CurrentCignaPolicy N/A

Cerdelga (eliglustat) prior authorization for Gaucher disease type 1

Defines prior authorization and medical necessity criteria for coverage of Cerdelga (eliglustat capsules) for treatment of Gaucher disease type 1 under Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyCerdelga (eliglustat) prior authorization for Gaucher disease type 1

Policy CodePolicy N/A

Change TypeClarifiedAdded exclusion

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document CYP2D6 metabolizer status and diagnostic confirmation (enzyme assay or biallelic GBA genetic test); ensure prescribing or consultation by an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered: Concomitant use with other approved therapies for Gaucher disease was added.

Confirmation of a genetic mutation in the glucocerebrosidase gene was rephrased to specify 'genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants'.

1 yrInitial approval duration

Gaucher type 1Indication covered

3Major required criteria items for approval

Clinical Coverage Criteria for Cerdelga (eliglustat)

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Medically Necessary — FDA-Approved Indication (Gaucher Disease Type 1)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient is a cytochrome P450 2D6 extensive metabolizer, intermediate metabolizer, or poor metabolizer as detected by an approved test.
Diagnosis established by ONE of the following
- Demonstration of deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts.
- Molecular genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants.
Medication is prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or a physician who specializes in the treatment of Gaucher disease or related disorders.

Not Medically Necessary / Exclusions

Cerdelga is considered not medically necessary for any other use(s) including, but not limited to:

ANY of the following

Concomitant use with other treatments approved for Gaucher disease (e.g., imiglucerase [Cerezyme], taliglucerase alfa [Elelyso], velaglucerase alfa [Vpriv], miglustat [Zavesca]).

What Providers Must Do / Watch For

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for Cerdelga prescription benefit coverage; approvals are provided for the specified duration (1 year for FDA-approved indication when criteria met).

Approval duration: 1 year

Documentation Required

Documentation of CYP2D6 status

Provider must document CYP2D6 metabolizer status using an approved test (extensive, intermediate, or poor metabolizer) to meet coverage criteria.

Required test result must indicate extensive, intermediate, or poor metabolizer.

Documentation Required

Diagnostic confirmation required

Provider must document either deficient beta‑glucocerebrosidase enzyme activity or molecular genetic testing showing biallelic pathogenic GBA variants to establish the diagnosis.

Demonstration of deficient beta‑glucocerebrosidase activity in leukocytes or fibroblasts.
Molecular genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants.

Documentation Required

Specialist prescribing or consultation

Cerdelga must be prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or a physician who specializes in the treatment of Gaucher disease or related disorders.

Denial Risk

Denial risk for concomitant therapy

Requests for Cerdelga concomitant with other approved Gaucher disease therapies will be considered not medically necessary and risk denial.

Examples: imiglucerase (Cerezyme), taliglucerase alfa (Elelyso), velaglucerase alfa (Vpriv), miglustat (Zavesca).

Clinical Background

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor used as substrate reduction therapy for the long-term treatment of Gaucher disease type 1. By inhibiting glucosylceramide synthase, eliglustat reduces production of glucosylceramide, the substrate that accumulates because of deficiency of the lysosomal enzyme β-glucocerebrosidase, which underlies disease pathology.

Use of Cerdelga for the FDA‑approved indication is restricted to adults who are documented as cytochrome P450 2D6 (CYP2D6) extensive, intermediate, or poor metabolizers by an approved (FDA‑cleared) test. Documentation of the patient’s CYP2D6 metabolizer status is required for coverage determinations because metabolizer phenotype guides safe and effective eliglustat use.

Prior authorization is required, and treatment should be prescribed by or in consultation with a specialist experienced in Gaucher disease management (for example, a geneticist, endocrinologist, metabolic disorder subspecialist, or a physician who specializes in Gaucher disease). The policy history notes wording clarifications regarding genetic confirmation (now specified as a molecular genetic test documenting biallelic pathogenic GBA gene variants) and an explicit exclusion for concomitant use with other approved Gaucher therapies.

Policy Revision History

2024-08-14addedLatest

Added 'Conditions Not Covered' language specifying that concomitant use of Cerdelga with other therapies approved for Gaucher disease is considered not medically necessary.

2024-05-29clarified

Wording clarified to more specifically state 'genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants' for diagnosis confirmation.

Policy Summary

PayerCigna

PolicyCerdelga (eliglustat) prior authorization for Gaucher disease type 1

Policy CodePolicy N/A

Change TypeClarifiedAdded exclusion

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Cerdelga (eliglustat) prior authorization for Gaucher disease type 1

Clinical Coverage Criteria for Cerdelga (eliglustat)

What Providers Must Do / Watch For

Coding Information

Clinical Background

Defined Terms

Policy Revision History