J3385 — Injection, velaglucerase alfa, 100 units
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of confirmed diagnosis of Type 1 or Type 3 Gaucher disease (as specified by indication).
- For initial therapy: clinical documentation of symptomatic disease (examples provided: moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly).
- For continuation of therapy: documentation of positive clinical response to therapy (examples provided: reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly).
- Documentation that dosing is in accordance with FDA approved labeling for the specific product (including weight-based calculations where applicable).
Key Coverage Criteria
- Cerezyme, Elelyso and VPRIV are proven for the treatment of Type 1 Gaucher disease when all of the following criteria are met: For initial therapy: Diagnosis of Type 1 Gaucher disease; Symptomatic disease (e.g., moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); Dosing is in accordance with United States Food and Drug Administration (FDA) approved labeling; Initial authorization will be for no more than 12 months.
- Cerezyme, Elelyso and VPRIV are proven for the treatment of Type 1 Gaucher disease when all of the following criteria are met: For continuation of therapy: Documentation of positive clinical response to therapy (e.g., reduced severity or resolution of anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); Dosing is in accordance with FDA approved labeling; Continuation authorization will be for no more than 12 months.
- VPRIV is the preferred enzyme replacement therapy for Type 1 Gaucher disease.
- Enzyme replacement therapy with Elelyso is medically necessary for the treatment of Type 1 Gaucher disease when all of the following criteria are met: Diagnosis of Type 1 Gaucher disease; One of the following: History of failure of VPRIV due to failure to meet clinical goals (e.g., persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy; OR History of failure of VPRIV due to hypersensitivity to VPRIV therapy; Dosing is in accordance with FDA approv [...]
- Enzyme replacement therapy with Cerezyme is medically necessary for the treatment of Type 1 Gaucher disease when all of the following criteria are met: Diagnosis of Type 1 Gaucher disease; One of the following: History of failure of VPRIV due to failure to meet clinical goals despite VPRIV therapy; OR History of failure of VPRIV due to hypersensitivity to VPRIV therapy; Dosing is in accordance with FDA approved labeling; Initial authorization will be for no more than 12 months. [...]
- Enzyme replacement therapy with VPRIV is medically necessary for the treatment of Type 3 Gaucher disease when all of the following criteria are met: Diagnosis of Type 3 Gaucher disease; Symptomatic disease (e.g., moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); Dose does not exceed 60 units/kg every 2 weeks; Initial authorization will be for no more than 12 months. [...]
9 Active Policies
UHC-POL-intravenous-enzyme-replacement-therapy-gaucher-disease — Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-intravenous-enzyme-replacement-therapy-gaucher-disease — Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
Related Codes
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