DraftBlue Cross Blue Shield - TennesseePolicy ID_CHS_2025b

Nivolumab (Opdivo) — Coverage Criteria

Defines covered indications, documentation requirements, and exclusions for nivolumab (Opdivo) for Blue Cross Blue Shield Tennessee members when approval criteria are met.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyNivolumab (Opdivo) — Coverage Criteria

Policy CodePolicy ID_CHS_2025b

Change TypeNo material changes

Effective DateJun 30, 2025

Next Review DateJun 30, 202619d

Key ActionSubmit prior authorization with required tumor biomarker documentation (e.g., PD-L1, MSI-H/dMMR, EGFR/ALK) where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20listed tumor types/compendial uses

multiplecovered indications listed (≥10)

6 monthstypical authorization duration

3 monthsneoadjuvant NSCLC limit

PD-L1, MSI-H, EGFR/ALKmolecular tests requested

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Coverage Criteria — Indications and Conditions

Covered Indications (FDA-approved and Compendial)

Covered when ALL of the following are met for each listed indication:

Indication match: Patient diagnosis matches an FDA‑approved indication or a compendial use listed in this policy (see tumor‑type specific entries).

See cited tumor‑type sections for detailed requirements.

Approval criteria met: All indication‑specific approval criteria are satisfied (e.g., required line of therapy, prior therapies, and biomarker results where specified).

Documentation such as prior therapy records and laboratory reports may be required.

No exclusions present: Member does not meet exclusion criteria such as documented disease progression while on a PD‑1 or PD‑L1 inhibitor, except where the policy explicitly allows a melanoma ipilimumab combination after progression on single‑agent anti‑PD‑1 therapy.

See exclusion language in chunk 19 and melanoma exception in chunks 9 and 20.

Cutaneous Melanoma

Cutaneous melanoma — Authorization of 6 months may be granted when ANY of the following apply:

Cutaneous Melanoma criteria: (1) Single agent or in combination with ipilimumab (4 doses of ipilimumab followed by nivolumab) as adjuvant treatment of stage III or IV disease after complete resection or no evidence of disease; (2) Single agent or in combination with ipilimumab for unresectable or metastatic disease; (3) Single agent as adjuvant treatment of stage IIB or IIC disease following complete resection; (4) Single agent or in combination with ipilimumab as neoadjuvant treatment of resectable disease.6 months

Ipilimumab combination is defined as 4 doses of ipilimumab followed by nivolumab as single agent.

Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer (NSCLC) — Authorization of 6 months may be granted for recurrent, advanced or metastatic disease if ONE of the following is met:

NSCLC subsequent or ipilimumab regimen: (A) No EGFR exon 19 deletions/exon 21 L858R mutations or ALK rearrangements (unless testing not feasible) and used in a regimen containing ipilimumab; (B) Used as single‑agent subsequent therapy after prior platinum‑based chemotherapy;6 months

Neoadjuvant resectable NSCLC: 6 months may be granted when conditions met; when used with platinum‑doublet chemotherapy neoadjuvant authorization may be limited to 3 months (up to 3 cycles) or up to 4 cycles followed by adjuvant nivolumab (up to 13 cycles) per policy (see chunks 5–6, 22).

Renal Cell Carcinoma

Renal Cell Carcinoma — Authorization of 6 months may be granted when ANY of the following are met:

RCC criteria: (1) Single agent for non‑clear cell histology; (2) Single agent for clear cell histology as subsequent therapy; (3) In combination with ipilimumab (4 doses followed by nivolumab) for clear cell histology; (4) In combination with cabozantinib as a first‑line option.6 months

See chunk 8 for first‑line and prior anti‑angiogenic therapy context.

Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma (cHL) — Authorization of 6 months may be granted when ANY of the following are met:

cHL criteria: (1) In combination with brentuximab vedotin or ICE for relapsed/refractory disease; (2) As single‑agent subsequent therapy for relapsed/refractory disease in heavily pretreated patients or those with decreased cardiac function; (3) Single agent for disease refractory to at least three prior lines; (4) In combination with AVD for stage III–IV disease.6 months

Policy aligns with FDA‑indicated relapsed/refractory cHL settings.

Head and Neck Cancers

Head and Neck Cancers — Authorization of 6 months may be granted when EITHER condition is met:

Head and Neck criteria: (1) Nasopharyngeal cancer in combination with cisplatin and gemcitabine for unresectable, recurrent, persistent or metastatic disease; (2) For unresectable, recurrent, persistent or metastatic head and neck disease (single‑agent use in appropriate settings per FDA/compendia).6 months

See chunk 10 for SCCHN progression on/after platinum‑based therapy context.

Urothelial Carcinoma - Bladder Cancer

Urothelial Carcinoma - Bladder Cancer — Authorization of 6 months may be granted for:

Bladder cancer criteria: (1) In combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance as first‑line therapy; (2) As single agent as subsequent therapy for stage II/locally advanced/recurrent/persistent/metastatic disease; (3) As adjuvant therapy in members at high risk of recurrence after resection.6 months

Combination then maintenance described in chunk 26–27 and dosing guidance in chunk 73.

Primary Carcinoma of the Urethra

Urothelial Carcinoma - Primary Carcinoma of the Urethra — Authorization of 6 months may be granted when:

Urethra carcinoma criteria: (1) In combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance as first‑line therapy; (2) As single agent for subsequent recurrent/locally advanced/metastatic disease; (3) As adjuvant therapy in members at high risk of recurrence after resection.6 months

See chunk 28 for urethra‑specific language.

Upper GU Tract / Urothelial Carcinoma of the Prostate

Urothelial Carcinoma - Upper GU Tract or Prostate — Authorization of 6 months may be granted when:

Upper GU/prostate urothelial criteria: (1) In combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance as first‑line therapy for metastatic disease; (2) As single agent for subsequent locally advanced/metastatic disease; (3) As adjuvant therapy in members at high risk of recurrence after resection.6 months

See chunk 29 for upper GU/prostate details.

Colorectal Cancer

Colorectal Cancer — Authorization of 6 months may be granted when ALL of the following apply:

Colorectal MSI‑H/dMMR/POLE tumors: Tumor demonstrates MSI‑H, dMMR, or POLE/POLD1 status and nivolumab is used as single agent or in combination with ipilimumab (4 doses followed by nivolumab).6 months

Includes appendiceal and anal adenocarcinomas as specified in chunk 16 and 30.

Small Bowel Adenocarcinoma

Small Bowel Adenocarcinoma — Authorization of 6 months may be granted when ALL of the following apply:

Small bowel MSI‑H/dMMR/POLE tumors: Unresectable, medically inoperable, advanced or metastatic disease with MSI‑H, dMMR, or POLE/POLD1 tumor status; used as single agent or with ipilimumab (4 doses followed by nivolumab).6 months

See chunk 31 for eligibility specifics.

Ampullary Adenocarcinoma

Ampullary Adenocarcinoma — Authorization of 6 months may be granted when ALL of the following apply:

Ampullary MSI‑H/dMMR tumors: Progressive, unresectable, or metastatic disease with MSI‑H or dMMR status and use in combination with ipilimumab (4 doses followed by nivolumab).6 months

Refer to chunk 32 for details.

Hepatocellular Carcinoma

Hepatocellular Carcinoma — Authorization of 6 months may be granted when used as:

Hepatocellular carcinoma: Single agent or in combination with ipilimumab (4 doses followed by nivolumab) for unresectable or metastatic HCC, including after prior sorafenib per FDA label.6 months

See chunk 13 for FDA and compendial context.

Uveal Melanoma

Uveal Melanoma — Authorization of 6 months may be granted when used as:

Uveal melanoma: Single agent or in combination with ipilimumab (4 doses followed by nivolumab) for unresectable or metastatic disease.6 months

See chunks 34 and 2 for indication details.

Anal Carcinoma

Anal Carcinoma — Authorization of 6 months may be granted when:

Anal carcinoma: Used as a single agent for subsequent treatment of metastatic anal carcinoma.6 months

See chunk 35 for scope.

Merkel Cell Carcinoma

Merkel Cell Carcinoma — Authorization of 6 months may be granted when ANY of the following are met:

Merkel cell criteria: (1) Neoadjuvant treatment of node‑positive disease and node‑negative locally advanced disease as single agent; (2) Metastatic disease; (3) Unresectable, recurrent, or stage IV disease when used with ipilimumab (4 doses followed by nivolumab).6 months

See chunk 36 for full settings.

CNS Brain Metastases

CNS Brain Metastases — Authorization of 6 months may be granted when EITHER condition is met:

CNS brain metastases criteria: (1) Single agent in members with PD‑L1 positive non‑small cell lung cancer; (2) Single agent or in combination with ipilimumab (4 doses followed by nivolumab) in members with melanoma.6 months

PD‑L1 positivity required for NSCLC single‑agent use (see chunk 37).

Merkel Cell Carcinoma

Covered when any of the following are met for Merkel cell carcinoma:

Merkel cell carcinoma settings: Neoadjuvant treatment of node‑positive and node‑negative locally advanced disease as single agent; metastatic disease; unresectable, recurrent, or stage IV disease when used with ipilimumab (4 doses of ipilimumab followed by nivolumab as single agent).6 months

Authorization length = 6 months.

CNS Brain Metastases

Covered when any of the following are met for CNS brain metastases:

CNS brain metastases settings: Single‑agent use in PD‑L1 positive NSCLC; single‑agent or with ipilimumab (4 doses then nivolumab) in melanoma.PD‑L1 positive for NSCLC per document

Authorization length = 6 months.

Gestational Trophoblastic Neoplasia

Covered when any of the following are met for gestational trophoblastic neoplasia:

GTN refractory disease: Single agent or in combination with ipilimumab for multiagent chemotherapy‑resistant disease when member has high‑risk disease or recurrent/progressive intermediate trophoblastic tumor (placental site or epithelioid).6 months

Authorization length = 6 months; see chunk 38.

Pleural or Peritoneal Mesothelioma

Covered when any of the following are met for pleural or peritoneal mesothelioma:

Mesothelioma settings: Subsequent therapy as single agent or with ipilimumab; or first‑line therapy in combination with ipilimumab for unresectable malignant pleural or peritoneal mesothelioma (includes pericardial and tunica vaginalis testis subtypes).6 months

See chunks 7 and 39 for first‑line ipilimumab combination indication.

Esophageal and Esophagogastric Junction Cancer

Esophageal and Esophagogastric Junction Cancer — Covered when ALL of the following are met for esophageal and EGJ cancer (various settings):

Unresectable/advanced/metastatic esophageal cancer: Not surgical candidates or unresectable locally advanced, recurrent or metastatic disease when used in combination with ipilimumab or chemotherapy or as subsequent therapy.6 months

See chunks 15 and 40.

Neoadjuvant/perioperative adenocarcinoma: Single agent or with ipilimumab for neoadjuvant or perioperative treatment of esophageal or EGJ adenocarcinoma if tumor is MSI‑H/dMMR and member is medically fit for surgery.MSI‑H/dMMR and surgical fitness

Authorization length = 6 months (see chunk 41).

Adjuvant treatment of completely resected disease with residual pathologic disease.6 months

Extranodal NK/T-Cell Lymphoma

Extranodal NK/T-cell lymphoma: Relapsed or refractory disease treated with the requested medication.6 months

Authorization length = 6 months (see chunk 42).

Endometrial Carcinoma

Endometrial carcinoma: Subsequent treatment of recurrent or metastatic MSI‑H/dMMR endometrial carcinoma as single agent.MSI‑H/dMMR; 6 months

See chunk 43.

Vulvar Cancer

Vulvar cancer: HPV‑related advanced, recurrent, or metastatic vulvar cancer as subsequent single‑agent therapy.6 months

See chunk 44.

Gastric Cancer

Gastric Cancer — Covered when any of the following are met for gastric cancer:

Neoadjuvant/perioperative MSI‑H/dMMR gastric adenocarcinoma: Single agent or with ipilimumab for neoadjuvant/perioperative treatment if tumor is MSI‑H/dMMR and member is medically fit for surgery.MSI‑H/dMMR and surgical fitness; 6 months

See chunk 45 and 63.

Unresectable/recurrent/metastatic gastric disease: Single agent or with ipilimumab or with chemotherapy for members not surgical candidates or with unresectable/recurrent/metastatic disease.6 months

See chunk 45.

Early stage MSI‑H/dMMR post‑endoscopic resection: In combination with ipilimumab for early stage MSI‑H/dMMR tumors after completed endoscopic resection.MSI‑H/dMMR; 6 months

Small Cell Lung Cancer

Small cell lung cancer: Subsequent treatment of relapsed or progressive small cell lung cancer as a single agent.6 months

See chunk 46.

Cervical Cancer

Cervical cancer: Subsequent treatment of recurrent or metastatic cervical cancer as a single agent if PD‑L1 positive (combined positive score [CPS] ≥ 1).PD‑L1 CPS ≥ 1; 6 months

See chunk 47.

Pediatric Diffuse High-Grade Gliomas

Pediatric diffuse high‑grade gliomas: Hypermutant tumor pediatric diffuse high‑grade glioma as adjuvant treatment or for recurrent/progressive disease.6 months

Pediatric dosing and age thresholds referenced in chunk 73.

Primary Mediastinal Large B-Cell Lymphoma

Primary mediastinal large B‑cell lymphoma: Relapsed or refractory disease as single agent or in combination with brentuximab vedotin.6 months

See chunk 49 for context and chunk 73 for pediatric dosing entries if applicable.

Kaposi Sarcoma

Kaposi sarcoma: Subsequent treatment of relapsed/refractory classic Kaposi Sarcoma as single agent or in combination with ipilimumab.6 months

See chunk 50.

Bone Cancer

Bone cancer (unresectable/metastatic): Used in combination with ipilimumab when disease has progressed following prior treatment, no satisfactory alternative treatment options exist, and tumor is TMB‑H (≥ 10 mut/Mb).TMB‑H ≥ 10 mut/Mb; 6 months

See chunk 51 for TMB requirement and prior progression condition.

Biliary Tract Cancers

Biliary tract cancers: Combination with ipilimumab for unresectable or R2 resected or metastatic disease that is TMB‑H; or neoadjuvant treatment of resectable locoregionally advanced gallbladder cancer that is TMB‑H.TMB‑H; 6 months

See chunk 52 for neoadjuvant and other setting durations.

Soft Tissue Sarcoma

Soft tissue sarcoma: In combination with ipilimumab for angiosarcoma; single agent or with ipilimumab for extremity/body wall, head/neck, retroperitoneal/intra‑abdominal sarcomas and rhabdomyosarcoma.6 months

See chunk 53.

Anaplastic Thyroid Carcinoma

Anaplastic thyroid carcinoma: Stage IVC anaplastic thyroid carcinoma as single agent.6 months

See chunk 54.

Histologic (Richter) transformation to DLBCL

Richter transformation to DLBCL: Histologic (Richter) transformation to diffuse large B‑cell lymphoma as single agent or in combination with ibrutinib.6 months

See chunk 55.

Anaplastic Thyroid Carcinoma

Covered when ALL of the following are met for anaplastic thyroid carcinoma:

Anaplastic Thyroid Carcinoma reauthorization: Authorization of 6 months may be granted as a single agent for treatment of stage IVC anaplastic thyroid carcinoma.6 months

Single agent; stage IVC per chunk 54.

Histologic (Richter) transformation to DLBCL

Covered when ALL of the following are met for Richter transformation:

Histologic (Richter) transformation: Authorization of 6 months may be granted for treatment of Richter transformation to diffuse large B‑cell lymphoma as a single agent or in combination with ibrutinib.6 months

See chunk 55.

Vaginal Cancer

Covered when ALL of the following are met for vaginal cancer:

Vaginal Cancer subsequent therapy: Authorization of 6 months may be granted as subsequent therapy for recurrent or metastatic vaginal cancer when used as a single agent.6 months

See chunk 56.

Squamous Cell Skin Cancer

Covered when ALL of the following are met for squamous cell skin cancer:

Initial/continued treatment: Authorization of 6 months may be granted as a single agent for locally advanced, unresectable, inoperable, incompletely resected, recurrent or metastatic squamous cell carcinoma when curative surgery and curative radiation are not feasible.6 months

May be authorized up to 24 months total for continued treatment when criteria are met (see chunks 57 and 65).

Reauthorization: Authorization of 6 months may be granted (up to 24 months total) for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.6 months; up to 24 months total

See chunk 65 for reauthorization limits.

Adjuvant treatment of melanoma

Covered when ALL of the following are met for adjuvant melanoma:

Adjuvant melanoma continuation: Authorization of 6 months may be granted (up to 12 months total) for continued adjuvant treatment in members requesting reauthorization who have not experienced disease recurrence or unacceptable toxicity.6 months (up to 12 months total)

See chunk 58.

Urothelial carcinoma

Covered when ALL of the following are met for urothelial carcinoma:

Urothelial carcinoma options: (1) Authorization of 6 months may be granted (up to 12 months total) for continued adjuvant treatment when no recurrence or unacceptable toxicity; (2) Authorization of 6 months may be granted (up to 24 months total) when used in combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance provided no progression or unacceptable toxicity.6 months; up to 12 or 24 months total

See chunks 26 and 59 for combination/maintenance sequence.

Non-small cell lung cancer or pleural/peritoneal mesothelioma

Covered when ALL of the following are met for NSCLC or pleural/peritoneal mesothelioma:

NSCLC/mesothelioma continued treatment: Authorization of 6 months may be granted (up to 24 months total when used with ipilimumab) for continued treatment when no unacceptable toxicity or disease progression.6 months; up to 24 months with ipilimumab

Includes specified mesothelioma subtypes (see chunk 60).

Neoadjuvant resectable NSCLC: Authorization of 6 months may be granted for neoadjuvant treatment of resectable NSCLC (up to 4 cycles in combination with chemotherapy, followed by single‑agent adjuvant up to 13 cycles) when there is no evidence of unacceptable toxicity or disease progression.neoadjuvant up to 4 cycles; adjuvant up to 13 cycles

See chunks 5–6 and 60.

Neoadjuvant short‑course NSCLC: Neoadjuvant treatment of resectable NSCLC may be approved for a total of 3 months of therapy (up to 3 cycles) when used with platinum‑doublet chemotherapy and there is no evidence of unacceptable toxicity or disease progression.

Renal Cell Carcinoma

Covered when ALL of the following are met for renal cell carcinoma:

Renal Cell Carcinoma continued treatment: Authorization of 6 months may be granted (up to 24 months total when used in combination with cabozantinib) for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.6 months; up to 24 months with cabozantinib

Dosing options and initial/maintenance sequences referenced in chunk 73.

Gastric, Esophageal, and Esophagogastric Junction Carcinoma

Covered when ALL of the following are met for gastric/esophageal/EGJ cancers:

Esophageal SCC unresectable: Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma as a single agent until disease progression or unacceptable toxicity.until progression or unacceptable toxicity

See chunk 62.

Esophageal SCC with ipilimumab/chemo: Authorization of 6 months may be granted in combination with ipilimumab or chemotherapy for up to 24 months.up to 24 months

See chunk 62.

Adjuvant resected esophageal/EGJ: Adjuvant treatment as a single agent for up to 12 months may be authorized.up to 12 months

Biliary Tract Cancer (with ipilimumab)

Covered when ALL of the following are met for biliary tract cancer (with ipilimumab):

Biliary tract cancer with ipilimumab: Authorization of 6 months may be granted when used in combination with ipilimumab; neoadjuvant durations of 2–6 months total and up to 24 months total for other settings are specified when there is no evidence of unacceptable toxicity or disease progression.neoadjuvant 2–6 months; other up to 24 months

Combination with ipilimumab is required for this entry (see chunk 64).

All other indications

Covered when ALL of the following are met for other indications:

Other listed indications continued treatment: Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for all other indications listed in the coverage criteria when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.6 months

Catch‑all reauthorization language; see chunk 66.

Covered Indications and Dosing

Covered indications and dosing as listed; off‑label uses require compendia or literature support per state statute

Indication entries: Each cancer type listed in the policy with the dosing regimens specified (e.g., IV 240 mg q2w, 360 mg q3w, 480 mg q4w; pediatric 3 mg/kg q2w where applicable) is covered when consistent with FDA labeling or recognized compendia and the indication‑specific criteria in this policy.

Off‑label uses require recognition in a statutorily recognized compendium or peer‑reviewed literature per chunk 75; dosing specifics in chunks 72–74.

All indications not explicitly listed in the policy are considered experimental/investigational and not medically necessary. Requests for coverage of uses outside the FDA‑approved or compendial indications described in this document should be considered non‑covered unless the clinical scenario is supported by a statutorily recognized compendium or peer‑reviewed literature per Tennessee law.

Coverage will not be provided for members who have experienced disease progression while on a PD‑1 or PD‑L1 inhibitor, except for the specific melanoma exception described (second‑line or subsequent therapy for metastatic or unresectable melanoma in combination with ipilimumab after progression on single‑agent anti‑PD‑1 therapy).

Authorization for cervical cancer requires documentation that the tumor is PD‑L1 positive with a combined positive score (CPS) ≥ 1. Requests for cervical cancer with PD‑L1 CPS < 1 do not meet the policy’s listed authorization criterion.

For certain squamous cell carcinoma indications (e.g., locally advanced or unresectable cutaneous squamous cell carcinoma), authorization is contingent on the patient being unsuitable for curative surgery and curative radiation. If curative surgery or curative radiation remains feasible, the nivolumab authorization pathway does not apply.

Off‑label uses that are not supported by a statutorily recognized compendium or peer‑reviewed medical literature may be excluded from coverage in accordance with Tennessee Code Annotated Section 56‑7‑2352. Providers must supply compendial citations or peer‑reviewed references when requesting off‑label coverage.

Indications not listed among the FDA‑approved or compendial sections of this policy are considered experimental/investigational and not medically necessary, and requests for such indications should be denied unless appropriate compendial or literature support is provided.

Continued treatment authorization will not be supported if there is evidence of disease progression or an unacceptable toxicity while the member is receiving the current nivolumab regimen. Reauthorization requires documentation demonstrating absence of progression and acceptable tolerability.

Per Tennessee statute, off‑label indications lacking recognition in a statutorily recognized compendium or absence of peer‑reviewed literature support are not eligible for coverage. Providers requesting coverage for off‑label uses must include the supporting compendial or literature citations.

Covered Regimens and Combinations

Regimen	Examples / Indications	Coverage Status
Opdivo + ipilimumab	Multiple tumor types (e.g., metastatic NSCLC, melanoma, hepatocellular carcinoma, mesothelioma) where combination ipilimumab induction (4 doses) followed by nivolumab is indicated or compendial	Covered
Opdivo + chemotherapy (platinum-doublet or fluoropyrimidine-platinum)	NSCLC neoadjuvant/adjuvant and metastatic settings; esophageal, gastric, and gastroesophageal junction cancers first-line with fluoropyrimidine- and platinum-containing chemo	Covered
Opdivo + cabozantinib	Advanced renal cell carcinoma — indicated as first-line combination with cabozantinib	Covered
Opdivo + cisplatin + gemcitabine	Unresectable or metastatic urothelial carcinoma — first-line combination for up to 6 cycles followed by nivolumab maintenance	Covered

Regimen	Typical Indications / Dosing Sequence	Coverage Status
Nivolumab + ipilimumab (induction then maintenance)	Induction: ipilimumab 4 doses followed by nivolumab monotherapy; used across multiple tumor types including cutaneous melanoma (adjuvant, neoadjuvant, unresectable/metastatic), renal cell carcinoma (clear cell), hepatocellular carcinoma, mesothelioma, Merkel cell carcinoma, CNS/melanoma brain metastases, and others per indication-specific criteria	Covered

Regimen	Indication / Notes	Coverage Status
Nivolumab + cabozantinib	Advanced renal cell carcinoma — indicated as a first-line combination; continued treatment may be authorized in 6-month increments (up to 24 months total when used with cabozantinib)	Covered

Regimen	Indication / Context	Coverage Status
Nivolumab + brentuximab vedotin	Relapsed/refractory classical Hodgkin lymphoma — combination use described as an authorized regimen for relapsed/refractory disease	Covered
Nivolumab + ICE (ifosfamide, carboplatin, etoposide)	Relapsed/refractory classical Hodgkin lymphoma — combination with ICE permitted for relapsed or refractory disease per policy criteria	Covered

Regimen / Sequence	Clinical Setting / Limits	Coverage Status
Gemcitabine + cisplatin (up to 6 cycles) → nivolumab maintenance	First-line treatment of unresectable or metastatic urothelial carcinoma: combination with gemcitabine and cisplatin for up to 6 cycles followed by nivolumab maintenance; authorization of 6 months with specified total-duration allowances per policy	Covered

Regimen	Indications / Examples	Coverage Status
Nivolumab (single-agent)	Multiple indications as single-agent therapy for subsequent or first-line settings depending on tumor type (e.g., cutaneous melanoma adjuvant, metastatic anal carcinoma, mesothelioma subsequent therapy, many MSI-H/dMMR GI tumors)	Covered
Nivolumab + ipilimumab	Combination with ipilimumab (4-dose induction then nivolumab) for multiple tumor types including melanoma, RCC, HCC, mesothelioma, Merkel cell carcinoma, small bowel/colorectal/ampullary MSI-H tumors	Covered
Nivolumab + chemotherapy	Used with platinum-doublet or fluoropyrimidine-platinum chemotherapy in NSCLC neoadjuvant/adjuvant or metastatic settings, and in esophageal/gastric/EGJ cancers per indication	Covered
Nivolumab + brentuximab vedotin	Relapsed/refractory classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma contexts per policy	Covered
Nivolumab + ibrutinib	Histologic (Richter) transformation to diffuse large B-cell lymphoma — combination with ibrutinib noted for this indication	Covered

Dosing Option	Typical Use / Age Considerations	Coverage Status
240 mg IV every 2 weeks	Common maintenance regimen for adult indications; referenced across multiple tumor types in dosing tables	Covered
480 mg IV every 4 weeks	Alternative maintenance regimen for adults; listed as a common maintenance schedule across indications	Covered
3 mg/kg (weight-based) initial/induction schedules	Weight-based and mg/kg regimens specified for initial/induction dosing and for pediatric or select adult indications (e.g., initial 3 mg/kg every 3 weeks for 4 doses)	Covered
Pediatric dosing: 3 mg/kg every 2 weeks (<18 years)	Pediatric-specific dosing distinctions noted for listed pediatric indications (e.g., pediatric diffuse high-grade gliomas, primary mediastinal large B-cell lymphoma) with weight/age thresholds described	Covered

Regimen / Schedule	Details / Variations	Coverage Status
240 mg IV every 2 weeks; 360 mg IV every 3 weeks; 480 mg IV every 4 weeks	Fixed dosing schedules listed across indications; 360 mg q3w and other fixed schedules used for neoadjuvant/adjuvant sequences in some tumor types	Covered
3 mg/kg weight-based schedules	Initial: 3 mg/kg every 3 weeks for 4 doses (example for certain indications); maintenance then switches to fixed dosing (240 mg q2w or 480 mg q4w) in many adult indications	Covered
Pediatric: <18 years — 3 mg/kg every 2 weeks	Pediatric dosing and weight thresholds provided (e.g., ≥12 years and ≥40 kg may use adult fixed dosing vs lower-weight pediatric mg/kg schedules)	Covered

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for covered indications (FDA‑approved and compendial). Indications are considered a covered benefit only when all approval criteria are met and necessary documentation is submitted.

Prior authorization durations are indication‑specific; common initial approvals are for 6 months with some indications allowed 3 months (neoadjuvant NSCLC with platinum‑doublet chemotherapy).
Coverage for off‑label uses follows Tennessee statute and requires recognition in a statutorily recognized compendium or peer‑reviewed literature.

Prior Authorization

Indication‑Specific Prior Authorization Durations

Authorization durations are typically granted for fixed intervals by indication. Common initial and reauthorization approvals are for 6 months; select neoadjuvant regimens (e.g., NSCLC with platinum‑doublet chemotherapy) may be authorized for 3 months (up to 3 cycles).

Many oncology indications (listed in the coverage criteria) receive a 6‑month authorization for initial or continued therapy.
Neoadjuvant resectable NSCLC in combination with platinum‑doublet chemotherapy: authorization of 3 months (up to 3 cycles).
Neoadjuvant resectable NSCLC with ipilimumab/chemotherapy regimens have specific cycle limits and adjuvant continuation up to stated cycle counts.

Prior Authorization

6‑Month Authorization for Indicated Oncology Uses

A prior authorization of 6 months may be granted for the requested medication when used in the specified oncology settings and combinations; many indications and reauthorizations default to 6‑month approvals unless otherwise noted.

6‑month approvals apply to multiple cancers (e.g., melanoma, renal cell carcinoma, urothelial carcinoma, colorectal MSI‑H/dMMR/POLE, small bowel adenocarcinoma, ampullary adenocarcinoma, hepatocellular carcinoma, uveal melanoma, anal carcinoma, Merkel cell carcinoma, CNS brain metastases when criteria met, and others).
Reauthorization for ongoing benefit is typically granted in 6‑month increments when there is no disease progression or unacceptable toxicity.
Some combination regimens have total duration limits (e.g., up to 24 months when used with cabozantinib for RCC; up to 24 months for certain NSCLC/ipilimumab combinations).

Documentation Required

Off‑Label Coverage Condition

Off‑label (non‑FDA) uses are covered only when consistent with Tennessee Code: the off‑label indication must be recognized in a statutorily recognized compendium or supported by published peer‑reviewed medical literature.

Providers must cite the compendium or peer‑reviewed reference supporting the off‑label use when submitting prior authorization requests.
Standard compendia include NCCN Drugs & Biologics Compendium, Drugdex, AHFS, and similar recognized sources.

Documentation Required

Required Tumor and Biomarker Documentation

Providers must submit tumor biomarker documentation where applicable to support medical necessity.

PD‑L1 tumor expression documentation is required where applicable (include assay and combined positive score [CPS] when relevant, e.g., cervical cancer CPS ≥1).
Laboratory report confirming MSI‑H, dMMR, or POLE/POLD1 tumor status is required where applicable (e.g., colorectal, small bowel, ampullary, gastric when MSI‑H/dMMR criteria apply).
Documentation of EGFR exon 19 deletions/exon 21 L858R mutations and ALK rearrangements is required for NSCLC when therapy is planned in combination with ipilimumab (absence of these alterations is a prerequisite unless testing not feasible).

Documentation Required

MSI‑H/dMMR and Surgical Fitness Documentation

When authorization depends on MSI‑H/dMMR status or surgical fitness, submit supporting documentation to confirm eligibility.

For indications conditioned on MSI‑H/dMMR (or POLE/POLD1) with curative intent (e.g., certain gastric, esophageal, colorectal, small bowel tumors), include lab reports and documentation of medical operability or inoperability as applicable.
For neoadjuvant or adjuvant settings where fitness for surgery is part of criteria, provide clinical notes documenting surgical candidacy or rationale for non‑operative management.

Prior Authorization

Biomarker Prerequisite for NSCLC with Ipilimumab

Specific biomarker prerequisites apply to NSCLC when used with ipilimumab — testing must demonstrate absence of actionable EGFR or ALK alterations unless insufficient tissue prevents testing.

Prior authorization for regimens containing ipilimumab requires documentation showing no EGFR exon 19 deletions or exon 21 L858R mutations and no ALK rearrangements, unless testing is not feasible due to insufficient tissue.
If testing cannot be performed, provide documentation explaining infeasibility (e.g., insufficient tissue sample).

Prior Authorization

Prior Progression and No Satisfactory Alternatives for Bone Cancer

For certain bone cancers, authorization in combination with ipilimumab is contingent on prior progression and lack of satisfactory alternatives; submit supporting clinical history.

Bone cancer (unresectable/metastatic) when requested in combination with ipilimumab requires documentation that disease progressed after prior treatment and that no satisfactory alternative treatments exist.
Include prior therapy history, response documentation, and rationale for no acceptable alternatives.

Prior Authorization

Combination/Sequence Note (Urothelial Carcinoma)

When combination sequencing is part of the indication (e.g., urothelial carcinoma), document regimen sequence, cycles, and planned maintenance.

Urothelial carcinoma first‑line: combination with gemcitabine and cisplatin may be authorized for up to 6 cycles followed by nivolumab maintenance — include planned number of cycles and maintenance intent.
Provide documentation of prior lines of therapy when requesting subsequent or adjuvant use and confirm absence of progression or unacceptable toxicity for reauthorization requests.

Dosing, Codes, and Key Values

Dosing regimens (no billing codes provided)mixed

NDC/CPT not specified

No explicit CPT/HCPCS/NDC codes listed in this document section; dosing and route described only.

Tumor mutation burden — numeric threshold TMB-H ≥ 10 mut/Mb

Tumor mutation burden (TMB-H) thresholdTMB-H ≥ 10 mutations/megabase (mut/Mb)

Use case exampleRequired for authorization in bone cancer and certain biliary tract cancer entries when combined with ipilimumab

Documentation neededLaboratory report confirming TMB-H status must be submitted where applicable

PD-L1 combined positive score — CPS ≥ 1 (cervical cancer requirement)

PD-L1 (Cervical cancer) thresholdCombined positive score (CPS) ≥ 1 for recurrent or metastatic cervical cancer

Evidence sourcePolicy requires PD-L1 CPS ≥ 1 as eligibility for single-agent subsequent treatment of cervical cancer

Documentation neededProvide PD-L1 tumor expression report (FDA‑approved test) when requesting authorization

Weight-based pediatric thresholds — ≥ 12 years and ≥ 40 kg vs <40 kg dosing differences

Pediatric weight/age splitFor patients ≥12 years and ≥40 kg — use adult fixed dosing (e.g., 240 mg q2w or 480 mg q4w); for patients ≥12 years and <40 kg — use weight-based pediatric dosing as specified

Example regimens (≥12 yr, ≥40 kg)240 mg IV every 2 weeks or 480 mg IV every 4 weeks (maintenance) with indicated initial schedules per tumor type

Example regimens (≥12 yr, <40 kg)3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks as listed for select indications

Age-based pediatric dosing — <18 years: 3 mg/kg every 2 weeks (selected pediatric indications)

Age-based pediatric dosing (selected indications)Patients <18 years: 3 mg/kg IV every 2 weeks for listed pediatric indications (e.g., pediatric diffuse high-grade gliomas, primary mediastinal large B‑cell lymphoma)

Route and frequencyIntravenous administration every 2 weeks for 3 mg/kg pediatric dosing

DocumentationIndication must be among listed pediatric uses and supporting documentation required for prior authorization

Line of Therapy Designations

first-line | second-line | salvage

Line‑of‑therapy distinctions: Line‑of‑therapy specification applies per indication (first‑line, neoadjuvant, adjuvant, subsequent/second‑line or salvage) as listed in each tumor‑type section; refer to dosing/regimen entries for initial versus maintenance sequences.

See chunks 4–6, 20–24, 60–63 for examples.

second-line | subsequent

Subsequent therapy: Policy specifies use as subsequent therapy in multiple indications (e.g., RCC clear cell as subsequent, bladder cancer as subsequent, anal carcinoma as subsequent), often permitting single‑agent use in later lines.

See chunks 23, 24, 26, 30, 31.

first-line | neoadjuvant | adjuvant

Adjuvant / Neoadjuvant uses: Adjuvant and neoadjuvant uses are specified for melanoma and NSCLC and other GI tumors when tumor biomarkers and surgical fitness criteria are met; neoadjuvant NSCLC with platinum‑doublet chemotherapy has a specified short‑course limit.

See chunks 20, 22, 5, 6.

first-line | subsequent

First‑line or subsequent examples: Used as first‑line in combination with ipilimumab in mesothelioma and as neoadjuvant/perioperative/adjuvant in esophageal and gastric cancers when criteria met; subsequent therapy in many tumor types as specified.

See chunks 36, 39, 45.

neoadjuvant

Neoadjuvant specifics: Neoadjuvant approvals include NSCLC and selected GI and biliary indications with specified cycle or month limits (e.g., NSCLC up to 3 months/3 cycles or up to 4 cycles followed by adjuvant therapy; biliary neoadjuvant 2–6 months).

See chunks 60, 62, 64.

first-line

First‑line dosing examples: First‑line regimens and induction sequences are specified per indication; dosing options include initial mg/kg or fixed dosing followed by maintenance schedules.

See chunks 72–74 for dosing examples.

mixed

Mixed line entries: Some indications contain mixed line‑of‑therapy entries (neoadjuvant/adjuvant/first‑line/subsequent) and should be interpreted per the specific tumor‑type criteria.

See chunk 72.

Biomarker and Testing Requirements

PD-L1 — PD-L1 ≥ 1% for one NSCLC listed indication

PD-L1 ≥ 1% entry (NSCLC)Opdivo in combination with ipilimumab is indicated for first‑line metastatic NSCLC whose tumors express PD‑L1 ≥ 1% by an FDA‑approved test

ContextThis PD‑L1 threshold applies to the NSCLC first‑line regimen when combined with ipilimumab and no EGFR/ALK aberrations

DocumentationSubmit PD‑L1 tumor expression report when requesting authorization for PD‑L1‑selected NSCLC uses

MSI-H / dMMR — biomarker requirement entries

MSI‑H / dMMR requirementMSI‑H or dMMR tumor status required for coverage in colorectal cancer, small bowel adenocarcinoma, ampullary adenocarcinoma and certain other GI tumors

Therapy contextMay be treated as single agent or in combination with ipilimumab per indication-specific entries

DocumentationLaboratory report confirming MSI‑H or dMMR status must be provided where applicable

EGFR / ALK — testing required to rule out targetable alterations

EGFR/ALK testing requirementTesting for EGFR exon 19 deletions/exon 21 L858R mutations and ALK rearrangements is required to exclude targetable alterations before use in certain NSCLC regimens (e.g., regimens containing ipilimumab), unless testing is not feasible

Referenced scenariosApplies to first‑line NSCLC regimens with ipilimumab and neoadjuvant/adjuvant NSCLC settings per policy

DocumentationProvide documentation of EGFR/ALK test results when applicable for prior authorization

PD-L1 — additional PD-L1 entries across indications

Additional PD‑L1 entriesPD‑L1 expression is required or considered where applicable across multiple indications (e.g., PD‑L1 selection for NSCLC regimens and CNS brain metastases NSCLC single‑agent use)

Cervical cancer noteCervical cancer specifically requires PD‑L1 CPS ≥ 1 for authorization (see separate CPS entry)

DocumentationPD‑L1 tumor expression reports should be submitted when indicated by the coverage criteria

MSI-H / dMMR / POLE/POLD1 — tumor genomic instability marker requirements

MSI‑H/dMMR/POLE/POLD1 markersMicrosatellite instability‑high (MSI‑H), mismatch repair deficiency (dMMR), or POLE/POLD1 mutations are required biomarkers for coverage in specified colorectal, small bowel, ampullary and other GI tumors

UsageAllows single‑agent nivolumab or nivolumab + ipilimumab per indication criteria

DocumentationSubmit laboratory confirmation of MSI‑H/dMMR or POLE/POLD1 tumor status when applicable

EGFR exon 19 deletions / exon 21 L858R mutations / ALK rearrangements — explicit genomic alterations to test for in NSCLC prior to some regimens

EGFR exon 19 / exon 21 / ALK alterations to testTesting must exclude EGFR exon 19 deletions, exon 21 L858R mutations, and ALK rearrangements before nivolumab use in certain NSCLC regimens containing ipilimumab (unless testing not feasible)

RationaleThese alterations represent targetable genomic aberrations that alter therapy selection in NSCLC

DocumentationProvide test results of EGFR exon 19/21 and ALK status for prior authorization where required

PD-L1 (CPS) — CPS ≥ 1 (cervical cancer requirement)

PD‑L1 (CPS) threshold for cervical cancerCPS ≥ 1 required for authorization of single‑agent nivolumab for recurrent or metastatic cervical cancer

Policy implicationRequests with PD‑L1 CPS < 1 do not meet the listed authorization criterion

DocumentationSubmit PD‑L1 combined positive score from an FDA‑approved test when requesting coverage

MSI-H / dMMR — MSI/dMMR biomarker specific entry

MSI‑H / dMMR entryMSI‑H or dMMR tumor status is required for coverage in applicable indications (e.g., colorectal and other MSI‑H–specified tumors)

DocumentationLaboratory report confirming MSI‑H or dMMR status must be provided for authorization

Use casesApplies to colorectal cancer, endometrial carcinoma, select gastric/esophageal neoadjuvant/perioperative settings, and others as specified

Tumor mutation burden (TMB) — TMB-H ≥ 10 mut/Mb

TMB requirement summaryTumor mutation burden‑high (TMB‑H ≥ 10 mut/Mb) is required for authorization in bone cancer and certain biliary tract cancer entries when combined with ipilimumab

DocumentationLaboratory report confirming TMB‑H status must be submitted where applicable

Policy referencesSee Bone Cancer and Biliary Tract Cancer sections for TMB‑H‑linked authorization criteria

Background and Definitions

Nivolumab (Opdivo) is a monoclonal antibody that inhibits programmed death‑1 (PD‑1), an immune checkpoint receptor. It has multiple FDA‑approved indications across tumor types — including cutaneous melanoma, non‑small cell lung cancer, renal cell carcinoma, urothelial carcinoma, MSI‑H/dMMR colorectal cancer, hepatocellular carcinoma, and others — and is used as monotherapy or in combination regimens (commonly with ipilimumab, chemotherapy, or targeted agents) depending on tumor type and line of therapy.

MSI-H / dMMR definition

MSI‑H / dMMR definitionMicrosatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) tumor status is typically confirmed by laboratory testing and required documentation for applicable indications

ApplicabilityRequired for coverage in colorectal cancer and other specified tumor types per policy

Documentation guidanceSubmit lab report confirming MSI‑H or dMMR when applicable

EGFR / ALK genomic tumor aberrations — description and relevance to testing

EGFR / ALK genomic aberrations definitionPresence of EGFR exon 19 deletions or exon 21 L858R mutations or ALK rearrangements — alterations that alter therapy selection in NSCLC

Relevance to testingDocumentation of these aberrations is required where applicable to rule out targetable alterations before certain nivolumab regimens

Testing exceptionIf testing is not feasible due to insufficient tissue, the policy allows proceeding when noted

MSI-H/dMMR/POLE/POLD1 — tumor genomic instability markers (definition)

MSI‑H/dMMR/POLE/POLD1 definitionTumor genomic instability markers including microsatellite instability‑high (MSI‑H), mismatch repair deficiency (dMMR), or polymerase epsilon/delta (POLE/POLD1) mutations — required biomarkers for certain GI and other tumor indications

Clinical impactPresence of these markers qualifies tumors for specific nivolumab coverage entries (single agent or with ipilimumab)

DocumentationLaboratory confirmation is required for authorization where these markers are listed

EGFR/ALK testing — testing required to rule out targetable alterations before certain regimens

EGFR/ALK testing requirement (definition)Testing for EGFR exon 19 deletions/exon 21 L858R mutations and ALK rearrangements is required to rule out targetable alterations before certain nivolumab‑containing regimens in NSCLC

When appliedSpecifically required before regimens containing ipilimumab and in neoadjuvant/adjuvant NSCLC entries as noted

DocumentationProvide test results unless testing not feasible due to insufficient tissue

MSI-H / dMMR / TMB-H — biomarker statuses referenced as authorization criteria

MSI‑H / dMMR / TMB‑H as authorization biomarkersMSI‑H or dMMR and TMB‑H are listed biomarker statuses referenced as authorization criteria across multiple indications (e.g., GI tumors, bone cancer, biliary tract cancers)

ImplicationPresence of these biomarker statuses is required to meet specific coverage criteria in the policy

DocumentationLaboratory confirmation should be submitted with prior authorization requests when these biomarkers are relevant

Histologic (Richter) transformation — definition entry for Richter transformation to DLBCL

Histologic (Richter) transformation definitionTransformation of chronic lymphocytic leukemia/small lymphocytic lymphoma to diffuse large B‑cell lymphoma (Richter transformation) requiring specific authorization for treatment

Therapy contextPolicy allows nivolumab as single agent or in combination with ibrutinib for Richter transformation

Authorization lengthPrior authorization of 6 months may be granted per the policy entry

Neoadjuvant — definition

Policy limitsNeoadjuvant NSCLC in combination with platinum‑doublet chemotherapy may have a 3‑month (up to 3 cycles) approval per policy

DocumentationMember must be medically fit for surgery when neoadjuvant approval is contingent on surgical candidacy

Adjuvant — definition

Policy examplesAdjuvant melanoma continuation approvals up to 12 months total and NSCLC adjuvant single‑agent up to 13 cycles are described in the policy

DocumentationAuthorization requires documentation of no disease recurrence and acceptable toxicity for reauthorization in adjuvant settings

Dosing and Administration Summary

Dosing Schedule	Indication / Notes	Coverage Status
240 mg IV q2w or 480 mg IV q4w (maintenance)	Common maintenance regimens referenced for many adult indications in the medication quantity limits and dosing tables	Covered
Initial/induction weight-based or mg/kg regimens (e.g., 1 mg/kg or 3 mg/kg schedules for induction)	Multiple initial/induction mg/kg regimens specified across indications (examples include 1 mg/kg every 3 weeks for 4 doses or 3 mg/kg every 3 weeks for 4 doses for certain indications)	Covered
Pediatric weight/age distinctions	Dosing tables differentiate pediatric patients (e.g., <18 years: 3 mg/kg q2w) and weight thresholds (≥12 years and ≥40 kg may use adult fixed dosing)	Covered

Schedule	Examples / Notes	Coverage Status
240 mg q2w	Listed as a frequent maintenance regimen across many adult indications	Covered
360 mg q3w	Included as an initial or neoadjuvant schedule for select NSCLC neoadjuvant/adjuvant sequences (e.g., 360 mg q3w for 3–4 doses) per dosing tables	Covered
480 mg q4w	Alternative maintenance schedule commonly listed across indications	Covered
3 mg/kg schedules	Weight-based 3 mg/kg initial or maintenance schedules referenced for pediatric and some adult indications	Covered
Pediatric dosing details	<18 years: 3 mg/kg every 2 weeks for listed pediatric indications; weight thresholds (≥40 kg) may permit adult fixed dosing	Covered

Revision History and References

2025-04package_insert

Opdivo (nivolumab) package insert (Bristol-Myers Squibb) dated April 2025 cited as a reference for dosing, contraindications, and monitoring.

2024-12-11compendium_access

NCCN Guidelines and other compendia (NCCN Drugs & Biologics Compendium, Lexicomp) accessed and cited to support compendia-referenced off‑label uses and dosing recommendations.

2026-06-30policy_effective_dateLatest

Policy ID_CHS_2025b effective date set to 2026-06-30 and references the package insert and standard compendia for regimen/dosing and monitoring guidance.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyNivolumab (Opdivo) — Coverage Criteria

Policy CodePolicy ID_CHS_2025b

Change TypeNo material changes

Effective DateJun 30, 2025

Next Review DateJun 30, 202619d

Key ActionSubmit prior authorization with required tumor biomarker documentation (e.g., PD-L1, MSI-H/dMMR, EGFR/ALK) where applicable.

SourceLink

On This Page

See chunk 14 for adjuvant FDA indication; authorization length = 6 months.

Induction for dysphagia: Induction therapy for relieving dysphagia in combination with ipilimumab or chemotherapy for members planned for esophagectomy.6 months

See chunk 41 for induction language.

See chunk 45 and 63 for post‑endoscopic resection duration up to 24 months.

Early stage HER2‑negative post‑endoscopic resection: In combination with chemotherapy for early stage HER2 overexpression‑negative disease after completed endoscopic resection.6 months

See chunk 45.

3 months/up to 3 cycles

See chunk 22 and 60 for explicit 3‑month limit.

Gastric/EGJ/Esophageal adenocarcinoma with chemo: Authorization of 6 months may be granted in combination with chemotherapy for up to 24 months.up to 24 months

See chunk 62 and 63 for post‑endoscopic resection up to 24 months.

Post‑endoscopic resection gastric cancer: Gastric cancer in members who have completed endoscopic resection may be authorized for up to 24 months.up to 24 months

See chunk 63.