CurrentCignaPolicy IP0441

Eliglustat (Cerdelga) — Coverage Criteria for Gaucher Disease Type 1

Defines medical necessity, reauthorization, and coverage limits for eliglustat (Cerdelga) for treatment of Gaucher disease type 1 for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEliglustat (Cerdelga) — Coverage Criteria for Gaucher Disease Type 1

Policy CodePolicy IP0441

Change TypeMaterial updates and clarifications

Effective DateJul 15, 2025

Next Review DateJul 15, 2025

Key ActionObtain prior authorization with documentation of diagnostic confirmation (enzyme assay or genetic test), CYP2D6 status by an approved test, prescriber specialty, and evidence of benefit for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Removed criterion 'Individual is age 18 years or older'.

Updated enzyme deficiency documentation wording to 'demonstration of deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts.'

Updated genetic confirmation wording to 'Confirmation of molecular genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants.'

Clarified CYP2D6 metabolizer requirement to specify detection 'by an approved test.'

Reauthorization criterion wording updated to specify continuation is for Gaucher Disease Type 1 and requires documentation of beneficial response.

Conditions Not Covered: Concomitant use with other approved therapies for Gaucher disease is considered not medically necessary.

12 monthsapproval duration

Gaucher type 1

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EM/IM/PMCYP2D6 requirement

Sample receiptsample policy

Concomitant useexplicit exclusion

Coverage Criteria for Eliglustat (Cerdelga)

Initial Therapy — Eliglustat (Cerdelga)

Eliglustat (Cerdelga) is considered medically necessary when ALL of the following are met for Gaucher Disease Type 1:

Gaucher disease diagnosis

Diagnostic confirmation: Documentation of EITHER: (i) demonstration of deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts OR (ii) confirmation of molecular genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants.
Specimen types: leukocytes or fibroblasts

Pharmacogenomic status: Individual is ONE of the following as detected by an approved test: CYP2D6 extensive metabolizer (EM), CYP2D6 intermediate metabolizer (IM), or CYP2D6 poor metabolizer (PM).

CYP2D6 status must be detected by an approved/FDA-cleared test

Prescriber specialty: 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.

Reauthorization Therapy — Eliglustat (Cerdelga)

Continuation of therapy is considered medically necessary when ALL of the following are met:

Ongoing criteria: All initial medical necessity criteria for Eliglustat (Cerdelga) continue to be met (diagnostic confirmation, CYP2D6 status by an approved test, and prescriber specialty) AND there is documentation of beneficial response to eliglustat.

Beneficial response should be documented in the medical record; policy does not further define specific measures of response

Eliglustat (Cerdelga) is not medically necessary for any indication other than treatment of Gaucher disease type 1. The policy explicitly states that eliglustat for any other use is considered not medically necessary and that the list of excluded uses may be updated as new evidence becomes available.

Concomitant use of eliglustat with other therapies approved for Gaucher disease is not covered and is considered not medically necessary. The policy notes that combined use with approved treatments (for example, imiglucerase, taliglucerase alfa, velaglucerase alfa, and miglustat) has not been evaluated and therefore is excluded from coverage.

Coding and Authorization Duration

Covered ICD/CPT/HCPCS codesmixed

No codes listed

inv-06: Authorization duration

Standard approval periodInitial and reauthorization approval duration: 12 months

Provider Actions, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for eliglustat (Cerdelga) for treatment of Gaucher disease type 1. Requests must demonstrate that the patient meets the policy's medical necessity criteria, including enzymatic OR molecular confirmation of disease and CYP2D6 status by an approved test.

Prior authorization required before initiation of therapy
Must demonstrate Gaucher disease type 1 and meet all Medical Necessity Criteria

Billing Rule

Billing and Coverage Determination

Claims submitted without covered diagnosis and/or procedure codes that support medical necessity will be denied. Benefit coverage is determined by the member's applicable plan; verify member benefits and plan terms. When billing, providers must use the most appropriate codes as of the date of service.

Background

Gaucher disease type 1 is an inherited lysosomal storage disorder caused by deficiency of the enzyme β‑glucocerebrosidase. This enzymatic defect leads to accumulation of glucosylceramide within macrophages, producing characteristic lipid‑laden “Gaucher” cells that can infiltrate the spleen, liver, bone marrow, and other tissues. Clinical manifestations include hepatosplenomegaly, cytopenias (anemia, thrombocytopenia), and skeletal disease; eliglustat (a glucosylceramide synthase inhibitor) acts as substrate reduction therapy for long‑term treatment in adults with Gaucher disease type 1 who meet the policy’s diagnostic and pharmacogenomic criteria.

Definitions and Diagnostic Criteria

inv-13: CYP2D6 metabolizer status

Required CYP2D6 statusesCYP2D6 extensive metabolizer (EM), intermediate metabolizer (IM), or poor metabolizer (PM)

Test requirementMetabolizer status must be detected by an approved/FDA‑cleared test

PopulationAdults with Gaucher disease type 1 as specified in indication

inv-14: Diagnostic confirmation

Acceptable enzymatic confirmationDemonstration of deficient beta‑glucocerebrosidase activity in leukocytes or fibroblasts

Acceptable molecular confirmationMolecular genetic test documenting biallelic pathogenic glucocerebrosidase (GBA) gene variants

Policy Summary

PayerCigna

PolicyEliglustat (Cerdelga) — Coverage Criteria for Gaucher Disease Type 1

Policy CodePolicy IP0441

Change TypeMaterial updates and clarifications

Effective DateJul 15, 2025

Next Review DateJul 15, 2025

SourceLink

On This Page

Claims lacking covered diagnosis/procedure codes will be denied as not covered
Reimbursement depends on the applicable benefit plan document

Denial Risk

Concomitant Therapy Denial Risk

Eliglustat used concurrently with other treatments approved for Gaucher disease may be denied as not medically necessary because concomitant use has not been evaluated.

Requests for eliglustat with Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), Vpriv (velaglucerase alfa), Zavesca (miglustat), or other approved Gaucher therapies may be denied

Documentation Required

Required Clinical Documentation

Required clinical documentation must be provided with the prior authorization request to support medical necessity.

Documentation of EITHER: demonstration of deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts OR molecular genetic confirmation of biallelic pathogenic GBA variants
Documentation of CYP2D6 metabolizer status (extensive, intermediate, or poor) by an approved test
Provider specialty documentation: prescribed by or in consultation with a geneticist, endocrinologist, metabolic disorder subspecialist, or a physician who specializes in Gaucher disease

Note

Concomitant Therapy Guidance

No concurrent use with other approved Gaucher therapies is recommended; the policy does not specify step sequencing. If concomitant therapy is being considered, document justification and prior authorization rationale, but be aware such requests may be denied.

Do not prescribe eliglustat concurrently with other approved Gaucher disease therapies unless supported by documented rationale and approved by prior authorization
Policy does not define step therapy sequence between eliglustat and other Gaucher treatments

Either/or requirement

Diagnosis requires documentation of EITHER enzymatic deficiency (leukocytes or fibroblasts) OR biallelic pathogenic GBA variants by molecular testing