CurrentNeighborhood Health Plan of Rhode IslandPolicy 1933-A

Xtandi 1933-A SGM P2023

Defines coverage criteria, exclusions, and authorization durations for Xtandi for FDA-approved indications (castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer) and compendial use in prostate cancer. Also specifies combination therapy exclusions and reauthorization conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXtandi 1933-A SGM P2023

Policy CodePolicy 1933-A

Change Typeclarified

Effective Date

Next Review Date

Key ActionAuthorize up to 12 months when criteria are met and document orchiectomy status or plan for concomitant GnRH agonist/degarelix as required.

POLICY UPDATE CHANGES

Policy lists FDA-approved indications (CRPC and mCSPC) and permits compendial use limited to prostate cancer; other indications are investigational.

2Covered Indications (FDA-approved)

1Compendial Indication Category (prostate cancer)

12Authorization Duration (months)

Coverage Summary

Policy 1933-A — Xtandi (enzalutamide) coverage for prostate cancer: Covers FDA-approved indications castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC), and permits compendial use limited to prostate cancer per recognized compendia. The policy excludes use in specified combinations with other oral androgen pathway agents (see exclusions) and authorizes treatment durations per policy guidance, with initial and continuation authorizations subject to meeting the stated criteria.

Initial Therapy Criteria

Covered Indications (Initial Authorization)

Covered when ALL of the following are met:

ALL of the following

Either CRPC or mCSPC satisfies indication requirement.: Indication is an FDA-approved indication for Xtandi: castration-resistant prostate cancer (CRPC) OR metastatic castration-sensitive prostate cancer (mCSPC).
Alternatively, compendial use for prostate cancer per recognized compendia (NCCN Drugs & Biologics Compendium) is acceptable.
Compendial use limited to prostate cancer; all other indications are not medically necessary.
Member has no exclusions to the prescribed therapy (see Exclusions section).

Exclusions / Contraindicated Combinations

Not covered when ANY of the following apply:

ANY of the following

Requested medication is used in combination with a second-generation oral anti-androgen (example: apalutamide [Erleada]).
Requested medication is used in combination with an oral androgen metabolism inhibitor (example: abiraterone acetate [Zytiga]).

ref':

The policy explicitly disallows use of Xtandi in combination with a second-generation oral anti-androgen (e.g., apalutamide) or an oral androgen metabolism inhibitor (e.g., abiraterone); such combination uses are considered exclusions and are not covered/investigational.

Continuation / Reauthorization Criteria

Authorization may be granted for up to 12 months when criteria are met. Reauthorization assessments must confirm the indication remains listed in the policy and that there is no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

Provider Actions

Prior Authorization

Authorization required

Authorization of up to 12 months may be granted when the approval criteria are met. Initial and continuation authorizations require that the indication is an approved indication (CRPC or mCSPC/compendial prostate cancer) and that the combination/orchiectomy requirements are satisfied (member has had a bilateral orchiectomy or will be using Xtandi with a GnRH agonist or degarelix).

Denial Risk

Denied for excluded combinations

Claims will not be covered if Xtandi is requested in combination with a second-generation oral anti-androgen (for example, apalutamide) or an oral androgen metabolism inhibitor (for example, abiraterone acetate); such uses are excluded from coverage.

Documentation Required

Clinical documentation for orchiectomy or concomitant therapy

Provider must document whether the member has had a bilateral orchiectomy or provide a clinical plan showing use of Xtandi with a GnRH agonist or degarelix when required by the indication (CRPC or mCSPC) to qualify for authorization.

Background & Clinical Evidence

Background: Xtandi (enzalutamide) is FDA-approved for CRPC and mCSPC, compendial use is accepted for prostate cancer, and the policy disallows combinations with certain other oral androgen pathway agents.

Evidence: Xtandi package insert (Sep 2022); NCCN Drugs & Biologics Compendium (accessed Aug 6, 2023).

Term	Definition
CRPC	Castration-resistant prostate cancer.
mCSPC	Metastatic castration-sensitive prostate cancer.

Revision History

policy_changeLatest

Standard coverage/authorization language applied; no material change indicated in document. Clarified that coverage follows FDA-approved indications (CRPC and mCSPC), allows compendial use for prostate cancer only, specifies 12-month authorization conditions (orchiectomy or use with GnRH agonist/degarelix), and reiterates exclusions for combinations with second-generation oral anti-androgens or oral androgen metabolism inhibitors.