CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cerdelga (eliglustat) — Coverage and Authorization Criteria for Gaucher Disease Type 1

Defines coverage and authorization criteria for Cerdelga (eliglustat) for treatment of adult patients with Gaucher disease type 1 for Neighborhood Health Plan of Rhode Island members; applies when FDA-approved indications and approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCerdelga (eliglustat) — Coverage and Authorization Criteria for Gaucher Disease Type 1

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateNov 15, 2020

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization with documentation of diagnosis (enzyme assay or genetic testing) and FDA‑cleared CYP2D6 metabolizer status to determine eligibility and dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

2 caps/dayqty limit (EM/IM)

1 cap/dayqty limit (PM)

FDA‑clearedCYP2D6 test required

Coverage Criteria for Cerdelga (eliglustat)

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inv-01: Initial approval — Gaucher disease type 1

Covered when ALL of the following are met:

Eligibility for Cerdelga for GD1

CYP2D6 status: CYP2D6 extensive metabolizer OR CYP2D6 intermediate metabolizer OR CYP2D6 poor metabolizer as detected by an FDA‑cleared test.
(chunk 2)

Coverage limits: Use for indications other than the FDA‑approved indication for Gaucher disease type 1 is considered experimental/investigational and not medically necessary.

(chunk 1)

inv-02: Continuation therapy

Continuation covered when ALL of the following are met:

Continuation criteria: Documentation that the patient continues to meet the criteria for initial approval AND documentation that the patient is not experiencing an inadequate response or any intolerable adverse events from eliglustat therapy.

Authorization of up to 6 months may be granted for reauthorization (chunk 3)

All indications other than the FDA‑approved indication for Gaucher disease type 1 (GD1) are considered experimental/investigational and not medically necessary.

Use of eliglustat (Cerdelga) for non‑FDA‑approved indications is not medically necessary and is excluded from coverage.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of a confirmed diagnosis of Gaucher disease type 1 and CYP2D6 metabolizer status (FDA-cleared test). Initial authorizations are for up to 6 months.

Affecting drug: Cerdelga (eligibility tied to CYP2D6 status)
Initial authorization duration: up to 6 months

Prior Authorization

Reauthorization / Continuation Criteria

Reauthorization requires documentation that the initial approval criteria continue to be met and that the member is not experiencing inadequate response or intolerable adverse events. Reauthorization may be granted for up to 6 months.

Reauthorization duration: up to 6 months
Must document continued meeting of initial approval criteria and absence of inadequate response or intolerable adverse events

Documentation Required

Required Clinical Documentation

Providers must submit clinical documentation confirming the diagnosis of Gaucher disease type 1 and results from an FDA-cleared CYP2D6 test showing metabolizer status (extensive, intermediate, or poor). Documentation of enzyme assay or genetic testing confirming betaglucocerebrosidase deficiency is required.

Required: enzyme assay OR genetic testing confirming betaglucocerebrosidase deficiency
Required: FDA-cleared CYP2D6 test result indicating EM, IM, or PM

Denial Risk

Non‑FDA Indications Not Covered

Use of Cerdelga for indications other than FDA‑approved Gaucher disease type 1 (and compendial uses meeting criteria) is considered experimental/investigational and is not covered.

Non‑FDA indications: Not covered (experimental/investigational)

Note

Provider Actions

Provider action: ensure prior authorization is requested with the required documentation (diagnosis confirmation and CYP2D6 test result) and that reauthorization requests include evidence the patient continues to meet criteria and is tolerating therapy.

Submit prior authorization with enzyme assay or genetic testing results and FDA-cleared CYP2D6 test
For reauthorization, include documentation of continued clinical benefit and tolerability

Initial Therapy Authorization Rules

inv-12: Initial therapy — Initial authorization rules

Initial authorization rules

Initial: Documented diagnosis of Gaucher disease confirmed by enzyme assay demonstrating deficient beta‑glucocerebrosidase activity OR by genetic testing; AND documented CYP2D6 metabolizer status (extensive, intermediate, or poor) as detected by an FDA‑cleared test.

Authorization of up to 6 months may be granted (chunk 2)

Continuation / Reauthorization Criteria

inv-13: Continuation — Reauthorization criteria for continued eliglustat therapy

Reauthorization criteria for continued eliglustat therapy

Reauthorization: Patient continues to meet the criteria for initial approval AND is not experiencing an inadequate response or intolerable adverse events from eliglustat therapy.

6‑month reauthorizations may be granted (chunk 3)

Definitions

CYP2D6 metabolizer status — definition

DefinitionClassification of patients as CYP2D6 extensive (EM), intermediate (IM), or poor (PM) metabolizers as determined by an FDA-cleared test; status determines eligibility and dosing for eliglustat (Cerdelga).

Determination methodMetabolizer status must be detected by an FDA-cleared CYP2D6 test.

Clinical relevanceCYP2D6 status is required to establish eligibility for Cerdelga and to guide dosing and quantity limits.

Included categoriesExtensive metabolizer (EM), Intermediate metabolizer (IM), Poor metabolizer (PM).