CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Enzalutamide (Xtandi) for Prostate Cancer — Coverage Criteria

Defines clinical coverage, authorization duration, and exclusions for enzalutamide (Xtandi) when used to treat specified prostate cancer indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnzalutamide (Xtandi) for Prostate Cancer — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when member meets indication and documentation requirements, including orchiectomy status or concurrent LHRH therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑approved indications covered

12 motypical authorization period

1explicit exclusion: combo therapy

NCCN & PIreferences cited

Coverage criteria for enzalutamide (Xtandi)

Indication: Member has one of the FDA‑approved indications: castration‑resistant prostate cancer (CRPC); metastatic castration‑sensitive prostate cancer (mCSPC); or non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis (nmCSPC high‑risk BCR).

from source

Androgen‑deprivation status: Member has had a bilateral orchiectomy OR will be using enzalutamide in combination with a luteinizing hormone‑releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix), where specified for the indication.

from source

inv-02: Continuation of therapy

Continuation (reauthorization):

Continuation of therapy: Authorization for continued treatment may be granted for 12 months when there is no evidence of unacceptable toxicity and no disease progression while on the current regimen.

from source

Requests for enzalutamide (Xtandi) used in combination with a second‑generation oral anti‑androgen (for example, apalutamide) or an oral androgen metabolism inhibitor (for example, abiraterone acetate) are excluded from coverage.

Provider requirements and authorization details

Prior Authorization

Prior authorization required — 12‑month authorization when criteria met

Authorization of 12 months may be granted for covered indications when criteria are met. This applies to castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC), non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with high‑risk biochemical recurrence, and for continuation of therapy when there is no unacceptable toxicity or disease progression.

Authorization period: 12 months for covered indications when approval criteria are met
Applies to: CRPC, mCSPC, nmCSPC (high‑risk BCR), and continuation of therapy

Denial Risk

Combination therapy exclusion — not covered

Requests for use of the medication in combination with a second‑generation oral anti‑androgen (e.g., apalutamide [Erleada]) or an oral androgen metabolism inhibitor (e.g., abiraterone acetate [Zytiga]) are not covered. Deny authorization for combination therapy with these agents.

Examples of excluded combinations: apalutamide (Erleada); abiraterone acetate (Zytiga)

Documentation Required

Required documentation — diagnosis, castration status, and supporting clinical evidence

Providers must submit documentation to support medical necessity with initial and reauthorization requests. Documentation should include: diagnosis, evidence of castration status (bilateral orchiectomy or concurrent LHRH agonist/antagonist use), treatment history, and evidence of clinical benefit or lack of disease progression for continuation requests.

Required documentation: diagnosis and staging
Castration status: bilateral orchiectomy OR documentation of concurrent LHRH agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix)
For continuation: evidence of no unacceptable toxicity and no disease progression

Note

Provider follow‑up — submit requested information promptly

(Provider action placeholder) If additional provider actions are required that are not otherwise specified, follow payer instructions on the prior authorization form and communicate any missing clinical information promptly to avoid delays.

Definitions and key terms

inv-11: high‑risk BCR (biochemical recurrence) — definition and criteria

DefinitionNon-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR).

Covered indicationHigh-risk BCR is listed as an FDA-approved indication for use of enzalutamide (Xtandi).

Authorization periodAuthorization of 12 months may be granted for treatment of high-risk BCR when criteria are met.

Androgen-deprivation requirementCoverage tied to the policy's requirement for concurrent androgen-deprivation (bilateral orchiectomy OR LHRH agonist/antagonist) where specified for the indication.

inv-12: LHRH agonist/antagonist — examples and requirement when combined with enzalutamide

Definition / examplesLHRH agonists: goserelin, leuprolide; LHRH antagonists: degarelix, relugolix.

When requiredAn LHRH agonist or antagonist is required (unless the member has had bilateral orchiectomy) when enzalutamide is used for CRPC, mCSPC, or other indications as specified in the policy.

Authorization linkAuthorization of 12 months may be granted when the member has had bilateral orchiectomy or will use enzalutamide with an LHRH agonist/antagonist.

Background

Enzalutamide (Xtandi) is an oral androgen receptor inhibitor indicated for multiple prostate cancer states. This policy covers its use for the FDA‑approved indications of castration‑resistant prostate cancer (CRPC), metastatic castration‑sensitive prostate cancer (mCSPC), and certain non‑metastatic castration‑sensitive prostate cancer with high‑risk biochemical recurrence (nmCSPC high‑risk BCR). Coverage is contingent on meeting the specific authorization criteria for the indicated disease state and any required concurrent androgen‑deprivation therapy or bilateral orchiectomy where specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnzalutamide (Xtandi) for Prostate Cancer — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when member meets indication and documentation requirements, including orchiectomy status or concurrent LHRH therapy.

SourceLink

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Enzalutamide (Xtandi) for Prostate Cancer — Coverage Criteria

Coverage criteria for enzalutamide (Xtandi)

Provider requirements and authorization details

Coding

Definitions and key terms

Background