EmblemHealth Opdivo Qvantig Coverage & Prior Auth

Coverage Criteria for Opdivo Qvantig

Universal criteria (Initial)

Covered when ALL of the following universal criteria are met:

Universal eligibility: Patient is at least 18 years of age; AND patient has not received prior PD-1/PD-L1-directed therapy unless otherwise specified (switch-therapy with IV nivolumab is an exception); AND therapy will not be used concomitantly with intravenous nivolumab; AND IV formulation must be used for patients <80 kg, for patients requiring the 900 mg/15,000 units dose, or when used in combination with ipilimumab.

Universal prior-therapy and formulation requirements

Urothelial carcinoma (bladder) initial criteria

Urothelial Carcinoma — Covered when ALL of the following are met:

Urothelial single-agent or combination: Used as a single agent AND (disease progressed during or following platinum-containing chemotherapy OR progression within 12 months of neoadjuvant/adjuvant platinum regimen) OR used as adjuvant therapy in patients at high risk for recurrence after surgical resection; OR used in combination with cisplatin and gemcitabine as first-line therapy for unresectable or metastatic disease.

High risk defined by ypT2-ypT4a or ypN+ after neoadjuvant cisplatin, or pT3-pT4a or pN+ if no neoadjuvant cisplatin and ineligible/refused adjuvant cisplatin

Colorectal cancer (MSI-H/dMMR) criteria

Colorectal Cancer (CRC) — Covered when ALL of the following are met:

CRC MSI-H/dMMR: Patient has MSI-H/dMMR disease as determined by an FDA-approved or CLIA-compliant test; AND used as a single agent; AND used as subsequent therapy for metastatic disease; AND patient has disease progression following treatment with a fluoropyrimidine, oxaliplatin and irinotecan regimen.

Biomarker (MSI-H/dMMR) required per FDA/CLIA testing

Gastric/Esophageal/GEJ cancer criteria

Gastric/Esophageal/GEJ cancers — Covered when ALL of the following apply (indication-dependent branches):

Adjuvant after neoadjuvant CRT: Used as adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease after neoadjuvant chemoradiotherapy (single-agent use).

Adjuvant duration limits apply per regimen

Subsequent therapy or combination: Used as subsequent therapy after prior fluoropyrimidine- and platinum-based chemotherapy for unresectable advanced, recurrent, or metastatic ESCC; OR used in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line therapy for unresectable, advanced or metastatic ESCC, gastric, GEJ, or esophageal adenocarcinomas.

Combination regimens may have maximum combined-duration limits (up to 2 years)

SCCHN criteria

Head and Neck Squamous Cell Carcinoma (SCCHN) — Covered when ALL are met:

SCCHN: Used as single-agent therapy; AND patient has metastatic disease with disease progression on or after platinum-based therapy; AND disease is not of the nasopharynx.

HCC criteria

Hepatocellular Carcinoma (HCC) — Covered when ALL are met:

HCC: Used as a single agent; AND patient was previously treated with sorafenib following treatment with nivolumab/ipilimumab.

RCC criteria

Renal Cell Carcinoma (RCC) — Covered when ANY of the following applies:

RCC single-agent: Used as single agent for first-line therapy in intermediate or poor risk disease following prior treatment with nivolumab and ipilimumab combination therapy; OR used as subsequent therapy after prior anti-angiogenic therapy.

RCC with cabozantinib: Used in combination with cabozantinib (Cabometyx) as first-line therapy for advanced disease.

Combination dosing and maximum duration (up to 2 years) apply

Cutaneous melanoma criteria

Cutaneous Melanoma — Covered when ANY of the following applies:

Melanoma first-line or subsequent: Used as single-agent therapy as first-line treatment for unresectable or metastatic disease; OR used as subsequent therapy after prior nivolumab/ipilimumab combination therapy; OR used as adjuvant treatment for stage IIB, IIC, stage III or metastatic disease after complete resection.

Adjuvant therapy limited to up to 1 year

NSCLC criteria

Non-Small Cell Lung Cancer (NSCLC) — Covered when criteria below are met:

NSCLC single-agent metastatic: Used as single-agent therapy for metastatic disease AND used as subsequent therapy on or after platinum-based chemotherapy (patients with EGFR or ALK aberrations should have progressed on targeted therapies first).

NSCLC neoadjuvant/adjuvant: Used in combination with platinum-doublet chemotherapy as neoadjuvant therapy in resectable tumors ≥4 cm or node positive disease OR used as neoadjuvant with option to continue as adjuvant single-agent Opdivo Qvantig after surgery; maximum of 12 months (13 cycles) for neoadjuvant/adjuvant treatment.12 months / 13 cycles

See length limits

Indication- and regimen-specific coverage

Coverage for Opdivo Qvantig is indication- and regimen-specific and is covered when dosing and duration align with the listed indication-specific regimens and notes.

General coverage conditions: Agent must be administered subcutaneously by a healthcare professional in the abdomen or thigh; dosing must follow indication-specific schedules; maximum durations for adjuvant settings (typically up to 1 year) and NSCLC perioperative therapy (up to 13 cycles/12 months) must be respected.

Opdivo Qvantig has different administration instructions than IV nivolumab; for certain 900 mg regimens IV product is preferred to avoid wastage.

Covered dosing regimens by indication

Examples of indication-specific dosing (covered when matching the listed regimen):

Renal cell carcinoma: 600 mg every 2 weeks or 1,200 mg every 4 weeks; or same doses with cabozantinib 40 mg daily in combination, up to a maximum of 2 years when combined; until progression or unacceptable toxicity for metastatic disease.

Melanoma: 600 mg every 2 weeks or 1,200 mg every 4 weeks until progression or unacceptable toxicity; adjuvant therapy up to 1 year.

NSCLC - Neoadjuvant/Adjuvant: 900 mg with platinum-doublet chemotherapy every 3 weeks for 3 cycles (neoadjuvant), then single-agent 1,200 mg every 4 weeks after surgery for up to 13 cycles (adjuvant), not to exceed 12 months/13 cycles. Patients may re-initiate PD-directed therapy if relapse occurs ≥ 6 months after discontinuation.

Metastatic NSCLC: 600 mg every 2 weeks or 1,200 mg every 4 weeks until progression or unacceptable toxicity.

Therapy with Opdivo Qvantig must not be used concomitantly with intravenous nivolumab. Additionally, the policy requires use of the IV nivolumab formulation rather than the subcutaneous Opdivo Qvantig in the following situations: for patients weighing <80 kg; for patients who require the 900 mg / 15,000 units dose; or when nivolumab is being given in combination with ipilimumab. These formulation and weight-based rules are part of the universal coverage criteria and must be documented with the prior authorization request.

The policy notes that the 900 mg / 15,000 units dosing appears in the prescribing information but specifies that the IV formulation of nivolumab should be used instead of Opdivo Qvantig for those regimens to avoid product wastage. Opdivo Qvantig is a subcutaneous product with different dosing and administration instructions than IV nivolumab; when a 900 mg regimen is clinically selected, providers should choose IV nivolumab per the policy guidance to prevent unnecessary wastage and to align with billing/administration expectations.

Use of Opdivo Qvantig in patients who do not meet the policy's prior PD-1/PD-L1 therapy restriction or the formulation/weight criteria (for example, prior exposure to a PD-1/PD-L1 agent when not allowed by a given indication, or when the IV formulation is required by weight or dosing) may be considered not medically necessary. If a provider requests Opdivo Qvantig outside those restrictions, the submission should include clear clinical justification and supporting documentation for review; lack of such documentation may result in denial.

Opdivo Qvantig is for subcutaneous administration only and must be given in the abdomen or thigh. It is intended to be administered by a healthcare professional over 3–5 minutes. Administration via intravenous routes or other injection sites is inconsistent with the product instructions and is not supported by the policy.

Covered Regimens and Combination Therapies

Indication	Permitted combination / setting	Coverage status
Urothelial carcinoma (first-line unresectable or metastatic)
900 mg every 3 weeks with cisplatin + gemcitabine (same day) for up to 6 cycles; then maintenance per listed single-agent dosing
Renal cell carcinoma (advanced, first-line)
In combination with cabozantinib 40 mg once daily as first-line therapy for advanced disease; dosing per regimen (600 mg q2w or 1,200 mg q4w)
Non‑small cell lung cancer (neoadjuvant)
900 mg every 3 weeks with platinum-doublet chemotherapy (same day) for 3 cycles as neoadjuvant therapy; may continue as adjuvant single-agent after surgery

Dose option (mg)	Schedule / typical use	Duration / limits
600 mg
Every 2 weeks (600 mg/10,000 units) — used as single-agent dosing for multiple indications including RCC, melanoma, metastatic NSCLC, SCCHN, urothelial carcinoma, HCC, gastric/GEJ/esophageal when not combined
Until disease progression or unacceptable toxicity (or up to 1 year for adjuvant indications)
1,200 mg
Every 4 weeks (1,200 mg/20,000 units) — alternative single-agent schedule for multiple indications
Until disease progression or unacceptable toxicity (or up to 1 year for adjuvant indications); HCPCS max units per dose 1,200 mg/20,000 units
900 mg
Every 3 weeks (900 mg/15,000 units) when given in combination with chemotherapy (e.g., platinum-doublet for NSCLC neoadjuvant; cisplatin + gemcitabine for first-line urothelial; 900 mg q3w with fluoropyrimidine- and platinum-containing chemo for gastric/GEJ/esophageal)
Combination regimens: generally limited to up to 2 years when given with chemotherapy for select indications; specific neoadjuvant/adjuvant NSCLC course is 3 cycles neoadjuvant then adjuvant single-agent up to 13 cycles (≤12 months)

Line of Therapy Specifications

first-line | second-line | salvage

First-line: Policy specifies first-line use in some indications (e.g., urothelial carcinoma in combination with cisplatin/gemcitabine; RCC with cabozantinib; melanoma first-line; NSCLC neoadjuvant when combined with chemotherapy).

Indication-specific

Subsequent therapy: Multiple indications specify use as subsequent therapy after defined prior regimens (e.g., CRC after fluoropyrimidine/oxaliplatin/irinotecan; NSCLC after platinum chemotherapy; melanoma after prior nivolumab/ipilimumab).

Indication-specific

first-line | adjuvant | neoadjuvant

Neoadjuvant NSCLC: 900 mg with platinum-doublet every 3 weeks for 3 cycles (given same day).

Biomarker and Test Requirements

MSI-H/dMMR — Determined by FDA-approved or CLIA-compliant test

MSI-H/dMMR requirementMSI-H/dMMR disease must be determined by an FDA-approved or CLIA-compliant test.

Indication tied to CRC coverageRequired for coverage of Opdivo Qvantig as single-agent subsequent therapy for metastatic colorectal cancer.

Prior therapy contextPatient must have progressed after fluoropyrimidine, oxaliplatin and irinotecan regimen to qualify under CRC criteria.

MSI/MMR status — biomarker detail and test citation

MSI/MMR status roleMSI/MMR status may guide re-initiation decisions; tumors that convert from MSS to MSI-H on re‑biopsy can permit re-initiation of PD-directed therapy and are evaluated case-by-case.

Documentation

Coding, Dosing Units, and Identifiers

Dosing Limits (Medical Benefit) - HCPCS UnitsHCPCSCovered

Max Units

1,200 mg/20,000 units every 4 weeks (per dose maximum and unit rule)

Applicable Procedure CodesHCPCS

J9999	Not otherwise classified, antineoplastic drugs
C9399	Unclassified drugs or biologics (hospital outpatient use only)

Applicable NDCsNDC

00003-6120-xx

Opdivo Qvantig single-dose vial providing 600 mg nivolumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL)

ICD-10 Diagnoses — Covered/Applicable DiagnosesICD-10Covered

C00.0	Malignant neoplasm of external upper lip
C00.1	Malignant neoplasm of external lower lip
C00.2	Malignant neoplasm of external lip, unspecified
C00.3	Malignant neoplasm of upper lip, inner aspect
C00.4	Malignant neoplasm of lower lip, inner aspect
C00.5	Malignant neoplasm of lip, unspecified, inner aspect
C00.6	Malignant neoplasm of commissure of lip, unspecified
C00.8	Malignant neoplasm of overlapping sites of lip
C00.9	Malignant neoplasm of lip, unspecified
C01	Malignant neoplasm of base of tongue

1–10 of 184

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Dosing frequency and maximum number of doses — schedules and maximum cumulative limits (examples every 3 or 4 weeks; up to 1 year etc.)

Dosing frequency examplesEvery 3 weeks — up to 35 doses; Every 4 weeks — up to 13 doses (1 year) or up to 26 doses (2 years)

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required. The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria. Requests missing required clinical documentation cannot be properly reviewed and will be denied or pended until information is received.

Submit clinical records, relevant pathology and imaging reports, prior treatment history, and rationale for selected route/regimen.
Requests without submitted clinical documentation will not be able to be properly reviewed.

Documentation Required

Documentation — What to Submit

Required clinical documentation must be provided with the prior authorization request to support medical necessity and appropriate dosing/route selection.

Indication for therapy (e.g., NSCLC neoadjuvant/adjuvant, RCC, melanoma, urothelial carcinoma).

Background and Scope

Background: Opdivo Qvantig is a fixed-dose, subcutaneous co-formulation of nivolumab and hyaluronidase-nvhy intended for administration by a healthcare professional. It has different dosage and administration instructions than intravenous nivolumab products, is given subcutaneously in the abdomen or thigh over approximately 3–5 minutes, and is indicated across multiple adult solid tumor types when the specific indication and dosing criteria in the policy are met.

Definitions

Opdivo Qvantig definition — PD-1 blocking antibody combined with hyaluronidase-nvhy

DefinitionOpdivo Qvantig is a programmed death receptor-1 (PD-1) blocking antibody (nivolumab) combined with hyaluronidase-nvhy.

Therapeutic classPD-1 blocking antibody (nivolumab) co-formulated with an endoglycosidase (hyaluronidase-nvhy).

Indications (summary)Indicated for multiple adult solid tumor types including colorectal, NSCLC, melanoma, RCC, urothelial, HCC, esophageal/gastric/GEJ, and head & neck cancers.

Opdivo Qvantig formulation details — subcutaneous formulation, administration details

FormulationOpdivo Qvantig is a subcutaneous formulation of nivolumab co-formulated with hyaluronidase-nvhy for subcutaneous use only.

Administration details

Dosing and Regimen Summary

inv-32 (cross-ref): first-line/second-line/salvage

Therapy-line mapping summary:

Mapping summary: First-line indications include select combinations (urothelial with cisplatin/gemcitabine; RCC with cabozantinib; melanoma). Subsequent-line uses are specified for metastatic disease after defined prior regimens. Neoadjuvant/adjuvant NSCLC has defined perioperative sequencing with maximum duration of 12 months (13 cycles).

See individual indication criteria for specifics

inv-33 (cross-ref): first-line/adjuvant/neoadjuvant

Therapy-line mapping summary:

Mapping summary: Neoadjuvant NSCLC: 900 mg q3w with platinum-doublet for 3 cycles; Adjuvant NSCLC: single-agent 1,200 mg q4w up to 13 cycles (≤12 months). First-line combinations follow indication-specific regimens and duration limits; adjuvant therapy generally limited to up to 1 year.

See dosing tables for full regimens

Revision History

2025-03-24policy_effectiveLatest

Policy MG.MM.PH.434 (Opdivo Qvantig coverage criteria) published/effective with comprehensive indication- and regimen-specific coverage criteria, dosing schedules (600 mg q2w, 1,200 mg q4w, 900 mg q3w), authorization length (initial 6 months) and administration requirements (subcutaneous abdomen or thigh); material changes: none (no clinical policy statement changes).

2024-12-01reference_update

Opdivo Qvantig package insert (December 2024) was added to the policy references to support dosing and administration guidance for subcutaneous nivolumab with hyaluronidase-nvhy.

OpenPayer

Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Coverage Criteria