CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cerezyme Elelyso VPRIV

Defines prior authorization criteria, coverage, dosing limits, continuation criteria, billing codes, and investigational exclusions for intravenous Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), and VPRIV (velaglucerase alfa) for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCerezyme Elelyso VPRIV

Policy CodePolicy N/A

Change TypeReferences updatedno material coverage changes

Effective DateJan 1, 2020

Next Review DateDec 9, 2025

Key ActionCoverage of Cerezyme, Elelyso, and VPRIV will be reviewed prospectively via the prior authorization process and requests must meet all criteria in the procedure section.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed multiple times; latest review dates listed through 12/09/2025 with no explicit clinical policy statement changes noted.

3Products covered

6 monthsAuthorization duration

3Applicable HCPCS codes listed

Coverage Summary

This policy covers Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), and VPRIV (velaglucerase alfa) with prior authorization and product-specific step therapy requirements determined by payer. Authorization is granted for 6 months. The overall purpose is to ensure the safe, effective, and appropriate use of these enzyme replacement therapies consistent with FDA labeling and the clinical literature.

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Initial Coverage Criteria / Medical Necessity

Coverage when ALL of the following are met:

ALL of the following

Confirmed diagnosis of Type 1 Gaucher disease by enzyme assay demonstrating deficiency of beta-glucocerebrosidase (glucosidase) enzyme activity or by genetic testing
Product-specific step therapy exceptions
- For Medicaid members requesting VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa): documented failure, intolerance or contraindication to Cerezyme (imiglucerase)
- For Commercial members requesting VPRIV (velaglucerase alfa): documented failure, intolerance or contraindication to both Cerezyme (imiglucerase) and Elelyso (taliglucerase alfa)
- For Medicare members: members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements

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Continuation of Therapy Criteria

Coverage continued when ALL of the following are met:

ALL of the following

Member continues to meet all initial criteria
Member is tolerating and responding to medication with improvement in symptoms compared to pre-treatment baseline (examples: bone pain, fatigue, dyspnea, angina, abdominal distension, diminished quality of life) and there continues to be a medical need for the medication

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Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Coverage of Cerezyme, Elelyso, and VPRIV will be reviewed prospectively via the prior authorization process and requests must meet all criteria in the procedure section.

Affected HCPCS codes: J1786, J3060, J3385
Requests must meet ALL criteria in the Procedure/Coverage Criteria section

Documentation Required

Diagnostic documentation required

Provide diagnostic documentation as part of the prior authorization submission: enzyme assay demonstrating beta-glucocerebrosidase (glucosidase) deficiency or genetic testing confirming Type 1 Gaucher disease.

Step Therapy

Step therapy requirements (product-specific by payer)

Step therapy requirements vary by payer and are applied as follows.

Medicaid: For requests of VPRIV (velaglucerase alfa) or Elelyso (taliglucerase alfa), documented failure, intolerance, or contraindication to Cerezyme (imiglucerase) is required.
Commercial: For requests of VPRIV, documented failure, intolerance, or contraindication to both Cerezyme and Elelyso is required.
Medicare: Members who have previously received this medication within the past 365 days are exempt from step therapy requirements.

Denial Risk

Investigational/Unsupported Use

Requests for doses or indications outside FDA-labeled or recognized compendia-supported indications are considered investigational and are not covered.

Billing Rule

Billable unit definition

Billing guidance and billable unit definitions: 1 billable unit = 10 units for Cerezyme and Elelyso. HCPCS unit reporting: J1786 and J3060 reported per 10 units; J3385 reported per 100 units. Ensure submitted billing units and quantities match these HCPCS unit definitions and the policy's billable unit conversions and dosing thresholds.

1 billable unit = 10 units (Cerezyme and Elelyso)
J1786 (imiglucerase) — 10 units per HCPCS unit
J3060 (taliglucerase alfa / Elelyso) — 10 units per HCPCS unit
J3385 (velaglucerase alfa / VPRIV) — 100 units per HCPCS unit
Maximum doses per policy: Cerezyme and Elelyso — 700 billable units every 14 days (1 billable unit = 10 units); VPRIV — 72 billable units every 14 days (1 billable unit = 10 units)

Clinical Evidence Summary

30Cerezyme pivotal trial (RC 91-0110) participants

99VPRIV evidence base (total patients across 3 studies)

31Elelyso 9-month randomized trial (adult participants)

Cerezyme: The pivotal randomized trial RC 91-0110 (30 patients) demonstrated improvements in hemoglobin, platelet counts, and reductions in spleen and liver volumes at the 6-month assessment, with additional radiographic bone improvements reported in responders.

VPRIV: The VPRIV evidence base comprises three studies (totaling 99 patients) including randomized trials and an open-label switch study. These studies showed clinically meaningful increases or maintenance of hemoglobin and platelet counts and stability or improvement in liver and spleen volumes over follow-up, supporting VPRIV's efficacy and maintenance of clinical parameters.

Elelyso: A 9-month randomized trial in 31 adults showed significant decreases in spleen volume and increases in hemoglobin; an extension to 24 months demonstrated continued improvements. A separate 9-month switch study of 25 patients switching from imiglucerase found hemoglobin and spleen volume remained stable, supporting effectiveness when transitioned.

These findings and the overall coverage approach were reviewed by the P&T committee, which prioritized coverage for medically accepted indications and cost-effective sequencing of therapies as appropriate.

Background & Definitions

This policy supports the safe, effective, and appropriate use of enzyme replacement therapies (Cerezyme, Elelyso, and VPRIV) for Type 1 Gaucher disease in accordance with FDA labeling and relevant clinical literature. The policy and criteria were reviewed and adopted by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee to ensure medically accepted use and to encourage cost-effective sequencing.

Scope: The policy applies to Medicaid, Commercial, and Medicare members and governs coverage under the medical benefit when used within the specified guidelines.

Billable unit: 1 billable unit = 10 units (used for Cerezyme and Elelyso in this policy).

Revision History

2020-01-01effective_date

Policy effective date established for coverage of Cerezyme, Elelyso, and VPRIV for Type 1 Gaucher disease per FDA labeling and clinical literature; prior authorization required.

2025-05-14last_reviewLatest

P&T committee review completed; coverage criteria and clinical rationale reaffirmed (continuation and initial criteria, step therapy exceptions, dosing and billing rules). References updated through May 2025.

2025-12-09reference_update

References updated to package inserts dated 2024-2025 (Elelyso Jan 2025; Cerezyme Dec 2024; VPRIV Nov 2024). Policy reviewed through 12/09/2025 with no material coverage changes (is_material=false).