Opdivo Qvantig (nivolumab biosimilar) — Coverage Criteria
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This policy describes indications, prior authorization requirements, documentation, exclusions, and authorization durations for Opdivo Qvantig for Blue Cross Blue Shield of Tennessee members. It applies to providers requesting coverage for the listed oncology indications when approval criteria are met.
No material clinical or coverage changes in this revision.
Coverage criteria by indication
Indication-specific Dosing
Advanced Renal Cell Carcinoma — Indication-specific dosing and authorization limits.
ALL of the following
- Indication: Advanced renal cell carcinoma (RCC) as described in the policy (including first-line in combination with cabozantinib; monotherapy for intermediate/poor risk after IV nivolumab + ipilimumab; monotherapy after prior anti-angiogenic therapy).
See labeled indications.
- Authorization duration: Initial authorization of 6 months may be granted. Continued treatment reauthorization may be granted in 6-month increments up to a total of 24 months when used as a single agent, provided there is no unacceptable toxicity or disease progression while on the current regimen.
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- Dosing: Use the FDA‑approved dosing and administration schedule for Opdivo Qvantig for RCC (per product labeling).
Provider must document dosing schedule consistent with labeling.
- Combination therapy: When used in combination (e.g., with cabozantinib), dosing and administration should follow the specific combination regimen in the FDA‑approved labeling; coverage limited to those combinations and settings listed in the indications.
Indication-specific Dosing
Melanoma (adjuvant and metastatic) — Indication-specific dosing and authorization limits.
ALL of the following
- Indication: Unresectable or metastatic melanoma and adjuvant treatment of completely resected Stage IIB, IIC, III, or IV melanoma, per labeled indications.
See labeled indications.
- Authorization duration: Initial authorization of 6 months may be granted for either adjuvant or unresectable/metastatic settings.
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- Dosing: Use the FDA‑approved Opdivo Qvantig dosing schedule for adjuvant and metastatic melanoma as specified in product labeling.
Provider must document dosing consistent with labeling.
- Prior therapy considerations: For patients receiving Opdivo Qvantig after IV nivolumab + ipilimumab, ensure indication alignment with labeling (monotherapy after combination therapy).
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Indication-specific Dosing
Non‑Small Cell Lung Cancer (NSCLC) — Indication-specific dosing and authorization limits.
ANY of the following
Metastatic NSCLC
- Indication: Metastatic NSCLC after progression on or after platinum‑based chemotherapy; patients with EGFR or ALK genomic tumor aberrations must have progressed on FDA‑approved targeted therapy prior to receiving Opdivo Qvantig.
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- Dosing: Use FDA‑approved monotherapy dosing for metastatic NSCLC as specified in product labeling.
Provider must document dosing consistent with labeling.
- Authorization duration: Initial authorization of 6 months may be granted.
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Neoadjuvant/Adjuvant resectable NSCLC
- Indication: Neoadjuvant treatment in combination with platinum‑doublet chemotherapy for resectable NSCLC (tumors ≥ 4 cm or node positive) followed by adjuvant monotherapy post‑resection when no EGFR mutations or ALK rearrangements are present.
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- Dosing and cycles: Neoadjuvant combination may be authorized for up to 3 months (up to 3 cycles total) when used with platinum‑based chemotherapy; combination dosing per FDA labeling. Adjuvant monotherapy may be authorized for up to 13 cycles following surgery, with overall neoadjuvant+adjuvant regimen limited per labeling.
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- Authorization duration: 6 months may be granted for neoadjuvant+adjuvant pathway (operational limits apply as above).
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Indication-specific Dosing
Squamous Cell Carcinoma of the Head and Neck — Indication-specific dosing and authorization limits.
ALL of the following
- Indication: Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum‑based therapy.
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- Dosing: Use FDA‑approved monotherapy dosing for SCCHN as specified in the product labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted when the member had disease progression on or after platinum‑based chemotherapy and has recurrent or metastatic disease.
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Indication-specific Dosing
Urothelial Carcinoma — Indication-specific dosing and authorization limits.
ANY of the following
First‑line combination
- Indication: First‑line treatment of unresectable or metastatic urothelial carcinoma (UC) in combination with cisplatin and gemcitabine.
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- Dosing: Use combination dosing per FDA‑approved labeling for Opdivo Qvantig with cisplatin and gemcitabine.
Document dosing per labeling.
- Authorization duration: Authorization of 6 months may be granted in combination with cisplatin and gemcitabine for up to 6 cycles.
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Adjuvant or subsequent therapy
- Indication: Adjuvant treatment for patients at high risk of recurrence after radical resection; or treatment of locally advanced/metastatic UC with progression during or following platinum‑containing chemotherapy or within 12 months of neoadjuvant/adjuvant platinum therapy.
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- Dosing: Use FDA‑approved monotherapy dosing for adjuvant or subsequent therapy as specified in labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted for monotherapy indications.
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Indication-specific Dosing
Microsatellite Instability‑High (MSI‑H) / dMMR Metastatic Colorectal Cancer — Indication-specific dosing and authorization limits.
ALL of the following
- Indication: MSI‑H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; includes use as monotherapy or following IV nivolumab + ipilimumab per labeled indications.
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- Dosing: Use FDA‑approved monotherapy dosing for MSI‑H/dMMR CRC as specified in product labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted for monotherapy; continuation requires evidence of clinical benefit and absence of unacceptable toxicity.
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Indication-specific Dosing
Hepatocellular Carcinoma — Indication-specific dosing and authorization limits.
ALL of the following
- Indication: HCC in adult patients previously treated with sorafenib and following treatment with IV nivolumab and ipilimumab as indicated in labeling.
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- Dosing: Use FDA‑approved monotherapy dosing for HCC per product labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted; continuation requires documentation of clinical benefit and absence of unacceptable toxicity.
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Indication-specific Dosing
Esophageal, Gastric, and Gastroesophageal Junction Cancers — Indication-specific dosing and authorization limits.
ANY of the following
Esophageal squamous cell carcinoma (ESCC) first‑line
- Indication: First‑line treatment of unresectable advanced or metastatic ESCC in combination with fluoropyrimidine‑ and platinum‑containing chemotherapy.
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- Dosing: Use combination dosing per FDA‑approved labeling for Opdivo Qvantig with fluoropyrimidine and platinum agents.
Document dosing per labeling.
- Authorization duration: Authorization of 6 months may be granted for combination first‑line therapy as specified in labeling.
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Adjuvant esophageal/GEJ after neoadjuvant CRT
- Indication: Adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease following neoadjuvant chemoradiotherapy (CRT).
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- Dosing: Use FDA‑approved monotherapy adjuvant dosing per labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted for adjuvant monotherapy in this setting.
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Unresectable advanced/recurrent/metastatic ESCC after prior chemo
- Indication: Treatment of unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine‑ and platinum‑based chemotherapy.
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- Dosing: Use FDA‑approved monotherapy dosing per labeling.
Document dosing per labeling.
- Authorization duration: Initial authorization of 6 months may be granted for monotherapy in this setting.
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Gastric/GEJ/esophageal adenocarcinoma
- Indication: In combination with fluoropyrimidine‑ and platinum‑containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
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- Dosing: Use combination dosing per FDA‑approved labeling.
Document dosing per labeling.
- Authorization duration: Authorization of 6 months may be granted for combination therapy in these indications.
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Indication-specific Dosing
General combination and labeling limitations — dosing considerations.
ALL of the following
- Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma, unresectable or metastatic melanoma, metastatic NSCLC, MSI‑H/dMMR metastatic CRC, hepatocellular carcinoma, or unresectable advanced or metastatic ESCC. Combination use with ipilimumab for these indications is therefore not covered.
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- All dosing must follow FDA‑approved labeling; off‑label dosing requests must be supported by references in recognized compendia or peer‑reviewed literature and comply with applicable state mandates.
Refer to state mandate requirements.
Initial therapy rules and requirements
Initial Therapy
applies to other indications listed in coverage criteria (chunk 33)
Initial dosing
Initial dosing examples provided in the document
from chunk 36
Reauthorization and continued therapy criteria
Reauthorization / Continued Therapy
Reauthorization rules vary by indication and are tied to absence of disease progression or unacceptable toxicity; maximum total durations are specified for some indications.
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All Other Indications (Reauthorization)
applies to other indications listed in coverage criteria (chunk 33)
What providers must submit and watch for
Prior Authorization Required
Prior authorization is required for the indications listed in this policy. Typical authorization duration is 6 months for most metastatic and adjuvant/other indications; neoadjuvant resectable NSCLC combination use may be authorized for up to 3 months (up to 3 cycles) when used with platinum-based chemotherapy.
- Prior authorization required; typical authorization = 6 months (see neoadjuvant exception below).
Authorization Required for Listed Oncology Indications
Authorization will be granted only for the oncology indications and single-agent versus combination uses specified in the policy. Requests for single-agent use must match an approved indication and dosing. Off-label uses require supporting evidence from a statutorily recognized compendium or the peer-reviewed medical literature.
- Authorization required for listed oncology indications and for single-agent use where specified.
- Off-label use must have compendia or peer-reviewed literature support (see applicable state mandate).
Coverage Requires Indication/Dosing and Compendia Support
Coverage for any requested indication or dosing must be supported by the documented indication and by one of the recognized compendia or peer-reviewed literature. Off-label requests lacking compendia support will be denied.
- Coverage requires indication/dosing match and compendia support (e.g., NCCN, Micromedex, AHFS).
- Off-label = require compendia or peer-reviewed literature support per Tennessee statute.
Denial Trigger: Prior PD-1/PD-L1 Progression
Do not authorize treatment for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy; such prior progression is a denial trigger.
- Prior PD-1/PD-L1 progression = not covered / denial trigger.
NSCLC Prior Therapy and Sequencing Relative to Targeted Therapies
For metastatic NSCLC, if the tumor harbors EGFR mutations or ALK rearrangements, the member must have documented disease progression on FDA‑approved targeted therapy for those aberrations prior to receiving this therapy. Additionally, the member must have had disease progression on or after platinum-based chemotherapy when required by the indication.
- If EGFR mutation or ALK rearrangement present → require progression on FDA‑approved targeted therapy before authorization.
- Metastatic NSCLC also requires progression on or after platinum-based chemotherapy when indicated.
NSCLC Neoadjuvant/Adjuvant Requirements and Documentation
Neoadjuvant authorization for resectable NSCLC in combination with platinum-based chemotherapy may be approved for up to 3 months (for up to 3 cycles total) only when there are no EGFR mutations or ALK rearrangements. Adjuvant use follows the neoadjuvant regimen per the policy (single-agent adjuvant for up to specified cycles). Documentation must explicitly show absence of EGFR/ALK alterations for neoadjuvant combination use.
- Neoadjuvant resectable NSCLC: up to 3 months (up to 3 cycles) when combined with platinum chemo.
- Must document no EGFR mutations or ALK rearrangements for neoadjuvant combination authorization.
- Adjuvant single-agent use follows surgical resection per policy dosing limits.
Required Documentation: Molecular and Treatment History
Submit supporting documentation with the prior authorization request: pathology and laboratory reports confirming molecular tumor status (e.g., MSI‑H/dMMR where applicable), and explicit EGFR mutation and ALK rearrangement testing results when relevant. For neoadjuvant NSCLC requests, include documentation demonstrating absence of EGFR/ALK alterations.
- Attach lab/pathology reports confirming MSI‑H/dMMR when applicable.
- Include EGFR and ALK test results; for neoadjuvant NSCLC, show absence of EGFR/ALK alterations.
State Off-Label Coverage Compliance (Tennessee)
This policy complies with Tennessee statutory requirements for off-label coverage: off-label FDA‑approved drug uses are covered only when recognized in a statutorily allowed compendium or the peer‑reviewed medical literature. Noncompliance with Tennessee Code Annotated Section 56‑7‑2352 may lead to noncoverage.
- Tennessee mandate: off-label uses require recognition in a statutorily recognized compendium or peer-reviewed literature.
- Noncompliance with state requirements may result in denial.
Reference Documentation
For regimen details, dosing schedules, contraindications, precautions, and monitoring, refer to the product package insert and standard reference compendia (e.g., NCCN, Micromedex, AHFS). Include citations or compendium excerpts with off-label requests to expedite review.
- Reference: Opdivo Qvantig package insert and NCCN, Micromedex, AHFS for dosing and monitoring.
- Provide compendium citations with off-label requests.
Provider Actions and Operational Notes
Additional provider actions: ensure prior therapies are documented in the medical record, attach progression notes for prior PD‑1/PD‑L1 or targeted therapies where applicable, and supply chemotherapy regimen details when requesting neoadjuvant combination use.
- Document prior therapies and progression notes (PD‑1/PD‑L1, EGFR/ALK targeted agents, platinum chemotherapy).
- Include chemotherapy regimen details for neoadjuvant combination requests.
Dose descriptions, pediatric tiers, and coding notes
| NDC/HCPCS not specified | Document lists Opdivo Qvantig dosing by mg-units but does not provide explicit CPT/HCPCS/NDC codes in this extract. |
| No codes listed |
Dose units and administration frequency
Approved routes and settings
Route: subcutaneous administration (office, infusion center, hospital outpatient)
Route of administration for Opdivo Qvantig dosing regimens is subcutaneous; specify intended site (office, infusion center, or hospital outpatient) when requesting authorization.
- List subcutaneous administration in the request
- Specify anticipated site of care
Office setting: route specified as subcutaneous
Specify subcutaneous administration and site of care (office) on the authorization request when Opdivo Qvantig will be given in the office setting.
- Document subcutaneous route and office as the planned site of care
Biosimilar considerations
Biosimilar substitution and sequencing relative to IV nivolumab (RCC)
When substituting Opdivo Qvantig for intravenous nivolumab (e.g., renal cell carcinoma), document compendial support and prior IV nivolumab/ipilimumab sequencing where required by the indication.
- Provide compendia citation supporting biosimilar substitution for IV nivolumab
- Document prior IV nivolumab+ipilimumab when required for specific RCC indications
Key clinical definitions used in this policy
Step therapy / sequencing requirements
| Requirement | Details |
|---|---|
| Prior targeted therapy failure when EGFR or ALK tumor aberrations are present | |
| If member has EGFR mutations or ALK rearrangements, disease must have progressed on FDA-approved targeted therapy prior to Opdivo Qvantig | |
| Member must have had disease progression on or after platinum-based chemotherapy for metastatic NSCLC |
| Neoadjuvant Combination Limitation | Policy Details / Authorization |
|---|---|
| EGFR/ALK genomic alterations | |
| Neoadjuvant combination with platinum-based chemotherapy is limited to patients without EGFR mutations or ALK rearrangements | |
| Authorization: up to 3 months (for up to 3 cycles) when used neoadjuvantly in combination; combination used up to 4 cycles then single-agent adjuvant up to 13 cycles as specified |
Background and scope
Opdivo Qvantig (nivolumab with hyaluronidase) is a subcutaneous formulation of nivolumab indicated across multiple malignancies as monotherapy or in defined combinations. Indications include advanced renal cell carcinoma, unresectable or metastatic melanoma (including adjuvant treatment of completely resected Stage IIB–IV disease), resectable NSCLC in neoadjuvant/adjuvant settings when used with platinum‑doublet chemotherapy, metastatic NSCLC after progression on platinum‑based chemotherapy, squamous cell carcinoma of the head and neck after platinum failure, urothelial carcinoma in first‑line combination settings or as single‑agent in appropriate settings, MSI‑H/dMMR metastatic colorectal cancer after prior chemotherapy, hepatocellular carcinoma following prior sorafenib and/ or prior IV nivolumab+ipilimumab per labeling, and esophageal/gastric/GEJ cancers per approved regimens. The policy defines indication‑specific authorization criteria, required documentation (e.g., molecular testing results), and typical prior authorization durations.
Policy revision history
Medical Policy Manual approved; do not implement until 6/30/26 — policy effective 2026-06-30 for Opdivo Qvantig (ID_CHS_2025_R).
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