CurrentCignaPolicy N/A

Gaucher Disease - Substrate Reduction Therapy Preferred Specialty Management Policy

Defines Cigna's preferred specialty management and non-preferred product exception criteria for substrate reduction therapies (Cerdelga/eliglustat and miglustat products) used to treat Gaucher disease type 1 for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyGaucher Disease - Substrate Reduction Therapy Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypePreferred product additionexception criteria expanded

Effective Date

Next Review DateOct 2, 2024

Key ActionObtain prior authorization and document trials of preferred products (Cerdelga, generic miglustat, or Yargesa) when requesting non-preferred Zavesca; include supporting chart notes and prescription records.

SourceLink

POLICY UPDATE CHANGES

Added Yargesa, a branded generic miglustat product, to the Policy as a Preferred Product.

Added criteria for approval of brand Zavesca for other conditions with supportive evidence.

3named products in policy

1 yrtypical approval duration

Requireddocumentation

Type 1

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Gaucher disease type

Coverage Criteria

Non-Preferred Product Exception Criteria (Zavesca)

Zavesca (brand) is covered as medically necessary only when the following exception criteria are met:

Main conditions

i: Patient meets the standard Gaucher Disease Substrate Reduction Therapy - Miglustat Prior Authorization criteria
refers to separate standard PA criteria
ii: Patient has tried Cerdelga (eliglustat capsules) [documentation required]
documentation required
iii
- a: Patient has tried ONE of Yargesa or generic miglustat capsules [documentation required]
  documentation required
- b: Brand Zavesca is being requested due to a formulation difference in the inactive ingredient(s) (e.g., preservatives) between the Brand and the bioequivalent generic product which, per the prescriber, has or would result in a significant allergy or serious adverse reaction
  clinical rationale for brand request

Other Conditions pathway

i: Patient meets the standard Gaucher Disease Substrate Reduction Therapy - Miglustat Prior Authorization criteria
standard PA criteria
ii
- a: Patient has tried ONE of Yargesa or generic miglustat capsules [documentation required]
  documentation required
- b: Brand Zavesca is being requested due to a formulation difference in the inactive ingredient(s) (e.g., preservatives) between the Brand and the bioequivalent generic product which, per the prescriber, has or would result in a significant allergy or serious adverse reaction
  same as 1Aiii(b)

Offer preferred review: For a patient who meets criteria Ai but does not meet criteria Aii and Aiii, offer to review for one of the Preferred Products using the standard Prior Authorization criteria

If trials of preferred products not documented, offer preferred product review

Any exception request that does not meet the specified non-preferred product exception criteria for Zavesca is considered not medically necessary.

Requests for the non-preferred product (Zavesca) that do not meet the non-preferred product exception criteria are considered not medically necessary and may be denied.

Prior Authorization and Affected Codes

Prior authorization / affected codesmixed

affected codes

policy references prior authorization and program; specific CPT/HCPCS codes not listed in document

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all medications (preferred and non-preferred). Requests will be reviewed under the standard Prior Authorization criteria for Gaucher Disease Substrate Reduction Therapy. Approval durations follow the policy-specified timeframes.

All medications require standard Prior Authorization Policy criteria to be met.

Step Therapy

Step Therapy Requirement

Step therapy is required: members must try the Preferred Products (Cerdelga, generic miglustat, or Yargesa) before a Non-Preferred product (e.g., brand Zavesca) will be approved, unless exception criteria are met.

Preferred Products: Cerdelga, generic miglustat, Yargesa
Non-Preferred Product example: Zavesca

Background

Eliglustat (Cerdelga) and miglustat formulations (brand Zavesca, branded generic Yargesa, and generic miglustat) are substrate reduction therapies indicated for long-term treatment of Gaucher disease type 1. Cerdelga (eliglustat capsules) is a preferred product in this program; miglustat is indicated as monotherapy for adult patients with mild to moderate Gaucher disease type 1 when enzyme replacement therapy is not an option. Brand Zavesca is treated as a non-preferred product and may be approved only when the program's exception criteria are met, including documented trials of preferred products or a prescriber-documented formulation-related allergy or serious adverse reaction that justifies use of the brand.

Definitions / Product Names

eliglustat capsules (Cerdelga)

Generic nameEliglustat capsules

Brand name (per policy)Cerdelga

Indication (per policy)Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers as detected by an FDA-cleared test

Therapy classSubstrate reduction therapy

Related products mentionedMiglustat formulations (Zavesca, Yargesa, generic)

miglustat capsules (Zavesca, Yargesa, generic)

Active ingredient

Policy Summary

PayerCigna

PolicyGaucher Disease - Substrate Reduction Therapy Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypePreferred product additionexception criteria expanded

Effective Date

Next Review DateOct 2, 2024

SourceLink

On This Page

Documentation Required

Documentation must be provided to support trials of Preferred Products and any claimed exceptions. Acceptable documentation includes, but is not limited to: chart notes, prescription claims records, and prescription receipts. Specific criteria callouts (e.g., trial of Cerdelga, trial of Yargesa or generic miglustat) are labeled in the criteria as [documentation required].

Documentation examples: chart notes, prescription claims records, prescription receipts
Criteria-marked requirements: trials of Cerdelga and of Yargesa or generic miglustat are noted as [documentation required].

Denial Risk

Non-Preferred Product Denial Risk

Requests for Non-Preferred products that do not meet the established exception criteria are considered not medically necessary and may be denied. If a patient meets Prior Authorization criteria for a Non-Preferred product but has not tried Preferred Products, the patient will be offered review for a Preferred Product.

Non-preferred approvals require meeting the exception criteria (e.g., prior trial of Cerdelga and Yargesa or generic miglustat plus formulation-specific allergy justification for brand Zavesca).
Failure to meet exception criteria = not medically necessary; may be denied.

Brand formulations listedZavesca (brand) and Yargesa (branded generic)

Indication (per policy)Monotherapy for adult patients with mild to moderate Gaucher disease type 1 when enzyme replacement therapy is not an option

Dosage/formulation noteYargesa is a branded generic product supplied in the same dosage strength as Zavesca

Therapy classSubstrate reduction therapy