Enzalutamide (Xtandi) Coverage Criteria
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Defines medical necessity and prior authorization criteria for enzalutamide (Xtandi) for prostate cancer indications for Delaware First Health members across Commercial, HIM, and Medicaid lines of business.
No material clinical or coverage changes in this revision.
Coverage & Medical Necessity Criteria
inv-01: Initial Therapy — Prostate Cancer — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Prescribed regimen must be FDA-approved or recommended by NCCN
inv-02: Continuation Therapy — Prostate Cancer — Continued therapy covered when ALL of the following are met:
Continued therapy covered when ALL of the following are met:
Approval duration 12 months
Non-FDA approved indications not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).
For Medicaid members, any state Medicaid coverage provisions that conflict with this clinical policy take precedence. Refer to the applicable state Medicaid manual for specific coverage provisions governing enzalutamide.
Initial Therapy Requirements
inv-17: Initial Therapy — Initial approval requires all of the following:
Initial approval requires all of the following:
Approval duration 12 months
Criteria for Continued Authorization
inv-18: Continuation Criteria — Criteria required for continued authorization:
Criteria required for continued authorization:
Approval duration 12 months
Provider Responsibilities & Prior Authorization
Prior authorization required
Prior authorization is required for enzalutamide (Xtandi); approval is contingent on meeting the specified initial or continuation criteria such as diagnosis, prescriber specialty, age, requirement for concurrent ADT/orchiectomy when indicated, dosing limits with CYP interactions, and formulary/generic use.
- Approval duration: 12 months (initial and continued).
- Prescribed regimen must be FDA‑approved or recommended by NCCN when applicable.
Follow Health Plan prior authorization processes
This clinical policy is intended to guide medical necessity and coverage decisions; providers should follow the Health Plan's applicable prior authorization processes and coding/benefit requirements when requesting coverage.
- The policy provides guidance but does not guarantee payment or replace plan-specific prior authorization procedures.
Generic enzalutamide required when available
For all initial and continued enzalutamide requests, the member must use generic enzalutamide if an interchangeable generic is available unless the generic is contraindicated or the member experiences clinically significant adverse effects.
- Generic preference applies to both initial approval and continuation requests.
Health Plan may change or withdraw this policy
The Health Plan reserves the right to change, amend, or withdraw this clinical policy and related administrative policies at any time; such changes may affect coverage, step therapy, and prior authorization requirements.
- If discrepancies exist between this policy and legal/regulatory requirements, law governs.
- Effective date and posting date may differ; the Health Plan determines the effective date.
Submit clinical documentation to support request
Providers must submit supporting clinical documentation with prior authorization requests, such as office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria.
- Include documentation of diagnosis, prescriber specialty/consultation, age, concurrent ADT/orchiectomy when required, PSA values and doubling time when applicable, and any evidence supporting dose changes.
Provider responsibility for medical judgment and documentation
Providers are expected to exercise professional medical judgment and remain responsible for documentation that supports medical necessity; this clinical policy is a guide and does not replace the provider's responsibility for treatment decisions and records.
- Providers must supply supporting evidence (e.g., guidelines or peer‑reviewed literature) when requesting doses outside standard limits for drug interactions or off‑label uses.
Incomplete documentation may lead to denial
Failure to provide required documentation (for example, chart notes or laboratory results) that demonstrates the member meets all approval criteria may result in denial of the request.
- Denials may occur if evidence of concurrent ADT, PSA values/doubling time, or response to therapy is not supplied when required.
Coverage subject to plan terms and regulatory requirements
Coverage determinations and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and to applicable state and federal requirements.
- For Medicaid members, state Medicaid provisions take precedence when they conflict with this policy.
Clinical Thresholds & Key Values
Definitions & Dosing
Step Therapy / Product Selection
| Step | Requirement |
|---|---|
| 1 | |
| Preference for generic enzalutamide if available unless contraindicated or clinically significant adverse effects are experienced. |
Quantity Limitations
Background
Enzalutamide is an androgen receptor inhibitor used in prostate cancer management. The policy covers enzalutamide for castration‑resistant prostate cancer (CRPC), metastatic castration‑sensitive prostate cancer (CSPC), and certain cases of non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with high‑risk biochemical recurrence when the specified criteria are met. Providers should follow the approval criteria, submit required documentation to support off‑label uses when applicable, and consult state Medicaid provisions for Medicaid members when there is any conflict.
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