ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Opdivo (nivolumab) and Opdivo Qvantig coverage criteria

Defines accepted indications, dosing notes, substitutions, and coverage criteria for nivolumab (Opdivo) and Opdivo Qvantig across multiple tumor types for Neighborhood Health Plan of Rhode Island; applies to medication authorization and reimbursement decisions processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpdivo (nivolumab) and Opdivo Qvantig coverage criteria

Policy CodePolicy N/A

Change TypeMultiple material and non-material updates (coverage and coding)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with documentation supporting the specific indication and adherence to single-dose limits.

SourceLink

POLICY UPDATE CHANGES

Updated colorectal cancer indication to include combination nivolumab + ipilimumab for MSI-H/dMMR/POLE/POLD1 mutated unresectable, metastatic, or recurrent colorectal cancer for members 12 years and older.

Added new HCPCS code and description for nivolumab formulations.

Added use in combination with doxorubicin, vinblastine, and dacarbazine as first-line therapy for newly diagnosed, stage III-IV classical Hodgkin's Lymphoma.

Updated NSCLC neoadjuvant and adjuvant indication language specifying tumor size, EGFR/ALK negativity, and adjuvant duration.

multiplecancer indications listed

2HCPCS codes listed

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.

Coverage Criteria and Indications

Colorectal Cancer (combination and monotherapy rules)

Covered when ALL of the following are met

Colorectal Cancer - Combination: Member age >= 12 with unresectable, metastatic, or recurrent colorectal cancer AND tumor is MSI-H, dMMR, or has POLE/POLD1 mutation AND nivolumab used in combination with ipilimumab (Yervoy)

Opdivo Qvantig may be substituted for IV nivolumab except when used in combination with ipilimumab

Colorectal Cancer - Monotherapy after chemotherapy: Member age >= 12 with unresectable, metastatic, or recurrent colorectal cancer AND tumor is MSI-H, dMMR, or has POLE/POLD1 mutation AND disease progressed following treatment with a fluoropyrimidine (eg, 5‑fluorouracil or capecitabine), oxaliplatin, and irinotecan AND nivolumab used as single agent

Opdivo Qvantig may be substituted for IV nivolumab except when used in combination with ipilimumab

Esophageal carcinoma indications

Esophageal Squamous Cell Carcinoma (ESCC): Member has advanced, recurrent, or metastatic esophageal squamous cell carcinoma regardless of PD-L1 status AND one of the following: nivolumab monotherapy after progression on or after prior fluoropyrimidine- and platinum-based chemotherapy; nivolumab in combination with ipilimumab; OR nivolumab in combination with a fluoropyrimidine + platinum-containing chemotherapy as first-line treatment

When combined with ipilimumab, ipilimumab dose supported is 1 mg/kg every 6 weeks with nivolumab dosed per policy for a maximum of 2 years; when combined with chemotherapy, chemotherapy may continue until progression or unacceptable toxicity

Esophageal Adenocarcinoma: Member has advanced/metastatic esophageal adenocarcinoma with PD-L1 CPS >= 5 AND nivolumab in combination with an oxaliplatin-containing chemotherapy regimen as initial therapyPD-L1 CPS >=5

Opdivo Qvantig may be substituted for IV nivolumab except when used with ipilimumab

Post-neoadjuvant residual disease: Member with stage II or III esophageal carcinoma (squamous or adenocarcinoma) who has residual disease after neoadjuvant chemoradiotherapy and surgery AND nivolumab single-agent therapy for a total duration of 1 year1 year duration

Gastric and gastroesophageal junction cancer

Gastric / GEJ carcinoma: Member has advanced or metastatic gastric or gastroesophageal junction cancer with PD-L1 CPS >= 5 AND nivolumab in combination with an oxaliplatin-containing chemotherapy regimen (eg, FOLFOX/CapeOX) as initial therapyPD-L1 CPS >=5

Opdivo Qvantig may be substituted for IV nivolumab

Head and neck cancer

Head and neck squamous cell carcinoma: Member has recurrent or metastatic non-nasopharyngeal squamous cell carcinoma of the head and neck AND disease progressed during or after platinum-based chemotherapy AND nivolumab is being used as single-agent therapy

Opdivo Qvantig may be substituted for IV nivolumab

Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) - subsequent line: Member has unresectable or metastatic hepatocellular carcinoma AND nivolumab in combination with ipilimumab (Yervoy) as subsequent-line therapy if the member has not been previously treated with a checkpoint inhibitor

Opdivo + ipilimumab is not supported in first-line HCC per policy; Opdivo Qvantig may substitute for IV nivolumab except when combined with ipilimumab

Hodgkin lymphoma

Classical Hodgkin lymphoma: Member has classical Hodgkin lymphoma that is relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin OR has progressed after three or more prior systemic therapies AND member has not received prior immune checkpoint inhibitor therapy AND nivolumab is being used per regimen

Opdivo may be used in combination with doxorubicin, vinblastine, and dacarbazine as first-line therapy for newly diagnosed stage III–IV classical Hodgkin lymphoma (per policy history)

Malignant pleural mesothelioma

Malignant pleural mesothelioma: Member has metastatic or unresectable malignant pleural mesothelioma AND nivolumab in combination with ipilimumab as first-line or subsequent therapy (if not used previously)up to 24 months

Dosing: nivolumab 3 mg/kg (up to 360 mg) q3w or maintenance schedules 240 mg q2w or 480 mg q4w + ipilimumab 1 mg/kg q6w until progression, unacceptable toxicity, or up to 24 months

Melanoma

Melanoma: Member has recurrent or metastatic melanoma AND nivolumab as single agent OR nivolumab in combination with ipilimumab (if combination not used previously) for initial or subsequent therapy

Yervoy +/- Opdivo is not supported for adjuvant high-risk resected melanoma; ipilimumab dosing should not exceed 1 mg/kg (policy limits); Opdivo Qvantig may be substituted except when combined with ipilimumab

NSCLC

Non-small cell lung cancer (NSCLC): Member has NSCLC and meets ONE of the following: (1) Early-stage IB–IIIA with tumor >= 4 cm, EGFR and ALK negative: neoadjuvant nivolumab + platinum doublet for up to 4 cycles followed by adjuvant single-agent nivolumab for up to 13 cycles; OR (2) Recurrent/metastatic disease negative for EGFR/ALK who progressed on platinum-based chemotherapy (and no prior checkpoint inhibitor failure): single-agent nivolumab as second-line or subsequent therapy; OR (3) EGFR/ALK altered disease after progression on targeted and platinum therapy (no prior checkpoint inhibitor failure): single-agent nivolumab; OR (4) Metastatic EGFR/ALK negative with PD-L1 <1%: nivolumab + ipilimumab may be usedtumor >=4 cm where specified; EGFR/ALK negative where specified

Opdivo Qvantig may be substituted for IV nivolumab except when used with ipilimumab; ipilimumab dosing limited to 1 mg/kg q6w in some settings; combination not supported for PD-L1 >=1%

Renal cell carcinoma

Renal cell carcinoma (RCC): Member has recurrent, metastatic, or unresectable stage IV RCC AND nivolumab is being used as one of the following: first-line monotherapy; OR in combination with ipilimumab for IMDC intermediate or poor risk disease; OR in combination with cabozantinib for IMDC intermediate/poor risk; OR as subsequent single-agent therapy after progression on one or more tyrosine kinase inhibitors provided the member has not received prior immune checkpoint inhibitor therapyIMDC risk categorization applies where specified

Per policy, ipilimumab dosing and nivolumab induction/maintenance schedules provided; Opdivo Qvantig may substitute except with ipilimumab

Small cell lung cancer

Small cell lung cancer (SCLC): Single-agent nivolumab for metastatic SCLC is not supported due to FDA withdrawal of the indication and failed confirmatory trials (eg, CheckMate-451, CheckMate-331)

Refer to alternative regimens per Evolent Pathways

Renal Cell Carcinoma — subsequent single-agent therapy

Covered as subsequent therapy in renal cell carcinoma when ALL of the following are met

RCC subsequent therapy: Member has disease progression on prior therapy with one or more tyrosine kinase inhibitors (eg, sorafenib, sunitinib, cabozantinib, pazopanib) AND member has not received prior immune checkpoint inhibitor therapy AND nivolumab is intended as single-agent subsequent therapy

Opdivo Qvantig may be substituted for IV nivolumab except when used in combination with ipilimumab

Small Cell Lung Cancer

Not covered/Supported

SCLC single-agent nivolumab: Single-agent nivolumab for metastatic Small Cell Lung Cancer is not supported due to FDA withdrawal and failed confirmatory trials (eg, CheckMate-451, CheckMate-331)

Evolent recommends alternative regimens per Evolent Pathways

Urothelial Carcinoma

Covered indications for urothelial carcinoma include ANY of the following

Urothelial carcinoma criteria list: (1) Locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-based chemotherapy; (2) Adjuvant treatment for high-risk urothelial carcinoma for up to 1 year when member is not eligible for or declined cisplatin-based chemotherapy OR pathologic ypT2–ypT4 or ypNode+ after neoadjuvant cisplatin; (3) Monotherapy for high‑risk nonmuscle invasive bladder cancer (Tis with/without papillary tumors) refractory to BCG and not eligible for cystectomy; (4) In combination with cisplatin and gemcitabine for first-line unresectable or metastatic disease1 year for adjuvant use

Opdivo Qvantig may be substituted for IV nivolumab

This policy explicitly excludes several uses of nivolumab (Opdivo) and Opdivo Qvantig. Not supported are: nivolumab + ipilimumab as first-line therapy for hepatocellular carcinoma (HCC) (policy favors alternative first-line regimens and cites lack of Level 1 evidence), Yervoy (ipilimumab) with or without Opdivo as adjuvant therapy for high‑risk resected melanoma, and ipilimumab dosing of 3 mg/kg when combined with nivolumab for melanoma (policy limits ipilimumab dose with nivolumab).

Additionally, the policy excludes single-agent nivolumab for metastatic small cell lung cancer (SCLC) because the FDA indication was withdrawn and confirmatory trials failed to show survival benefit. The policy also identifies investigational or off‑label uses lacking adequate evidence and specific regimen representation as excluded (see investigational/off‑label criteria for evidence thresholds).

Use of Opdivo (nivolumab) or Opdivo Qvantig for investigational or off‑label indications is not supported unless the indication is backed by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature that meets the policy's evidence requirements. The policy defines sufficiency of evidence by clinical representation of the patient population and regimen, study design appropriateness, and demonstration of clinically meaningful outcomes (for example, ASCO‑style thresholds such as hazard ratio < 0.80 and survival benefit of at least 3 months for OS or PFS).

Case reports or meeting abstracts without a full peer‑reviewed article generally do not provide adequate supportive evidence; when such evidence is lacking the use is considered investigational and excluded.

The subcutaneous formulation Opdivo Qvantig (nivolumab and hyaluronidase‑nvhy) is specifically excluded from combination use with Yervoy (ipilimumab) in any cancer. Requests for Opdivo Qvantig administered together with ipilimumab will be denied per policy.

Dosing that exceeds the policy's single‑dose limits is excluded. For intravenous Opdivo (nivolumab) the single‑dose limits are 240 mg every 2 weeks, 360 mg every 3 weeks, or 480 mg every 4 weeks. For Opdivo Qvantig the single‑dose limits are 600 mg every 2 weeks, 900 mg every 3 weeks, or 1200 mg every 4 weeks. Requests for doses above these limits may be denied.

For the adjuvant treatment of melanoma, the policy excludes treatment duration beyond 12 months for Opdivo or Opdivo Qvantig. Adjuvant use exceeding a total of 12 months will not be supported.

Single‑agent nivolumab is not supported for metastatic small cell lung cancer (SCLC); this indication was withdrawn by the FDA after confirmatory trials (e.g., CheckMate‑451 and CheckMate‑331) failed to demonstrate overall survival benefit. In addition, the policy advises caution about certain combinations and dosing approaches in other tumor types (for example, ipilimumab dosing limits when used with nivolumab in melanoma and NSCLC), and those non‑supported combinations or doses are addressed elsewhere in the policy.

Because the FDA withdrew the metastatic SCLC indication and confirmatory trials did not meet primary endpoints, single‑agent Opdivo (nivolumab) for metastatic SCLC is considered not medically necessary and is not supported by this policy. Providers should follow alternative regimens recommended by Evolent Pathways for SCLC.

Accepted Regimens and Regimen Limits

Tumor type / Setting	Ipilimumab dosing (policy-constrained)	Nivolumab dosing / maintenance	Notes / Exceptions
Malignant pleural mesothelioma — first-line or subsequent (if not previously used)	1 mg/kg every 6 weeks	3 mg/kg (up to 360 mg) q3w OR 240 mg q2w OR 480 mg q4w; continue until progression, unacceptable toxicity, or up to 24 months	Opdivo Qvantig may be substituted for Opdivo EXCEPT when used with ipilimumab
Melanoma — recurrent/metastatic (combination if not used previously)	1 mg/kg every 3 weeks for a maximum of 4 cycles (policy does not support ipilimumab 3 mg/kg except specific brain mets regimen)	3 mg/kg (up to 360 mg) q3w x4 cycles followed by maintenance 240 mg q2w, 360 mg q3w, or 480 mg q4w	Adjuvant Yervoy +/- Opdivo is not supported; brain metastases regimen is a defined exception per policy notes
Esophageal carcinoma — first-line or subsequent (where combination appropriate)	1 mg/kg every 6 weeks (policy-supported dose when combined with nivolumab)	Nivolumab dosed 3 mg/kg (up to 360 mg) q3w OR 240 mg q2w OR 480 mg q4w for up to 2 years when used with ipilimumab	When combined with chemotherapy, chemo may continue until progression/toxicity; Qvantig substitution not allowed with ipilimumab
Hepatocellular carcinoma — subsequent-line (if no prior checkpoint inhibitor)	1 mg/kg (policy indicates ipilimumab limited to 1 mg/kg schedules)	Nivolumab 3 mg/kg (up to 360 mg) q3w OR 240 mg q2w OR 480 mg q4w until progression or toxicity	Combination not supported in first-line per policy; Qvantig substitution excluded with ipilimumab
Renal cell carcinoma — first-line combination or subsequent (if eligible)	1 mg/kg every 3 weeks x4 cycles (first-line combination regimen) or 1 mg/kg q6w alternative schedules per tumor notes	Nivolumab 3 mg/kg (up to 360 mg) q3w x4 cycles then maintenance 240 mg q2w, 360 mg q3w, or 480 mg q4w; single-agent maintenance until progression/toxicity	IMDC risk stratification applies for first-line use; Qvantig excluded when combined with ipilimumab

Setting	Neoadjuvant regimen	Adjuvant regimen / Duration	Eligibility notes
Early-stage NSCLC (IB-IIIA) with tumor >=4 cm	Nivolumab in combination with platinum-doublet chemotherapy for up to 4 cycles (neoadjuvant)	Single-agent nivolumab after surgery as adjuvant therapy for a maximum of 13 cycles	Tumor must be EGFR and ALK negative; neoadjuvant use regardless of PD-L1 status

Indication	Combination regimen	Line of therapy	Notes / Documentation
Unresectable or metastatic urothelial carcinoma (adult)	Opdivo (nivolumab) in combination with cisplatin and gemcitabine	First-line treatment	Use when member has unresectable or metastatic disease; documentation should support eligibility and whether member is eligible for or declined cisplatin-based chemotherapy when relevant

Indication	Regimen	Prior therapy requirement	Coverage stance
Recurrent/metastatic/unresectable stage IV renal cell carcinoma — subsequent therapy	Single-agent nivolumab	Disease progression on one or more tyrosine kinase inhibitors (e.g., sorafenib, sunitinib, cabozantinib, pazopanib); member must not have received prior checkpoint inhibitor therapy	Covered when above conditions met

Indication	Regimen	Policy position	Notes / Alternatives
Metastatic small cell lung cancer (SCLC)	Single-agent nivolumab	Not supported — indication withdrawn by FDA; confirmatory trials failed to meet OS endpoints	Refer to Evolent alternative regimens (e.g., via Evolent Pathways)

Line of Therapy Mapping

first-line

First-line uses: Tumor types and settings where nivolumab (alone, with ipilimumab, or with chemotherapy) is supported as initial therapy per tumor-specific criteria (eg, esophageal first-line combinations, gastric/GEJ with chemo if PD-L1 CPS >=5, mesothelioma first-line ipilimumab+nivolumab, RCC first-line for IMDC intermediate/poor risk)

second-line

Second-line uses: Tumor types and settings where nivolumab is supported after prior therapies (eg, colorectal after fluoropyrimidine/oxaliplatin/irinotecan; HCC subsequent-line with ipilimumab+nivolumab if no prior checkpoint inhibitor; Hodgkin lymphoma after HSCT and brentuximab or >=3 prior lines; NSCLC second-line uses)

subsequent

Subsequent-line uses:

Biomarker and Diagnostic Requirements

MSI-H / dMMR / POLE/POLD1 biomarker requirement for certain colorectal indications

Required biomarkersTumor must be MSI-H, dMMR, or have POLE/POLD1 mutation for the colorectal indication

Age rangeApproved for adult and pediatric members 12 years and older

Allowed regimensNivolumab may be used in combination with ipilimumab for unresectable, metastatic, or recurrent disease

Monotherapy allowanceNivolumab monotherapy is allowed for MSI-H/dMMR/POLE/POLD1 colorectal cancer after progression on fluoropyrimidine, oxaliplatin, and irinotecan

Formulation substitutionOpdivo Qvantig may be substituted for IV nivolumab except when used with ipilimumab

PD-L1 CPS biomarker requirement (e.g., >=5) for esophageal/gastric indications

Billing Codes and Dose Limits

HCPCS codesHCPCS

J9299

Injection, nivolumab, 1 mg

HCPCS codesHCPCS

J9289

Injection, nivolumab, 2 mg and hyaluronidase-nvhy

Opdivo single-dose limits (240 mg q2w; 360 mg q3w; 480 mg q4w)

Opdivo IV single‑dose limits240 mg every 2 weeks; 360 mg every 3 weeks; 480 mg every 4 weeks

Coding referenceHCPCS code J9299 identifies injection, nivolumab, 1 mg

Denial riskRequests exceeding the above single‑dose limits may be denied per exclusion criteria

Opdivo Qvantig single-dose limits (600 mg q2w; 900 mg q3w; 1200 mg q4w)

Opdivo Qvantig single‑dose limits600 mg every 2 weeks; 900 mg every 3 weeks; 1200 mg every 4 weeks

Coding referenceHCPCS code J9289 identifies injection, nivolumab 2 mg and hyaluronidase-nvhy

Authorization, Documentation, and Denial Risks

Prior Authorization

Authorization and continuation requirements

- Prior authorization and continuation: Evolent is responsible for processing all medication requests from network ordering providers. Prior authorization is required for requests for Opdivo or Opdivo Qvantig unless a continuation exemption applies. Continuation requests for a medication not approvable under this policy are exempt from prior authorization when ALL of the following are true: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Evolent processes all medication requests — medications not authorized by Evolent may be deemed not approvable and not reimbursable.
Continuation exemption conditions: no disease progression on requested medication; used within last year with ≤30-day lapse; no additional agents added.

Documentation Required

Evidence support requirement

- Evidence requirement: Use of Opdivo or Opdivo Qvantig must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Requests lacking such evidence may be considered investigational and excluded.

Definitions and Formulation Notes

Nivolumab (Opdivo) is an immune checkpoint inhibitor targeting the PD‑1 pathway used across multiple tumor types either as monotherapy or in combination with ipilimumab (Yervoy) or chemotherapy. The policy specifies tumor‑specific indications, dosing constraints (including single‑dose limits and ipilimumab dose caps), biomarker requirements (e.g., MSI‑H/dMMR, PD‑L1 CPS), and prior‑therapy conditions that govern authorization and reimbursement decisions.

MSI-H / dMMR / PD-L1 CPS biomarker definitions referenced in policy

MSI-H / dMMR definitionMicrosatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor status referenced as eligibility biomarkers for colorectal indications

POLE/POLD1 definitionPolymerase epsilon/delta (POLE/POLD1) mutation referenced alongside MSI-H/dMMR for colorectal eligibility

PD-L1 CPS definitionPD-L1 combined positive score (CPS) used to determine eligibility for esophageal adenocarcinoma and gastric/GEJ indications; threshold >=5

Opdivo Qvantig — subcutaneous formulation substitution rules and exceptions

Forms, Documentation, and Useful Notes

Note

RCC sequencing: single‑agent nivolumab authorized after progression on TKIs (if checkpoint‑naïve)

For renal cell carcinoma sequencing questions, note that nivolumab may be used as subsequent single‑agent therapy after progression on one or more TKIs in patients without prior checkpoint inhibitor exposure; ensure documentation of prior TKI therapy and checkpoint‑inhibitor‑naïve status when requesting authorization.

Confirm and document prior TKI agents and progression dates (e.g., sorafenib, sunitinib, cabozantinib, pazopanib).
Confirm no prior immune checkpoint inhibitor exposure.

Documentation Required

Required supporting documentation: specific indication and prior therapies must be documented

Authorization requests must include documentation that supports the specific indication and any prior therapies required by the policy (for example, prior platinum‑based chemotherapy for urothelial carcinoma or prior TKI therapy for RCC). Include dates, agents, and disease progression or response information to substantiate the request.

Provide prior therapy details (agent names, treatment dates, reason for discontinuation/progression).
For adjuvant urothelial claims, document cisplatin ineligibility or patient declination when relying on the up‑to‑1‑year adjuvant indication.

Policy Revision History

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpdivo (nivolumab) and Opdivo Qvantig coverage criteria

Policy CodePolicy N/A

Change TypeMultiple material and non-material updates (coverage and coding)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with documentation supporting the specific indication and adherence to single-dose limits.

SourceLink

On This Page

PD-L1 thresholdPD-L1 combined positive score (CPS) must be greater than or equal to 5 for esophageal adenocarcinoma and gastric/GEJ indications when used with chemotherapy

Esophageal adenocarcinoma useNivolumab may be used as initial therapy in combination with an oxaliplatin-containing chemotherapy when PD-L1 CPS >=5

Gastric/GEJ useNivolumab may be used as primary therapy with oxaliplatin-containing chemotherapy when PD-L1 CPS >=5

Duration note for post‑neoadjuvant diseaseFor stage II–III esophageal disease with residual disease after neoadjuvant chemoradiotherapy and surgery, nivolumab monotherapy total duration is 1 year

EGFR / ALK negative requirement for some NSCLC indications

Required negative markersEGFR and ALK genomic alterations must be negative/absent for specified neoadjuvant/adjuvant NSCLC uses

Neoadjuvant criterionNeoadjuvant nivolumab + platinum-doublet indicated for early stage IB-IIIA with tumor >=4 cm that is EGFR/ALK negative

Second-line/subsequent useSingle-agent nivolumab may be used as second-line/subsequent therapy in EGFR/ALK-negative NSCLC after platinum progression (unless prior checkpoint inhibitor failure)

Formulation substitutionOpdivo Qvantig may be substituted for IV nivolumab except when used with ipilimumab

Documentation Required

Indication documentation required

- Indication documentation: Documentation submitted with the request must clearly support the specific indication claimed and must include prior therapy details when required by the indication (for example, prior platinum chemotherapy, prior TKIs, prior HSCT and brentuximab for Hodgkin lymphoma, or prior checkpoint inhibitor exposure). Lack of adequate documentation to substantiate the indication or prior therapies may result in denial.

Include clinical rationale, relevant pathology/staging, prior systemic therapies with dates, and prior response/progression information as applicable.

Note

Renal cell carcinoma sequencing

- Renal cell carcinoma sequencing: For metastatic renal cell carcinoma, Opdivo may be used as subsequent single‑agent therapy after disease progression on one or more tyrosine kinase inhibitors (e.g., sorafenib, sunitinib, cabozantinib, pazopanib) provided the member has not received prior therapy with an immune checkpoint inhibitor. Opdivo Qvantig may substitute for Opdivo except when combined with Yervoy (ipilimumab).

Use as single‑agent subsequent therapy after progression on ≥1 TKI and no prior checkpoint inhibitor exposure.
Opdivo Qvantig interchangeable with Opdivo except when used with ipilimumab.

Denial Risk

Requests for medications not authorized

- Requests not authorized by Evolent: Requests for indications, combinations, durations, or dosing that are not supported by Evolent policy or the required evidence sources may be deemed not approvable and not reimbursable. Examples include investigational/off‑label uses without sufficient evidence, combinations explicitly excluded by policy, and single‑agent use in indications withdrawn by FDA.

Investigational/off‑label uses lacking CMS compendia or acceptable peer‑reviewed evidence are excluded.
Opdivo Qvantig + ipilimumab is excluded and will be denied.
Single‑agent Opdivo for metastatic small cell lung cancer is not supported (FDA withdrawal).

Denial Risk

Denial risk for dosing above single‑dose limits

- Dosing and duration denial risks: Requests that exceed the policy single‑dose limits or exceed allowed adjuvant duration will be denied. Single‑dose limits: Opdivo (nivolumab IV) — 240 mg every 2 weeks, 360 mg every 3 weeks, or 480 mg every 4 weeks (regardless of weight); Opdivo Qvantig (nivolumab + hyaluronidase) — 600 mg/10,000 units every 2 weeks, 900 mg/15,000 units every 3 weeks, or 1200 mg/20,000 units every 4 weeks. Adjuvant melanoma treatment beyond 12 months is excluded.

Opdivo single‑dose limits: 240 mg q2w; 360 mg q3w; 480 mg q4w.
Opdivo Qvantig single‑dose limits: 600 mg/10,000 units q2w; 900 mg/15,000 units q3w; 1200 mg/20,000 units q4w.
Adjuvant melanoma duration limit: ≤12 months.