CurrentColorado Rocky Mountain Health PlansPolicy CSOH2025D0048.C

Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease (Ohio Only)

Defines medical benefit coverage and clinical criteria references for IV enzyme replacement therapies (imiglucerase, taliglucerase alfa, velaglucerase alfa) used to treat Gaucher disease for members in Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIntravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease (Ohio Only)

Policy CodePolicy CSOH2025D0048.C

Change TypeRoutine reviewno content changes

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests that meet the current InterQual CP: Specialty Rx Non-Oncology criteria for the requested ERT product.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes.

3drugs referenced

Ohioapplicable state

3HCPCS codes listed

InterQualexternal clinical criteria used

Coverage and Medical Necessity Criteria

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Medical necessity per InterQual

Covered when ALL of the following are met per referenced InterQual criteria for each product

InterQual-based approval: Member meets the current InterQual CP: Specialty Rx Non-Oncology criteria specific to the requested ERT product (imiglucerase [Cerezyme], taliglucerase alfa [Elelyso], or velaglucerase alfa [VPRIV]).see InterQual

Provider must follow the InterQual criteria linked in the policy for exact clinical requirements.

The listing of a procedure or diagnosis code in this policy is provided for reference only and does not imply that the service described by the code is covered. Benefit coverage for any service is determined by applicable federal, state, or contractual requirements and laws, which may mandate coverage for specific services. Inclusion of a code in this document does not guarantee reimbursement or claim payment; other policies and guidelines may apply.

This policy underwent a routine review on 08/01/2025 with no content changes. The previous policy version CSOH2024D0048.B has been archived. There are no explicit statements in this document designating any services as "not medically necessary."

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required per InterQual criteria — Coverage and medical necessity determinations for imiglucerase, taliglucerase, and velaglucerase follow the referenced InterQual criteria. Providers must obtain prior authorization before administration to ensure coverage under the member's benefit plan.

Affected products: Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), VPRIV (velaglucerase alfa)
Reference InterQual criteria: Type 1 Gaucher disease (current release)

Note

Provider Action

Actionable provider step: confirm member eligibility, benefit type, and prior authorization requirements before scheduling infusion. Include diagnosis, prior treatment history, relevant labs, and InterQual decision support documentation with the prior authorization request.

Include ICD-10 diagnosis and medical records supporting Gaucher disease diagnosis
Attach documentation of prior therapies and rationale if switching products
Provide relevant laboratory and clinical assessments referenced in InterQual

Documentation Required

Documentation and Governing Rules

Documentation and governing rules — Coverage determinations reference federal, state (Ohio Administrative Code where applicable), and contractual benefit terms; in the event of a conflict, those governing requirements prevail. This policy is informational and does not replace plan-specific benefit language. UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in clinical determinations. Providers must retain and submit clinical documentation supporting medical necessity upon request.

Benefit coverage determined by federal, state (OAC), or contractual requirements and applicable laws
Listing of a code does not guarantee coverage or payment
Providers must maintain and provide medical records to support authorization and claims

Documentation Required

Coverage Conditional on Benefit Terms

Listing of a code does not imply the service is covered — Benefit coverage for services and drugs (including J1786, J3060, J3385) is determined by the member's plan terms and applicable federal/state/contractual requirements. Check plan benefits and authorization requirements prior to service.

HCPCS: J1786 (imiglucerase 10 units), J3060 (taliglucerase alfa 10 units), J3385 (velaglucerase alfa 100 units)
Verify benefit coverage and prior authorization before administration

Background and Scope

Intravenous enzyme replacement therapies referenced in this policy—imiglucerase (Cerezyme), taliglucerase alfa (Elelyso), and velaglucerase alfa (VPRIV)—are approved treatments used to manage certain presentations of Gaucher disease. Coverage and medical necessity determinations for these products are governed by the current InterQual CP: Specialty Rx Non-Oncology criteria specific to each enzyme replacement therapy; providers should reference the InterQual guidance for the detailed clinical requirements for initiation and continuation of therapy.

Key Definitions

IV ERT — Enzyme replacement therapy (ERT)

TermIV ERT

DefinitionIntravenous enzyme replacement therapy (ERT) — intravenous infusion of recombinant enzymes to replace deficient lysosomal enzyme activity in Gaucher disease.

Drugs referencedCerezyme (imiglucerase); Elelyso (taliglucerase alfa); VPRIV (velaglucerase alfa)

Indication referencedTreatment of certain presentations of Gaucher disease (see InterQual CP: Specialty Rx Non-Oncology criteria for Type 1 Gaucher disease)

Clinical criteria sourceCoverage and medical necessity determinations follow the current InterQual CP: Specialty Rx Non-Oncology criteria for each specific ERT product (imiglucerase, taliglucerase alfa, velaglucerase alfa).

Initial Authorization Criteria

Initial therapy

Initial authorization decisions follow the InterQual CP: Specialty Rx Non-Oncology criteria for each specific product

Initial therapy: Member meets initial InterQual criteria for the requested ERT product (imiglucerase [Cerezyme], taliglucerase alfa [Elelyso], or velaglucerase alfa [VPRIV]).see InterQual

Provider must reference the current InterQual release linked in the policy.

Step	Policy statement
1	This policy does not define a payer‑specific step‑therapy sequence. Coverage and medical necessity determinations for imiglucerase (Cerezyme), taliglucerase (Elelyso), and velaglucerase (VPRIV) are governed by the current InterQual CP: Specialty Rx Non‑Oncology criteria referenced for each product; providers must follow the InterQual requirements for initial and continuation therapy.

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