CurrentCignaPolicy v020126

Gazyva (obinutuzumab) prior authorization form

This document is a Cigna prior authorization form for requests to obtain Gazyva (obinutuzumab) for covered members; it directs providers on required clinical information, site/dispensing options, and submission instructions.

Policy Summary

PayerCigna

PolicyGazyva (obinutuzumab) prior authorization form

Policy CodePolicy v020126

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form listing medication, ICD-10 diagnosis, dose, frequency, duration, J-code, required patient and prescriber identifiers, site of dispensing, and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

800.882.4462phone for urgent requests

Fax (855) 840-1678fax to submit completed form

Accredonationally preferred specialty pharmacy

Coverage Criteria

Coverage criteria based on diagnosis and prior therapy

Coverage assessment will be based on the selected diagnosis and completion of disease‑specific criteria and prior treatment history.

General submission requirements: Form completed with patient identifiers (Cigna ID, DOB), prescriber identifiers (DEA, NPI or TIN), selected diagnosis, dose/frequency/duration, J‑code when applicable, site of care, and prescriber attestation and signature.

Supports administrative and clinical review

Diagnosis-specific information: Provider must indicate one or more diagnoses from the provided list (eg, CLL/SLL, FL, DLBCL, MCL, MALT, NMZL, SMZL, CBCL, PTLD, lupus nephritis, etc.) and answer the follow-up questions applicable to the chosen diagnosis (prior chemotherapy, rituximab substitution, disease extent, refractory/progressive status, combination regimens, biopsy confirmation for lupus nephritis, response if currently on therapy).

Responses inform medical necessity determinations

Therapy-line and regimen details:

Policy Summary

PayerCigna

PolicyGazyva (obinutuzumab) prior authorization form

Policy CodePolicy v020126

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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For follicular lymphoma indicate first‑line vs subsequent therapy, monotherapy vs combination and specify regimen (CHOP, CVP, bendamustine, or other). For CLL/SLL indicate combination with venetoclax and planned duration. For gastric/nongastric MALT, NMZL, SMZL indicate prior chemotherapy and whether disease is recurrent/progressive. For primary CBCL document extent and prior regimens/refractoriness as requested. For lupus nephritis indicate specialist involvement and concurrent immunosuppressive regimen and whether biopsy confirmation (eg, WHO class III, IV, or V) is present for initial therapy.

These specifics are required to evaluate appropriateness

No explicit exclusion list is printed on the authorization form. Determinations about coverage exclusions are made through policy review beyond the information collected on this form; providers should not assume that an indication not listed or lacking required supporting documentation is automatically eligible.

The form requires detailed prior-therapy and response information for the selected diagnosis and thereby implies that coverage decisions depend on prior treatments and documented response. Examples collected include prior chemotherapy regimens, whether the request is first-line versus subsequent therapy (eg, follicular lymphoma), prior use or substitution for rituximab, refractory or progressive disease status, planned combination regimens (eg, CHOP, CVP, bendamustine, venetoclax), and, for lupus nephritis, biopsy confirmation or documented clinical response when continuing therapy.

Coding

Requested drug billing codeHCPCS

J-code

Requested J-code for the medication (form requests J-code)

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gazyva. Incomplete submissions may delay or result in denial of the request. Provide complete attestation and all required clinical information.

Medication requested (include name and NDC if available)
ICD-10 diagnosis code(s)
Dose, frequency, and duration of therapy
J-code (if applicable)
Urgency indicator (Standard or Urgent)

Documentation Required

Treatment History Required

Document the patient’s prior treatment history and current line of therapy. Indicate whether the requested use is first-line or second-line/subsequent therapy, prior chemotherapy or rituximab use and responses, and whether the drug is replacing rituximab for rare complications when applicable.

Specify prior chemotherapy regimens and dates
State prior rituximab exposure and reason for substitution (e.g., severe mucocutaneous reaction)
For follicular lymphoma: note monotherapy vs combination and prior response to obinutuzumab plus chemotherapy if applicable

Documentation Required

Required Documentation Checklist

Provide full patient and prescriber identifiers and supporting documentation. Ensure the attestation is signed and dated by the prescriber. Missing required fields or documentation (patient identifiers, prescriber DEA/NPI/TIN, diagnosis, clinical rationale, and attestation) can delay or cause denial of the request.

Patient name, Cigna ID, date of birth, address, and phone
Prescriber name, specialty, DEA, NPI or TIN, office contact, phone and fax
Clinical documentation: diagnosis, relevant biopsy/pathology reports (if required), prior treatment notes, and response assessments
Signed prescriber attestation and date

Note

Attestation and Submission Instructions

Attest that the information provided is true and accurate. The health plan or its designees may audit and request medical records to verify accuracy. For faster processing, submit online at CoverMyMeds or via SureScripts in the prescriber’s EHR.

Prescriber signature and date (attestation)
Submit online: www.covermymeds.com/main/prior-authorization-forms/cigna/
Standard review time: 5 business days; call to expedite urgent requests

Initial Therapy Criteria

Initial therapy requirements

Initial therapy requests require diagnosis‑specific confirmations and line‑of‑therapy details.

Initial therapy specifics: If the request is for initial therapy, complete the diagnosis‑specific initial items: for lupus nephritis confirm biopsy (eg, WHO class III, IV, or V); for follicular lymphoma indicate whether this is first‑line therapy and if given in combination (specify CHOP, CVP, bendamustine, or other); for other listed diagnoses complete the applicable prior chemotherapy and disease‑status questions on the form.

Biopsy confirmation requested for lupus nephritis; combination and line‑of‑therapy details required for FL

Continuation Therapy Criteria

Continuation therapy for ongoing users

When the patient is currently receiving the requested medication, prescriber attestation of clinical benefit is required to support continuation.

Continuation assessment: Prescriber must attest whether the patient has responded to therapy. Examples of response include improvement in organ dysfunction, reduction in disease flares, reduction in corticosteroid dose, reduction in proteinuria, decrease in anti‑dsDNA titer, and improvement in complement levels (C3, C4).

Response documentation supports continuation

Step Therapy / Prior Regimens

Prior chemotherapy/regimen	Outcome / disease status	Applicable diagnoses / notes
Was the patient previously treated with only one other chemotherapy regimen for this diagnosis?
Indicate whether patient has refractory or progressive disease or recurrent/progressive disease as applicable (yes/no).
Primary cutaneous B-cell lymphoma (CBCL): question applies when not extensive disease; document refractory/progressive status if asked.

Site of Care & Dispensing Options

Billing Rule

Specify site of care/dispensing — Accredo preferred specialty pharmacy noted

Indicate where the medication will be obtained and provide dispensing/facility details; Accredo is listed as Cigna’s nationally preferred specialty pharmacy.

Select one: Accredo Specialty Pharmacy, Prescriber's office stock (billing on medical claim), Retail pharmacy, Home Health/Home Infusion vendor, or Other (specify).
If facility/doctor will dispense, provide facility name, state, Tax ID, and address.
Accredo contact and NCPDP (4436920) are provided for medication orders (phone/fax/verbal options).

Definitions & Key Items

Diagnoses considered for Gazyva requests

Primary eligible B-cell lymphomasAIDS-related B-cell lymphoma; Burkitt lymphoma; diffuse large B-cell lymphoma (DLBCL); High‑Grade B‑Cell Lymphomas; Histologic transformation of MZL to DLBCL; mantle cell lymphoma (MCL); primary cutaneous B‑cell lymphoma (CBCL); post‑transplant lymphoproliferative disorder (PTLD)

Indolent/other B‑cell lymphomasFollicular lymphoma (FL); gastric MALT lymphoma; nongastric MALT lymphoma; nodal marginal zone lymphoma (NMZL); splenic marginal zone lymphoma (SMZL)

Chronic lymphocytic leukemiaChronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)

Autoimmune indicationLupus nephritis

Other/unspecifiedCastleman's disease; All others (allows specification of other indications on the form)

Rituximab substitution (when to use Gazyva as a rituximab alternative)

When substitution is applicableRequested medication may be used as a substitute for rituximab when the patient is experiencing rare complications (for example, mucocutaneous reactions).

Diagnostic contexts where substitution is askedQuestion about rituximab substitution is specifically prompted for AIDS‑related B‑cell lymphoma, Burkitt, Castleman’s, DLBCL, high‑grade B‑cell lymphomas, histologic transformation, MCL, and PTLD.

Required documentation of substitution reasonForm requires the provider to indicate ‘Yes’ or ‘No’ if the medication is being used as a rituximab substitute and to provide clinical information supporting the substitution when applicable.

Background

Obinutuzumab (Gazyva) is an anti‑CD20 monoclonal antibody used in multiple B‑cell lymphomas and in selected immune‑mediated indications such as lupus nephritis. The form collects diagnosis‑specific clinical details and prior therapy history (including combination regimens and specialist involvement for lupus nephritis) to support medical‑necessity review for oncology and certain autoimmune uses.