ModifiedHealth NetPolicy CP.PHAR.154

Imiglucerase (Cerezyme) coverage

Defines medical necessity criteria, authorization requirements, dosing limits, and coverage duration for imiglucerase (Cerezyme) for members across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyImiglucerase (Cerezyme) coverage

Policy CodePolicy CP.PHAR.154

Change TypeMaterial clinical revisions and dosing/approval updates

Effective DateFeb 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, current weight, diagnostic confirmation, and dosing not to exceed 60 units/kg every two weeks.

SourceLink

POLICY UPDATE CHANGES

Updated FDA-approved indications to include Gaucher disease type 3 (GD3) and removed the age restriction previously set at ≥ 2 years old.

Initial approval duration updated from 6 months to 12 months.

Added requirement for documentation of member's current weight for dose calculation purposes and added max dosing recommendations per Prescribing Information.

Added Boxed Warning from the Prescribing Information.

60 U/kgmaximum dose q2w

400Uvial size

12 moinitial approval (updated)

Boxed Warning

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Coverage Criteria

Initial Therapy — Covered when ALL of the following are met for Gaucher Disease (Initial)

Covered when ALL of the following are met for Gaucher Disease (Initial):

Initial Gaucher criteria: 1. Diagnosis of type 1 (GD1) or type 3 (GD3) confirmed by either (a) enzyme assay demonstrating a deficiency of beta-glucocerebrosidase (glucosidase) activity OR (b) DNA testing; 2. Member is symptomatic (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); 3. Cerezyme (imiglucerase) is not prescribed concurrently with VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa); 4. Documentation of the member's current weight (in kg) is provided; 5. Dose does not exceed 60 units/kg every two weeks.

Continuation Therapy — Continuation covered when ALL of the following are met

Continuation covered when ALL of the following are met:

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by increased or stabilized platelet count or hemoglobin, reduced or stabilized spleen or liver volume, or decreased bone pain; 3. Cerezyme is not prescribed concurrently with VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa); 4. Documentation of the member's current weight (in kg); 5. If request is for a dose increase, the new dose does not exceed 60 units/kg every two weeks.

Other Indications / Off-label handling — For other diagnoses/indications or recent label changes

For other diagnoses/indications or recent label changes:

Other indications handling: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, dosing change), refer to the appropriate formulary/no-coverage or non-formulary policy for the relevant line of business (policy references provided in this clinical policy). 2. If the requested use (diagnosis, age, dosing regimen) is NOT listed in section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (policy references provided).

References to specific payer policy numbers are provided in the policy text (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, CP.CPA.09, HIM.PA.154, CP.PMN.53).

Non‑FDA–approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy or evidence of coverage documents (see off‑label policies CP.CPA.09 for commercial, HIM.PA.154 for marketplace/ICHRA, and CP.PMN.53 for Medicaid).

When coverage provisions in this clinical policy conflict with a state Medicaid program's coverage provisions, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules that may supersede this policy for Medicaid members.

There is insufficient clinical evidence to support the combination use of enzyme replacement therapy with miglustat (Zavesca) or eliglustat (Cerdelga), or the concurrent use of two or more enzyme replacement therapies. Combination therapy is therefore not supported by this policy and requests for concurrent ERTs or ERT plus the listed oral agents should include clear, compelling clinical rationale and supporting evidence; lack of such evidence may result in non‑coverage.

Initial Therapy Criteria

Initial Therapy — Initial therapy dosing and diagnostic confirmation requirements.

Initial therapy dosing and diagnostic confirmation requirements.

Initial therapy nodes: Diagnosis confirmed by enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity or by DNA testing; member is symptomatic; Cerezyme is not to be used concurrently with VPRIV or Elelyso; documentation of current weight (kg) required for dose calculation; recommended dosing ranges from 2.5 U/kg IV three times weekly up to 60 U/kg every two weeks with titration based on clinical response; maximum dose = 60 U/kg every two weeks.

Initial therapy — Initial authorization requirements (updated initial approval duration to 12 months noted elsewhere).

Initial authorization requirements.

Initial Approval Conditions: Initial approval duration is 12 months; dosing must be calculated using the current member weight and must not exceed maximum dosing per Prescribing Information.12 months

Continuation Therapy Criteria

Continuation Therapy — Continuation therapy criteria mirror initial criteria with evidence of positive response required.

Continuation therapy criteria mirror initial criteria with evidence of positive response required.

Continuation nodes: Continuation requests must meet the same baseline requirements as initial approval (diagnostic confirmation, symptomatic disease, not concurrent with VPRIV or Elelyso, documentation of current weight). In addition, there must be evidence of positive response to therapy (increased or stabilized platelet count or hemoglobin; reduced or stabilized spleen or liver volume; or decreased bone pain). If a dose increase is requested, the new dose must not exceed 60 units/kg every two weeks.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required — Documentation & Criteria

Prior authorization is required. Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria, including diagnostic confirmation, symptomatic disease, weight, dosing limits, and absence of concurrent enzyme replacement therapies. Lack of required documentation may result in denial of the request.

Documentation must include diagnostic confirmation by enzyme assay demonstrating deficiency of beta-glucocerebrosidase or DNA testing.
Documentation must show the member is symptomatic (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly).
Provider must submit member's current weight (kg) for dose calculation.
Dose must not exceed 60 units/kg every two weeks (or per updated Prescribing Information).
Cerezyme (imiglucerase) must not be prescribed concurrently with VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa).

Coding

HCPCS CodesHCPCS

J1786

Injection, imiglucerase, 10 units

Therapeutic response thresholds (examples used in trials)

HemoglobinDecrease <1.5 g/dL (threshold used in trials)

Platelet countDecrease <25% (threshold used in trials)

Liver volumeIncrease <20% (threshold used in trials)

Spleen volumeIncrease <25% (threshold used in trials)

Initial approval duration

Initial approval duration12 months

Previous duration (before 2Q 2026 update)

Quantity Limits & Dosing

Imiglucerase (Cerezyme) — dosing limits

Dosing formatVial-based dosing; calculate dose using current member weight (kg)

Maximum doseMaximum 60 U/kg every 2 weeks

Recommended dosing rangeRanges from 2.5 U/kg IV three times weekly to 60 U/kg once every 2 weeks; titrate per clinical response

Imiglucerase (Cerezyme) — vial availability

Available vial size400 units vial available

Product availability sectionListed in Product Availability as Vial: 400 units

Implication for dosing

Site of Care

Note

Administer via IV infusion

Imiglucerase is administered via intravenous infusion; arrange administration at an appropriate infusion setting per local practice and facility capabilities.

Dosing regimens are IV infusion-based (examples: 2.5 U/kg IV three times weekly to 60 U/kg q2w)

Note

No explicit site‑of‑care restriction specified

The policy does not impose an explicit site‑of‑care restriction in this section; providers may use appropriate infusion settings per clinical judgment and payer/site rules.

No explicit site restriction stated in the cited policy section

Step Therapy

Step	Requirement
1	Policy indicates insufficient clinical evidence to support combination use of enzyme replacement therapy with miglustat (Zavesca) or eliglustat (Cerdelga), or concurrent use of two or more enzyme replacement therapies; combination therapy is not supported.

Step	Requirement
1	No step therapy requirements specified in the referenced sections of the policy.

Definitions

ERT — definition and context

DefinitionEnzyme replacement therapy (ERT)

Role in Gaucher diseaseERT ameliorates systemic (non-CNS) manifestations of Gaucher disease

LimitationsERT does not alter neurological progression in neuronopathic disease

GD1 / GD3 — definitions

GD1Type 1 Gaucher disease

GD3Type 3 Gaucher disease

Clinical noteCerezyme indicated for non-central nervous system manifestations of GD1 and GD3

Background

Gaucher disease is a lysosomal storage disorder with visceral, hematologic and bone manifestations. Imiglucerase (Cerezyme) is an enzyme replacement therapy indicated for the non‑central nervous system manifestations of Type 1 and Type 3 Gaucher disease; it can ameliorate systemic manifestations such as anemia, thrombocytopenia, hepatosplenomegaly and bone disease but does not alter the neurological progression of neuronopathic disease. Clinical use requires diagnostic confirmation (enzyme assay or DNA testing), evidence of symptomatic disease, documentation of current weight for dose calculations, and adherence to dosing limits and safety information noted in the Prescribing Information.