CurrentUnitedHealthcarePolicy CS2026D0048U

Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

UnitedHealthcare medical benefit drug policy for intravenous enzyme replacement therapies (Cerezyme, Elelyso, VPRIV) for treatment of Gaucher disease, defining initial and continuation coverage criteria by disease type (Type 1 and Type 3), dosing limits, and applicable HCPCS/J-codes. Excludes certain states or defers to state-specific policies as noted.

Policy Summary

PayerUnitedHealthcare

PolicyIntravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

Policy CodePolicy CS2026D0048U

Change TypeTemplate update (removed Louisiana-specific content)

Effective DateApril 1, 2026

Next Review Date

Key ActionInitial authorization for ERT is limited to no more than 12 months and requires documentation of diagnosis, symptomatic disease, and dosing aligned with FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Template Update removed content/language pertaining to the state of Louisiana and archived previous policy version CS2025D0048T.

3Drugs referenced (Cerezyme, Elelyso, VPRIV)

2Gaucher disease types with explicit criteria (Type 1, Type 3)

12 monthsMax authorization period

Coverage Summary

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Scope: UnitedHealthcare medical benefit drug policy for intravenous enzyme replacement therapies (Cerezyme, Elelyso, VPRIV) for treatment of Gaucher disease, defining initial and continuation coverage criteria by disease type (Type 1 and Type 3), applicable HCPCS/J-codes, dosing limits, and maximum authorization periods. The policy notes that some states have separate or differing policies (see Application), and a template update removed previous Louisiana-specific content on 04/01/2026.

Coverage stance: Mixed — the policy designates VPRIV as preferred and specifies medical necessity criteria for Cerezyme, Elelyso, and VPRIV with requirements for documented symptomatic Type 1 or Type 3 disease, dosing in accordance with FDA labeling, and authorization limits of up to 12 months for initial and continuation approvals. Relevant HCPCS/J-codes referenced include J1786 (imiglucerase), J3060 (taliglucerase alfa), and J3385 (velaglucerase alfa).

Key facts

Policy numberCS2026D0048U

SubjectIntravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

Effective dateApril 1, 2026

StatusCURRENT

Max authorization period12 months

Drugs referenced (count)3

VPRIV (velaglucerase) — Type 1 Criteria

Prior Authorization

VPRIV initial authorization requirements

Initial authorization for VPRIV is limited to no more than 12 months. Coverage requires documentation of a diagnosis of Type 1 Gaucher disease and evidence of symptomatic disease (for example: moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly). Dosing must be in accordance with U.S. FDA–approved labeling.

J1786
J3060
J3385

Elelyso (taliglucerase) — Type 1 Criteria

Documentation Required

Document history of VPRIV failure for Elelyso/Cerezyme

To cover Elelyso or Cerezyme for Type 1 Gaucher disease, the provider must document a history of VPRIV failure either due to failure to meet clinical goals (for example: persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy, or due to hypersensitivity to VPRIV.

J3060
J1786

Provider Actions & Prior Authorization

Prior Authorization

Initial authorization duration and requirement

Initial authorization for enzyme replacement therapy (all products) is limited to no more than 12 months and requires documentation of the diagnosis of Type 1 Gaucher disease, symptomatic disease (examples: moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly), and dosing in accordance with FDA-approved labeling.

J1786
J3060
J3385

Prior Authorization

Continuation authorization requirements

Continuation (renewal) authorization requires documentation of a positive clinical response to therapy (for example: reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly). Dosing must remain in accordance with FDA-approved labeling. Continuation authorizations are granted for no more than 12 months at a time.

J1786
J3060
J3385
Examples of acceptable clinical response: improved hemoglobin, increased platelet count, decreased spleen or liver volume, reduction in bone disease symptoms

Clinical Evidence

Mean increase ~2.75 g/dLVelaglucerase efficacy — hemoglobin increase (≈26% from baseline in extension study)

Mean platelet +120% (ext.)Velaglucerase efficacy — platelet increase (≈120% mean increase in extension study)

Phase 3 +65.9%Velaglucerase phase 3 platelet increase at 60 U/kg (+65.9% at 12 months)

Evidence from clinical studies includes long-term and controlled trial data for velaglucerase alfa: an extension study reporting a mean hemoglobin increase of ~2.75 g/dL (26%) and a mean platelet count increase of ~120%, and a multinational phase 3 trial reporting platelet increases of ~+65.9% at 60 U/kg with clinically meaningful improvements after 12 months. These study results are described as extension study and phase 3 contexts and are linked in the policy to the required clinical response criteria (improvement or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly) used to authorize continuation of therapy.

Policy Summary

PayerUnitedHealthcare

PolicyIntravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

Policy CodePolicy CS2026D0048U

Change TypeTemplate update (removed Louisiana-specific content)

Effective DateApril 1, 2026

Next Review Date

Key ActionInitial authorization for ERT is limited to no more than 12 months and requires documentation of diagnosis, symptomatic disease, and dosing aligned with FDA labeling.

SourceLink

On This Page

OpenPayer

Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease

Coverage Summary

VPRIV (velaglucerase) — Type 1 Criteria

Elelyso (taliglucerase) — Type 1 Criteria

Cerezyme (imiglucerase) — Type 1 Criteria

Type 3 Gaucher Disease — ERT Criteria

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence

Background

Revision History

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