CurrentCentenePolicy CP.PHAR.435

Darolutamide (Nubeqa) (PDF)

Defines medical necessity criteria, coverage, continuation, excluded indications, dosing, and approvals for darolutamide (Nubeqa) for commercial, HIM, and Medicaid lines of business within Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyDarolutamide (Nubeqa) (PDF)

Policy CodePolicy CP.PHAR.435

Change TypeRevised indication and approval duration (multiple updates)

Effective Date09.03.19

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

RT4: added updated indication of mCSPC; removed criterion for combination with docetaxel; revised nomenclature of mHSPC to mCSPC per updated label.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

4Q 2021 annual review: references updated (HIM.PHAR.21 to HIM.PA.154); no significant clinical changes.

Annual reviews 2022-2025 noted; generally no significant changes except indicated revisions.

2Covered indications (FDA)

1200 mg/dayMaximum daily dose

12 monthsTypical approval duration

≥18

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Coverage Summary

Scope: This policy defines medical necessity criteria, coverage, continuation, excluded indications, dosing, and approvals for darolutamide (Nubeqa) for commercial, HIM, and Medicaid lines of business within Centene-affiliated health plans. Background: Darolutamide (Nubeqa) is an androgen receptor inhibitor indicated for non‑metastatic castration‑resistant prostate cancer (nmCRPC) and metastatic castration‑sensitive prostate cancer (mCSPC). The policy aligns coverage with FDA‑approved regimens and NCCN recommendations, and requires concomitant androgen deprivation therapy via a GnRH analog or prior bilateral orchiectomy.

Surface thresholds / key values

Maximum daily dose1,200 mg/day (4 tablets)

Minimum age≥ 18 years

Prior therapy duration for continuationAt least 30 days

Typical approval duration12 months

Initial Therapy Criteria

I. Initial Approval Criteria - Prostate Cancer

Covered when ALL of the following are met:

ALL of the following

Diagnosis of non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC).
Prescribed by or in consultation with an oncologist or urologist.
Age ≥ 18 years.
Concomitant ADT requirement: Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy.
For Nubeqa requests, member must use darolutamide, if available, unless contraindicated or clinically significant adverse effects are experienced.

Continuation Therapy Criteria

II. Continued Therapy (Renewal) - Prostate Cancer

Continuation is authorized when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member has been receiving Nubeqa for at least 30 days.At least 30 days
Member is responding positively to therapy.
For Nubeqa requests, member must use darolutamide, if available, unless contraindicated or clinically significant adverse effects are experienced.
Dose change conditions (one of):

Unapproved / Not Authorized Indications

III. Diagnoses/Indications NOT authorized

Not covered when ANY of the following apply:

ALL of the following

NOT authorized: Non-FDA approved indications which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

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Provider Actions & Authorization Requirements

Documentation Required

Supportive documentation required

Submit office chart notes, recent lab results, and any other clinical information that documents the diagnosis, prior treatments, and evidence that the member meets all approval criteria (including age and concomitant ADT status).

Prior Authorization

Prescriber specialty requirement

Initial requests must be prescribed by or in consultation with an oncologist or urologist; include specialty attestation or consultation notes with the prior authorization submission.

Prior Authorization

Concomitant ADT requirement

Member must be receiving a GnRH analog concurrently or have documentation of bilateral orchiectomy; include documentation (e.g., medication list or surgical history) confirming concurrent androgen deprivation therapy or orchiectomy.

Policy Identifiers & Cross-References

Policy identifiers / referencemixed

CP.PHAR.435	Reference Number / Clinical Policy
CP.CPA.190	Commercial no coverage policy (referenced)
HIM.PA.33	Health insurance marketplace no coverage policy (referenced)
CP.PMN.255	Medicaid no coverage policy (referenced)
HIM.PA.103	Health insurance marketplace non-formulary policy (referenced)
CP.PMN.16	Medicaid non-formulary policy (referenced)
CP.CPA.09	Commercial off-label use policy (referenced)
HIM.PA.154	Marketplace off-label policy (referenced)
CP.PMN.53	Medicaid off-label policy (referenced)

Primary reference: Nubeqa Prescribing Information (Bayer), June 2025; Guideline reference: National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2025.

Background

Drug description and indications: Darolutamide (Nubeqa) is an androgen receptor inhibitor indicated for adult patients with nmCRPC and mCSPC. The policy is aligned with FDA and NCCN guidance. Concomitant androgen deprivation therapy is required: the member must use a GnRH analog concurrently or have had a bilateral orchiectomy.

Policy at-a-glance

SubjectDarolutamide (Nubeqa)

Policy numberCP.PHAR.435

StatusCURRENT

Minimum age≥ 18 years

Maximum daily dose1,200 mg/day

Clinical Evidence & Guidelines

Evidence and alignment: Supporting documents include the Nubeqa Prescribing Information (Bayer) June 2025 and the NCCN Prostate Cancer Version 2.2025. Dosage information in the PI and policy specifies 600 mg PO twice daily (maximum 1,200 mg/day). This policy aligns with the FDA label and NCCN recommendations for indications and dosing.

Revision History

06.12.25materialLatest

RT4: added updated indication of mCSPC; removed criterion for combination with docetaxel; revised nomenclature of mHSPC to mCSPC per updated label.

01.20.22material

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

07.15.21non-material

Policy Summary

PayerCentene

PolicyDarolutamide (Nubeqa) (PDF)

Policy CodePolicy CP.PHAR.435

Change TypeRevised indication and approval duration (multiple updates)

Effective Date09.03.19

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Dose requirements (one of):

Dose does not exceed 1,200 mg (4 tablets) per day.1,200 mg/day
Standard maximum per policy
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN.

I. Initial Approval Criteria - Other diagnoses/indications

If not covered under primary criteria, must meet ONE of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable no-coverage or non-formulary policy for the relevant line of business (refer to CP.CPA.190, HIM.PA.33/HIM.PA.103, CP.PMN.255/CP.PMN.16).
Refer to specific referenced policies
If the requested use is not listed under section III and the recent-label-change path does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

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New dose does not exceed 1,200 mg (4 tablets) per day.1,200 mg/day

New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN.

Documentation Required

Dose justification for off-label/above-limit dosing

If the requested dose exceeds 1,200 mg/day (4 tablets) or the use is off-label, the prescriber must submit supporting evidence such as relevant practice guideline excerpts or peer‑reviewed literature to justify the dosing/indication.

Billing Rule

Approval duration

Approval lengths vary by line of business: Medicaid and Health Insurance Marketplace (HIM) approvals are for 12 months; Commercial approvals are for 12 months or the duration of the request, whichever is less.

Prescriber and regimen requirements: For Nubeqa requests, the prescriber must specify darolutamide as the agent to be used if it is available, unless contraindicated or clinically significant adverse effects occur. The prescribed regimen must be an FDA‑approved regimen or be recommended by NCCN.

4Q 2021 annual review: references updated (HIM.PHAR.21 to HIM.PA.154); no significant clinical changes.

07.10.23non-material

4Q 2023 annual review: no significant changes; references reviewed and updated.

07.11.24non-material

4Q 2024 annual review: no significant changes; references reviewed and updated.

07.11.25non-material

4Q 2025 annual review: no significant changes; references reviewed and updated.