CurrentmhnPolicy CP.PHAR.154

Imiglucerase (Cerezyme)

Coverage and medical necessity criteria for imiglucerase (Cerezyme) for treatment of Gaucher disease for commercial, HIM, and Medicaid lines of business; specifies initial and continuation approval criteria, dosing limits, and administrative requirements.

Policy Summary

Payermhn

PolicyImiglucerase (Cerezyme)

Policy CodePolicy CP.PHAR.154

Change TypeNo material change

Effective DateFeb 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic confirmation, member age ≥2 years, current weight, evidence of symptomatic disease, and dosing not to exceed 60 units/kg every 2 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum patient age for FDA indication

60 U/kgmaximum dose q2w

400vial size

J1786HCPCS code

6 moinitial approval duration

Coverage Criteria

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Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for any specific coverage rules that apply to Medicaid members.

Combination therapy with miglustat (Zavesca®) or eliglustat (Cerdelga®), and the concurrent use of two or more enzyme replacement therapies, is not supported by sufficient clinical evidence. Requests for coverage involving combination or concurrent use of these agents will be evaluated in light of existing evidence and may be denied when adequate supporting data are not provided.

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (office chart notes, lab results, genetic or enzyme testing results, dosing rationale, and other clinical information) supporting that the member meets all approval criteria for initiation or continuation of Cerezyme.

Diagnosis confirmation (enzyme assay showing beta-glucocerebrosidase deficiency or DNA testing) must be documented.
Age ≥ 2 years for initial therapy must be documented.
Member must be symptomatic (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly) for initial approval.
Documentation of current member weight (kg) is required for dose calculation.
Dose must not exceed 60 units/kg every two weeks per prescribing information.
Cerezyme must not be prescribed concurrently with other ERTs VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa).

Denial Risk

Insufficient Documentation or Unmet Criteria May Lead to Denial

Requests lacking required documentation or that do not meet the clinical criteria above may be denied. Providers should supply supporting progress notes, laboratory results, imaging, genetic/enzyme testing reports, and current weight at the time of request.

Insufficient or absent documentation of diagnosis, symptoms, current weight, or prior authorization history may result in denial.
If a dose increase is requested, documentation justifying the increase and the new weight-based dose (not exceeding 60 units/kg every two weeks) must be provided.

Step Therapy

No Step Therapy Requirement

There is no step therapy requirement for Cerezyme in this policy.

Billing Rule

Coding and Billing Note

Billing and coding guidance is informational and does not guarantee reimbursement. Providers should follow current coding guidance when submitting claims.

HCPCS: J1786 — Injection, imiglucerase, 10 units (code referenced for informational purposes).
Coding inclusion/exclusion does not guarantee coverage; verify up-to-date professional coding guidance prior to claim submission.

Documentation Required

Required Clinical Documentation

Providers must supply required clinical documentation to support medical necessity decisions.

Office chart notes, lab results, imaging, genetic or enzyme assay reports, current weight in kg, and documentation of clinical response for continuation requests (e.g., stabilized/increased hemoglobin or platelets, reduced/stabilized spleen or liver volume, decreased bone pain).
For members already receiving therapy, documentation that the member previously met initial approval criteria or that continuity-of-care rules apply (per state/product) should be included.

Initial Therapy Criteria

inv-21: Initial Therapy — initial approval requires diagnostic confirmation and symptomatic disease

Initial approval requires diagnostic confirmation and symptomatic disease:

Diagnostic confirmation: Diagnosis of type 1 (GD1) or type 3 (GD3) Gaucher disease confirmed by either: (a) enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity, or (b) DNA testing.

Age requirement: Age ≥ 2 years.

Symptomatic disease: Member is symptomatic (examples: anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly).

Continuation Therapy Criteria

inv-22: Continuation Therapy — requires prior approval or current use and evidence of clinical response

Continuation approval requires prior approval or current use and evidence of clinical response:

Prior approval or current use: Member is currently receiving medication via Centene benefit or previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity-of-care regulations.

Clinical response: 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.

Concurrent ERT restriction: Cerezyme is not prescribed concurrently with VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa).

Dose limit for increases: If request is for a dose increase, new dose does not exceed 60 units/kg every two weeks.dose ≤ 60 units/kg q2w

Step Therapy / Formulary Cross-References

Situation	Action / Policy to follow
Recent label change (within last 6 months) or newly approved indication/age expansion/dosing regimen not yet reflected in this policy	Refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business: CP.CPA.190 (commercial) or HIM.PA.33 (HIM) or CP.PMN.255 (Medicaid) for formulary agents; for non-formulary agents see CP.CPA.190 (commercial) or HIM.PA.103 (HIM) or CP.PMN.16 (Medicaid)
Requested use (diagnosis, age, dosing) is not listed in section III (Diagnoses/Indications for which coverage is NOT authorized) and no recent label change applies	Refer to the off‑label use policy for the relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid)

Site of Care

Note

Infusion administration — IV per dosing regimen

Administer imiglucerase via IV infusion according to the individualized dosing regimen; the policy specifies IV infusion dosing up to the recommended maximum (60 U/kg every 2 weeks) and does not impose an explicit site‑of‑care restriction in the cited sections.

IV infusion per dosing regimen
No explicit site‑of‑care restriction stated in these sections

Note

Site‑of‑care — no restriction specified

The policy does not specify a site‑of‑care restriction for administration of Cerezyme in the provided sections.

Definitions

inv-18: ERT — enzyme replacement therapy

DefinitionEnzyme replacement therapy (ERT): therapeutic approach replacing deficient enzymes such as beta-glucocerebrosidase

Role in Gaucher diseaseERT ameliorates systemic involvement in GD1 and GD3; palliative in GD2

Therapeutic response measuresHemoglobin, platelet count, liver and spleen volumes, and bone pain

inv-19: GD1 — type 1 Gaucher disease

DefinitionGD1: type 1 Gaucher disease

Diagnosis criteriaConfirmed by enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity or DNA testing

Clinical featuresOften symptomatic with anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly

inv-20: GD3 — type 3 Gaucher disease

DefinitionGD3: type 3 Gaucher disease

Response to ERTERT ameliorates systemic involvement in many GD3 patients but does not reverse neurological progression

Diagnosis criteriaConfirmed by enzyme assay or DNA testing (same diagnostic standards as GD1)

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