CurrentCentenePolicy CP PHAR.157

Taliglucerase Alfa (Elelyso)

Policy defines medical necessity criteria, approval durations, dosing limits, and prior-authorization documentation requirements for taliglucerase alfa (Elelyso) for Centene lines of business (Commercial, HIM, Medicaid). It includes initial and continuation criteria, contraindications/boxed warning, therapeutic alternatives, and HCPCS coding guidance.

Policy Summary

PayerCentene

PolicyTaliglucerase Alfa (Elelyso)

Policy CodePolicy CP PHAR.157

Change TypeClarified dosing/weight documentation; added boxed warning; IL HIM step therapy bypass

Effective DateFeb 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

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

Added maximum dosing recommendation per prescribing information (60 units/kg every 2 weeks).

Added boxed warning from the prescribing information (hypersensitivity reactions including anaphylaxis).

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

1FDA-approved indication(s)

≥4 yrsMinimum age for coverage

60 units/kgMax dosing every 2 weeks

J3060Primary billing code

Coverage Summary

Scope: This policy defines medical necessity criteria, prior‑authorization and documentation requirements, approval durations, dosing limits, and coding guidance for taliglucerase alfa (Elelyso) for treatment of Gaucher disease across Centene lines of business. Coverage stance: covered_with_criteria for patients with a confirmed diagnosis of Gaucher disease who meet the policy's initial or continued therapy criteria. FDA indication: Elelyso is indicated for treatment of patients 4 years and older with confirmed Type 1 Gaucher disease. Dosing threshold: the policy enforces a maximum dose of ≤ 60 units/kg every 2 weeks (per prescribing information and policy dose limits). The policy includes a boxed warning for hypersensitivity reactions including anaphylaxis and references therapeutic alternatives Cerezyme (imiglucerase) and Cerdelga (eliglustat). The policy also states there is insufficient evidence to support combination ERT or concurrent use of multiple enzyme replacement therapies.

Initial Approval Criteria

Elelyso is medically necessary when ALL of the following are met:

ALL of the following

ONE of
- Enzyme assay demonstrating deficiency of beta-glucocerebrosidase (glucosidase) activity
- DNA testing
Age ≥ 4 years
Member is symptomatic (e.g., anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly)
For GD1: Failure of Cerezyme (imiglucerase) and Cerdelga (eliglustat) unless clinically significant adverse effects are experienced or both are contraindicated
Per policy text; prior authorization may be required for Cerezyme and Cerdelga
For GD3: Failure of Cerezyme unless contraindicated or clinically significant adverse effects are experienced
Documentation of member's current weight (in kg)
Elelyso is not prescribed concurrently with VPRIV (velaglucerase alfa) or Cerezyme (imiglucerase)
Dose does not exceed 60 units/kg every two weeks≤ 60 units/kg every 2 weeks
Maximum dose per prescribing information

Continued Therapy (Renewal) Criteria

Member meets ALL of the following for continued therapy:

ALL of the following

Member is currently receiving medication via Centene benefit or has previously met initial approval criteria
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
Measures of therapeutic response per policy
Documentation of member's current weight (in kg)
Elelyso is not prescribed concurrently with VPRIV (velaglucerase alfa) or Cerezyme (imiglucerase)
If request is for a dose increase, new dose does not exceed 60 units/kg every 2 weeks

Other Diagnoses/Indications

For requests not meeting the above or other diagnoses/indications:

ANY of the following

If drug is on formulary/PDL, follow applicable no coverage criteria policy for the line of business (CP.CPA.190 for commercial, HIM.PA.33 for HIX, CP.PMN.255 for Medicaid)
If drug is NOT on formulary/PDL, follow non-formulary policy for the line of business (CP.CPA.190 commercial, HIM.PA.103 HIX, CP.PMN.16 Medicaid)
If requested use (diagnosis, age, dosing) is NOT listed under Diagnoses/Indications NOT authorized and initial criteria do not apply, refer to off-label use policy (CP.CPA.09 commercial, HIM.PA.154 HIX, CP.PMN.53 Medicaid)

Approval Durations

Approval Duration (Initial)

ANY of the following

HIM/Medicaid: approval duration 6 months
Commercial: approval duration 6 months or to the member's renewal date, whichever is longer

Approval Duration (Continued Therapy)

ANY of the following

HIM/Medicaid: 12 months
Commercial: 6 months or to the member's renewal date, whichever is longer

Applicable Codes

Drug HCPCS (billing)HCPCSCovered

J3060

Injection, taliglucerase alfa, 10 units

Provider Actions & Billing Rules

Prior Authorization

Prior authorization and step therapy requirements

Prior authorization and step therapy requirements may apply for Cerezyme and Cerdelga. For GD1 initial approval generally requires failure of Cerezyme and Cerdelga unless both are contraindicated or the member experienced clinically significant adverse effects; for GD3 initial approval generally requires failure of Cerezyme unless contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, step therapy requirements do not apply as of 01/01/2026 per IL HB 5395 (step therapy bypass).

Prior authorization may be required for Cerezyme and Cerdelga
GD1: failure of Cerezyme and Cerdelga required unless contraindicated or clinically significant adverse effects
GD3: failure of Cerezyme required unless contraindicated or clinically significant adverse effects
IL HIM: step therapy bypass per IL HB 5395 (effective 1/1/2026)

Clinical Evidence & Safety

Key evidence and safety information: The prescribing information is cited as Elelyso Prescribing Information, Pfizer; January 2025. The product carries a boxed warning for hypersensitivity reactions including anaphylaxis. Policy language and Appendix D note that there is insufficient clinical evidence to support combination use of enzyme replacement therapy with eliglustat or miglustat, or concurrent use of two or more ERTs. The policy initial and continued therapy sections reiterate the dose cap of 60 units/kg every 2 weeks and state Elelyso must not be prescribed concurrently with VPRIV (velaglucerase alfa) or Cerezyme (imiglucerase).

Background & Definitions

Background: Taliglucerase alfa (Elelyso) is a hydrolytic lysosomal glucocerebroside‑specific enzyme replacement therapy indicated for treatment of patients aged ≥ 4 years with confirmed Type 1 Gaucher disease. Therapeutic alternatives listed in the policy include Cerezyme (imiglucerase) and Cerdelga (eliglustat), which may require prior authorization per the policy. The prescribing information and policy note individualized dosing with a maximum of 60 units/kg every other week. The policy and Appendix D state there is currently insufficient clinical evidence to support combination use of ERT with miglustat or eliglustat, or concurrent use of two or more enzyme replacement therapies.

Term	Definition
ERT	Enzyme replacement therapy
GD1	Type 1 Gaucher disease
GD3	Type 3 Gaucher disease

Exclusions / Not Authorized

Diagnoses/Indications NOT authorized

ALL of the following

Non–FDA approved indications not addressed in this policy are not covered unless sufficient documentation of efficacy and safety per the off-label use policy is provided

Revision History

2Q 2022clarification

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

2Q 2022clarification

Added maximum dosing recommendation per prescribing information: dose does not exceed 60 units/kg every two weeks.

2Q 2025addition

Added boxed warning from the prescribing information: hypersensitivity reactions including anaphylaxis.