mp-638 - mp-638 - Medical Policies
Enteral Feeding Cartridge for Pancreatic Insufficiency
Policy Number: MP-638
Latest Review Date: December 2020
Policy Grade: B
Use of a cartridge device (e.g. RELiZORB™ immobilized lipase cartridge) to deliver digestive enzymes to enteral formula is considered not medically necessary and investigational for all indications.
DESCRIPTION OF PROCEDURE OR SERVICE:
Insufficient production of pancreatic enzymes (exocrine pancreatic insufficiency, often referred to simply as pancreatic insufficiency) causes malabsorption of fat, protein, and several micronutrients including the vitamins A, D, E, and K. Malabsorption of fat is exacerbated by bile salt abnormalities if there is concurrent intestinal or liver disease. Pancreatic function tends to decline with age. Across all age groups, about 90% of patients with Cystic Fibrosis have marked pancreatic insufficiency and 12% require enteral nutrition. Pancreatic insufficiency is a major contributor to nutritional problems in patients with Cystic Fibrosis (CF).
Guidance to optimize nutrition should be provided to all individuals with Cystic Fibrosis. Those who do not meet target goals for BMI, whose linear growth is less than expected for their genetic potential, or whose growth rates begin to plateau, require additional attention. These patients should be given intensive counseling to optimize nutrition. They should also be further evaluated to identify reasons for nutritional deficits and potential contributors to malnutrition, including inadequate pancreatic enzyme replacement therapy (PERT) and small bowel bacterial overgrowth. In addition, assessment of psychosocial, economic, and behavioral factors that may contribute to suboptimal nutrition is essential. As soon as a decline in growth parameters is documented, nutritional intervention should begin.
There is little evidence to determine the best way to administer pancreatic enzyme replacement therapy (PERT) in conjunction with enteral nutrition. The mainstay of treatment for pancreatic insufficiency in CF is pancreatic enzyme replacement therapy (PERT). Multiple formulations of pancreatic enzymes exist with different combinations of lipase, protease, and amylase.
A digestive enzyme cartridge (e.g., Relizorb™) is a medical device designed to mimic the normal function of pancreatic lipase for use in adults on enteral tube feeding who have trouble breaking down and absorbing fats. It is a point-of-care device designed to fit in line with enteral feeding circuits. The device is designed to hydrolyze (break down) fats present in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This breakdown of fats is intended to mimic the function of the enzyme lipase in patients who do not excrete sufficient levels of pancreatic lipase.
RELiZORB is comprised of a cylindrical, hollow cartridge with a single inlet port and a single outlet port connection. Inside the cartridge, there are small white beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipase™ (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed as it comes in contact with iLipase as the formula passes through the cartridge.
The most recent literature review was through December 2020.
SUMMARY OF EVIDENCE:
For individuals who have pancreatic insufficiency and who receive RELiZORB as an adjunct to maintenance enteral feeding, the evidence consists of multicenter crossover trials. The long term efficacy of RELiZORB has not been established at this time. Further corroboration of these results is needed in high-quality RCTs. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements:
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Relizorb, digestive enzyme, enteral feeding, tube feeding, enzyme cartridge, RELiZORB™, pancreatic insufficiency, iLipase™
APPROVED BY GOVERNING BODIES:
Relizorb ™, (Alcresta Pharmaceuticals) is a digestive enzyme cartridge that received de novo approval by the FDA (Nov. 2015) for use in adults to hydrolyze (breakdown) fats in enteral formula. In July 2017, the FDA expanded use of Relizorb to include pediatric patients 5 years of age and older.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Prior to 07/01/2018, there was no specific CPT code for this cartridge.
|B4105||In-line cartridge containing digestive enzyme(s) for enteral feeding, each (Effective 01/01/2019)|
|B9998||NOC for Enteral Supplies|
In-line cartridge containing digestive enzyme(s) for enteral feeding, each (Deleted 12/31/18)
- Alcresta Therapeutics. Relizorb: (Immobilized Lipase) Cartridge, 2017. Accessed on June 5, 2017 and available at: relizorb.com/.
- Alcresta Therapeutics. Absorption and Safety With Sustained Use of Relizorb Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. Accessed on August 1, 2017. www.cff.org/Trials/Finder/details/470/ASSURE-Study-of-Relizorb-in-people-with-CF-who-receive-enteral-tube-feeding.
- BioSpace, October 28, 2016. PRNewswire: Alcresta’ Relizorb increases fat absorption in adult and pediatric patients with cystic fibrosis receiving enteral nutrition. Newton, Massachusetts. Accessed on April 14, 2017 and available at: www.biospace.com/news_story.aspx?StoryID=437369.
- ClinicalTrials.gov. Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb), ClinicalTrials.gov Identifier: NCT02598128. Last updated: June 2016. Accessed on June 7, 2017 and available at: clinicaltrials.gov/ct2/show/NCT02598128.
- Freedman S., Orenstein D et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with Cystic Fibrosis. www.ncbi.nlm.nih.gov/pubmed/?term=relizorb
- Freedman SD, Wyatt C, Stevens J, et al. Absorption and safety with sustained use of Relizorb evaluation (ASSURE) study in patients with cystic fibrosis receiving enteral feeding. J Pediatr Gastroenterol Nutr. 2018;67(4):527-532.
- Hayes, Inc. Search and summary, Relizorb (Alcresta Pharmaceuticals). February 4, 2016.www.hayesinc.com/hayes/publications/search-summary/hss-relizorb3607/ Accessed Dec 2020.
- Maki, J., Neelagiri, M., Olshaw, B., Devarakonda, S., Loring, G. ePS05.2 Novel point of care immobilized lipase device (EFIC™) is compatible with a range of nutritional formulas and can simplify delivery of hydrolyzed fat during tube feeding, 1993. Journal of Cystic Fibrosis. Accessed on April 10, 2017 and available at: www.cysticfibrosisjournal.com/article/S1569-1993 (15)30161-2/pdf.
- Medscape, LLC. FDA clears Relizorb for use with enteral tube feedings. Medscape, LLC. New York, NY. December 03, 2015.Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN150001 Accessed Dec 2020.
- Stevens T., Conwell D.L. Exocrine pancreatic insufficiency www.uptodate.com/contents/cystic-fibrosis-nutritional-issues?source=search_result&search=digestive%20enzymes%20cystic&selectedTitle=1~150
- Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. J Pediatr Gastroenterol Nutr. 2018 Oct;67(4):527-532.
- U.S. Food and Drug Administration. Relizorb enzyme packed cartridge. 510(k) No. K163057 (traditional). Silver Spring, MD: FDA; July 12, 2017.
- U.S. Food and Drug Administration. 510(k) Summary. K161247. Relizorb™. 2016 June 30. Accessed December 19, 2019. Available at URL address: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161247.pdf
Medical Policy Group, August 2017
Medical Policy Administration Committee, September 2017
Medical Policy Group, August 2017 (6): New Policy
Medical Policy Group, June 2018: Quarterly Coding Update, July 2018. Added new CPT code Q9994 to Current Coding.
Medical Policy Group, December 2018: 2019 Annual Coding Update. Added HCPC code B4105 to the Current coding section and moved HCPC code from Current coding section to Previous coding. Created Previous coding section to include code Q9994.
Medical Policy Group, December 2019 (6): Updates to Description, Key Points, Governing Bodies, Key Words (iLipase™) and References. No change to policy intent.
Medical Policy Group, December 2020 (6): Updates to Key Points and Governing Bodies. No change to policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.