CurrentCignaPolicy CNF573

Oncology – Xtandi Prior Authorization Policy - (CNF573)

Defines Cigna prior authorization requirements and medical necessity criteria for Xtandi (enzalutamide capsules and tablets) for FDA‑approved prostate cancer indications (castration‑resistant, metastatic castration‑sensitive, and non‑metastatic castration‑sensitive with high‑risk biochemical recurrence), including duration of approval and non‑covered uses.

Policy Summary

PayerCigna

PolicyOncology (Oral - Androgen Receptor Inhibitor) - Xtandi Prior Authorization Policy

Policy CodePolicy CNF573

Change TypeAdded indication; revised GnRH language; administrative name change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Xtandi; document castration status or concurrent GnRH analog use and, for non‑metastatic cases, document high‑risk biochemical recurrence (PSA doubling time ≤ 9 months).

SourceLink

POLICY UPDATE CHANGES

Prostate Cancer - Non‑Metastatic, Castration‑Sensitive indication and criteria were added based on new indication approval.

Changed requirement language from 'gonadotropin‑releasing hormone agonist' to 'analog' to allow agonists and antagonists; added Firmagon and Orgovyx as examples.

Policy name updated to 'Oncology (Oral - Androgen Receptor Inhibitor) - Xtandi PA Policy'.

3Covered Indications (FDA‑approved)

1 yearApproval duration

PSADT ≤ 9 moNon‑metastatic high‑risk threshold

Coverage Summary

Defines Cigna prior authorization requirements and medical necessity criteria for Xtandi (enzalutamide capsules and tablets) for FDA‑approved prostate cancer indications: castration‑resistant (metastatic or non‑metastatic), metastatic castration‑sensitive, and non‑metastatic castration‑sensitive with high‑risk biochemical recurrence. Approvals are for 1 year. For castration‑resistant and metastatic castration‑sensitive indications, patients must be ≥ 18 years and either be receiving a concurrent GnRH analog (or antagonist) to maintain castrate testosterone levels or have had a bilateral orchiectomy. Xtandi is considered not medically necessary for any other uses not meeting these criteria.

Key thresholds and approval duration

Covered Indications3 (CRPC, mCSPC, nmCSPC with high-risk biochemical recurrence)

Approval duration1 year

Non-metastatic high-risk thresholdPSA doubling time ≤ 9 months

FDA-Approved Indications (Medical Necessity Criteria)

FDA‑Approved Indications

Approvals are for 1 year. Xtandi is covered as medically necessary for the following FDA‑approved prostate cancer indications when ALL criteria shown are met.

1. Prostate Cancer - Castration‑Resistant (Metastatic or Non‑Metastatic) - Approve for 1 year

Patient is ≥ 18 years of age
ONE of
- The medication is used concurrently with a gonadotropin‑releasing hormone (GnRH) analog
- Patient has had a bilateral orchiectomy

2. Prostate Cancer - Metastatic, Castration‑Sensitive - Approve for 1 year

Patient is ≥ 18 years of age

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Xtandi prescription benefit coverage. Approvals are provided for 1 year. See policy CNF573 for full prior authorization requirements and criteria.

Approval duration: 1 year (per policy CNF573)

Documentation Required

Documentation of castration status or concurrent GnRH analog

For the castration‑resistant and metastatic castration‑sensitive indications, document that the patient is ≥ 18 years of age and either is receiving concurrent GnRH analog (or antagonist) therapy or has had a bilateral orchiectomy. Include the agent name when applicable.

Example GnRH agents: Firmagon, Orgovyx, leuprolide, triptorelin, goserelin, histrelin

Applicable Codes

Drug (NDC) codesNDC

No codes listed

Relevant diagnosis context (ICD-10)ICD-10

No codes listed

Clinical Evidence & References

NCCN Prostate Cancer Clinical Practice Guidelines in Oncology (version 5.2026 - January 23, 2026).

Xtandi prescribing information, Astellas/Pfizer; December 2025.

Background

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for castration‑resistant prostate cancer (CRPC), metastatic castration‑sensitive prostate cancer (mCSPC), and non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with high‑risk biochemical recurrence. For CRPC and mCSPC, patients should receive Xtandi with a concurrent gonadotropin‑releasing hormone (GnRH) analog (including agonists or antagonists) or should have had a bilateral orchiectomy to maintain castrate testosterone levels.

GnRH analog: Includes GnRH agonists and antagonists; examples listed include leuprolide acetate, triptorelin, goserelin, histrelin, degarelix (Firmagon), and relugolix (Orgovyx).

High‑risk biochemical recurrence: defined as PSA doubling time ≤ 9 months.

Revision History

11/29/2023added

Prostate Cancer - Non‑Metastatic, Castration‑Sensitive indication and criteria were added based on new indication approval; high‑risk biochemical recurrence criterion specified (PSA doubling time ≤ 9 months); approval duration set to 1 year.

Annual Revision (date not specified in entry) / noted in HISTORY as part of prior annual revisionrevised

Changed requirement language from 'gonadotropin‑releasing hormone agonist' to 'analog' to allow agonists and antagonists; added Firmagon and Orgovyx as examples; applied to castration‑resistant and metastatic castration‑sensitive criteria.

04/17/2025revisedLatest