CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nubeqa (darolutamide) — Coverage Criteria

Defines coverage, inclusion and exclusion criteria, and authorization requirements for Nubeqa (darolutamide) for prostate cancer treatment for the payer's covered population and network providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNubeqa (darolutamide) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 27, 2024

Next Review DateSep 18, 2024

Key ActionObtain prior authorization; continuation requests may be approved without reauthorization if medication used in last year, no progression or intolerance, and no new agents are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mgsingle dose limit

120 tabs/momonthly limit

PSA DT ≤10mM0 CRPC criterion

within 6 wksDocetaxel timing

FDA/NCCN/ASCO/CMSEvidence sources

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Coverage Criteria for Nubeqa (darolutamide)

Initial and continuation coverage criteria

Covered when ALL of the following are met (inclusion and continuation rules):

Continuation exemption: Continuation requests are exempt from new authorization if ALL: (1) the requested medication was used within the last year, AND (2) the member has not experienced disease progression and/or intolerance to the requested medication, AND (3) additional medication(s) are not being added to the continuation request.

Indications - Prostate cancer: Darolutamide (Nubeqa) used in combination with androgen deprivation therapy (e.g., LHRH analog or following orchiectomy) for either: (A) Non‑metastatic castration‑resistant prostate cancer (M0) with PSA doubling time ≤ 10 months and no documented metastases by conventional imaging (pelvic lymph nodes below aortic bifurcation <2 cm allowed), OR (B) Metastatic castration‑sensitive prostate cancer in combination with docetaxel (Taxotere) where the first dose of docetaxel is started within 6 weeks after darolutamide initiation and may be given up to 6 cycles.

The policy excludes members with disease progression on or after treatment with Nubeqa (darolutamide) or another androgen receptor signaling inhibitor (for example, enzalutamide or apalutamide). Concurrent administration with other androgen receptor signaling inhibitors or with CYP17 inhibitors (for example, abiraterone) is not permitted. Requests that exceed dosing thresholds are also excluded: a single dose greater than 600 mg or monthly treatment that exceeds 120 tablets per month (300 mg tablets) will be denied. These exclusions apply whether the concern is treatment failure, potentially duplicative mechanism of action, or dose/quantity limits.

Use of Nubeqa (darolutamide) for off‑label or investigational indications will be considered not medically necessary / investigational when the indication lacks adequate supporting evidence as defined by this policy. Insufficient evidence includes reliance on case reports or meeting abstracts without full peer‑reviewed articles, or studies that do not adequately represent the patient population, regimen, or clinically meaningful outcomes (per ASCO criteria). Indications not supported by the FDA label, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature may be denied.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nubeqa (darolutamide). Requests will be reviewed by Utilization Management. Continuation requests for medications that were used within the last year may be exempt from a full clinical review when the member has not experienced disease progression or intolerance and no additional medications are being added to the continuation request.

Prior authorization reviewed by Utilization Management
Continuation exemption: medication used within last year; no disease progression or intolerance; no additional meds added

Note

Combination with Docetaxel

Nubeqa (darolutamide) may be used in combination with androgen deprivation therapy (ADT). For metastatic castration-sensitive prostate cancer (mCSPC) when given with docetaxel (Taxotere), the first dose of docetaxel must be initiated within 6 weeks after the start of darolutamide; docetaxel may be given for up to 6 cycles.

Combination use allowed: darolutamide + ADT
mCSPC + docetaxel: first docetaxel dose within 6 weeks of starting darolutamide; up to 6 cycles

Documentation Required

Supporting Evidence and Continuation Documentation

Requests must be supported by one or more acceptable sources: FDA-approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature that meets CMS evidentiary standards. Continuation documentation should demonstrate prior use within the last year, absence of disease progression or intolerance, and that no additional medications are being added. Utilization Management will evaluate whether submitted evidence adequately represents the patient population, treatment regimen, clinically meaningful outcomes, and appropriate study design.

Acceptable evidence: FDA label, CMS compendia, NCCN, ASCO guidelines, or qualifying peer-reviewed literature
Continuation documentation: prior use within 1 year; no progression/intolerance; no added medications
Evidence assessment considers patient representation, regimen representation, clinically meaningful outcomes (eg, ASCO standards), and study design adequacy

Billing Rule

Dose and Quantity Limits

Dose and quantity limits: single dose should not exceed 600 mg (darolutamide), and total dispensed quantity must not exceed 120 tablets (300 mg tablets equivalent) per month. Requests exceeding these limits will be denied.

Single dose limit: 600 mg
Maximum monthly supply limit: 120 tablets (300 mg tablet equivalent)
Requests exceeding dose or quantity limits are excluded

Denial Risk

Prohibited Concurrent Therapy

Concurrent use of darolutamide with other androgen receptor signaling inhibitors (for example, enzalutamide, apalutamide) or with CYP17 inhibitors (for example, abiraterone) is prohibited and will be excluded.

Prohibited concurrent therapy: other AR signaling inhibitors (eg, enzalutamide, apalutamide)
Prohibited concurrent therapy: CYP17 inhibitors (eg, abiraterone)

Denial Risk

Insufficient Evidence for Off-Label Use

Off-label or investigational uses lacking sufficient supporting evidence (per CMS compendia or acceptable peer-reviewed literature) will be denied. Sufficiency of evidence will be evaluated based on whether the clinical characteristics and treatment regimen are represented, outcomes are clinically meaningful (for example, ASCO-recommended thresholds such as hazard ratio < 0.80 and survival benefit ≥ 3 months where applicable), and whether the study design and size provide reliable support.

Investigational/off-label use without CMS compendia or acceptable peer-reviewed support will be denied
Evidence sufficiency criteria include patient and regimen representation, clinically meaningful outcomes, and appropriate study design (randomization, sample size, etc.)

Regimen	Requirement / Timing
Darolutamide (Nubeqa) used in combination with docetaxel (Taxotere) for metastatic castration‑sensitive prostate cancer (mCSPC)
First dose of docetaxel (Taxotere) must be started within 6 weeks after initiation of darolutamide; docetaxel may be given for up to 6 cycles.

Definitions and Clinical Concepts

Non‑metastatic castration‑resistant prostate cancer (M0 CRPC)

DefinitionNon‑metastatic castration‑resistant prostate cancer (M0 CRPC): PSA doubling time ≤ 10 months and absence of documented metastases on conventional imaging; pelvic lymph nodes below aortic bifurcation <2 cm allowed.

Required background therapyUsed in combination with androgen deprivation therapy (e.g., LHRH analog or following orchiectomy)

Imaging requirementNo documented metastases by conventional imaging

Metastatic castration‑sensitive prostate cancer (mCSPC)

DefinitionMetastatic castration‑sensitive prostate cancer (mCSPC): prostate cancer with distant metastases responsive to androgen deprivation therapy.

Combination allowanceDarolutamide may be used in combination with docetaxel (Taxotere) plus androgen deprivation therapy; first docetaxel dose must start within 6 weeks after darolutamide initiation and may be given up to 6 cycles.

Required concomitant therapyAndrogen deprivation therapy (e.g., LHRH analog or prior orchiectomy)

Background

Darolutamide (Nubeqa) is an oral androgen receptor signaling inhibitor indicated in select prostate cancer settings. This policy defines coverage for two primary scenarios: (1) non‑metastatic castration‑resistant prostate cancer (M0 CRPC)—patients without documented metastases and with a PSA doubling time ≤ 10 months (pelvic lymph nodes <2 cm allowed); and (2) metastatic castration‑sensitive prostate cancer (mCSPC) when used in combination with androgen deprivation therapy and docetaxel where the first docetaxel dose begins within 6 weeks of darolutamide initiation (up to 6 cycles). The policy also specifies prior authorization requirements, continuation exemptions for members with prior use within the last year and no progression or intolerance, required supporting evidence sources (FDA label, CMS compendia, NCCN/ASCO guidelines or acceptable peer‑reviewed literature), and quantity limits including a 600 mg single‑dose cap and a monthly maximum of 120 (300 mg) tablets.

OpenPayer

Nubeqa (darolutamide) — Coverage Criteria

Coverage Criteria for Nubeqa (darolutamide)

Initial Therapy Indications

Continuation Therapy Requirements

Provider Actions, Prior Authorization, and Documentation

Step Therapy / Sequencing Rules

Quantity and Dose Limits

Definitions and Clinical Concepts

Background

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