ModifiedCentenePolicy CP.PHAR.157

Taliglucerase Alfa (Elelyso) coverage

Governs medical necessity criteria and prior authorization requirements for taliglucerase alfa (Elelyso) for members of Centene-affiliated health plans across listed lines of business.

Policy Summary

PayerCentene

PolicyTaliglucerase Alfa (Elelyso) coverage

Policy CodePolicy CP.PHAR.157

Change TypeMaterial clinical updates (dosing, boxed warning, step therapy bypass, approval duration)

Effective DateFeb 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including diagnosis evidence, current weight (kg), and supporting clinical records to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated initial approval duration from 6 months to 12 months.

Added boxed warning for hypersensitivity reactions including anaphylaxis.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added requirement for documentation of member's current weight for dose calculation purposes.

Added maximum dosing recommendations per Prescribing Information (dose does not exceed 60 units/kg every 2 weeks).

12 monthsInitial approval duration (updated)

60 units/kg q2wMaximum recommended dose

J3060HCPCS code

200-unit vial

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Coverage Criteria

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy - Gaucher Disease: 1) Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and 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; 3) Elelyso is not prescribed concurrently with VPRIV (velaglucerase alfa) or Cerezyme (imiglucerase); 4) Documentation of member's current weight (in kg); 5) If request is for a dose increase, the new dose does not exceed 60 units/kg every 2 weeks.

Coverage for indications that are not FDA‑approved is not authorized under this policy unless the provider supplies sufficient documentation of safety and efficacy per the applicable off‑label use policies or evidence of coverage documents. Refer to off‑label use policy: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid when seeking authorization for non‑FDA indications.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules that apply to Medicaid members.

Combination therapy consisting of an enzyme replacement therapy (ERT) together with miglustat (Zavesca®) or eliglustat (Cerdelga®), as well as concurrent use of two or more ERT products, is not supported due to insufficient clinical evidence. Requests for combined or concurrent ERTs will not be authorized under this policy.

Initial Therapy

inv-20: Initial Therapy

Initial Therapy: Diagnosis confirmation by enzyme assay or DNA testing; age \u2265 4 years; member symptomatic; step therapy failures as specified (GD1: Cerezyme and Cerdelga; GD3: Cerezyme) unless contraindicated or clinically significant adverse effects; Elelyso not used concurrently with other ERTs; documentation of current weight in kg; dosing per Prescribing Information and does not exceed 60 units/kg IV every other week.

inv-21: Initial therapy duration

Initial approval duration changed from 6 months to 12 months.

Continuation Therapy

inv-22: Continued Therapy

Continued Therapy: Member meets continued therapy criteria: currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies); clinical response documented (stabilized/improved platelets or hemoglobin, reduced/stable spleen or liver volume, or decreased bone pain); Elelyso not used concurrently with VPRIV or Cerezyme; documentation of current weight (kg); if dose increase requested, new dose does not exceed 60 units/kg every 2 weeks.

inv-23: Continued therapy updates

Template changes and updates applied to continued therapy as noted in reviews:

Continued therapy updates: Policy edits include requirement to document member's current weight for dose calculation purposes and explicit maximum dosing recommendations per Prescribing Information (dose does not exceed 60 units/kg every 2 weeks). Template changes to the continued therapy section were applied as recorded in annual reviews.

Step Therapy / Redirections

Requirement	Details
Must document prior failure or contraindication/clinically significant adverse effects to prior agents	For GD1: failure of Cerezyme and Cerdelga unless both are contraindicated or clinically significant adverse effects occurred; For GD3: failure of Cerezyme unless contraindicated or clinically significant adverse effects occurred. Documentation of member's current weight (kg) and dose not to exceed 60 units/kg every two weeks are also required.

Step therapy redirection / bypass	Policy detail
Redirections to alternative products	Per prior guidance, step therapy redirections to Cerdelga and Cerezyme were added (2Q 2023).
Illinois HIM step therapy bypass	Step therapy requirements do not apply for Illinois HIM requests effective 1/1/2026 per IL HB 5395; policy explicitly notes the bypass.

Coding

HCPCS CodesHCPCS

J3060

Injection, taliglucerase alfa, 10 units

HCPCS CodesHCPCS

J3060

Injection, taliglucerase alfa, 10 units

inv-08: Maximum Dose — 60 units/kg every two weeks.

Maximum dose60 units/kg every two weeks

Dosing frequencyIntravenous every other week (q2w)

Dose contextApplies to both treatment‑naïve patients and dose increases for continued therapy as the maximum recommended dose

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required. Provider must demonstrate the member meets initial or continued therapy criteria and submit requested documentation to support medical necessity.

Initial approval duration: 12 months (per 2Q 2026 update).
Prior authorization may be required for Cerezyme and Cerdelga.

Documentation Required

Required Documentation: Provider must submit documentation (such as office chart notes, lab results, DNA or enzyme testing reports, dosing calculations and other clinical information) that supports the diagnosis and that the member meets all approval criteria. Documentation must include the member's current weight (kg) for dose calculation and evidence of clinical response for continued therapy.

Examples: office chart notes, laboratory results, imaging or genetics reports, platelet/hemoglobin trends, spleen/liver volume assessments, bone pain documentation.

Quantity Limits & Dosing

inv-26: Taliglucerase alfa (Elelyso) — dosing guidance, vial size 200 units; billing via J3060 = 10 units.

Vial sizeSingle‑dose vial: 200 units

Billing unit (HCPCS)J3060 = Injection, taliglucerase alfa, 10 units

Quantity guidanceDose and quantity should follow dosing guidance; providers should convert vial units to billing units (J3060 = 10 units) when submitting claims

inv-27: taliglucerase alfa — maximum dosing recommendations per Prescribing Information.

Maximum dosing per Prescribing InformationDose does not exceed 60 units/kg every two weeks (maximum recommended dose)

Initial dosing for treatment‑naïve patients60 units/kg IV every other week

Site of Care

Note

Infusion center — IV administration every other week

Administration is by intravenous infusion every other week per the dosing guidance.

Definitions

inv-18: enzyme replacement therapy — ERT definition.

DefinitionEnzyme replacement therapy (ERT)

PurposeTherapy that replaces deficient lysosomal enzymes to ameliorate systemic manifestations of lysosomal storage disorders such as Gaucher disease

Clinical noteERT (e.g., taliglucerase alfa) can improve visceral and hematologic manifestations but does not alter neurological progression in neuronopathic disease

inv-19: GD1 / GD3 definitions — Type 1 and Type 3 Gaucher disease.

GD1 (Type 1 Gaucher disease)Non‑neuronopathic Gaucher disease characterized by visceral involvement, bone marrow and bone disease; patients may present with anemia, thrombocytopenia, hepatomegaly, splenomegaly, and bone complications

GD3 (Type 3 Gaucher disease)

Background

Gaucher disease is a lysosomal storage disorder that commonly produces anemia, thrombocytopenia, hepatosplenomegaly, and bone disease. Measures used to assess therapeutic response include hemoglobin, platelet count, liver and spleen volume, and bone pain; trial definitions of stability have used thresholds such as hemoglobin decrease < 1.5 g/dL, platelet count decrease < 25%, liver volume increase < 20%, and spleen volume increase < 25%.

Enzyme replacement therapy (ERT), including taliglucerase alfa (Elelyso), is indicated to ameliorate systemic manifestations in type 1 (GD1) and can improve systemic findings in chronic neuronopathic type 3 (GD3), but ERT does not alter neurologic progression. ERT is administered intravenously per dosing guidance and is intended to improve hematologic and visceral disease parameters.

Revision History

2026-04-23annual_reviewLatest

Updated initial approval duration from 6 months to 12 months and added ICHRA line of business.

2025-07-15policy_change

Added step therapy bypass for Illinois HIM per IL HB 5395 (Illinois HIM requests do not have step therapy requirements effective 1/1/2026).

2025-03-10safety_update