CurrentCommunity-CarePolicy N/A

Cerezyme (imiglucerase) — Medical Benefit Coverage Criteria for Gaucher Disease Type 1

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Defines medical benefit coverage criteria, authorization, and coding for Cerezyme (imiglucerase) for members with Gaucher disease type 1; applies to prescribers and payers managing medication benefits.

Policy Summary

PayerCommunity-Care

PolicyCerezyme (imiglucerase) — Medical Benefit Coverage Criteria for Gaucher Disease Type 1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewNov 1, 2024

Next Review DateNov 1, 2024

Key ActionSubmit prior authorization demonstrating diagnosis, enzyme deficiency, prescriber specialty, age ≥2, and at least one qualifying complication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum age for initiation

Hb<8severe anemia threshold

Plt<60ksevere thrombocytopenia

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CurrentCommunity-CarePolicy N/A

Cerezyme (imiglucerase) — Medical Benefit Coverage Criteria for Gaucher Disease Type 1

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Policy Summary

PayerCommunity-Care

PolicyCerezyme (imiglucerase) — Medical Benefit Coverage Criteria for Gaucher Disease Type 1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewNov 1, 2024

Next Review DateNov 1, 2024

Key ActionSubmit prior authorization demonstrating diagnosis, enzyme deficiency, prescriber specialty, age ≥2, and at least one qualifying complication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum age for initiation

Hb<8severe anemia threshold

Plt<60ksevere thrombocytopenia

Coverage Criteria for Cerezyme (imiglucerase)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Initial Approval for Gaucher disease type 1

Complications (at least one required): 1. Severe anemia (Hb < 8 mg/dL) 2. Severe thrombocytopenia (< 60,000 cells/mL) 3. Absolute leukocyte count < 3,000 cells/mL 4. Symptomatic bone disease (prior bone crisis and osteonecrosis) 5. Active bone disease 6. Pubertal delay 7. Sibling with severe disease requiring enzyme replacement or substrate reduction therapy 8. Genotype associated with severe disease 9. Height < 5th percentile or significantly decreased growth velocity 10. Bone mineral density Z-score < -2.0 11. Spleen volume > 2.0 multiples of normal (MN) with liver volume > 2.0 MNat least 1
Complications list from policy

Continuation Therapy — Covered when ALL of the following are met for continuation therapy

Covered when ALL of the following are met for continuation therapy:

Continuation Therapy for Gaucher disease type 1: Patient has diagnosis of Gaucher disease type 1; documentation of positive response to treatment with imiglucerase (Cerezyme); and will not be used in combination with another enzyme replacement or substrate reduction therapy for Gaucher disease.see text

Continuation requires documented clinical benefit; authorization period = 1 year if approved

Use of imiglucerase (Cerezyme) in combination with another enzyme replacement or a substrate reduction therapy for Gaucher disease is not permitted. Requests for initial or continuation therapy must confirm that the agent will not be used in combination with another enzyme replacement or substrate reduction therapy for Gaucher disease.

Gaucher disease type 1 with documented deficient β-glucocerebrosidase enzyme activity (genotype associated with severe disease qualifies)

Covered indication:

Covered Indication: Gaucher disease type 1 with documented deficient β-glucocerebrosidase enzyme activity.

Genotype associated with severe disease is listed as one qualifying complication for initiation; laboratory documentation of enzyme deficiency required; weight required for approval

Coding and Laboratory Thresholds

Applicable HCPCS CodesHCPCSCovered

J1786

Injection, imiglucerase, 10 units

inv-05: Hemoglobin threshold

Hemoglobin thresholdSevere anemia defined as hemoglobin (Hb) < 8 mg/dL

ContextOne of the qualifying complications required for initial approval of imiglucerase (Cerezyme)

Actionable useDocument current Hb in prior authorization request to demonstrate eligibility

inv-06: Platelet count threshold

Platelet count thresholdSevere thrombocytopenia defined as platelets < 60,000 cells/mL

ContextListed as a qualifying complication for initial therapy with imiglucerase

Provider Actions and Requirements

Prior Authorization

Prior authorization required for Cerezyme (imiglucerase)

Prior authorization is required for Cerezyme (imiglucerase). Requests for initial therapy must document diagnosis of Gaucher disease type 1, laboratory evidence of deficient β‑glucocerebrosidase enzyme activity, be prescribed by a medical geneticist or other prescriber who specializes in the treatment of Gaucher disease, show the patient is age ≥ 2 years, include at least one qualifying complication, and provide patient weight for dosing. If approved, authorization is granted for one year.

HCPCS J1786 is the applicable billing code for imiglucerase (10 units).
A weight is required for approval.

Step Therapy

Combination therapy restriction

Cerezyme must not be used in combination with another enzyme replacement or substrate reduction therapy for Gaucher disease for either initial approval or continuation of therapy.

Member Eligibility Requirements

A sibling with severe Gaucher disease who requires enzyme replacement or substrate reduction therapy counts as a qualifying complication for initiating therapy with imiglucerase. Presence of this family history should be documented as one of the required complications to meet eligibility for initial approval.

Prior to initiation of imiglucerase (Cerezyme), documentation of deficient β-glucocerebrosidase enzyme activity is required. Laboratory evidence of the enzyme deficiency must be included in the request to establish the diagnosis of Gaucher disease type 1.

Background

Gaucher disease type 1 is caused by deficient activity of the β-glucocerebrosidase enzyme, which leads to hematologic, visceral, and skeletal complications. Enzyme replacement therapy with imiglucerase (Cerezyme) is used to treat symptomatic manifestations and to prevent progression of these disease-related complications.

inv-15: Definition — β-glucocerebrosidase enzyme deficiency (laboratory documentation required to confirm diagnosis)

DefinitionDeficient activity of β-glucocerebrosidase enzyme (laboratory documentation required to confirm diagnosis)

RequirementDocumentation of deficient β-glucocerebrosidase enzyme activity is required prior to initiation of imiglucerase (Cerezyme)

Use in coverage logicPresence of documented enzyme deficiency is part of initial and continuation coverage criteria for Gaucher disease type 1

Documentation tipInclude specific enzyme assay results in prior authorization submission to avoid denial

Policy Summary

PayerCommunity-Care

PolicyCerezyme (imiglucerase) — Medical Benefit Coverage Criteria for Gaucher Disease Type 1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewNov 1, 2024

Next Review DateNov 1, 2024

Key ActionSubmit prior authorization demonstrating diagnosis, enzyme deficiency, prescriber specialty, age ≥2, and at least one qualifying complication.

SourceLink

On This Page

Include most recent platelet count in documentation for prior authorization

inv-07: Absolute leukocyte count threshold

Absolute leukocyte count thresholdAbsolute leukocyte count < 3,000 cells/mL

ContextIncluded as a qualifying complication for initiation of Cerezyme therapy

Actionable useProvide lab report showing leukocyte count when requesting initial approval

inv-08: Bone mineral density Z-score threshold

Bone mineral density thresholdBone mineral density Z-score < -2.0

ContextCounts as one of the complications required for initial approval of imiglucerase

Actionable useAttach DEXA report with Z-score to support initiation request

inv-09: Spleen and liver volume thresholds

Spleen and liver volume thresholdsSpleen volume > 2.0 multiples of normal (MN) with liver volume > 2.0 MN

ContextSpecified as a combined visceral volume criterion among qualifying complications for initial therapy

Actionable useProvide imaging report documenting spleen and liver volumes in MN when submitting prior authorization

Documentation Required

Required documentation for authorization

Documentation submitted with the request must include the diagnosis of Gaucher disease type 1, laboratory evidence of deficient activity of β‑glucocerebrosidase enzyme, patient weight for dosing, and evidence of at least one qualifying complication when requesting initial therapy.

Qualifying complications include severe anemia (Hb < 8 mg/dL), severe thrombocytopenia (platelets < 60,000 cells/mL), absolute leukocyte count < 3,000 cells/mL, symptomatic or active bone disease, pubertal delay, sibling with severe disease requiring therapy, genotype associated with severe disease, height < 5th percentile or decreased growth velocity, bone mineral density Z‑score < -2.0, and spleen/liver volume criteria.

Denial Risk

Denial triggers for Cerezyme requests

Requests may be denied if they do not include documentation of deficient β‑glucocerebrosidase enzyme activity, are not prescribed by a medical geneticist or a prescriber who specializes in Gaucher disease, do not meet the minimum age criterion (≥ 2 years) or lack evidence of at least one qualifying complication for initial therapy.

Note

Prescriber specialty requirement for initial approval

For initial approval, the medication must be prescribed by a medical geneticist or another prescriber who specializes in the treatment of Gaucher disease.

Billing Rule

Not covered: unrelated genetic testing

Genetic tests or uses that are not performed to establish enzyme deficiency or to identify a genotype associated with severe disease are not described as covered under this policy.