CurrentNeighborhood Health Plan of Rhode IslandPolicy Nubeqa 3147-A SGM P2023

Nubeqa (darolutamide) — Coverage Criteria and Prior Authorization

This policy governs coverage and prior authorization criteria for Nubeqa (darolutamide) for adult patients with prostate cancer, including non‑metastatic castration‑resistant and metastatic hormone‑sensitive disease, and applies to members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNubeqa (darolutamide) — Coverage Criteria and Prior Authorization

Policy CodePolicy Nubeqa 3147-A SGM P2023

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; authorization of up to 12 months may be granted when approval criteria and castration conditions are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved indications listed

12 monthsTypical authorization duration

combination restrictionProhibited combinations

includedCompendial use permitted

Coverage Criteria for Nubeqa (darolutamide)

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Covered Indications and Authorization Conditions

Covered when ALL of the following are met for the specified indication:

General coverage condition: Requested use must be an FDA‑approved indication or a compendial prostate cancer use, and the member must have no exclusions to the prescribed therapy.

See exclusions for prohibited combinations.

FDA‑approved indications: Either: (1) non‑metastatic castration‑resistant prostate cancer (nmCRPC) OR (2) metastatic hormone‑sensitive prostate cancer (mHSPC) when used in combination with docetaxel.

Castration requirement and authorization duration: For nmCRPC, member must have had a bilateral orchiectomy or will use concurrent medical castration (GnRH agonist or degarelix). For mHSPC, the drug must be used in combination with docetaxel AND the member must have had a bilateral orchiectomy or will use concurrent medical castration (GnRH agonist or degarelix).

Authorization of up to 12 months may be granted when these criteria are met.

Requests for Nubeqa (darolutamide) used concurrently with a second‑generation oral anti‑androgen (for example, apalutamide) or an oral androgen metabolism inhibitor (for example, abiraterone acetate) are excluded and will not be covered. Providers should not pursue combination therapy with these agents when requesting authorization for Nubeqa.

All uses of Nubeqa outside the FDA‑approved prostate cancer indications and recognized compendial prostate cancer uses are considered experimental/investigational and not medically necessary. Requests for coverage for non‑prostate cancer indications or other unlisted conditions will be denied.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nubeqa. Typical authorization may be approved for up to 12 months when criteria are met.

Prior authorization required
Typical approval duration: up to 12 months

Documentation Required

Castration Status / Plan Required

Document the patient’s castration status or planned concurrent medical castration. Approval requires either documentation of bilateral orchiectomy or a plan to use concurrent medical castration with a GnRH agonist or degarelix.

Castration documented (bilateral orchiectomy) or
Planned concurrent medical castration with a GnRH agonist or degarelix

Documentation Required

Concurrent Docetaxel for mHSPC

For mHSPC, include documentation that Nubeqa will be used in combination with docetaxel. Ensure records or prior auth notes explicitly state combination with docetaxel to meet approval criteria.

mHSPC requests must show concurrent use with docetaxel

Denial Risk

Prohibited Drug Combinations

Requests for Nubeqa combined with a second‑generation oral anti‑androgen (e.g., apalutamide) or an oral androgen metabolism inhibitor (e.g., abiraterone) are not allowed and will be denied.

Do not combine Nubeqa with apalutamide (Erleada)
Do not combine Nubeqa with abiraterone acetate (Zytiga)

Definitions

inv-09: nmCRPC — definition and FDA indication

DefinitionNon-metastatic castration-resistant prostate cancer (nmCRPC): prostate cancer that has no radiographic evidence of distant metastases and demonstrates disease progression despite castrate levels of testosterone; listed as an FDA‑approved indication for Nubeqa (darolutamide).

Regulatory statusFDA‑approved indication for Nubeqa for treatment of adult patients with nmCRPC.

Authorization noteCoverage requires meeting general authorization conditions (see policy), including castration status or plan (surgical orchiectomy or concurrent medical castration).

inv-10: mHSPC — definition and combination use

DefinitionMetastatic hormone‑sensitive prostate cancer (mHSPC): prostate cancer with radiographic evidence of metastatic disease in patients whose tumors remain responsive to androgen deprivation therapy; listed as an FDA‑approved indication for Nubeqa when used in combination with docetaxel.

Indication detailNubeqa is indicated specifically for adult patients with mHSPC in combination with docetaxel as an FDA‑approved use.

Authorization notePrior authorization may be granted (up to 12 months) when used with docetaxel for mHSPC and other approval criteria are satisfied.

Background

Nubeqa (darolutamide) is an androgen receptor inhibitor indicated for treatment of adult patients with prostate cancer. The policy recognizes the FDA‑approved indication for non‑metastatic castration‑resistant prostate cancer (nmCRPC) and for metastatic hormone‑sensitive prostate cancer (mHSPC) when used in combination with docetaxel. The policy allows compendial prostate cancer uses and requires documentation of castration status or a plan for concurrent medical castration when applicable.