CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa) Intravenous

Medicaid, Commercial, and Medicare coverage and prior authorization requirements for intravenous enzyme replacement therapies (imiglucerase, taliglucerase alfa, velaglucerase alfa) for treatment of Type 1 Gaucher disease.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa) Intravenous

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review DateN/A

Key ActionSubmit prior authorization with confirmed Type 1 Gaucher disease diagnosis and required documentation; step therapy requires failure or intolerance to Cerezyme before VPRIV or Elelyso.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical coverage duration for approvals

700 units/14dmax dose Cerezyme/Elelyso

60 units/kg q2wcommon dosing frequency

J1786,J3060,J3385billing codes listed

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met

Initial coverage criteria for enzyme replacement therapy: Confirmed diagnosis of Type 1 Gaucher disease by enzyme assay demonstrating deficiency of beta-glucocerebrosidase or by genetic testing; AND for members requesting VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa), documented failure, intolerance, or contraindication to Cerezyme (imiglucerase); OR Medicare members who have previously received the medication within the past 365 days are exempt from the step therapy requirement.

Medicare members with prior use in the past 365 days are not subject to step therapy requirements

Continuation Therapy

Continuation of therapy is covered when ALL are met

Continuation criteria: The patient meets all initial criteria; AND the patient is tolerating and responding to the medication with documented clinical improvement compared to pre-treatment baseline (examples: improved bone pain, fatigue, dyspnea, angina, abdominal distension, or quality-of-life measures) and there continues to be a medical need for the medication.Coverage duration: 6 months

Investigational/Not Medically Accepted Uses

Investigational/Not covered uses: Therapies used at doses or for conditions outside recognized medically accepted indications (per AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed published literature) are considered investigational and are not covered.

Neighborhood does not provide coverage for investigational uses.

Use of VPRIV, Cerezyme, Elelyso, or other enzyme replacement therapies at doses or for clinical indications that are not recognized as medically accepted per standard reference compendia is considered investigational and not covered. Accepted references include AHFS-DI, Micromedex (DrugDex), Clinical Pharmacology, Lexi-Drugs, or peer‑reviewed medical literature demonstrating sufficient evidence to support the use.

Medications to treat Gaucher disease are covered only when used within the policy’s stated guidelines; use outside these guidelines or for investigational purposes may result in non-payment unless an approved exception is documented. Neighborhood Health Plan does not provide coverage for drugs used for investigational purposes.

Initial Therapy

Initial therapy

Initial coverage criteria with dosing guidance

Initial therapy rules: Confirmed diagnosis of Type 1 Gaucher disease by enzyme assay or genetic testing; for VPRIV or Elelyso, documented failure, intolerance, or contraindication to Cerezyme unless the member is a Medicare member with prior use within the past 365 days; dosing per labeled ranges for each product (see dosing nodes).

Prior authorization required

Cerezyme (imiglucerase) dosing: Initial dosages range from 2.5 units/kg three times weekly to 60 units/kg once every 2 weeks based on disease severity. Maximum: 700 billable units every 14 days (1 billable unit = 10 units).Maximum 700 billable units/14 days

1 billable unit = 10 units

Elelyso (taliglucerase alfa) dosing: Up to 60 units/kg every other week as a 60–120 minute intravenous infusion. Maximum: 700 billable units every 14 days (1 billable unit = 10 units).Maximum 700 billable units/14 days

1 billable unit = 10 units

VPRIV (velaglucerase alfa) dosing: Up to 60 units/kg every other week as a 60-minute intravenous infusion. Maximum: 72 billable units every 14 days (1 billable unit = 10 units).Maximum 72 billable units/14 days

1 billable unit = 10 units

Provider Actions / Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), and VPRIV (velaglucerase alfa). Coverage will be reviewed prospectively via the prior authorization process and use outside these guidelines may result in non-payment unless approved through an exception process.

Affected agents: Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa)

Step Therapy

Step Therapy Requirement

Step therapy: Members requesting VPRIV or Elelyso must have documented failure, intolerance, or contraindication to Cerezyme prior to coverage of VPRIV or Elelyso. Exception: Medicare members who have received the medication within the past 365 days are not subject to the step therapy requirement.

Step requirement applies to non-Medicare members requesting VPRIV or Elelyso
Medicare members with prior receipt in past 365 days are exempt from step therapy

Documentation Required

Required Documentation

Documentation must include confirmation of diagnosis and supporting clinical information. Specifically, a confirmed diagnosis of type 1 Gaucher disease by enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity or by genetic testing must be provided with the prior authorization request.

Include enzyme assay results or genetic testing demonstrating GD1
Provide clinical rationale and history of prior therapies, intolerances, or contraindications as applicable

Denial Risk

Noncompliant Use May Be Denied

Use outside the stated coverage criteria may be denied and result in non-payment. Coverage of requests that do not meet criteria will be reviewed via the prior authorization process and may require additional clinical justification or exception review.

Noncompliant use may be denied or require an exception
Prior authorization review determines coverage when criteria are not clearly met

Step	Requirement
1	Documented failure, intolerance, or contraindication to Cerezyme (imiglucerase) is required prior to coverage of VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa).
Exception	Medicare members who have previously received VPRIV or Elelyso within the past 365 days are exempt from the step therapy requirement.

Quantity Limits / Maximum Dosing

inv-17: Cerezyme — quantity limit and dosing

AgentCerezyme (imiglucerase)

Maximum dosingMaximum 700 billable units every 14 days (1 billable unit = 10 units).

Labeled dosing rangeInitial dosages range from 2.5 U/kg 3 times weekly to 60 U/kg every 2 weeks.

inv-18: Elelyso — quantity limit and dosing

AgentElelyso (taliglucerase alfa)

Maximum dosingMaximum 700 billable units every 14 days (1 billable unit = 10 units).

Labeled dosing rangeUp to 60 units/kg every other week as a 60–120 minute IV infusion.

inv-19: VPRIV — quantity limit and dosing

AgentVPRIV (velaglucerase alfa)

Maximum dosingMaximum 72 billable units every 14 days (1 billable unit = 10 units).

Labeled dosing rangeUp to 60 units/kg every other week as a 60-minute IV infusion.

Definitions

inv-13: Type 1 Gaucher disease (GD1) — definition and clinical features

DefinitionType 1 Gaucher disease (GD1) is the non-neuronopathic form of Gaucher disease caused by deficiency of beta-glucocerebrosidase.

Key clinical featuresAnemia, thrombocytopenia, hepatomegaly, splenomegaly, and bone involvement (bone disease).

DiagnosisConfirmed by enzyme assay demonstrating deficient beta-glucocerebrosidase activity or by genetic testing.

Therapeutic approachEnzyme replacement therapy (Cerezyme, Elelyso, VPRIV) is indicated to improve hemoglobin, platelet counts, and reduce organ volumes.

Background

Type 1 Gaucher disease (GD1) is a non‑neuronopathic lysosomal storage disorder caused by deficiency of beta‑glucocerebrosidase, leading to anemia, thrombocytopenia, hepatosplenomegaly, and progressive bone disease. Management of GD1 commonly includes enzyme replacement therapy (ERT) with recombinant glucocerebrosidase products to reduce organ volumes, improve hemoglobin and platelet counts, and ameliorate bone manifestations.

Approved intravenous ERT options referenced in this policy include Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), and VPRIV (velaglucerase alfa). Dosing for these agents is consistent with labeled ranges (for example, up to 60 units/kg every other week for Elelyso and VPRIV), and maximum billable units are specified in the policy. Use outside labeled doses or for unrecognized indications is considered investigational and not covered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa) Intravenous

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review DateN/A

Key ActionSubmit prior authorization with confirmed Type 1 Gaucher disease diagnosis and required documentation; step therapy requires failure or intolerance to Cerezyme before VPRIV or Elelyso.

SourceLink

On This Page

OpenPayer

Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa) Intravenous

Coverage Criteria

Initial Therapy

Continuation Therapy

Provider Actions / Requirements

Coding / Billing

Step Therapy Requirements

Quantity Limits / Maximum Dosing

Definitions

Background

J1786	Injection, imiglucerase, 10 units
J3060	Injection, taliglucerase alfa, 10 units
J3385	Injection, velaglucerase alfa, 100 units