CurrentViva HealthPolicy IC-0141

Velaglucerase alfa (VPRIV) for Type 1 Gaucher disease (IV)

Prior authorization policy for outpatient intravenous velaglucerase alfa (VPRIV) for treatment of Type 1 Gaucher disease, governing Viva Health members (including pediatric patients age ≥4) and providers requesting coverage under the medical benefit.

Policy Summary

PayerViva Health

PolicyVelaglucerase alfa (VPRIV) for Type 1 Gaucher disease (IV)

Policy CodePolicy IC-0141

Change TypeNo material changes

Effective Date

Next Review DateApr 1, 2026

Key ActionObtain prior authorization for VPRIV; initial approvals issued for 12 months with renewals every 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3385HCPCS code for velaglucerase alfa

E75.22covered diagnosis ICD-10

Age ≥ 4 yearsminimum covered age

12 monthsinitial authorization period

72 units/14 daysmaximum billable units per 14 days

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Coverage Criteria for Velaglucerase alfa (VPRIV)

Initial Therapy

Covered when ALL of the following are met

Age and prior therapy: Member is at least 4 years of age; AND patient has a contraindication, intolerance, or failure to Cerezyme (imiglucerase) prior to consideration of VPRIV

Step requirement versus imiglucerase

Use and agent: Used as a single agent

No combination therapy specified

Diagnosis confirmation: Documented diagnosis of Type 1 Gaucher disease confirmed by either significantly reduced or absent glucocerebrosidase enzyme activity measured by a beta-glucosidase leukocyte (BGL) test OR detection of mutations in the glucocerebrosidase (GBA) gene

Laboratory or genetic confirmation required

Clinical manifestations: Member's disease results in one or more of: anemia-related symptoms (including blood transfusion dependency or hemoglobin ≤11 g/dL for women and children or ≤12 g/dL for men); thrombocytopenia (platelet count ≤120,000/mm3); hepatomegaly or splenomegaly; skeletal disease (e.g., lesions, remodeling defects, osteopenia/osteoporosis); or symptomatic disease (e.g., bone pain, fatigue, dyspnea, abdominal distension, diminished quality of life)

At least one clinical manifestation required

Renewal Therapy

Renewal is allowed when ALL of the following are met

Ongoing criteria: Member continues to meet the universal and indication-specific criteria identified for initial approval (e.g., concomitant therapy requirements, performance status); AND absence of unacceptable toxicity from VPRIV (examples include hypersensitivity reactions, including anaphylaxis); AND disease response defined by one or more of: improvement in anemia-related symptoms (improved hemoglobin or reduced transfusion dependency), improvement in platelet counts, reduction in liver or spleen size, improvement in skeletal disease, or improvement in symptoms compared to pretreatment baseline

Renewal requires documented benefit and tolerability

Requests for VPRIV (velaglucerase alfa) will not be considered unless the patient has previously experienced a contraindication, intolerance, or treatment failure to Cerezyme (imiglucerase). This step requirement must be documented in the medical record and submitted with the prior authorization request; absence of documented prior Cerezyme contraindication/intolerance/failure is a basis for denial.

Therapy with VPRIV is not supported when there is no diagnostic confirmation of Type 1 Gaucher disease or when the patient lacks qualifying clinical manifestations. The medical record must include confirmatory testing (either significantly reduced/absent glucocerebrosidase activity by beta‑glucosidase leukocyte test or detection of GBA gene mutations) and evidence of at least one qualifying manifestation (e.g., anemia per thresholds, thrombocytopenia, hepatomegaly/splenomegaly, skeletal disease, or other symptomatic disease). Requests lacking both diagnostic confirmation and qualifying manifestations may be denied.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J3385

Injection, velaglucerase alfa, 100 units

NDCNDC

54092-0701-xx

VPRIV 400 unit powder for injection, single-dose vial

Covered Diagnosis CodesICD-10Covered

E75.22

Gaucher disease

inv-08: Maximum billing

Maximum billing72 billable units every 14 days

Billing intervalPer 14-day period

Unit definition1 billable unit = 100 units (HCPCS J3385) per source coding

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required — initial 12‑month approval

Prior authorization is required for velaglucerase alfa (VPRIV). Initial authorization will be provided for 12 months (365 days).

Step Therapy

Step therapy: trial or intolerance to Cerezyme required

Patient must have a contraindication, intolerance, or documented failure to Cerezyme (imiglucerase) before VPRIV will be considered.

Documentation Required

Required clinical documentation

Include diagnostic confirmation of Type 1 Gaucher disease and evidence of qualifying clinical manifestations.

Confirmatory test: significantly reduced or absent glucocerebrosidase activity measured by beta‑glucosidase leukocyte (BGL) test OR detection of GBA gene mutations
Documentation of at least one clinical manifestation (e.g., anemia with transfusion dependency or Hb ≤11 g/dL for women/children or ≤12 g/dL for men; platelets ≤120,000/mm3; hepatomegaly or splenomegaly; skeletal disease; or symptomatic disease)
Include the diagnosis code E75.22 (Gaucher disease)

Denial Risk

Denial triggers — common reasons for denial

Requests may be denied if the step requirement to Cerezyme is not met, the member is under 4 years of age, or diagnostic confirmation and required clinical manifestations are not documented.

Absence of contraindication/intolerance/failure to Cerezyme prior to VPRIV consideration
Member younger than 4 years of age
Missing confirmatory enzyme or genetic test results or lack of qualifying clinical manifestations

Background

Velaglucerase alfa (VPRIV) is an enzyme replacement therapy indicated for Type 1 Gaucher disease. Coverage under this policy applies to members with documented disease confirmed by laboratory or genetic testing—either significantly reduced/absent glucocerebrosidase activity on a beta‑glucosidase leukocyte (BGL) test or detection of pathogenic GBA gene mutations—and who demonstrate clinical manifestations such as anemia, thrombocytopenia, hepatomegaly or splenomegaly, skeletal disease, or other symptomatic disease.

Definitions

inv-14: Type 1 Gaucher Disease diagnostic confirmation

Diagnostic confirmation — enzyme activitySignificantly reduced or absent glucocerebrosidase enzyme activity as measured by a beta-glucosidase leukocyte (BGL) test

Diagnostic confirmation — genetic testingDetection of mutations in the glucocerebrosidase (GBA) gene

Required clinical manifestationsAt least one: anemia-related symptoms, thrombocytopenia (≤120,000/mm3), hepatomegaly or splenomegaly, skeletal disease, or symptomatic disease (e.g., bone pain, fatigue, dyspnea)