Xtandi (enzalutamide) Letter of Medical Necessity
Xtandi (enzalutamide) prior authorization requires documentation of castration resistance, disease stage, and line of therapy. Formulary preference for newer agents like apalutamide may require clinical justification.
FDA-Approved Indications
- ● metastatic castration-resistant prostate cancer
- ● non-metastatic castration-resistant prostate cancer
- ● metastatic castration-sensitive prostate cancer
Why Xtandi Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. Castration-resistant status not documented (testosterone level)
- 2. Line of therapy not specified
- 3. Preferred androgen receptor inhibitor on formulary (apalutamide or darolutamide)
- 4. Concurrent ADT not documented
What to Include in a Xtandi Letter of Medical Necessity
Document prostate cancer diagnosis with Gleason score, stage, castration-resistant status (serum testosterone <50 ng/dL on ADT), PSA doubling time, prior systemic therapies including ADT, imaging findings, ECOG status, and clinical rationale for enzalutamide selection over preferred alternatives.
Key clinical evidence to cite:
- ✓ AFFIRM (post-chemo mCRPC)
- ✓ PREVAIL (pre-chemo mCRPC)
- ✓ PROSPER (nmCRPC)
- ✓ ARCHES (mCSPC)
- ✓ ENZAMET (mCSPC)
Relevant guidelines:
- 📖 NCCN Prostate Cancer Guidelines
- 📖 AUA/ASTRO/SUO Advanced Prostate Cancer Guidelines
Payers Covering Xtandi
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Xtandi Prior Authorization FAQ
Why was my Xtandi prior authorization denied?
The most common denial reasons for Xtandi are: Castration-resistant status not documented (testosterone level); Line of therapy not specified; Preferred androgen receptor inhibitor on formulary (apalutamide or darolutamide); Concurrent ADT not documented.
What should a Xtandi Letter of Medical Necessity include?
Document prostate cancer diagnosis with Gleason score, stage, castration-resistant status (serum testosterone <50 ng/dL on ADT), PSA doubling time, prior systemic therapies including ADT, imaging findings, ECOG status, and clinical rationale for enzalutamide selection over preferred alternatives.
Which payers cover Xtandi?
Xtandi is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part D, though formulary tier and prior authorization criteria vary.