ModifiedmhnPolicy CP.PHAR.84

Clinical Policy: Abiraterone (Zytiga, Yonsa)

Defines medical necessity, prescribing and documentation requirements, dosing limits, and approval durations for abiraterone (Zytiga and Yonsa) for members covered by the payer across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Abiraterone (Zytiga, Yonsa)

Policy CodePolicy CP.PHAR.84

Change TypeMaterial revisions to indications and approval durations

Effective DateOct 1, 2011

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Added requirement per NCCN if prescribed concurrently with Lynparza or Zejula, request is for metastatic castration-resistant prostate cancer.

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

Added NCCN off-label use for non-metastatic prostate cancer with PSA persistence or recurrence after radical prostatectomy and life expectancy > 5 years.

12 monthsstandard approval duration

Commercial, HIM, Medicaidlines of business

1000 mgZytiga max daily dose

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Coverage Criteria

Initial Therapy - Prostate Cancer

Covered when ALL of the following are met for Initial Approval — Prostate Cancer:

Initial Approval - Prostate Cancer: 1. Diagnosis: either (a) metastatic prostate cancer OR (b) non-metastatic prostate cancer with life expectancy > 5 years and one of: (i) PSA persistence after radical prostatectomy, (ii) PSA recurrence or positive digital rectal exam after radiation with positive regional lymph nodes, or (iii) initial therapy for very-high-risk or regional prostate cancer (any T, N1, M0).

PSA persistence and recurrence definitions per policy

Prescriber and Age: 2. Prescribed by or in consultation with an oncologist or urologist; 3. Age >= 18 years.

Generic-first and ADT: 4. For brand Zytiga and brand Yonsa requests: member must use generic abiraterone unless contraindicated or clinically significant adverse effects occur; 5. Prescribed concurrently with a gonadotropin-releasing hormone (GnRH) analog or member has had bilateral orchiectomy.

Concurrent PARP inhibitors: 6. If prescribed concurrently with Lynparza or Zejula, the request must be for metastatic castration-resistant prostate cancer.

Prior authorization may be required for Lynparza and Zejula

Corticosteroid co-prescription by product: 7. Zytiga: prescribed in combination with prednisone or dexamethasone; 8. Yonsa: prescribed in combination with methylprednisolone or dexamethasone.

Quantity and dose limits: 9. Request does not exceed health plan-approved quantity limit, if applicable; 10. Dose must meet one of: (a) Zytiga dose ≤ 1,000 mg once daily (or 1,000 mg twice daily if concomitant with a strong CYP3A4 inducer), (b) Yonsa dose ≤ 500 mg once daily (or 500 mg twice daily if concomitant with a strong CYP3A4 inducer), or (c) dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Strong CYP3A4 inducers listed in policy; prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Salivary Gland Tumors (off-label)

Covered when ALL of the following are met for Salivary Gland Tumors (off-label):

Initial Approval - Salivary Gland Tumor (off-label): 1. Diagnosis of salivary gland tumor; 2. Request is for abiraterone (Zytiga); 3. Prescribed by or in consultation with an oncologist; 4. Disease is recurrent and androgen receptor positive; 5. Prescribed in combination with prednisone and a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide, goserelin, triptorelin); 6. For brand Zytiga requests: member must use generic abiraterone unless contraindicated or clinically significant adverse effects occur; 7. Request does not exceed health plan-approved quantity limit, if applicable; 8. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence).

Off-label per NCCN Compendium; prescribed regimen must be FDA‑approved or recommended by NCCN

Continuation Therapy

Covered when ALL of the following are met for Continuation/Refill:

Continuation Therapy: 1. Member is currently receiving medication via the Centene benefit, or documentation supports that member is currently receiving Zytiga or Yonsa for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. For brand Zytiga and brand Yonsa requests: member must use generic abiraterone unless contraindicated or clinically significant adverse effects occur; 4. If request is for a dose increase, the new dose must meet one of: (a) Zytiga ≤ 1,000 mg once daily (or 1,000 mg twice daily if concomitant with a strong CYP3A4 inducer), (b) Yonsa ≤ 500 mg once daily (or 500 mg twice daily if concomitant with a strong CYP3A4 inducer), or (c) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; strong CYP3A4 inducers listed in policy

General coverage stance and approval durations

Policy-level coverage stance, off-label allowances per NCCN Compendium, and initial approval durations by line of business:

Coverage stance and off-label allowances: Policy covers FDA-approved indications for abiraterone and allows select NCCN Compendium off-label uses (including specific non-metastatic prostate cancer scenarios and salivary gland tumors) when criteria are met and supporting evidence provided.

Off-label uses require supporting documentation per off-label policies

Approval durations: Initial approval durations: Commercial — up to 12 months or duration of request, whichever is less; Medicaid/HIM — initial approval duration revised to 12 months (previously 6 to 12 months). Prior authorization is required per this clinical policy.

Renewal/continuation criteria and exact renewal durations are in other sections

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the prescriber submits sufficient documentation of efficacy and safety in accordance with the payer's applicable off-label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or unless coverage is otherwise established in evidence of coverage documents.

For members covered under Medicaid, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy; refer to the applicable state Medicaid manual for specific coverage determinations.

Uses for non‑FDA approved indications that lack the required supporting documentation as described above are considered not authorized (i.e., not medically necessary) per the referenced off‑label use policies and will not be approved absent adequate evidence.

This clinical policy is intended to provide a framework for determining medical necessity based on current standards of practice and available evidence. The policy does not by itself guarantee payment or coverage for a particular individual; coverage decisions are subject to the member's benefit plan, applicable laws and regulations, and any other terms and conditions of coverage.

Coding

Coding (documented absence)mixed

N/A	No CPT/HCPCS/ICD codes listed in this portion of the document.

Covered/affected codes (unspecified in fragment)mixed

affected codes

Policy references affected codes for prior authorization but specific CPT/HCPCS/ICD-10/NDC codes are not listed in this fragment.

Age

Age requirement>= 18 years

ContextApplies to initial approval for prostate cancer (must meet all other criteria).

Source noteListed under Initial Approval Criteria — Prescribed by/on consultation with oncologist or urologist and age >= 18 years required.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required. Standard approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less.

Prior authorization required for Lynparza and Zejula when used concurrently (per NCCN)

Documentation Required

Required Clinical Documentation

Providers must submit documentation (e.g., office/chart notes, relevant labs, imaging, pathology reports, medication history) demonstrating the member meets all approval criteria. Lack of adequate supporting documentation may result in denial.

Examples: office visit notes, PSA values/trends, surgical reports (e.g., orchiectomy), imaging reports, prior medication records showing at least 30 days of therapy when applicable

Background

Abiraterone acetate is an androgen‑biosynthesis inhibitor that irreversibly inhibits CYP17, an enzyme required for extragonadal androgen production. It is administered in combination with a corticosteroid and continued androgen‑deprivation therapy as indicated. Abiraterone (brand examples: Zytiga, Yonsa) is labeled for metastatic prostate cancer and is used in castration‑resistant disease and select castration‑sensitive settings; dosing and formulation details are provided in the dosing appendix and prescribing information.

Definitions

CRPC (Castration-Resistant Prostate Cancer)

DefinitionCastration-resistant prostate cancer (CRPC) is prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL).

Clinical implicationPer NCCN, androgen deprivation therapy (ADT) should be continued in the setting of CRPC while additional therapies are applied.

Appendix referenceCRPC abbreviation listed in Appendix A (castration-resistant prostate cancer).

ADT (Androgen Deprivation Therapy)

DefinitionAndrogen deprivation therapy (ADT) refers to therapies that reduce androgen activity, including bilateral orchiectomy, LHRH agonists/antagonists, and anti-androgens.

Examples of surgical ADTBilateral orchiectomy (surgical castration).