CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nubeqa (darolutamide) drug coverage

Defines accepted indications, continuation and exclusion criteria, and utilization management authority for coverage of Nubeqa (darolutamide) for members; applies to UM reviewers and network providers submitting medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNubeqa (darolutamide) drug coverage

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateSep 27, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mgsingle dose maximum

120maximum monthly limit

PSA ≤10moM0 CRPC criterion

≤6 weeksdocetaxel timing

09/18/24committee approval

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Initial and continuation coverage criteria

Covered when ALL of the following are met for continuation requests or specified prostate cancer indications:

Continuation request exemptions: Continuation requests are exempt from this policy if all of the following are met: (1) the requested medication was used within the last year; AND (2) the member has not experienced disease progression and/or has not had intolerance to the requested medication; AND (3) additional medication(s) are not being added to the continuation request.

Prostate cancer indications: Use of Nubeqa (darolutamide) in combination with androgen deprivation therapy (e.g., an LHRH analog or following orchiectomy) for ONE of the following: (a) Non‑metastatic castration‑resistant prostate cancer (M0) with a PSA doubling time ≤ 10 months AND absence of documented metastases by conventional imaging (pelvic lymph nodes < 2 cm below the aortic bifurcation are 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 the start of darolutamide and may be given for up to 6 cycles.PSA doubling time ≤ 10 months

Requests for coverage will be denied when there is evidence of 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 (e.g., enzalutamide) or with CYP17 inhibitors (e.g., abiraterone) is excluded. Coverage will also be denied when dosing exceeds the single dose limit of 600 mg or when the treatment regimen surpasses the maximum of 120 (300 mg) tablets per month.

Use of Nubeqa (darolutamide) for investigational or off‑label indications that lack adequate, accepted evidence is not covered. The policy specifies that supportive evidence must be found in CMS‑recognized compendia or acceptable peer‑reviewed literature; case reports and meeting abstracts without full peer‑reviewed articles are explicitly called out as insufficient to establish accepted use. Coverage exclusions apply when the available evidence does not adequately represent the patient population, regimen, clinically meaningful outcomes, or appropriate study design.

Initial Therapy

Initial therapy — coverage when used with ADT for specified prostate cancer indications

Initial therapy is covered when used with androgen deprivation therapy (ADT) for the prostate cancer indications below:

Initial indications: Nubeqa (darolutamide) used in combination with ADT for ONE of the following indications: (1) Non‑metastatic castration‑resistant prostate cancer (M0) with PSA doubling time ≤ 10 months and absence of documented metastases on conventional imaging (pelvic lymph nodes < 2 cm below the aortic bifurcation allowed); OR (2) Metastatic castration‑sensitive prostate cancer in combination with docetaxel where the first dose of docetaxel is administered within 6 weeks after the start of darolutamide (up to 6 cycles).PSA doubling time ≤ 10 months

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. All medication requests are processed by Evolent; requests not authorized may be denied and not reimbursed. Use must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS manual standards.

Evolent prior authorization required for Nubeqa (darolutamide) requests
Supporting documentation: FDA label, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature

Step Therapy

Step therapy is not required beyond the listed indications; no explicit step-through medication is mandated in this policy.

No mandatory trial of alternative ARSIs specified prior to approval

Documentation Required

Supporting Evidence Required

Requests must include supporting evidence consistent with CMS Medicare Benefit Policy Manual Chapter 15: FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that addresses patient and regimen characteristics and reports clinically meaningful outcomes.

Evidence should represent the patient's clinical characteristics and the oncologic regimen used
Outcomes should be clinically meaningful (ASCO-recommended benchmarks, e.g., HR < 0.80; OS/PFS benefit generally ≥ 3 months)
Study design considerations (randomization, controls) and adequacy of subject representation will be evaluated

Documentation Required

Continuation Request Exemptions

Continuation requests are exempt from standard prior authorization rules if the medication was used within the last year, there is no disease progression or intolerance, and no additional medications are being added to the request.

Used within the last 12 months
No disease progression and no intolerance to the medication
No new medications added to the continuation request

Denial Risk

Denial Triggers

Denials may be issued for disease progression, dosing or quantity limits exceeded, investigational/unaccepted off‑label use without sufficient evidence, or disallowed concurrent therapies.

Disease progression on or after Nubeqa or another ARSI = denial trigger
Single dose limit exceeded (> 600 mg) = denial trigger
Monthly maximum exceeded (> 120 tablets of 300 mg equivalent) = denial trigger
Off-label use lacking CMS compendia or acceptable peer-reviewed evidence = investigational/not covered

Denial Risk

Drug Interaction / Duplication Denial

Requests will be denied for concurrent use with other Androgen Receptor Signaling Inhibitors or with CYP17 inhibitors due to duplicate mechanism or interaction risk.

Concurrent use with ARSIs (e.g., enzalutamide, apalutamide) is not allowed
Concurrent use with CYP17 inhibitors (e.g., abiraterone) is not allowed

Step	Requirement / Notes
No explicit step therapy sequence required
Policy does not require prior failure of other androgen receptor signaling inhibitors (ARSIs) before coverage; darolutamide may be used for the specified prostate cancer indications when combined with ADT as described.

Background

Darolutamide (Nubeqa) is an androgen receptor inhibitor indicated for use in prostate cancer settings defined in this policy. Approved uses include treatment of non‑metastatic castration‑resistant prostate cancer (M0 CRPC) with rapid PSA kinetics and use in combination with androgen deprivation therapy and docetaxel for specified metastatic castration‑sensitive disease. When indicated, darolutamide should be used in combination with androgen deprivation therapy (ADT) and in the mCSPC setting be timed per the policy (docetaxel initiation within the stated interval). Coverage is subject to the clinical criteria and exclusion rules described herein.

OpenPayer

Nubeqa (darolutamide) drug coverage

Coverage Criteria for Nubeqa (darolutamide)

Initial Therapy

Continuation Therapy

Provider Actions and Prior Authorization

Quantity Limits and Dosing

Step Therapy

Definitions

Background