Pharmacy Prior Authorization Criteria

Nubeqa (darolutamide)

For diagnosis of Non-metastatic castration-resistant prostate cancer
Indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC).
For diagnosis of Metastatic castration-sensitive prostate cancer (mCSPC)
Indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) or for patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

Prior Authorization (Initial Authorization)

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

Diagnosis of castration-resistant (chemical or surgical) prostate cancer (CRPC)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Diagnosis of metastatic castration-sensitive prostate cancer (mCSPC) [also known as metastatic hormone-sensitive prostate cancer (mHSPC)]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

1970-01-01, 2024-08-16, 2023-08-03, 2023-07-05, 2023-05-05, 2022-08-22, 2021-09-07, 2020-08-25, 2020-01-22, 2020-01-16, 2019-09-05, 2019-08-29

Nubeqa Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. June 2025.
Klotz L, O’Callaghan C, Ding K, et al. Nadir testosterone within first year of androgen-deprivation therapy (ADT) predicts for time to castration-resistant progression: a secondary analysis of the PR-7 trial of intermittent versus continuous ADT. J Clin Oncol 2015;33:1151-56. doi:10.1200/JCO.2014.58.2973.
Smith, M., Hussain, M. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. Available at https://www.nejm.org/doi/10.1056/NEJMoa2119115?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Accessed August 13, 2022.

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). [1]