patients receiving their nutrition through enteral feeding — will be covered by Medicare.

The local coverage determination (LCD) “is an important addition to the expanding medical policy gains achieved across commercial and government payers in recent years,” Jason Weiner said in a press release. Weiner is chief commercial officer at Alcresta Therapeutics, which markets Relizorb.

Enteral feeding, also called tube feeding, is a method to deliver nutrients directly into the digestive tract. Relizorb is a first-of-its-kind digestive enzyme cartridge for use in enteral feeding in people with CF who have exocrine pancreatic insufficiency (EPI), or other conditions in which impaired pancreatic function leads to problems with digestion.

In EPI, the thick mucus that’s characteristic of CF builds up in the pancreas and blocks the release of digestive enzymes that are needed to break down certain nutrients, most notably fats. 

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Relizorb is a cartridge that can be attached to the end of a feeding tube. The cartridge mimics the function of pancreatic fat-digesting enzymes (lipase), so that as feeding formula passes the cartridge, fat molecules are broken down into components that are easier for the body to absorb. 

According to Alcresta, Relizorb can break down up to 90% of fat molecules found in most enteral feeding tube formulas, including molecules that are comparatively difficult to digest but are critical for growth and development, such as certain omega-3 fatty acids.

In the U.S., Relizorb is approved for use by CF patients ages 5 and older who require supplemental nutrition.

Results from an Alcresta-sponsored clinical trial called ASSURE (NCT02750501) showed that Relizorb can improve the absorption of omega-3 fatty acids in tube-fed CF patients. Other studies have shown the therapy can ease digestion-related symptoms. Results from a year-long observational study released late last year showed that using Relizorb led to significant improvements in weight and height among CF patients with EPI who require tube feeding.

The CMS gave Relizorb a permanent billing code (B4105) in late 2018. With the newly issued LCD, the CMS has basically stated that Relizorb is both reasonable and necessary as a treatment for eligible patients. As such, Relizorb will be covered by Medicare, the government program that insures elderly and disabled individuals in the U.S.

The new LCD “reflects the clinical benefits RELiZORB provides patients suffering from rare and acute EPI conditions like cystic fibrosis and pancreatitis [inflammation of the pancreas],” Weiner said.