CurrentCignaPolicy N/A

Oncology - Xtandi Prior Authorization Policy

This Cigna prior authorization policy defines medical necessity criteria, duration of approval, and exclusions for Xtandi (enzalutamide capsules and tablets) for prostate cancer indications (castration-resistant, metastatic castration-sensitive, and non-metastatic castration-sensitive with high-risk biochemical recurrence). It applies to prescription benefit coverage under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Xtandi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual Revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended/required for Xtandi; approvals are provided for 1 year for covered indications.

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

Previously required 'agonist' changed to 'analog' to allow agonists and antagonists; Firmagon and Orgovyx were added as examples.

Non-Metastatic, Castration-Sensitive indication with high-risk biochemical recurrence was added previously based on new indication approval.

3Covered Indications

1 yrApproval Duration

≤9 moPSA doubling time threshold

Coverage Summary

This Cigna prescription benefit policy covers Xtandi (enzalutamide) with criteria for the following prostate cancer indications: castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC), and non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence. Approvals are provided for 1 year when criteria are met.

For the CRPC and mCSPC indications, approval requires documentation that the patient is receiving Xtandi concurrently with a gonadotropin-releasing hormone (GnRH) analog (examples include leuprolide, triptorelin, goserelin, histrelin, degarelix, relugolix) or that the patient has had a bilateral orchiectomy.

For the nmCSPC indication with high-risk biochemical recurrence, Xtandi may be used with or without a GnRH analog per the indication (high-risk defined by PSA doubling time threshold described elsewhere in the policy).

High-risk biochemical recurrence (PSA doubling time)≤ 9 months

Castration testosterone level< 50 ng/dL

Approval Duration1 year

Covered Indications3

Initial Therapy Criteria

Prostate Cancer - Castration-Resistant (Metastatic or Non-Metastatic)

Approve for 1 year if the patient meets BOTH of the following (A and B):

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Prostate Cancer - Metastatic, Castration-Sensitive

Approve for 1 year if the patient meets BOTH of the following (A and B):

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Provider Actions & Documentation

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Xtandi (enzalutamide). Approvals are provided for a duration of 1 year for covered indications.

Approval duration: 1 year

Documentation Required

Document concomitant ADT or orchiectomy

For castration-resistant and metastatic castration-sensitive indications, document that the patient is receiving concurrent gonadotropin-releasing hormone (GnRH) analog therapy or has had a bilateral orchiectomy. For non-metastatic castration-sensitive disease with high-risk biochemical recurrence, document that the patient has a prostate‑specific antigen (PSA) doubling time ≤ 9 months.

Examples: leuprolide acetate (Lupron Depot), triptorelin pamoate (Trelstar), goserelin acetate (Zoladex), histrelin acetate (Vantas), degarelix (Firmagon), relugolix (Orgovyx)

Applicable Codes

DrugNDCCovered

No codes listed

Clinical Evidence & References

Prescribing information: Xtandi capsules and tablets prescribing information, Astellas/Pfizer; Jan 2025.

Guideline: NCCN Prostate Cancer Clinical Practice Guidelines (version 1.2025 - Dec 4, 2024).

High-risk biochemical recurrenceProstate-specific antigen (PSA) doubling time ≤ 9 months

GnRH analog (definition)Includes GnRH agonists and antagonists such as leuprolide, triptorelin, goserelin, histrelin, degarelix, relugolix

Background

Xtandi (enzalutamide) is indicated for castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC), and non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis. For CRPC and mCSPC, patients should receive Xtandi with a concurrent gonadotropin-releasing hormone (GnRH) analog or should have had a bilateral orchiectomy. Patients with nmCSPC with high-risk biochemical recurrence may be treated with or without a GnRH analog.

Revision History

2025-03-26annual_revisionLatest

Annual revision: no clinical criteria changes (Summary of Changes = No criteria changes).

2024-04-10annual_revision

Annual revision: no clinical criteria changes (Review Date = 04/10/2024).

2023-11-29selected_revision

Added Non-Metastatic, Castration-Sensitive indication for high-risk biochemical recurrence based on new indication approval.

2023-04-05annual_revision

Annual revision (Review Date = 04/05/2023).

2023-04-05terminology_change

Changed wording from gonadotropin-releasing hormone 'agonist' to 'analog' to allow both agonists and antagonists; Firmagon (degarelix) and Orgovyx (relugolix) were added as examples and related redundant criterion deleted.

Policy Summary

PayerCigna

PolicyOncology - Xtandi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual Revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended/required for Xtandi; approvals are provided for 1 year for covered indications.

On This Page

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