Pharmacy Prior Authorization Criteria

Xtandi (enzalutamide)

For diagnosis of Castration-resistant prostate cancer (CRPC)
Indicated for the treatment of patients with castration-resistant prostate cancer (CRPC).
For diagnosis of Metastatic castration-sensitive prostate cancer (mCSPC)
Indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
For diagnosis of Non-metastatic castration-sensitive prostate cancer (nmCSPC)
Indicated for the treatment of patients with non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
For diagnosis of HRR Gene-mutated mCRPC [3]
Indicated for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in combination with Talzenna (talazoparib).

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Castration-resistant prostate cancer (CRPC)

AND

If HRR gene-mutated metastatic disease, medication will be taken in combination with Talzenna (talazoparib)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic castration-sensitive prostate cancer (mCSPC)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non‑metastatic castration‑sensitive prostate cancer (nmCSPC)

AND

Patient has high-risk biochemical recurrence (BCR) defined by a PSA doubling time less than or equal to 9 months and one of the following:

PSA values greater than or equal to 1 ng/mL if the patient had prior prostatectomy (with or without radiotherapy)
PSA values at least 2 ng/mL above the nadir if the patient had prior radiotherapy only

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

2024-04-02, 2024-01-10, 2023-07-28, 2023-07-05, 2023-05-04, 2022-03-25, 2021-09-27, 2021-05-26, 2021-05-25, 2021-03-22, 2020-04-09, 2020-01-27

Xtandi prescribing information. Astellas Pharma Inc. Northbrook, IL. November 2023.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Prostate Cancer v.3.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed March 2024.
Agarwal, Neeraj, et al. “Talazoparib plus Enzalutamide in Men with First-Line Metastatic Castration-Resistant Prostate Cancer (TALAPRO-2): A Randomised, Placebo-Controlled, Phase 3 Trial.” The Lancet, 4 June 2023, https://doi.org/10.1016/s0140-6736(23)01055-3.

Most men with advanced disease eventually stop responding to traditional androgen deprivation therapy (ADT) and are categorized as castration-resistant (also known as castration-recurrent). [2]

2024-04-02: Annual review: Updated to clarify non-metastatic CSPC vs metastatic CSPC – no change to clinical intent. Updated background and references.
2024-01-10: Addition of new indication for non‑metastatic castration‑sensitive prostate cancer.
2023-07-28: Addition of new indication for HRR gene-mutated metastatic castration-resistant prostate cancer
2023-07-05: Removed specialist requirement
2023-05-04: Annual review: Updated criteria, updated references and background.
2022-03-25: Annual review: No changes to criteria. Updated references.
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
2021-03-22: Updated guideline to add GPIs for 40 mg and 80 mg tablets to already existing indications.
2020-04-09: Annual review: Updated background and references
2020-01-27: Revised guideline to add new indication of metastatic castration-sensitive prostate cancer (mCSPC)