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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAetna Epkinly prior auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAetnaPolicy N/A

    Epkinly (epcoritamab-bysp) Medication Precertification Request - Coverage Criteria

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    Precertification notification and required clinical/administrative information for requesting coverage of Epkinly (epcoritamab-bysp) for members; intended for prescribing providers and dispensing/administration sites submitting prior authorization to Aetna.

    Policy Summary
    PayerAetna
    PolicyEpkinly (epcoritamab-bysp) Medication Precertification Request - Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionRequest precertification by phone or fax to Aetna using the form and provide required clinical and administrative documentation.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2 pagesform length
    1-866-752-7021precert phone

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    1-888-267-3277
    fax
    requires clinical documentationrequirements

    Coverage Criteria Overview

    Initiation Therapy Criteria

    Information requested to support coverage decisions for initiation:

    Initiation requirements captured on form: Patient has a B-cell lymphoma subtype listed (Diffuse large B-cell lymphoma [including DLBCL NOS, arising from indolent lymphoma], High grade B-cell lymphoma, Histologic transformation of indolent lymphoma to DLBCL, HIV-related B-cell lymphoma [including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, NOS], Monomorphic post-transplant lymphoproliferative disorder, or Other) AND provider indicates whether Epkinly will be used as a single agent (Yes/No) AND provider documents whether the patient has tried at least 2 prior lines of systemic therapy (Yes/No) AND the clinical setting for use is provided (Partial response, No response, Progressive disease, Relapsed disease, Refractory disease, or Other)

    Form collects these items to support medical necessity decisions.

    Continuation Therapy Criteria

    Information requested to support continuation:

    Continuation requirements captured on form: For continuation requests, documentation must state whether there is evidence of unacceptable toxicity or disease progression while on the current regimen (Yes/No).

    Form requires this to evaluate ongoing coverage.

    The precertification form does not list any explicit clinical exclusions. Instead, it captures the patient’s specific B-cell lymphoma diagnosis using checkboxes for multiple subtypes, including Diffuse large B-cell lymphoma (DLBCL) (including DLBCL NOS and DLBCL arising from indolent lymphoma), High-grade B-cell lymphoma, Histologic transformation of indolent lymphoma to DLBCL, HIV-related B-cell lymphomas (including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL, NOS), Monomorphic post-transplant lymphoproliferative disorder, and an Other option. Providers must select the applicable subtype(s) on the form to support the authorization request.

    Initial Therapy Requirements

    Initiation data requirements

    Initiation requests require subtype, prior therapy history, single-agent use, and disease status.

    Initiation data fields: Select lymphoma subtype from the listed options; indicate whether Epkinly will be used as a single agent (Yes/No); indicate whether the patient has tried at least 2 prior lines of systemic therapy (Yes/No); specify clinical setting (Partial response, No response, Progressive disease, Relapsed disease, Refractory disease, Other).

    These fields are required on the precertification form to support initiation authorization.

    Continuation Therapy Requirements

    Continuation requirements

    Continuation requests must document toxicity or progression.

    Continuation documentation: Document whether there is evidence of unacceptable toxicity or disease progression while on the current regimen (Yes/No).

    Required field on form for continuation review.

    Coding and Billing Codes

    Administration CPT codesCPT
    Administration code(s) (CPT):Place to list CPT administration codes as applicable
    Diagnosis ICD-10 CodesICD-10
    Primary ICD Code:Primary diagnosis ICD code field
    Secondary ICD Code:Secondary diagnosis ICD code field
    Other ICD Code:Other diagnosis ICD code field

    Precertification and Provider Requirements

    Prior Authorization

    Precertification submission

    Phone: 1-866-752-7021 (TTY: 711) FAX: 1-888-267-3277 For Medicare Advantage Part B: Please Use Medicare Request Form

    • Precertification request may be submitted by phone or fax using the numbers above.
    • For Medicare Advantage Part B members, use the Medicare Request Form instead of this fax/phone submission.
    Documentation Required

    Prior lines of therapy check

    The precertification form includes a checkbox asking whether the patient has tried at least two prior lines of systemic therapy. Providers must complete this field and document prior systemic therapies in the clinical record and attach supporting notes or oncology treatment history.

    • Check the box indicating whether the patient has tried ≥2 prior systemic therapy lines.

    Place of Administration

    Note

    Specify place of administration (office, infusion center, home)

    Specify the place of administration on the form by selecting the appropriate option provided.

    • Place of Administration options: Self-administered; Physician's Office; Outpatient Infusion Center; Home Infusion Center.
    • Record associated site phone, center/agency name, and address as requested.
    • Select dispensing provider type (Physician's Office, Retail Pharmacy, Specialty Pharmacy, Other) and provide contact/TIN information.

    Prior Therapy Documentation

    StepRequirementDocumentation needed
    1Patient has tried at least 2 prior lines of systemic therapy (when applicable)Form checkbox indicating whether the patient has tried ≥2 prior systemic therapies; list or describe prior systemic therapies in clinical documentation as applicable

    Background and Scope

    This form is specific to Epkinly (epcoritamab-bysp)single agent, documentation that the patient has tried at least 2 prior lines of systemic therapy (checkbox), and the clinical setting in which the drug will be used (options include partial response, no response, progressive disease, relapsed disease, refractory disease, or other). For continuation requests the form requires documentation indicating whether there is evidence of unacceptable toxicity or disease progression while on the current regimen.

    Key Definitions

    DLBCL and related subtypes
    Primary listed subtypeDiffuse large B-cell lymphoma (DLBCL) — including DLBCL NOS and DLBCL arising from indolent lymphoma
    Other named subtypesHigh-grade B-cell lymphoma; histologic transformation of indolent lymphoma to DLBCL
    HIV-related and related entitiesHIV-related B-cell lymphoma (including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, NOS)
    Post-transplant lymphoproliferative disorderMonomorphic post-transplant lymphoproliferative disorder listed as an applicable entity
    Actionable checklist itemIndicate whether Epkinly will be used as a single agent (Yes/No)
    Prior therapy requirement captured on formCheckbox asking whether the patient has tried at least 2 prior lines of systemic therapy (Yes/No)
    Policy Summary
    PayerAetna
    PolicyEpkinly (epcoritamab-bysp) Medication Precertification Request - Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionRequest precertification by phone or fax to Aetna using the form and provide required clinical and administrative documentation.
    SourceLink
    On This Page
    Coverage Criteria OverviewInitial Therapy RequirementsContinuation Therapy RequirementsCoding and Billing CodesPrecertification and Provider RequirementsPlace of AdministrationPrior Therapy DocumentationBackground and ScopeKey Definitions
  1. Include names, dates, and responses to prior regimens in submitted documentation.
    2. Documentation Required

    Required clinical documentation

    Complete all required clinical information for initiation or continuation requests. For initiation, indicate the B‑cell lymphoma subtype, whether the agent will be used as a single agent, clinical setting (relapsed, refractory, progressive, partial response, etc.), and confirm prior therapy history. For continuation, indicate evidence of unacceptable toxicity or disease progression while on the current regimen. Attach relevant medical records, pathology reports, prior treatment records, and response assessments.

    • Specify lymphoma subtype (DLBCL, high grade B‑cell, histologic transformation, HIV‑related B‑cell lymphoma, monomorphic post‑transplant lymphoproliferative disorder, or other).
    • For continuation requests, state whether there is evidence of progression or unacceptable toxicity.
    • Attach pathology, prior regimen details, dates, and objective response information.
    Note

    Administrative information

    Patient demographics, insurance, prescriber, and site of care information must be provided on the form. This includes patient name, DOB, contact info, weight/height, allergies; Aetna member ID, group, other coverage and Medicare/Medicaid IDs; prescriber name, credentials, NPI, license, specialty, office contact; and place of administration and dispensing provider details.

    • Provide complete patient contact and demographic details.
    • Include Aetna member ID and any other payer information.
    • Provide prescriber NPI, state license, specialty, and office contact.
    • Indicate place of administration and dispensing provider (physician office, infusion center, specialty pharmacy, etc.).
    Denial Risk

    Fraud / Incomplete Information

    Any person who knowingly submits materially false or concealed information to obtain authorization may be subject to criminal and civil penalties. The plan may request additional information or clarification to evaluate requests; incomplete or fraudulent information can affect authorization decisions.

    • Signed acknowledgement required on the form.
    • Materially false statements or concealment of information may constitute a fraudulent insurance act and lead to penalties.
    • The plan may request additional documentation or clarification as needed to complete review.