CurrentCignaPolicy V072220

Apalutamide (Erleada) and Darolutamide (Nubeqa) prior authorization

This document is a Cigna prior authorization form governing requests for coverage of apalutamide (Erleada) and darolutamide (Nubeqa) for patients with prostate cancer; it affects prescribers submitting drug coverage requests to Cigna.

Policy Summary

PayerCigna

PolicyApalutamide (Erleada) and Darolutamide (Nubeqa) prior authorization

Policy CodePolicy V072220

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete the prior authorization form with medication selection, dose, duration, J-code, ICD-10, metastatic and prior hormone therapy/orchiectomy status, and attach supporting chart notes and lab results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

2 medicationslisted medication choices on form

metastatic vs non-metastaticdisease status branching questions

Coverage Criteria

Prior Authorization Review Requirements

Coverage review requires completion of all relevant clinical questions on the form and submission of supporting documentation.

Required form elements: Provide medication selection (Erleada 60 mg, Nubeqa 300 mg, or Other), dose, duration, frequency, J-code, ICD-10 diagnosis code, and indicate whether the medication is for a chronic/long-term condition.

These items are required on the medication request portion of the form.

Supportive documentation: Attach supportive documentation (chart notes, laboratory/test results, and other medical records) for all answers on the form.

Requests lacking supportive documentation may be denied.

Disease status and prior therapy questions

Metastatic disease

Policy Summary

PayerCigna

PolicyApalutamide (Erleada) and Darolutamide (Nubeqa) prior authorization

Policy CodePolicy V072220

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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If non-metastatic: Has the patient had an orchiectomy? If no orchiectomy, indicate whether the patient has failed hormone therapy (e.g., Eligard, Lupron/leuprolide, Lupron Depot, Zoladex).

Complete both orchiectomy and prior hormone therapy questions when applicable.

If metastatic and requesting Erleada: Has the patient had an orchiectomy? If no orchiectomy, indicate whether the patient had a response to hormone therapy (e.g., Eligard, Lupron/leuprolide, Lupron Depot, Zoladex).

Complete these items when metastatic disease is present and Erleada is requested.

Additional clinical information: Provide additional pertinent information including disease stage, prior therapies, performance status, and names/doses/schedules of any concurrent agents.

This information should be included in the request to support clinical review.

Attestation and identifying information: Complete all required patient and physician identifying fields and attest/sign the form.

Standard contact information and attestation are required for processing.

The form does not list any explicit coverage exclusions. It provides a diagnosis checkbox that defaults to prostate cancer and also includes a separate checkbox for other (please specify), allowing requests for diagnoses besides prostate cancer to be submitted for review. The presence of an "other" option indicates the form can accept non-prostate diagnoses, but it does not itself state that such uses are covered or excluded.

The document contains no standalone section labeling specific conditions as "not medically necessary." Instead, it emphasizes that review is documentation-driven: the form requires supportive medical records for the clinical questions. Consequently, requests lacking required documentation or failing to provide the information requested on the form may be denied because the form states supportive documentation for all answers must be attached.

Requested Billing Codes

Requested billing codesmixed

J-code	J-Code field provided on form (specific J-code to be entered by requester)
ICD10	ICD-10 diagnosis code field to be provided by requester

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Erleada (apalutamide) and Nubeqa (darolutamide). Complete all required form fields: indication, dose, duration, J-code and ICD-10 (where applicable).

Medication requested (select Erleada or Nubeqa)
Dose and Duration of therapy
J-Code and ICD-10 diagnosis code (when present)

Prior Authorization

Prior Hormone Therapy / Orchiectomy Information

This request requires documentation of prior hormone therapy and/or orchiectomy status. Answer whether the patient has metastatic disease. If non‑metastatic, indicate if the patient has had an orchiectomy or, if not, whether the patient has failed prior hormone therapy (e.g., Eligard, Lupron/leuprolide, Lupron Depot, Zoladex). If metastatic and requesting Erleada, indicate orchiectomy status and, if no orchiectomy, whether the patient responded to prior hormone therapy.

Does your patient have metastatic disease? (Yes/No)
If non‑metastatic: Has the patient had an orchiectomy? (Yes/No)
If no orchiectomy (non‑metastatic): Has the patient failed hormone therapy? (Yes/No)
If metastatic and requesting Erleada: Has the patient had an orchiectomy? (Yes/No)
If no orchiectomy (metastatic + Erleada): Has the patient had a response to hormone therapy? (Yes/No)

Documentation Required

Required Supportive Documentation

Supportive clinical documentation is required with this request. Attach chart notes, relevant lab and test results, and any documentation that substantiates the responses to the clinical questions on the form. Failure to provide supporting documentation may result in denial of the request.

Attach chart notes and clinical progress notes
Attach labs and imaging/test results relevant to diagnosis and treatment
Include prior therapy records and dates

Note

Identifying Information and Attestation

Complete all asterisked (*) patient and prescriber fields on the form and sign the attestation. Include contact information for the office (phone and fax) so we can follow up if needed. Electronic submission via CoverMyMeds or SureScripts in the EHR is available to expedite processing.

Complete all asterisked patient and physician fields (e.g., Patient Name, Cigna ID, DOB, Physician Name, DEA/NPI/TIN)
Prescriber signature and date required
Office contact phone and fax required for follow‑up
Submit online at CoverMyMeds or via SureScripts to speed review

Denial Risk

Denial Risk for Missing Documentation

If required supportive documentation is missing or incomplete, the request is at risk of denial. Ensure all checklist items and attachments are included before submission to avoid delays.

Missing chart notes, labs, or prior therapy documentation increases denial risk
Incomplete fields (e.g., missing metastasis/orchiectomy answers) may result in denial or request for more information

Background

This prior authorization form is used to request coverage for apalutamide (Erleada) and darolutamide (Nubeqa). It collects the specific medication selection and treatment details (dose, duration, frequency and billing fields such as J-Code and ICD10), and it gathers disease status and prior therapy information relevant to review. The clinical section asks about metastatic vs non-metastatic disease, orchiectomy status, and prior response or failure to hormone therapies (for example, Eligard, Lupron/leuprolide, Lupron Depot, Zoladex), and it requests additional pertinent information including disease stage, prior therapies, performance status, and concurrent agents. The form also explicitly requires that supportive documentation (chart notes, lab/test results, etc.) be attached to substantiate the responses.

Definitions and Medication Details

Medication requested

ErleadaErleada (apalutamide) 60 mg

NubeqaNubeqa (darolutamide) 300 mg

OtherOther — free-text field provided for alternative medication specification

Supportive documentation (definition)

Chart notesProvider progress notes, consultation notes, and other clinical documentation that substantiate answers on the form

Lab/test resultsRelevant laboratory values and diagnostic test reports (e.g., PSA, imaging, pathology) that support the clinical status reported

Other medical recordsAdditional records such as operative reports, medication administration records, and prior therapy documentation (e.g., hormone therapy or orchiectomy history)