CurrentCignaPolicy N/A

Oncology - Abiraterone Acetate Preferred Specialty Policy

Defines Cigna's preferred product program and exception criteria for abiraterone acetate (Zytiga vs generic) for oncology indications; applies to Cigna-administered health benefit plans and providers submitting prior authorization requests.

Policy Summary

PayerCigna

PolicyOncology - Abiraterone Acetate Preferred Specialty Policy

Policy CodePolicy N/A

Change TypeClarified policy name

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization and documentation showing trial of generic abiraterone or evidence of serious adverse reaction to the preferred product when requesting Zytiga.

SourceLink

POLICY UPDATE CHANGES

The policy name was changed from 'Oncology - Abiraterone Acetate (Zytiga) Preferred Specialty Policy' to 'Oncology - Abiraterone Acetate Preferred Specialty Policy.'

1 yearapproval duration for Zytiga when exception criteria met

2indications listed in overview

2references cited

2product identifiers

Coverage Criteria for Zytiga and Generic Abiraterone Acetate

Zytiga Exception Criteria

Cigna covers Zytiga (non-preferred) as medically necessary when ALL of the following are met:

Zytiga exception criteria: A) Individual meets the standard Oncology - Abiraterone Acetate Prior Authorization Policy criteria; AND B) Individual has tried generic abiraterone acetate tablets; AND C) Individual cannot continue to use the Preferred medication due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction.documentation required

Approve for 1 year when all conditions A-C met

Preferred Product Authorization

If the individual meets the standard PA criteria but has not tried the preferred product or cannot meet exception B/C:

Preferred product authorization: Approve generic abiraterone acetate tablets when PA criteria are met but Zytiga exception criteria are not met.

Policy Summary

PayerCigna

PolicyOncology - Abiraterone Acetate Preferred Specialty Policy

Policy CodePolicy N/A

Change TypeClarified policy name

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization and documentation showing trial of generic abiraterone or evidence of serious adverse reaction to the preferred product when requesting Zytiga.

SourceLink

On This Page

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Regimen	Indication	Coverage status	Notes
abiraterone acetate + prednisone
Use in combination with prednisone for metastatic castration-resistant prostate cancer or metastatic high-risk castration-sensitive prostate cancer
Covered with criteria (see Zytiga exception criteria and preferred product requirements)
Approval for non-preferred product (Zytiga) requires meeting exception criteria; preferred generic product is favored per program

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for abiraterone acetate products per the Oncology Abiraterone Acetate (Zytiga) Prior Authorization Policy; requests for non-preferred products (Zytiga) are reviewed using exception criteria and all approvals are provided for the duration noted in the criteria (approve for 1 year when exception met).

All medications (Preferred and Non-Preferred) require meeting the Oncology Abiraterone Acetate (Zytiga) Prior Authorization Policy criteria.
Requests for non-preferred products (Zytiga) are reviewed using the exception criteria; approvals follow the durations in the criteria.

Step Therapy

Preferred product trial required

The program requires trying the preferred product (generic abiraterone acetate tablets) before approval of the non-preferred product; if PA criteria are met but the preferred product has not been tried, approval will be for the preferred product.

Preferred Product(s): generic abiraterone acetate tablets.
If the individual meets the Oncology Prior Authorization criteria but has not tried the preferred product, approve generic abiraterone acetate tablets rather than Zytiga.

Documentation Required

Documentation requirements

Documentation (e.g., chart notes, prescription claims records, prescription receipts) is required where noted; for exception approval to Zytiga, documentation that the member has tried generic abiraterone or that a formulation difference in inactive ingredients would cause a significant allergy/serious adverse reaction is required.

Documentation may include but is not limited to chart notes, prescription claims records, and prescription receipts.
Exception criterion C requires documentation (per prescriber) of inability to use the preferred medication due to an inactive ingredient causing significant allergy or serious adverse reaction.

Denial Risk

Denial risk for unmet criteria

Requests that do not meet the exception criteria or the standard prior authorization criteria are considered not medically necessary and may be denied.

Any other exception beyond those specified is considered not medically necessary.
Non-preferred product requests that do not meet the listed exception criteria will be treated as not medically necessary.

Definitions and Product Status

Preferred Product definition

Termgeneric abiraterone acetate tablets

Role in policyPreferred Product (preferred specialty management program) — members are directed to try this product before non-preferred alternatives

Prior authorizationSubject to the Oncology - Abiraterone Acetate Prior Authorization Policy; if PA criteria met but preferred product not tried, approval will be for the preferred product

DocumentationDocumentation may be required (e.g., chart notes, prescription claims records, prescription receipts) where noted

Coverage outcomeApproved when PA criteria are met or as the fallback when Zytiga exception criteria are not met

Non-Preferred Product / Exception subject

TermZytiga (brand abiraterone acetate)

Exception coverageCigna covers Zytiga as medically necessary only when ALL of the following are met: A) meets standard Oncology - Abiraterone Acetate Prior Authorization Policy criteria; B) has tried generic abiraterone acetate tablets; and C) cannot continue preferred medication due to a formulation difference in inactive ingredient(s) causing significant allergy or serious adverse reaction

Approval durationApprove for 1 year when all exception criteria A–C are met

Documentation requiredDocumentation required to support exception (e.g., prescriber statement that inactive ingredient difference would cause significant allergy or serious adverse reaction)

Fallback when exception not metIf PA criteria met but exception B and/or C not met, approve generic abiraterone acetate tablets instead

65618	Product identifier 65618 (as listed)
65619	Product identifier 65619 (as listed)

Component	Details	Required documentation	Approval duration / Notes
Abiraterone acetate
Oral abiraterone acetate (brand Zytiga is non-preferred; generic abiraterone acetate tablets are preferred)
If requesting Zytiga, documentation that member meets standard PA criteria and has tried generic product or has prescriber-documented significant allergy/serious adverse reaction to inactive ingredient(s)
When Zytiga exception criteria met: approve for 1 year; otherwise approve preferred generic product when PA criteria met

OpenPayer

Oncology - Abiraterone Acetate Preferred Specialty Policy

Coverage Criteria for Zytiga and Generic Abiraterone Acetate

Product Identifiers and Codes

Provider Actions, Prior Authorization, and Documentation

Definitions and Product Status

Line of Therapy Information

Background on Abiraterone Acetate

Covered Regimens and Combination Therapies