ModifiedHealth NetPolicy CP.PHAR.157

Taliglucerase Alfa (Elelyso)

Defines medical necessity, prior authorization, dosing limits, and continuation criteria for Elelyso (taliglucerase alfa) for members across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyTaliglucerase Alfa (Elelyso)

Policy CodePolicy CP.PHAR.157

Change TypeModified — material updates (approval duration, dosing, boxed warning, documentation)

Effective DateFeb 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, current weight (kg), and evidence of response or required prior agents per step therapy.

SourceLink

POLICY UPDATE CHANGES

Updated initial approval duration from 6 months to 12 months.

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

Added Boxed Warning from the Prescribing Information.

Added maximum dosing recommendations per Prescribing Information.

J3060HCPCS

60 units/kgMax dose

12 monthsInitial approval

≥4 yearsMin age

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Coverage Criteria

Coverage for indications that are not FDA‑approved is not authorized by this policy unless the provider supplies sufficient documentation supporting efficacy and safety per applicable off‑label use policies. For Commercial lines reference policy CP.CPA.09, for HIM/ICHRA reference HIM.PA.154, and for Medicaid reference CP.PMN.53. Alternatively, evidence of coverage documents demonstrating appropriate clinical support may be submitted for consideration.

When a member is covered under Medicaid, state Medicaid coverage provisions take precedence over conflicting provisions in this clinical policy. Providers should follow the applicable state Medicaid manual for coverage rules that supersede this policy.

Concurrent administration of two or more enzyme replacement therapies or combination therapy of enzyme replacement with miglustat (Zavesca) or eliglustat (Cerdelga) is not supported due to insufficient clinical evidence and therefore is considered not medically necessary under this policy. Requests proposing concurrent ERT agents should include justification and supporting evidence but are generally expected to be denied.

Coding and Dosing Limits

HCPCS CodesHCPCS

J3060

Injection, taliglucerase alfa, 10 units

HCPCS CodesHCPCS

J3060

Injection, taliglucerase alfa, 10 units

inv-08: Maximum dose — 60 units/kg every 2 weeks

Maximum dose60 units/kg every 2 weeks

Dosing frequency contextAdministered every other week (IV)

Dose limit applies toTreatment-naïve and continuation therapy dose increases

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Elelyso (taliglucerase alfa). Initial approvals will be granted for up to 12 months. Requests for continuation of therapy should include documentation demonstrating ongoing benefit. Providers must obtain prior authorization before initiating therapy to avoid claim denials.

Prior authorization required for Elelyso (HCPCS J3060).
Initial approval duration: up to 12 months (updated from 6 months).
Continuation/renewal: documentation of clinical benefit required for approval.

Documentation Required

Documentation Requirements and Handling of Incomplete Requests

Providers must submit clinical documentation (office notes, lab results, genetic or enzyme testing) supporting that the member meets all listed approval criteria. Required documentation must include confirmation of diagnosis, age, symptoms, prior agent history where applicable, current weight (kg) for dose calculation, and dosing rationale. Incomplete or missing documentation may result in denial or delay of the prior authorization request.

Initial Therapy Criteria

inv-20: Initial Therapy — initial coverage criteria and dosing

Initial coverage criteria and dosing

Initial Therapy: Confirmed diagnosis of GD1 or GD3 by enzyme assay (deficient beta-glucocerebrosidase activity) or DNA testing; age ≥ 4 years; symptomatic disease (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly); step therapy requirements: GD1 requires failure of Cerezyme and Cerdelga unless contraindicated or clinically significant adverse effects exist; GD3 requires failure of Cerezyme unless contraindicated; Elelyso must not be used concurrently with VPRIV or Cerezyme; documentation of current weight (kg) required; dosing for treatment-naive patients: 60 units/kg IV every other week; patients switching from imiglucerase should begin at the same unit/kg dose as prior imiglucerase dosing; individualize and adjust based on therapeutic goals and maintenance; maximum dose: 60 units/kg every two weeks.

inv-21: Initial therapy duration — initial approval duration criteria

Initial approval duration

Initial authorization duration: Initial prior authorization is granted for 12 months (updated from 6 months).

Continuation Therapy Criteria

inv-22: Continuation Therapy — criteria for continued coverage

Criteria for continued coverage

Continuation: Member meets prior therapy enrollment or continuity criteria (currently receiving via Centene benefit or previously met initial approval criteria, or enrolled under continuity-of-care provisions); member demonstrates clinical response or stabilization (increased/stabilized platelet count or hemoglobin, reduced/stabilized spleen or liver volume, or decreased bone pain); documentation of current weight (kg) provided; dose remains within limits (≤ 60 units/kg every 2 weeks); Elelyso is not prescribed concurrently with other ERT agents (VPRIV or Cerezyme).

Step Therapy and Prior Agents

Step	Required prior agent(s) before Elelyso	Notes / Exceptions
1	Cerezyme (imiglucerase) and Cerdelga (eliglustat)	Required failure of both agents for GD1 unless clinically significant adverse effects or both are contraindicated; for GD3, failure of Cerezyme is required unless contraindicated. For Illinois HIM requests (effective 1/1/2026 per IL HB 5395), step therapy requirements do not apply.

Step	Redirection / Alternate therapy	Bypass / Additional notes
1	Redirections added to Cerdelga (eliglustat) and Cerezyme (imiglucerase)	Per 2Q 2023 updates, redirections to Cerdelga and Cerezyme were added. Step therapy bypass for Illinois HIM requests noted (per IL HB 5395).

Quantity Limits

inv-25: Taliglucerase alfa (Elelyso) — per vial availability: 200 units single-dose

Vial presentationSingle-dose vial: 200 units

Unit size relevanceProduct available as 200-unit single-dose vial for IV administration

Billing implicationDose calculations should account for 200-unit vial packaging

Definitions

inv-18: Taliglucerase alfa (Elelyso) — drug definition and indication as ERT for Gaucher disease

Drug class and descriptionTaliglucerase alfa (Elelyso) is a hydrolytic lysosomal glucocerebroside-specific enzyme used as enzyme replacement therapy

IndicationIndicated for treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease

Therapeutic useUsed as enzyme replacement therapy to address systemic manifestations of Gaucher disease

inv-19: Dosing regimen (treatment-naïve) — 60 units/kg IV every other week; switching guidance from imiglucerase

Treatment-naïve dosing60 units/kg IV every other week

Switching from imiglucerasePatients switching from imiglucerase (imiglucerase) should begin taliglucerase alfa at the same unit/kg dose as their previous imiglucerase dose, administered every other week

Background

Gaucher disease is an inherited lysosomal storage disorder in which deficient beta‑glucocerebrosidase activity leads to accumulation of glucocerebroside in macrophages, causing systemic manifestations such as anemia, thrombocytopenia, hepatosplenomegaly, and bone disease. Enzyme replacement therapy (ERT) with agents such as taliglucerase alfa (Elelyso) is used to ameliorate these visceral and hematologic findings and improve quality of life in patients with non‑neuronopathic disease. Elelyso is indicated for patients aged ≥ 4 years with a confirmed diagnosis of Type 1 Gaucher disease; ERT generally does not alter the neurologic course of neuronopathic forms, and evidence for benefit in type 3 is limited to systemic manifestations rather than neurologic outcomes.