CurrentNeighborhood Health Plan of Rhode IslandPolicy 3147-A

Nubeqa (darolutamide)

Coverage policy for Nubeqa (darolutamide) for FDA-approved indications and compendial uses in prostate cancer, including authorization durations, continuation criteria, and exclusions related to combination therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNubeqa (darolutamide)

Policy CodePolicy 3147-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months when the member meets the listed indication-specific criteria and document castration status or use of an LHRH agonist/antagonist as applicable.

SourceLink

POLICY UPDATE CHANGES

No material changes

3FDA-approved indications listed

1Compendial indication category

2Combination therapies excluded

Coverage Summary

Policy number 3147-A. Coverage scope: Nubeqa (darolutamide) is indicated for treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and mCSPC in combination with docetaxel per the FDA-approved indications and NCCN compendial guidance. Coverage is provided for those FDA-approved and compendial prostate cancer uses when all policy criteria (including documentation of castration status or concomitant LHRH therapy, and authorization criteria) are met. All other uses are considered investigational and not medically necessary.

Initial Therapy Criteria / Covered Indications

Covered Indications / Initial Authorization

Authorization of 12 months may be granted when ALL of the following are met:

FDA-approved indications (ANY of the following)

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

Member has had a bilateral orchiectomy OR will be using Nubeqa in combination with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).

Required for nmCRPC; also required for mCSPC per policy

For mCSPC specific requirement (ANY of the following applies)

If mCSPC, the member has high-volume synchronous or metachronous metastases and requested medication will be used in combination with or without docetaxel.

Continuation Therapy Criteria / Reauthorization

Continuation of Therapy / Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member is requesting reauthorization for an indication listed in the coverage criteria section.
There is no evidence of unacceptable toxicity while on the current regimen.
There is no evidence of disease progression while on the current regimen.

Documentation Required

Reauthorization documentation

For reauthorization requests, provider must document that there is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.

Not Covered / Exclusions

Coverage will not be provided when ANY of the following exclusions apply:

ANY of the following

Requested medication is used in combination with a second-generation oral anti-androgen (example: apalutamide [Erleada]).
Requested medication is used in combination with an oral androgen metabolism inhibitor (example: abiraterone acetate [Zytiga]).
Indications other than FDA-approved indications and listed compendial uses for prostate cancer (all other indications are considered experimental/investigational and not medically necessary).

Denial Risk

Combination therapy exclusion

Claims will be denied if Nubeqa is used in combination with a second-generation oral anti-androgen or an oral androgen metabolism inhibitor.

Examples: apalutamide (Erleada)
abiraterone acetate (Zytiga)

Provider Actions / Authorization & Documentation

Prior Authorization

Authorization required

Authorization of 12 months may be granted when the member meets the listed indication-specific criteria; prior authorization is implied for initial and reauthorization requests per policy.

Documentation Required

Documentation of castration status or LHRH therapy

Provider must document that the member has had a bilateral orchiectomy OR will be using Nubeqa in combination with an LHRH agonist or antagonist as applicable.

Examples of LHRH agonists/antagonists: goserelin
leuprolide
degarelix
relugolix

Documentation Required

Documentation for mCSPC high-volume metastases

For metastatic castration-sensitive prostate cancer, provider must document high-volume synchronous or metachronous metastases when relevant and whether docetaxel will be used.

Providers should expect prior authorization for initial and reauthorization requests and must document castration status or planned use of an LHRH agonist/antagonist as applicable; for mCSPC, document high-volume synchronous or metachronous metastases and whether docetaxel will be used. Claims will be denied if Nubeqa is used in combination with a second-generation oral anti-androgen (e.g., apalutamide) or an oral androgen metabolism inhibitor (e.g., abiraterone).

Definitions

LHRH agonist/antagonist: luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide) or antagonists (e.g., degarelix, relugolix) used in combination with Nubeqa when bilateral orchiectomy has not been performed.

High-volume metastases: policy references 'high-volume synchronous or metachronous metastases' and relies on the treating clinician’s assessment and NCCN guidance to define high-volume disease for mCSPC.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNubeqa (darolutamide)

Policy CodePolicy 3147-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months when the member meets the listed indication-specific criteria and document castration status or use of an LHRH agonist/antagonist as applicable.

SourceLink

On This Page

OpenPayer

Nubeqa (darolutamide)

Coverage Summary

Initial Therapy Criteria / Covered Indications

Continuation Therapy Criteria / Reauthorization

Not Covered / Exclusions

Applicable Codes

Provider Actions / Authorization & Documentation

Clinical Evidence / References

Definitions

Revision History