CurrentCignaPolicy N/A

Abiraterone Acetate (Yonsa, Zytiga) Drug Quantity Management Policy - Per Rx

Defines per-prescription quantity limits, exceptions, and approval criteria for abiraterone acetate products (Yonsa and Zytiga) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAbiraterone Acetate (Yonsa, Zytiga) Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionApply the listed quantity limits at point of service; if exception criteria are met (including for strong CYP3A4 inducers), approve per the override rules and grant authorization for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120Retail max (Yonsa, Zytiga 250 mg)

360Home delivery max (Yonsa, Zytiga 250 mg)

60Retail max (Zytiga 500 mg)

180Home delivery max (Zytiga 500 mg)

1 yearAuthorization length

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Coverage Criteria

Quantity Limits and Exceptions

Drug Quantity Limits apply; exceptions are covered as medically necessary when specific criteria are met.

Default quantity limits

Yonsa 125 mg limits: Retail maximum 120 tablets per Rx; Home Delivery maximum 360 tablets per Rx
See CYP3A4 inducer override for increased quantity
Zytiga 250 mg limits: Retail maximum 120 tablets per Rx; Home Delivery maximum 360 tablets per Rx
No overrides recommended
Zytiga 500 mg limits: Retail maximum 60 tablets per Rx; Home Delivery maximum 180 tablets per Rx
See CYP3A4 inducer override for increased quantity

CYP3A4 inducer overrides

Exceptions for patients taking strong CYP3A4 inducers

Yonsa override for strong CYP3A4 inducer: If the patient is taking a strong CYP3A4 inducer, approve 240 tablets per dispensing at retail or 720 tablets per dispensing at home delivery for Yonsa 125 mg

Strong inducers include, but are not limited to, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital

Zytiga 500 mg override for strong CYP3A4 inducer: If the patient is taking a strong CYP3A4 inducer, approve 120 tablets per dispensing at retail or 360 tablets per dispensing at home delivery for Zytiga 500 mg

Strong inducers include, but are not limited to, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital

Any exceptions to the quantity limits not explicitly listed in this policy are considered not medically necessary.

Requests that exceed the listed per‑prescription quantity limits for Yonsa or Zytiga that do not meet the specified exception criteria in this policy are considered not medically necessary.

Provider Actions and Operational Notes

Denial Risk

Drug Quantity Limit enforcement and approval duration

Quantity limits apply at point of service. If the Drug Quantity Management rule is not met for the requested medication when presented, coverage will be determined by the applicable coverage criteria; exceptions require documentation that meets the listed clinical criteria. All approvals granted under this Drug Quantity Management program are provided for 1 year in duration.

Applies to Yonsa (abiraterone acetate) and generic Zytiga products
Retail and Home Delivery maximum quantities listed in the Drug Quantity Limits must be observed at dispensing

Documentation Required

Documentation and review expectations

Coverage determinations require review of the applicable benefit plan document, any applicable laws/regulations, relevant collateral materials (including this policy and related coverage criteria), and the specific facts of the individual request. Medical directors may exercise clinical judgment in individual cases.

Providers must submit supporting clinical documentation to demonstrate that requested exceptions meet the policy criteria
Decisions are made on case-by-case basis and may depend on plan-specific terms

Step Therapy

Step therapy

No step therapy requirements are specified within this Drug Quantity Management policy for Yonsa or abiraterone acetate (Zytiga, generic).

If a separate plan or program implements step therapy, that requirement would be enforced per that program — not by this quantity management policy

Denial Risk

Quantity rule noncompliance may trigger denial

If the Drug Quantity Management rule is not met at point of service coverage will be determined by the criteria in this policy; failure to meet the quantity rule may result in denial unless an exception meeting the documented clinical criteria is provided.

Denials may be issued when dispensing exceeds the listed Retail or Home Delivery maximum quantities and no approved exception is documented
Providers may request an exception by submitting the required clinical documentation for review

Background

Abiraterone acetate products have defined Drug Quantity Limits per prescription: Yonsa 125 mg — Retail 120 tablets per Rx; Home Delivery 360 tablets per Rx; Zytiga 250 mg — Retail 120 tablets per Rx; Home Delivery 360 tablets per Rx; Zytiga 500 mg — Retail 60 tablets per Rx; Home Delivery 180 tablets per Rx. Exceptions to these limits are permitted only when the specific criteria in this policy are met; otherwise the request is not covered.

Definitions

Yonsa — Definition

ProductYonsa (abiraterone acetate) 125 mg tablets

IndicationIndicated in combination with methylprednisolone for treatment of metastatic castration‑resistant prostate cancer (CRPC)

Drug classCYP17 (17α‑hydroxylase/C17,20‑lyase) inhibitor

Dosing note (label)Recommended dose: 500 mg (four 125 mg tablets) orally once daily with methylprednisolone; dose reduction for hepatic impairment; avoid strong CYP3A4 inducers or increase dosing frequency if coadministered

Zytiga / abiraterone acetate — Definition

ProductZytiga / abiraterone acetate (250 mg and 500 mg tablets)

IndicationsMetastatic castration‑resistant prostate cancer (CRPC); metastatic high‑risk castration‑sensitive prostate cancer (CSPC)

Dosing overview (CRPC)1,000 mg once daily with prednisone 5 mg twice daily; administer on empty stomach; tablets should not be chewed or crushed

Dosing overview (CSPC)1,000 mg once daily with prednisone 5 mg once daily

Initial Therapy Criteria

Initial therapy dosing

Dosing overview from product labeling

Yonsa dosing: Yonsa recommended dose 500 mg (four 125 mg tablets) orally once daily with methylprednisolone 4 mg twice daily; can be taken with or without food; dose reduction for hepatic impairment; avoid strong CYP3A4 inducers or increase to BID if must be co-administered

Tablets should not be crushed or chewed

Abiraterone (Zytiga) dosing: For metastatic CRPC: 1,000 mg QD with prednisone 5 mg BID; for metastatic CSPC: 1,000 mg QD with prednisone 5 mg QD; take on empty stomach; dose adjustments for hepatic impairment; avoid strong CYP3A4 inducers or increase to BID if must be co-administered

Patients should receive a GnRH analog concurrently or have had bilateral orchiectomy

Step	Requirement
1	No step therapy steps specified in this document.

Quantity Limits

Yonsa 125 mg tablets — Quantity limits

Retail maximum per Rx120 tablets per Rx

Home delivery maximum per Rx360 tablets per Rx

Package strength125 mg tablets

Zytiga (abiraterone) 250 mg tablets — Quantity limits

Retail maximum per Rx120 tablets per Rx

Home delivery maximum per Rx360 tablets per Rx

Package strength250 mg tablets

Zytiga (abiraterone) 500 mg tablets — Quantity limits

Retail maximum per Rx60 tablets per Rx

Home delivery maximum per Rx180 tablets per Rx

Package strength500 mg tablets