CurrentCentenePolicy CP.PHAR.84

Abiraterone (Zytiga, Yonsa) (PDF)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, acceptable indications (FDA and specified off-label NCCN-recommended uses), prescribing clinician requirements, and approval durations for abiraterone (brand Zytiga, brand Yonsa, and generic) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyAbiraterone (Zytiga, Yonsa) (PDF)

Policy CodePolicy CP.PHAR.84

Change TypeAnnual review revisions (2024-2026)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria (office notes, labs, other clinical information).

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review: added off-label use in salivary gland tumor per NCCN Compendium; revised initial approval duration for Medicaid/HIM in prostate cancer from 6 to 12 months; added template language 'Request does not exceed health plan-approved quantity limit, if applicable'.

1Q 2025 annual review: for non-metastatic disease added additional off-label uses per NCCN Compendium and revised policy/criteria to include generic abiraterone.

1Q 2024 annual review: added requirement per NCCN if prescribed concurrently with Lynparza or Zejula, request must be for metastatic castration-resistant prostate cancer; removed abiraterone from Appendix B; references updated.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (effective 01.20.22).

1Q 2022 annual review: no significant changes; added legacy WCG initial approval duration and updated references.

2FDA-approved indications listed

Off-label NCCN-supported indications added

12Approval duration - Medicaid/HIM (months)

12Approval duration - Commercial (months)

Coverage Summary

Abiraterone (Zytiga, Yonsa, and generic abiraterone) is covered with criteria across Commercial, HIM, and Medicaid when the policy's medical necessity requirements are met, including FDA-approved and specified NCCN-compendium supported off-label uses. The policy requires brand-specific steroid co-therapy: Zytiga with prednisone or dexamethasone and Yonsa with methylprednisolone or dexamethasone, and prefers generic abiraterone for brand requests unless contraindicated or clinically intolerable.

Key Thresholds

Age>= 18 years

Non-metastatic prostate cancer life expectancy> 5 years

Zytiga dose limits<= 1000 mg once daily; 1000 mg twice daily if concomitant strong CYP3A4 inducer

Yonsa dose limits<= 500 mg once daily (4 x125 mg tablets); 500 mg twice daily if concomitant strong CYP3A4 inducer

PSA recurrence threshold after prostatectomyPSA > 0.1 ng/mL or increasing on 2 or more determinations

Approval duration - Medicaid/HIM12 months

Approval duration - Commercial12 months or duration of request, whichever is less

Initial Therapy Criteria — Prostate Cancer

I. Initial Approval Criteria - Prostate Cancer

Covered when ALL of the following are met:

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Initial Therapy Criteria — Salivary Gland Tumors (off-label)

Continuation / Renewal Criteria

II. Continuation/All Indications (renewal)

Covered when ALL of the following are met:

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Other Indications / Off-Label Routing

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. The prior authorization must document the indication, the prescribing clinician specialty (oncologist or urologist), whether the member is receiving concomitant androgen deprivation therapy (ADT) or has had bilateral orchiectomy, the concomitant corticosteroid regimen (prednisone or dexamethasone for Zytiga; methylprednisolone or dexamethasone for Yonsa), and that the requested dose is within the policy dosing limits. Note: prior authorization may also be required if abiraterone is prescribed concurrently with Lynparza or Zejula (concurrent use must be for metastatic castration-resistant prostate cancer).

Indication (metastatic or approved off-label NCCN indication)
Prescribing clinician specialty (oncologist or urologist)
Concomitant ADT (or documentation of bilateral orchiectomy)
Concomitant corticosteroid regimen: Zytiga with prednisone or dexamethasone; Yonsa with methylprednisolone or dexamethasone
Dose is within policy limits (Zytiga ≤1000 mg QD or ≤1000 mg BID with strong CYP3A4 inducer; Yonsa ≤500 mg QD or ≤500 mg BID with strong CYP3A4 inducer)
If concurrent with Lynparza or Zejula: indication must be metastatic castration-resistant prostate cancer and PA may be required

Applicable Codes & Policy References

Reference / policy identifiermixed

CP.PHAR.84	Centene Clinical Policy Reference Number
CP.CPA.09	Off-label use policy (Commercial)
HIM.PA.154	Off-label use policy (Health Insurance Marketplace)
CP.PMN.53	Off-label use policy (Medicaid)
CP.CPA.190	No coverage criteria policy (Commercial)
HIM.PA.33	No coverage criteria policy (Health Insurance Marketplace)
CP.PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (Health Insurance Marketplace)
CP.PMN.16	Non-formulary policy (Medicaid)

Background

Abiraterone is a selective, irreversible inhibitor of the CYP17 enzyme (cytochrome 17 α‑hydroxylase/C17,20‑lyase), and is used to inhibit androgen biosynthesis in prostate cancer.

Zytiga is indicated in combination with prednisone for metastatic castration‑resistant prostate cancer (mCRPC) and metastatic high‑risk castration‑sensitive prostate cancer (CSPC). Yonsa is indicated in combination with methylprednisolone for mCRPC and is a fine‑particle formulation; per NCCN the fine‑particle formulation (Yonsa) may be used instead of the standard formulation (Zytiga) as an alternative.

Formulation differences include tablet strengths and recommended steroid co‑therapy: Zytiga is available as 500 mg film‑coated and 250 mg uncoated tablets (standard dosing described as 1,000 mg once daily with prednisone), while Yonsa is supplied as 125 mg tablets with a standard dose of 500 mg once daily in combination with methylprednisolone.

Clinical Evidence & References

Primary evidence sources cited in the policy include the Zytiga and Yonsa Prescribing Information and the NCCN Prostate Cancer and Salivary Gland Tumors compendia (NCCN Drugs and Biologics Compendium entries for abiraterone and the NCCN guideline documents).

Off‑label uses included in the policy (for example, specified non‑metastatic prostate cancer scenarios and salivary gland tumors) are supported where noted by the NCCN compendia or practice guidelines and require supporting evidence from the prescriber when approval relies on guideline or literature justification.

Definitions

ADTAndrogen deprivation therapy

CRPCCastration-resistant prostate cancer

CSPCCastration-sensitive prostate cancer

GnRHGonadotropin-releasing hormone

LHRHLuteinizing hormone-releasing hormone

Revision History

02.26.2026revisedLatest

02.25.2025revised

1Q 2025 annual review: for non-metastatic disease added additional off-label uses per NCCN Compendium and revised policy/criteria to include generic abiraterone.

02.24.2024revised

Policy Summary

PayerCentene

PolicyAbiraterone (Zytiga, Yonsa) (PDF)

Policy CodePolicy CP.PHAR.84

Change TypeAnnual review revisions (2024-2026)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria (office notes, labs, other clinical information).

SourceLink

On This Page

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Documentation Required

Submit supporting documentation

Submit supporting documentation such as office chart notes, laboratory results, and other clinical information that demonstrate the member meets all approval criteria.

Office notes documenting diagnosis and treatment history
Relevant laboratory results (e.g., PSA, other labs)
Consultation notes if prescribed in consultation with an oncologist or urologist
Documentation of response to therapy for continuation requests

Documentation Required

Generic substitution preference

For brand Zytiga and brand Yonsa requests, the provider must document a trial of generic abiraterone or document a contraindication or clinically significant adverse effects to generic abiraterone before the brand product will be approved.

Documentation of trial and failure or intolerance to generic abiraterone, or
Documentation of a contraindication to generic abiraterone

Billing Rule

Quantity limit adherence

Requests must not exceed any health plan–approved quantity limit. Verify that the requested quantity is within the health plan's approved quantity limit, if applicable.

Confirm request does not exceed health plan–approved quantity limit

Documentation Required

Off-label supporting evidence

For off-label uses or doses outside the standard policy dosing limits, the prescriber must submit supporting evidence such as practice guideline recommendations (e.g., NCCN) or peer-reviewed literature that justify the use or dose.

Practice guideline recommendation (e.g., NCCN) or
Peer-reviewed literature supporting the off-label indication or non-standard dose

05.22revised

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (effective 01.20.22).

11.16.21administrative

1Q 2022 annual review: no significant changes; added legacy WCG initial approval duration and updated references.