Health Net VPRIV Coverage & Prior Auth Update

Coverage Criteria

Initial Therapy — Initial Approval — Gaucher Disease

Initial Approval — Gaucher Disease (must meet ALL):

Initial GD criteria: 1. Diagnosis of type 1 (GD1) or type 3 (GD3) Gaucher disease confirmed by one of the following: (a) enzyme assay demonstrating a deficiency of beta-glucocerebrosidase activity; OR (b) DNA testing; 2. Age ≥ 4 years; 3. Member is symptomatic (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); 4. One of the following: (a) For GD1: failure of Cerezyme (imiglucerase) and Cerdelga (eliglustat) unless clinically significant adverse effects are experienced or both are contraindicated; OR (b) For GD3: failure of Cerezyme unless contraindicated or clinically significant adverse effects are experienced (Note: for Illinois HIM requests, step therapy requirements do not apply per IL HB 5395); 5. VPRIV is not prescribed concurrently with Elelyso (taliglucerase alfa) or Cerezyme (imiglucerase); 6. Documentation of member's current weight (in kg); 7. Dose does not exceed 60 units/kg every two weeks.

Items reflect internal numbered policy; step therapy exception for Illinois HIM noted.

Continuation Therapy — Continued Therapy — Gaucher Disease

Continued Therapy — Gaucher Disease (must meet ALL):

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by increased or stabilized platelet count or hemoglobin, reduced or stabilized spleen or liver volume, or decreased bone pain (therapeutic response measures per Appendix D thresholds); 3. VPRIV is not prescribed concurrently with Elelyso (taliglucerase alfa) or Cerezyme (imiglucerase); 4. Documentation of member's current weight (in kg); 5. Dose does not exceed 60 units/kg every two weeks.

Response measures referenced from Appendix D: hemoglobin decrease <1.5 g/dL; platelet decrease <25%; liver volume increase <20%; spleen volume increase <25%.

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy. Relevant off‑label policies include CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid. Requests for coverage of non‑FDA indications should include supporting clinical evidence per those referenced policies.

When a member is covered under a Medicaid product, state Medicaid coverage provisions supersede the coverage provisions in this clinical policy if there is a conflict. Providers should follow the applicable state Medicaid manual for any state‑specific coverage rules or exceptions that apply to this therapy.

Concurrent use of enzyme replacement therapies or combination therapy with substrate reduction agents is not supported. Specifically, coverage does not support VPRIV administered concurrently with another enzyme replacement therapy (for example, Elelyso or Cerezyme) or the combination use of ERT with miglustat (Zavesca) or eliglustat (Cerdelga) due to insufficient evidence of safety and effectiveness. Providers must prescribe VPRIV as a single enzyme replacement regimen and document that no contraindication or intolerance exists to prior therapies when step therapy requirements apply.

Coding

HCPCS CodesHCPCS

J3385

Injection, velaglucerase alfa, 100 units

Stability thresholds used in trials — Appendix D

Hemoglobin thresholdDecrease < 1.5 g/dL from baseline

Platelet thresholdDecrease < 25% from baseline

Liver volume thresholdIncrease < 20% from baseline

Spleen volume thresholdIncrease < 25% from baseline

Initial approval duration

Initial approval duration12 months

Prior duration (previous)

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for VPRIV. Provider must submit documentation (such as office chart notes, lab results, genetic or enzyme testing reports, weight in kg, dosing information, and any other clinical information) that supports the member meets all applicable approval criteria (see Initial and Continued Therapy criteria). Failure to provide sufficient documentation may result in denial.

Prior authorization required for VPRIV
Submit office notes, labs, genetic/enzyme testing, weight (kg), dosing, and other clinical information

Denial Risk

Non‑FDA Indications

Requests for non-FDA (off‑label) indications will be denied unless the provider submits sufficient documentation of efficacy and safety consistent with the Health Plan's off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace / ICHRA), and CP.PMN.53 (Medicaid), or evidence of coverage documents. Provide peer‑reviewed literature, clinical rationale, and supporting patient‑specific data.

Initial Therapy (Drug-specific)

Initial Therapy (Drug-specific) — VPRIV Dosing and Requirements

Initial therapy requirements and dosing for VPRIV:

Initial drug therapy nodes: 1. Diagnosis confirmed by enzyme assay demonstrating beta-glucocerebrosidase deficiency or by DNA testing; 2. Age ≥ 4 years; 3. Member is symptomatic; 4. Prior therapy failure per step therapy rules where applicable (failure of Cerezyme and Cerdelga for GD1; failure of Cerezyme for GD3) unless contraindicated or intolerant (note IL HIM step therapy bypass per IL HB 5395); 5. VPRIV is not prescribed concurrently with other ERT agents (Elelyso or Cerezyme); 6. Documentation of current weight (kg); 7. Dosing: patients naïve to enzyme replacement therapy — 60 units/kg IV every other week; patients switching from imiglucerase — initiate VPRIV at the previous imiglucerase dose two weeks after the last imiglucerase dose; individualize dosing up to a maximum of 60 units/kg every two weeks.Max dose 60 units/kg every 2 weeks

Administer IV infusion per dosing guidance; provide weight in kg for dosing calculations.

Continuation / Ongoing Therapy

Continued Therapy — Criteria for continued coverage

Criteria for continued coverage:

Continued Therapy: 1. Member currently receiving therapy via Centene benefit or previously met initial criteria, or is covered under applicable continuity of care provisions; 2. Demonstrated clinical response: increased or stabilized hemoglobin or platelet count, reduced or stabilized liver or spleen volume, or decreased bone pain (see Appendix D thresholds for stability); 3. VPRIV is not prescribed concurrently with Elelyso or Cerezyme; 4. Documentation of current weight (kg); 5. Dose does not exceed 60 units/kg every two weeks.

Therapeutic response thresholds: hemoglobin decrease <1.5 g/dL; platelet decrease <25%; liver volume increase <20%; spleen volume increase <25%.

Step Therapy Requirements

Step	Requirement / Prior trial	Notes
1
For GD1: Failure of Cerezyme (imiglucerase) and Cerdelga (eliglustat) prior to VPRIV unless both are contraindicated or clinically significant adverse effects are experienced.
Applies to GD1 patients initiating VPRIV; prior authorization may be required for Cerezyme and Cerdelga. Step therapy does not apply for Illinois HIM per IL HB 5395 (see state bypass).

State	Bypass / Legislative requirement	Effective date / Scope
Illinois (HIM line of business)
Step therapy requirements for VPRIV (prior trials of Cerezyme and Cerdelga as applicable) are bypassed per IL HB 5395.
Bypass added per policy annual reviews; referenced in policy notes as added step therapy bypass for IL HIM (IL HB 5395).

Quantity Limits

VPRIV (velaglucerase alfa) dosing metric

Maximum dosing frequency60 units/kg every 2 weeks (maximum dose)

Naïve patients dosing60 units/kg IV every other week

Switching from imigluceraseSwitch to VPRIV at previous imiglucerase dose 2 weeks after last imiglucerase dose

Site of Care

Billing Rule

Administer VPRIV via IV infusion per dosing guidance (infusion center)

VPRIV is administered by intravenous infusion per dosing guidance; follow the dosing regimen (e.g., 60 units/kg IV every other week for treatment‑naïve patients) and administer in an appropriate infusion setting.

Dosing for naïve patients: 60 units/kg IV every other week
Product available as single‑dose vial: 400 units
Administer in infusion center or appropriate outpatient/inpatient infusion setting per dosing guidance

Definitions

VPRIV — product definition and indication summary

Generic nameVelaglucerase alfa (VPRIV)

DescriptionA hydrolytic lysosomal glucocerebroside-specific enzyme for long-term enzyme replacement therapy

IndicationsIndicated for treatment of Gaucher disease (type 1 and coverage-defined type 3 for systemic manifestations); ameliorates systemic involvement but does not alter neurologic progression in neuronopathic disease

ERT — Definition

DefinitionEnzyme replacement therapy (ERT): replacement of deficient lysosomal enzymes to treat inherited enzyme deficiencies such as Gaucher disease

Role in Gaucher diseaseERT ameliorates systemic involvement (anemia, thrombocytopenia, hepatosplenomegaly, bone disease) in type 1 and type 3 but does not alter neurologic progression

Background

Gaucher disease types 1 and 3 are lysosomal storage disorders caused by deficient beta‑glucocerebrosidase activity, resulting in accumulation of glucocerebroside in macrophages. Clinical manifestations commonly include anemia, thrombocytopenia, hepatosplenomegaly, and bone disease

OpenPayer

Clinical Policy: Velaglucerase Alfa (VPRIV)