CurrentNeighborhood Health Plan of Rhode IslandPolicy 1934-A

Abiraterone products (Zytiga, Abirtega, generic abiraterone) — coverage criteria

Covers authorization criteria for abiraterone products for treatment of prostate cancer and androgen receptor–positive salivary gland tumors for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbiraterone products (Zytiga, Abirtega, generic abiraterone) — coverage criteria

Policy CodePolicy 1934-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals may be granted for up to 12 months when approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

2FDA-approved uses listed

4Compendial/other covered uses

1Excluded combination groups

Coverage Criteria for Abiraterone Products

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Prostate cancer — initial authorization

Covered when ALL of the following are met for prostate cancer:

Indication: Indicated diagnosis: metastatic castration-resistant prostate cancer (CRPC) OR metastatic high-risk castration-sensitive prostate cancer (CSPC) to be treated in combination with prednisone.

Supported by FDA-approved indications (chunk 3).

Androgen deprivation: Member has had bilateral orchiectomy OR will be using abiraterone with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).

Policy requires surgical orchiectomy or concurrent LHRH agonist/antagonist (chunk 6).

Disease extent: Either: (a) non‑metastatic disease that is node‑positive, high‑risk, or very‑high‑risk; OR (b) metastatic disease.

Coverage allows node‑positive/high‑risk non‑metastatic disease or metastatic disease (chunk 6).

Continuation therapy

Covered when ALL of the following are met for salivary gland tumor:

Indication: Recurrent, unresectable, or metastatic salivary gland tumor.

Policy lists salivary gland tumor as a compendial use for abiraterone (chunk 7).

Biomarker: Tumor is androgen receptor positive.

Androgen receptor positivity is required for coverage in this indication (chunk 7).

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Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for the medications and indications described in this policy. Approvals may be granted for up to 12 months when the applicable clinical criteria are met.

Authorization duration: up to 12 months when criteria met
PA required prior to initiation or reauthorization

Denial Risk

Excluded Combinations / Denial Risk

Requests for abiraterone will be denied if used in combination with a second-generation oral anti-androgen or an oral androgen metabolism inhibitor.

Examples of excluded combinations: apalutamide (Erleada), other second-generation oral anti-androgens
Oral androgen metabolism inhibitors (e.g., fine-particle abiraterone acetate [Yonsa])

Documentation Required

Required Documentation

Providers must document the diagnosis and that the member meets the specific coverage criteria for the requested indication. Acceptable documentation includes medical records showing surgical history, concurrent hormone therapy, tumor receptor status, and imaging or pathology confirming disease stage.

For prostate cancer: documentation of bilateral orchiectomy or planned/ongoing LHRH agonist/antagonist therapy (e.g., goserelin, leuprolide, degarelix, relugolix)
Disease staging: non-metastatic node-positive high/very-high risk OR metastatic disease (imaging/pathology reports)
For salivary gland tumor: pathology confirming androgen receptor positivity and documentation of recurrent, unresectable, or metastatic disease
For continuation: evidence of clinical benefit with no unacceptable toxicity or disease progression while on current regimen

Note

Provider Operational Notes

Ensure the requested therapy is not being combined with excluded agents and that all supporting documentation is attached to the PA request to avoid unnecessary denials or delays.

Attach operative reports, pathology/immunohistochemistry results, imaging reports, and medication history
Specify whether the member has undergone bilateral orchiectomy or the name and schedule of the LHRH agent if used

Background

Abiraterone (Zytiga, generic, Abirtega) is an androgen biosynthesis inhibitor used primarily in prostate cancer to suppress extragonadal androgen production; it is administered in clinical practice in combination with prednisone to mitigate mineralocorticoid excess and related adverse effects.

When used for prostate cancer this agent is given in the context of androgen deprivation—either after bilateral orchiectomy or concurrently with an LHRH agonist/antagonist per the policy’s treatment criteria.

Definitions and Requirements

Androgen deprivation requirement

RequirementMember must have had a bilateral orchiectomy OR will be using abiraterone with an LHRH agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).

Authorization durationApprovals may be granted for up to 12 months when the androgen deprivation requirement is met.

Example LHRH agonistsGoserelin, leuprolide.

Example LHRH antagonistsDegarelix, relugolix.

Androgen receptor–positive salivary gland tumor

DefinitionRecurrent, unresectable, or metastatic salivary gland tumor that is androgen receptor positive and is being treated in combination with prednisone.

Eligible disease statesRecurrent, unresectable, or metastatic salivary gland tumor.

Required biomarkerTumor must be androgen receptor (AR) positive.

Required concomitant medicationTreatment is given in combination with prednisone.