CurrentCignaPolicy N/A

Opdivo Qvantig (nivolumab; hyaluronidase) prior authorization form

This document is a Cigna prior authorization and clinical documentation form for requests to obtain Opdivo Qvantig (subcutaneous nivolumab with hyaluronidase). It governs information submission requirements and clinical questions providers must answer to support coverage determinations across multiple oncology indications.

Policy Summary

PayerCigna

PolicyOpdivo Qvantig prior authorization form (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization using the form (fax to (855) 840-1678) with medication details, directions, quantity, duration, J-code/ICD-10 and required supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiplelisted tumor/indication checkboxes on form

5 business daysstandard response time for prescription drug coverage requests

fax & phonesubmission methods

Accredopreferred specialty pharmacy

Coverage Criteria and Indication Requirements

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Indication-specific medical necessity

Coverage assessment requires documentation that the patient meets indication‑specific clinical criteria; the form collects indication selection and nested condition‑specific questions.

Supportive documentation: Attach supporting documentation (e.g., genetic testing, chart notes, lab/test results) for all answers; supportive documentation must be attached with the request.

see chunk 8

Indication‑specific prior therapy and disease state logic: For each selected diagnosis, answer the prompted prior treatment and disease status questions as applicable (examples include prior platinum therapy, prior targeted therapy and progression, prior IV nivolumab and ipilimumab, metastatic or unresectable disease, biomarker results such as dMMR/MSI‑H or TMB‑H, PD‑L1 positivity, prior exposure to checkpoint inhibitors, number of prior chemotherapy regimens, progression on prior therapy, and specifics for combination or single‑agent use).

see chunks 9-14

Clinical support and attestation: Provide additional pertinent clinical information (disease stage, prior therapy, performance status, concurrent agents with doses/schedule) and sign prescriber attestation affirming accuracy; audits may be performed.

see chunk 14

The form collects the planned site of administration (home, physician's office, hospital outpatient, or other) and asks whether the patient is a candidate for redirection to an alternate, lower-acuity setting. Per some Cigna plans, infusion of medication MUST occur in the least intensive, medically appropriate setting. Providers should document medical necessity rationale if declining redirection and confirm whether specialty care coordination (Case Manager) assistance is appropriate.

Initial Formulation and Trial Requirements

Initial formulation considerations

Document formulation considerations for initial therapy.

IV trial or inability: Document whether the patient has tried and cannot take intravenous (IV) nivolumab.

see chunk 8

IV access limitation: If the patient has not tried IV nivolumab or cannot take it, document whether the patient is unable to obtain IV access.

see chunk 8

Prior Therapies / Progression Documentation

Prior therapy / clinical question	Response (as prompted on form)
Has the patient tried and cannot take Opdivo intravenous (IV)?
[ ] Yes [ ] No (if No) Is the patient unable to obtain IV access? [ ] Yes [ ] No
(if anal cell carcinoma, non-pNET, squamous vaginal, squamous vulvar) Previously treated with only one other chemotherapy regimen for this diagnosis?
[ ] Yes [ ] No
(if non-pNET and previous first line chemo) Did patient experience progression while on first-line chemotherapy?
[ ] Yes [ ] No
(if CRC) Does patient have metastatic disease?
[ ] Yes [ ] No
(if CRC or SBA) Has patient undergone IHC or MSI testing? If yes, results: dMMR/MSI-H or pMMR/MSI-low-or-stable
[ ] Yes [ ] No (if Yes) Results: [ ] dMMR or MSI-H [ ] pMMR or MSI-low/stable
(if CRC) Has cancer progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan (or monotherapy following IV nivolumab + ipilimumab)?
[ ] Yes [ ] No
(if NSCLC, no resectable tumors) Does patient have metastatic disease and progression on or after platinum-based chemotherapy?
[ ] Yes [ ] No
(if NSCLC, no resectable tumors) Does the patient have EGFR or ALK genomic tumor aberrations?
[ ] Yes [ ] No (if Yes) Did patient progress on FDA‑approved therapy for these aberrations prior to Opdivo Qvantig? [ ] Yes [ ] No
(if UCC/TCC) Use of requested medication: adjuvant, first line, subsequent after progression, or none/unknown
[ ] As adjuvant treatment [ ] As first line treatment [ ] As subsequent therapy after progression [ ] None of the above or Unknown
(if adjuvant) Will drug be used as adjuvant treatment in patients at high risk of recurrence after radical resection?
[ ] Yes [ ] No
(if first line) Will drug be used in combination with cisplatin and gemcitabine for metastatic or unresectable disease?
[ ] Yes [ ] No
(if disease progression) Does patient have locally advanced or metastatic disease with progression during or after platinum-containing chemotherapy?
[ ] Yes [ ] No
(if no) Does patient have locally advanced or metastatic disease with progression within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy?
[ ] Yes [ ] No
(if melanoma) How is this medication being used for this diagnosis? (select applicable)
[ ] Adjuvant treatment for metastatic disease that has spread to lymph nodes [ ] Adjuvant treatment for completely resected Stage IIB, IIC, III, or IV [ ] Single-agent therapy [ ] Following combination treatment with IV nivolumab and ipilimumab [ ] Other

Submission Instructions, Documentation, and Attestations

Prior Authorization

Submission requirements — prior authorization form

Prior authorization requests must be submitted using the Cigna prior authorization form. Fax the completed form to (855) 840-1678. For urgent requests, call (800) 882-4462 (800.88.CIGNA). Save time by submitting online at www.covermymeds.com or via SureScripts in your EHR.

Fax: (855) 840-1678
Urgent requests: (800) 882-4462
Online: www.covermymeds.com or via SureScripts

Documentation Required

IV trial / access documentation

The form asks whether the patient has tried and cannot take intravenous (IV) nivolumab and whether IV access is possible. Complete these fields; if the patient cannot receive IV therapy or cannot obtain IV access, document this on the form.

Has the patient tried and cannot take Opdivo IV? (Yes/No)
If No: Is the patient unable to obtain IV access? (Yes/No)

Documentation Required

Required supporting documentation and attestation

Attach all required supportive documentation with the request. This includes relevant genetic testing (e.g., IHC or MSI results when applicable), chart notes, labs/test results, prior therapy records, and any other clinical information supporting the requested use (disease stage, prior therapy, performance status, concurrent agents with doses/schedules). The prescriber must complete the attestation and sign and date the form.

Include genetic testing results (e.g., IHC, MSI) when applicable
Attach chart notes, labs, and prior therapy documentation
Provide disease stage, performance status, prior and concurrent therapies with doses/schedules
Prescriber attestation, signature, and date required

Denial Risk

Missing supportive documentation — risk of non-approval

Requests submitted without the required supportive documentation (testing results, chart notes, labs, prior therapy documentation, and signed prescriber attestation) may not be approved. Ensure all checklist items on the form are completed and attachments included to avoid denial or delay.

Incomplete requests or missing attachments may not be approved
Ensure checklist items are completed and attachments uploaded or faxed with the form

Medication Acquisition and Administration Site

Note

Specify medication obtainment and administration site; consider least intensive setting

Indicate on the form where the medication will be obtained and where it will be administered (options include Accredo Specialty Pharmacy, hospital outpatient, prescriber’s office stock, retail, home health/home infusion, etc.). Some Cigna plans require infusion in the least intensive medically appropriate setting and the form asks whether the patient is a candidate for redirection to a lower-acuity setting.

Select pharmacy/source (e.g., Accredo Specialty Pharmacy) and administration site (patient’s home, physician’s office, hospital outpatient, other).
If applicable, respond to the question about redirection to an alternate, less intensive setting and provide medical necessity rationale.

Drug and Documentation Definitions

Opdivo Qvantig — definition

Drug name (commercial and components)Opdivo Qvantig (nivolumab; hyaluronidase)

FormulationSubcutaneous formulation of nivolumab combined with hyaluronidase

Drug classImmune checkpoint inhibitor (anti-PD-1 monoclonal antibody)

Common uses (per form)Multiple oncology indications listed on the request checklist (e.g., melanoma, NSCLC, RCC, urothelial carcinoma, colorectal cancer and others)

Supportive documentation — required evidence

Required attachmentsSupportive documentation such as genetic testing, chart notes, and lab/test results must be attached with the request

IV formulation documentationForm asks whether patient has tried and cannot take IV nivolumab and, if not, whether the patient is unable to obtain IV access

Biomarker testing examplesIHC or MSI testing for CRC/SBA with results options including dMMR/MSI-H or pMMR/MSI-low or MSI-stable

Prior therapy and disease status evidenceDocumentation of prior chemotherapy regimens, progression on prior therapy, metastatic/unresectable status, or recurrence as prompted by specific diagnoses must be provided

Provider attestationPrescriber attestation/signature and supporting records may be required for review and audits (supportive documentation must accompany answers)

Background and Purpose

Opdivo Qvantig is the subcutaneous formulation of nivolumab combined with hyaluronidase. The prior authorization form is used to document the patient’s diagnosis (selected from listed tumor types or specified), prior therapies and disease status (including progression, metastatic or unresectable disease), and relevant biomarker testing. The form explicitly requires attaching supportive documentation such as genetic testing, chart notes, and lab/test results and collects indication-specific prior therapy and progression information to support coverage determinations.

Policy Summary

PayerCigna

PolicyOpdivo Qvantig prior authorization form (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization using the form (fax to (855) 840-1678) with medication details, directions, quantity, duration, J-code/ICD-10 and required supporting documentation.

SourceLink

On This Page

OpenPayer

Opdivo Qvantig (nivolumab; hyaluronidase) prior authorization form

Coverage Criteria and Indication Requirements

Initial Formulation and Trial Requirements

Prior Therapies / Progression Documentation

Administrative Identifiers and Billing Codes

Submission Instructions, Documentation, and Attestations

Medication Acquisition and Administration Site

Drug and Documentation Definitions

Background and Purpose