Epkinly (epcoritamab-bysp) Medication Precertification Request - Coverage Criteria
Customize your policy alerts
Sign up for all Aetna policy alerts
Know when Aetna releases new policies or updates existing guidance.
Monitor payer policy activity
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.
No material clinical or coverage changes in this revision.
Coverage Criteria Overview
Initiation Therapy Criteria
Information requested to support coverage decisions for initiation:
Form collects these items to support medical necessity decisions.
Continuation Therapy Criteria
Information requested to support continuation:
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.
These fields are required on the precertification form to support initiation authorization.
Continuation Therapy Requirements
Continuation requirements
Continuation requests must document toxicity or progression.
Required field on form for continuation review.
Coding and Billing Codes
| Administration code(s) (CPT): | Place to list CPT administration codes as applicable |
| 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
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.
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.
- Include names, dates, and responses to prior regimens in submitted documentation.
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.
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.).
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.
Place of Administration
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
| Step | Requirement | Documentation needed |
|---|---|---|
| 1 | Patient 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
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.