CurrentCignaPolicy N/A

Oncology - Xtandi Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for Xtandi (enzalutamide capsules and tablets) for prostate cancer indications under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Xtandi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 26, 2025

Key ActionObtain prior authorization for Xtandi; approvals are issued for 1 year when the clinical criteria for the applicable prostate cancer indication are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Distinct indication groups

1 yearStandard approval duration

PSADT ≤ 9 moHigh-risk BCR threshold

Concurrent ADT requiredCastration requirement

Coverage Criteria for Xtandi (enzalutamide)

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Regimen / Setting	NCCN recommendation notes	Coverage status
Xtandi (enzalutamide) monotherapy	No prior docetaxel and no prior novel hormone therapy: Xtandi is a preferred option (Category 1).	Covered with criteria; prior authorization required
Xtandi + talazoparib (Talzenna)	Recommended for tumors with homologous recombination repair (HRR) mutation: Category 1 when no prior docetaxel/novel hormone therapy; Category 2A or 2B in other prior-therapy contexts per NCCN.	Covered with criteria for HRR-mutant tumors per guideline recommendation
Xtandi with concurrent androgen-deprivation therapy (ADT) for mCSPC	For metastatic castration-sensitive disease, ADT in combination with Xtandi is a Category 1 recommended preferred option.	Covered with criteria; concurrent ADT or orchiectomy required where specified
Xtandi ± leuprolide for progressive non-metastatic CSPC with high‑risk BCR	Recommended as 'useful in certain circumstances' (Category 2A) for high‑risk biochemical recurrence (e.g., PSADT ≤ 9 months and other listed high‑risk features).	Covered with criteria for high‑risk BCR (PSADT ≤ 9 months)
Xtandi after prior docetaxel or after prior novel hormone therapy	Xtandi remains a recommended or 'other recommended' regimen in various prior‑therapy settings (categories vary: category 1, 2A, or 2B depending on prior treatments and presence of visceral metastases).	Covered with criteria; recommendation category depends on prior therapies

Coding and Key Definitions

inv-05: PSA doubling time (PSADT)

PSA doubling time (PSADT) threshold≤ 9 months

Context of useUsed to define high‑risk biochemical recurrence for nmCSPC eligibility

Policy approval duration linkedApplies to criteria for 1‑year prior authorization approvals

inv-11: High-risk biochemical recurrence (high-risk BCR)

DefinitionHigh‑risk biochemical recurrence (high‑risk BCR) defined as PSA doubling time ≤ 9 months

ApplicationThreshold used to determine high risk for metastasis in non‑metastatic castration‑sensitive prostate cancer (nmCSPC)

Treatment implicationPatients meeting high‑risk BCR criteria may be eligible for Xtandi with 1‑year approval per policy

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xtandi. Approvals are issued for 1 year when the specific clinical criteria for the applicable prostate cancer indication are met.

Approval duration: 1 year
Applies to: enzalutamide (Xtandi) capsules and tablets

Step Therapy

Step Therapy / Sequencing (Informational)

No explicit step-therapy sequencing is mandated by this policy. NCCN–recommended preferred regimens and sequencing are provided for informational purposes only and are not required by the benefit policy. Examples of preferred regimens vary by prior therapy exposure (see guidelines): no prior docetaxel/novel hormone therapy, prior docetaxel only, prior novel hormone therapy only, or both prior docetaxel and novel hormone therapy.

NCCN-preferred options (informational): Xtandi, abiraterone, docetaxel; talazoparib + Xtandi for HRR mutations in selected settings

Documentation Required

Benefit Plan and Supporting Documentation

Providers must document that the requested use of Xtandi aligns with the member's applicable benefit plan terms and any controlling federal or state laws/regulations. Coverage determinations require consideration of: 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) relevant collateral materials including coverage policies; and 4) the specific clinical facts of the case. In the event of conflict, the member's benefit plan document supersedes this policy.

Include documentation of member age, diagnosis (metastatic vs non-metastatic; castration-sensitive vs castration-resistant), prior therapies, and whether concurrent GnRH analog therapy or prior bilateral orchiectomy is present
Attach relevant benefit plan provisions when available

Denial Risk

Unapproved Indications — Not Covered

Use of Xtandi for any indication not specified as covered in this policy is considered experimental, investigational or unproven and is excluded from coverage.

Non-covered uses will be updated as new published data are available

Background

Enzalutamide (Xtandi) is an androgen receptor inhibitor indicated for treatment of patients with castration‑resistant prostate cancer (both metastatic and non‑metastatic), for metastatic castration‑sensitive prostate cancer, and for non‑metastatic castration‑sensitive prostate cancer with high‑risk biochemical recurrence. For castration‑resistant and metastatic castration‑sensitive settings, therapy should be given with concurrent gonadotropin‑releasing hormone (GnRH) analog therapy or after bilateral orchiectomy; non‑metastatic castration‑sensitive patients with high‑risk biochemical recurrence may be treated with or without GnRH analog therapy depending on clinical context.

Revision History

2025-03-26Annual revisionLatest

Policy reviewed (Annual Revision) with no material changes to clinical criteria; Review Date recorded as 03/26/2025.

2024-04-10Annual revision

Policy reviewed (Annual Revision) with no criteria changes; Review Date recorded as 04/10/2024.

2023-11-29Selected revision

Added new condition and criteria for Prostate Cancer - Non-Metastatic, Castration-Sensitive based on new indication approval.

2023-04-05Annual revision

Policy reviewed (Annual Revision) with summary of changes noted as no criteria changes; Review Date recorded as 04/05/2023.

2022-04-10Selected revision

Updated wording for castration-related criterion: changed 'agonist' to 'analog' to allow both agonists and antagonists; added Firmagon and Orgovyx as examples and removed redundant Firmagon-specific concurrent-use criterion.