Medicare Advantage

Medical Policy

Title:

Enzyme Replacement for the Treatment of Gaucher's Disease

Policy #:

MA08.023d

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

MEDICALLY NECESSARY

Imiglucerase (Cerezyme®), taliglucerase alfa (Elelyso®) and velaglucerase alfa (VPRIV®) are considered medically necessary and, therefore, covered, as long-term enzyme replacement therapy (ERT) for pediatric and adult individuals with a confirmed diagnosis of Type 1 Gaucher's disease or those with clinical non-neuropathic manifestations of Type 3 Gaucher's disease, when all of the following criteria are met, including dosing and frequency:
- Diagnosis is confirmed by one of the following:
  - Deficiency of glucosylceramidase in peripheral blood leukocytes or other nucleated cells
  - Confirmation of biallelic pathogenic variant(s) in the GBA gene and resulting in one or more of the following conditions
- Dosing and frequency for imiglucerase (Cerezyme®): initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks. Maintenance dosages 30-60 U/kg every 2 weeks.
- Dosing and frequency for taliglucerase alfa (Elelyso®): initial dose 60 units/kg every 2 weeks, then dosing is individualized based on achievement and maintenance of therapeutic goals. If switching from imiglucerase therapy, use the same unit/kg dose in stable individuals.
- Dosing and frequency for velaglucerase alfa (VPRIV®): initial dosage for VPRIV in naïve adults and naïve pediatric individuals 4 years of age and older is 60 Units/kg administered every other week. Dosages are further individualized.

NOT ELIGIBLE FOR REIMBURSEMENT

Alglucerase (Ceredase®) is no longer manufactured and has been withdrawn from market, therefore, it is not eligible for reimbursement.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV™), or taliglucerase alfa (Elelyso™) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®), or taliglucerase alfa (Elelyso®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®), or taliglucerase alfa (Elelyso®) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the utilization management activities. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®), or taliglucerase alfa (Elelyso®).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of imiglucerase (Cerezyme®), velaglucerase alfa (VPRIV®), or taliglucerase alfa (Elelyso®) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

Guidelines

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, enzyme replacement therapy for the treatment of Gaucher's disease is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria including dosing and frequency requirements listed in this medical policy are met.

Certain drugs are available through the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when enzyme replacement therapy for the treatment of Gaucher's disease is covered under a member's medical benefit (Part B benefit). It does not address instances when enzyme replacement therapy for the treatment of Gaucher's disease is covered under a member’s pharmacy benefit (Part D benefit).

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA approved the use of alglucerase (Ceredase®) in April 1991 for long-term ERT for individuals who have a confirmed diagnosis of Type 1 Gaucher's disease.

The FDA approved the use of imiglucerase (Cerezyme®) in May 1994 for long-term ERT for individuals who have a confirmed diagnosis of Type 1 Gaucher's disease.

The FDA approved the use of velaglucerase alfa (VPRIV™) on February 26, 2010 for long-term ERT for adult individuals who have a confirmed diagnosis of Type 1 Gaucher's disease.

The FDA approved the use of taliglucerase alfa (Elelyso™) on May 1, 2012 for long-term ERT for adults who have a confirmed diagnosis of Type 1 Gaucher's disease.

The FDA approved the use of taliglucerase alfa (Elelyso®) on August 27, 2014, for long-term ERT for pediatric individuals who have a confirmed diagnosis of Type 1 Gaucher's disease.

The FDA approved the use of taliglucerase alfa (Elelyso®) on November 13, 2021, for long-term ERT for pediatric individuals four years and older who have a confirmed diagnosis of Type 1 Gaucher's disease.

PEDIATRIC USE

The safety and effectiveness of imiglucerase (Cerezyme®) have not been established in individuals younger than 2 years of age.

The safety and effectiveness of velaglucerase alfa (VPRIV™) have not been established in individuals younger than 4 years of age.

The safety and effectiveness of taliglucerase alfa (Elelyso™) have not been established in individuals younger than 4 years of age.

Description

Gaucher's disease, also called Gaucher disease, is a rare, genetic, metabolic disorder caused by a deficiency of the enzyme glucocerebrosidase. Deficiency of glucocerebrosidase causes an accumulation of glucosylceramide, which is highly insoluble, in storage cells of the liver, spleen, bone marrow, and lymph nodes. Disease variants are classified according to the presence or absence of neurologic involvement and the rate of its progression into three major clinical subtypes: Types 1, 2, and 3. Type 1, the most common, is a chronic, nonneuronopathic, or adult form; it is the most prevalent. Although Type 1 Gaucher's disease is sometimes referred to as the adult form, symptoms of Type 1 can manifest at any age. Symptoms include bruising easily; fatigue due to anemia and low blood platelets; an enlarged liver and spleen; skeletal disorders; and, in rare instances, lung and kidney involvement. In Type 2 Gaucher's disease, liver and spleen enlargement are apparent by 3 months of age. It is an acute, neuronopathic, or infantile form, characterized by rapid neurologic deterioration; survival beyond 2 years of age is rare. Type 3 is a subacute, neuronopathic, or juvenile form, with a variable course marked by slowly progressive neurologic involvement and some characteristics of Type 1 and 2. Liver and spleen enlargement is a variable, along with brain involvement, which becomes apparent when marked by seizures.

Based on current published research, systemic manifestations of Type 3 Gaucher’s disease can be reduced in individuals treated with enzyme replacement therapy (ERT), but neurologic manifestations of Gaucher's disease are not affected by ERT. According to the evidence, replacement of the missing enzyme glucocerebrosidase through ERT may improve the health outcome and quality of life in individuals significantly affected by Type 3 Gaucher’s disease. However, treatment with ERT is ineffective for individuals with Type 2 disease, the neuronopathic form, because it does not alter the neurodegenerative course of the Type 2 disease.

In April 1991 the US Food and Drug Administration (FDA) approved alglucerase (Ceredase®) as an orphan drug (a drug used to treat, prevent, or diagnose a rare disease) for use as long-term enzyme replacement therapy (ERT) for children, adolescents, and adult individuals with a confirmed diagnosis of Type 1 Gaucher's disease who have signs and symptoms severe enough to result in one or more of the following conditions:

moderate-to-severe anemia
thrombocytopenia with bleeding tendency
bone disease
significant hepatomegaly or splenomegaly

Alglucerase (Ceredase®) is a modified form of the human enzyme, beta-glucocerebrosidase, prepared from a large pool of human placental tissue collected from selected donors. The quantity of the drug is based on the amount that is collected from selected donors. Due to this limit, alglucerase (Ceredase®) was phased out and replaced with imiglucerase (Cerezyme®).

In May 1994 the FDA approved imiglucerase (Cerezyme®) as an orphan drug for use as a long-term ERT for pediatric and adult individuals with a confirmed diagnosis of Type 1 Gaucher's disease who have signs and symptoms severe enough to result in one or more of the following conditions:

anemia
thrombocytopenia
bone disease
hepatomegaly or splenomegaly

Imiglucerase (Cerezyme®) is an analogue of the human enzyme, beta-glucocerebrosidase, produced by recombinant DNA technology. It differs from placental glucocerebrosidase by one amino acid at position 495, where histidine is substituted for arginine. Imiglucerase (Cerezyme®) is equivalent to alglucerase (Ceredase®). In clinical trials, imiglucerase (Cerezyme®) improved anemia and thrombocytopenia, reduced spleen and liver size, and decreased cachexia to a degree similar to that observed with alglucerase (Ceredase®).

In February 2010 velaglucerase alfa (VPRIV™) was FDA-approved for long-term ERT for pediatric and adult individuals with Type 1 Gaucher's disease. Velaglucerase alfa (VPRIV™) has the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase. The safety and effectiveness of velaglucerase alfa (VPRIV™) was assessed in three clinical studies of naïve individuals to ERT and individuals who switched from imiglucerase (Cerezyme®) to velaglucerase alfa (VPRIV™). Per the FDA-approved prescribing information, individuals switching from imiglucerase (Cerezyme®) to velaglucerase alfa (VPRIV™) can begin treatment with velaglucerase alfa (VPRIV™) at the same stable dose of imiglucerase (Cerezyme®).

In May 2012 taliglucerase alfa (Elelyso™) was FDA- approved for long-tern ERT for adult and pediatric individuals with a confirmed diagnosis of Type 1 Gaucher's disease. Taliglucerase alfa (Elelyso™) is a recombinant active form of the lysosomal enzyme, glucocerebrosidase. Taliglucerase alfa (Elelyso™) is the first FDA-approved plant-cell-based ERT for Gaucher disease derived using genetically engineered carrot cells. Safety and efficacy of taliglucerase alfa (Elelyso™) was established in three studies containing individuals naïve to ERT and individuals switching from imiglucerase (Cerezyme®) to taliglucerase alfa (Elelyso™). Most individuals in the studies showed an improvement in their anemia, thrombocytopenia, and/or a decrease in their liver and spleen size.

According to published research, systemic manifestations of Type 3 Gaucher’s disease can be reduced in individuals treated with ERT, but neurologic manifestations of Gaucher's disease is not affected by ERT. There is evidence that replacement of the missing enzyme glucocerebrosidase through ERT may improve the health outcome and quality of life in individuals significantly affected by Type 3 Gaucher’s disease. However, treatment with ERT was ineffective for individuals with Type 2 disease, the neuronopathic form, as it does not alter the neurodegenerative course of the Type 2 disease.

On August 27, 2014, FDA approved the use of taliglucerase alfa (Elelyso®) for long-term ERT for pediatric individuals who have a confirmed diagnosis of Type 1 Gaucher's disease. In this clinical trial, the safety of Elelyso was assessed in individuals, 16 years and younger in 9 pediatric treatment-naïve individuals (ages two to 13 years) with Type 1 Gaucher disease in a 12 month randomized clinical trial. The most common adverse reaction (≥10%) was vomiting, which occurred in 4 of 9 patients. Two individuals had hypersensitivity reactions; one individual experienced severe vomiting and gastrointestinal inflammation, and one experienced mild throat irritation and chest discomfort. Both individuals were treated with antihistamines and continued treatment. In the clinical trial in individuals switching from Imiglucerase Treatment to Elelyso the safety of Elelyso was assessed in 31 patients (26 adult and 5 pediatric patients), ages 6 to 66 years old, with Type 1 Gaucher disease who had previously been receiving treatment with imiglucerase for a minimum of 2 years. Elelyso was administered for 9 months at the same number of units as each individual's previous imiglucerase dose.

On November 13, 2021, FDA approved the use of taliglucerase alfa (Elelyso®), for long-term ERT for pediatric individuals four years and older who have a confirmed diagnosis of Type 1 Gaucher's disease. The long-term efficacy and safety of Elelyso in pediatric individuals with Type 1 Gaucher disease who were treatment-naïve or previously treated with imiglucerase was evaluated in phase 3, multi-center, extension trial.

This pediatric-specific extension trial included 15 individuals aged two to 18 years from two study cohorts. The first study cohort included 10 previously treatment-naïve pediatric individuals treated with Elelyso (9 who completed) for up to 36 months (the first 24 months of which were conducted in a double-blind fashion) at 30 units per kg or 60 units per kg. The second study cohort included five pediatric individuals who were previously switched from imiglucerase (2 who completed) and administered Elelyso for a total of 33 months at the same dose as each individual's previous imiglucerase dose. At the end of the study, treatment-naïve individuals treated with Elelyso for 36 months demonstrated clinical improvements, as measured by a decrease in spleen and liver volume and an increase in platelet count. In patients previously switched from imiglucerase to Elelyso, mean spleen and liver volume, platelet count and hemoglobin value remained stable through 33 months of Elelyso treatment. The most common adverse events reported were upper respiratory tract infection, cough, headache, abdominal pain, diarrhea, nasopharyngitis, pain in extremity, swollen or enlarged lymph nodes, and fever.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Altarescu G, Hill S, Wiggs E, et al. The efficacy of enzyme replacement therapy in patients with chronic neuronopathic Gaucher's disease. J Pediatr. 2001;138(4):539-547.

American Hospital Formulary Service (AHFS). Drug Information 2018. Imiglucerase. 03/28/2022. [Lexicomp Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 22, 2023.

American Hospital Formulary Service (AHFS). Drug Information 2018. Taliglucerase alfa. 03/28/2022 [Lexicomp Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 22, 2023.

American Hospital Formulary Service (AHFS). Drug Information 2016. Velaglucerase alfa. 03/28/2022 [Lexicomp Web site]. Available at:http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 22, 2023.

Andersson HC, Charrow J, Kaplan P, et al; and the International Collaborative Gaucher Group U.S. Regional Coordinators. Individualization of long-term enzyme replacement therapy for Gaucher disease. Genet Med. 2005:7(2):105-110.

Charrow J, Andersson HC, Kaplan P, et al. Enzyme replacement therapy and monitoring for children with type 1 Gaucher disease: consensus recommendations. J Pediatr. 2004;144(1):112-120.

Derralynn Hughes D, Sidransky E, et al. Gaucher disease: Pathogenesis, clinical manifestations, and diagnosis. In UpToDate 2021. Available at: https://www.uptodate.com/contents/gaucher-disease-pathogenesis-clinical-manifestations-and-diagnosis#H21233118. Accessed February 22, 2023.

Elsevier’s Clinical Pharmacology Compendium. Alglucerase. [Clinical Key Web site]. 03/05/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 22, 2023.

Elsevier’s Clinical Pharmacology Compendium. Imiglucerase. [Clinical Key Web site]. 03/05/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 22, 2023.

Elsevier’s Clinical Pharmacology Compendium. Taliglucerase alfa. [Clinical Key Web site]. 09/26/2022. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 22, 2023.

Elsevier’s Clinical Pharmacology Compendium. Velaglucerase alfa. [Clinical Key Web site]. 03/05/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 22, 2023.

Genzyme Therapeutics. Cerezyme® (imiglucerase for injection). [Genzyme Web site]. Updated 12/2021. Available at: http://www.cerezyme.com/. Accessed February 22, 2023.

Grabowski GA. Endocrinology and Metabolism. In: Braunwald E, Fauci AS, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 15th ed. New York, NY: McGraw-Hill Professional Publishing; 2001:2276-2281.

Kaplan P. Revised recommendations for the management of Gaucher disease in children. Eur J Pediatric. 2013;172:447-458.

Lexi-Drugs Compendium. Imiglucerase alfa. [Lexicomp Online Web site]. 10/25/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 22, 2023.

Lexi-Drugs Compendium. Taliglucerase alfa. [Lexicomp Online Web site]. 01/24/2023. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 22, 2023.

Lexi-Drugs Compendium. Velaglucerase alfa. [Lexicomp Online Web site]. 01/24/2023. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed April 15, 2021.

Linari S. Clinical manifestations and management of Gaucher disease. Clin Cases Miner Bone Metab. 2015 May-Aug. 12(2):157-164.

Micromedex® Healthcare Series [Internet database]. 11/09/2022. Alglucerase. Greenwood Village, CO: Thomson Micromedex. Available at: http://www.micromedexsolutions.com [via subscription only]. Accessed February 22, 2023.

Micromedex® Healthcare Series [Internet database]. 11/15/2022. Imiglucerase. Greenwood Village, CO: Thomson Micromedex. Available at: http://www.micromedexsolutions.com [via subscription only]. Accessed February 22, 2023.

Micromedex® Healthcare Series [Internet database]. 12/01/2022. Taliglucerase alfa. Greenwood Village, CO: Thomson Micromedex. Available at: http://www.micromedexsolutions.com [via subscription only]. Accessed February 22, 2023.

Micromedex® Healthcare Series [Internet database]. 08/31/2021. Velaglucerase alfa. Greenwood Village, CO: Thomson Micromedex. Available at: http://www.micromedexsolutions.com [via subscription only]. Accessed February 22, 2023.

National Institute of Neurological Disorders and Stroke (NINDS). NINDS Gaucher’s disease information page. [NINDS Web site]. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Gaucher-Disease-Information-Page. Accessed February 22, 2023.

Pastores GM, Hughes DA. Gaucher disease. GeneReviews® [Internet]. 07/27/2000; updated 06/21/2018. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1269/#gaucher.Diagnosis. Accessed February 22, 2023.

Pastores GM, Weinreb NJ, Aerts H, et al. Therapeutic goals in the treatment of Gaucher disease. Semin Hematol. 2004;41(4 suppl 5):4-14.

Pramod K, Mistry J L. Batista , Andersson H C, et al. Transformation in pretreatment manifestations of Gaucher disease type 1 during two decades of alglucerase/imiglucerase enzyme replacement therapy in the International Collaborative Gaucher Group (ICGG) Gaucher Registry. Am J Hematol. 2017;92:929–939.

Schiffmann R, Heyes MP, Aerts JM, et al. Prospective study of neurological responses to treatment with macrophage-targeted glucocerebrosidase in patients with type 3 Gaucher's disease. Ann Neurol. 1997;42:613-621.

Schwartz IVD, Kishnanid ÖGSP, Lydie Renaultf AZ, Panahloof Z, et. al. Characteristics of 26 patients with type 3 Gaucher disease: A descriptive analysis from the Gaucher Outcome Survey. Elsevier journal [Internet]. 2018 Available at: https://www.sciencedirect.com/science/article/pii/S2214426917301416?via=ihub. Accessed February 22, 2023.

US Food and Drug Administration (FDA). Ceredase (Alglucerase). Approval history, letters, reviews, related documents, and label information. [FDA Web site]. 02/09/2006. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed February 22, 2023.

US Food and Drug Administration (FDA). Cerezyme (Imiglucerase). Approval history, letters, reviews, related documents, and label information. [FDA Web site]. 12/22/2021. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails Accessed February 22, 2023.

US Food and Drug Administration (FDA). Taliglucerase Alfa (Elelyso). Approval history, letters, reviews, related documents, and label information. [FDA Web site]. 08/31/22. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed February 22, 2023.

US Food and Drug Administration (FDA). Velagluceraase Alfa (VPRIV). Approval history, letters, reviews, related documents, and label information. [FDA Web site]. 12/10/20. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed February 22, 2023.

Vellodi A, Bembi B, De Villemeur TB, et al. Management of neuronopathic Gaucher disease: a European consensus. J Inherit Metab Dis. 2001;24:319-327.

Vellodi A. Management of neuronopathic Gaucher disease: Revised recommendations. J Inherit Metab Dis. 2009;32:660-664.

Weinreb NJ, Aggio MC, Andersson HC, et al. Gaucher disease type 1: revised recommendations on evaluations and monitoring for adult patients. Semin Hematol. 2004;41(4 suppl 5):15-22.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

E75.22 Gaucher disease

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

J1786 Injection, imiglucerase, 10 units

J3060 Injection, taliglucerace alfa, 10 units

J3385 Injection, velaglucerase alfa, 100 units

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA08.023d:

01/01/2026

This policy has been identified for HCPCS code update, effective 01/01/2026

The following HCPCS code has been deleted from this policy:
J0205: Injection, alglucerase, per 10 units

Revisions From MA08.023c:

05/28/2025	This policy has been reissued in accordance with the Company's annual review process.
09/18/2024	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
03/08/2023	This policy has been reissued in accordance with the Company's annual review process.
05/04/2022	This policy has been reissued in accordance with the Company's annual review process.
06/07/2021	This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling. Added long-term ERT use for pediatric individuals for taliglucerase alfa (Elelyso®).

Revisions From MA08.023b:

03/25/2020

This policy has been reissued in accordance with the Company's annual review process.

06/03/2019

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling. Dosing and frequency requirements were added for all the agents. Laboratory and/or genetic testing was added for all diagnoses. Code S9357 (Home infusion therapy, enzyme replacement intravenous therapy) was removed from the policy document, but remains eligible for administration in a home setting.

Revisions From MA08.023a:

10/24/2018	This policy has been reissued in accordance with the Company's annual review process.
07/19/2017	This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track. The references were updated accordingly.
03/16/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on enzyme replacement for the treatment of Gaucher's disease.
02/11/2015	This version of the policy will become effective 02/11/2015. This policy was updated to be consistent with US Food and Drug Administration (FDA) Labeling and Drug Compendia. The coverage position for alglucerase (Ceredase®) was changed from medically necessary to not eligible for reimbursement.

Revisions From MA08.023:

01/01/2015

This is a new policy.

Version Effective Date:

1/2/2026

Version Issued Date: