CurrentmhnPolicy CP.PHAR.121

OPDIVO (PDF)

Defines medical necessity criteria, initial and continuation approval requirements, covered indications (FDA-approved and NCCN-recommended off-label), age/weight constraints for Opdivo and Opdivo Qvantig, dosing limit checks, prior authorization notes (including for concomitant agents), approval durations by line of business, and references to appendices for dosing and step therapy exceptions. Applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyOPDIVO (PDF)

Policy CodePolicy CP.PHAR.121

Change TypeMultiple additions/revisions (coding, indications, dosing, durations, state exceptions)

Effective DateAug 1, 2015

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets approval criteria and obtain prior authorization when required.

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indications and detailed initial and continuation criteria for Opdivo and Opdivo Qvantig, including age and weight constraints, combination uses, dosing ceiling checks, and NCCN-recommended off-label indications.

HCPCS code J9289 added for nivolumab/hyaluronidase-nvhy.

Multiple indication and criteria updates over 2021–2026 reflecting FDA approvals and NCCN changes (examples: NSCLC neoadjuvant/adjuvant, ESCC PD-L1 requirement with chemotherapy, MSI-H/dMMR CRC full approval, HCC updates).

Clarified maximum duration limits for neoadjuvant and adjuvant therapy (e.g., neoadjuvant NSCLC cycles increased from 3 to 4, adjuvant NSCLC max 13 cycles).

Appendix F added: states with regulations against redirections in cancer therapies.

Opdivo Qvantig (subcutaneous formulation) dosing and indications added.

Dose limit revisions for combination regimens (e.g., NSCLC with ipilimumab/Yervoy dose revisions).

Limit use of first-line combination therapy in unresectable advanced/metastatic ESCC, gastric, GEJ, and esophageal adenocarcinoma to tumors expressing PD-L1 ≥1%.

HCPCS code J9289 added.

Updated indications: conversions from accelerated approval to full approvals for CRC, HCC, and cHL in specified settings and pediatric extensions for some indications.

Appendix F updated with jurisdictional exceptions including Tennessee and Indiana.

Expanded and clarified multiple off-label and NCCN-referenced uses (e.g., appendiceal neoplasms, squamous cell skin cancer, HLRCC-associated RCC, post allo-HCT use).

Initial approval duration extended from 6 to 12 months for this maintenance medication for chronic conditions.

Step therapy bypass added for Illinois per IL HB 5395.

MultipleCovered Indications (FDA + NCCN off-label)

VariesApproval Duration (varies by LOB)

RequiredOncologist involvement

12States with redirection prohibitions (Appendix F)

J9289New HCPCS J-code added

12Initial approval months (maintenance)

Coverage Summary

Scope: This policy addresses coverage for FDA‑approved indications and selected NCCN compendium off‑label indications for nivolumab (Opdivo) and the subcutaneous nivolumab/hyaluronidase product (Opdivo Qvantig). Coverage requires that therapy be prescribed by or in consultation with an oncologist and that the prescribed regimen be an FDA‑approved regimen or a NCCN‑recommended regimen. Age, weight, and biomarker thresholds are applied per indication: Age requirements vary by indication (commonly ≥12 years for Opdivo for certain pediatric extensions and ≥18 years for many adult indications); Opdivo Qvantig has specified weight constraints (e.g., member weight ≥ 30 kg for certain Qvantig requests) and formulation‑specific dosing; and some first‑line combination uses require tumor PD‑L1 expression ≥ 1% or CPS ≥1 where noted. Dosing ceilings and maximum durations are enforced (see section V and Appendix E for dose rounding and vial selection) and Appendix F lists jurisdictions with prohibitions on redirection/step therapy exceptions.

Quick thresholds & operational facts

Age requirementsVaries by indication: commonly ≥12 years for Opdivo for many pediatric-expanded indications; many adult indications require ≥18 years

Opdivo Qvantig weight limitMember weight ≥ 30 kg required for specified Opdivo Qvantig requests (e.g., melanoma, CRC pediatric/Qvantig criteria)

PD-L1 threshold where requiredTumor PD-L1 expression ≥1% (or CPS ≥1 where specified) required for certain first-line combination settings (e.g., ESCC, gastric/GEJ, esophageal adenocarcinoma, selected NSCLC pathways)

TMB-high definitionTMB-high defined as ≥10 mutations/megabase (mut/Mb) for TMB-H sarcoma indication

Adjuvant therapy durationAdjuvant treatments generally up to 1 year (e.g., melanoma, resected esophageal/EGJ), with specific caps applied per indication

Maximum continued therapy durationsSelected metastatic/recurrent indications (e.g., metastatic NSCLC with Yervoy, malignant pleural mesothelioma, advanced RCC with Cabometyx, unresectable/metastatic UC, ESCC with chemo, gastric/EGJ, first-line HCC, unresectable/metastatic CRC) limited to up to 2 years; adjuvant NSCLC capped at 13 cycles; previously untreated cHL with AVD capped at 6 cycles

Opdivo / Opdivo Qvantig dosing notes (operational)Dosing ceilings and formulation-specific schedules apply (see Section V and Appendix E dose rounding); Qvantig SC strengths and cycle specifics for neoadjuvant/adjuvant NSCLC described (neoadjuvant up to 4 cycles; adjuvant up to 13 cycles)

Coding update (HCPCS)New HCPCS code J9289 added for nivolumab/hyaluronidase‑nvhy (Opdivo Qvantig); J9299 remains for nivolumab 1 mg

Approval duration (initial auth)Initial authorization timeframe extended to 12 months for maintenance/chronic medication for Medicaid/HIM (commercial policies vary per line of business)

Initial Therapy Criteria (by Indication)

I. Initial Approval Criteria - Melanoma

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Diagnosis of unresectable or metastatic melanoma OR completely resected Stage IIB or IIC melanoma (as applicable to FDA indication).
ONE of
- Opdivo (intravenous nivolumab) for patients age ≥ 12 years when FDA-approved for the melanoma indication described.
- Opdivo Qvantig (nivolumab/hyaluronidase-nvhy) for patients age ≥ 12 years when FDA-approved for the melanoma indication described.

Continuation Therapy Criteria

II. Continued Therapy - Other diagnoses/indications

If NOT addressed elsewhere:

Continued Therapy - Other diagnoses/indications: If drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to corresponding formulary/no coverage or non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16); If requested use is NOT specifically listed under section III and above does not apply, refer to the off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Unproven / Exclusions

Diagnoses/Indications NOT authorized

Non-FDA approved indications are not addressed in this policy unless off-label use policy criteria met:

Diagnoses/Indications NOT authorized (off-label policy reference): Non-FDA approved indications are not covered under this policy unless there is sufficient documentation of efficacy and safety according to the off-label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid) or evidence of coverage documents.

Applicable Codes

HCPCS Codes (informational)HCPCS

J9299	Injection, nivolumab, 1 mg
J9289	Injection, nivolumab, 2 mg and hyaluronidase-nvhy

HCPCS / J-code additions mentionedHCPCS

J9289

HCPCS code added for nivolumab/hyaluronidase-nvhy (Opdivo Qvantig) per coding implications/revision log

Referenced related drugs (prior auth may be required)mixed

Yervoy	ipilimumab - prior authorization may be required when used in combination
Cabometyx	cabozantinib - referenced as combination partner for RCC; prior auth may be required
Adcetris	brentuximab vedotin - referenced for combinations in cHL and other indications
Loqtorzi	toripalimab - referenced for nasopharyngeal carcinoma step therapy failure/redirection
Tevimbra	tislelizumab - referenced for redirection/step therapy in ESCC and gastric/GEJ adenocarcinoma
Sutent	sunitinib - referenced as combination option for dedifferentiated chondrosarcoma; prior auth may be required
Imbruvica	ibrutinib - referenced for combination use in CLL/SLL; prior auth may be required

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required per clinical policy

Submit documentation to support that the requested use meets the clinical policy criteria. Include history, prior treatments, line of therapy, dosing schedule, and any relevant pathology or imaging reports.

Reference: Appendix E (supporting clinical documentation)
Include prior treatment details and dates

Documentation Required

Evidence for off-label dosing or indications

Appropriate documentation must be provided for any off-label dosing or indications requested. Clearly state the rationale, supporting literature, and dosing calculations used when deviating from FDA-approved regimens.

Reference: Appendix F (off-label evidence requirements)

Clinical Evidence & References

Evidence summary: Primary references informing the policy are the Opdivo Prescribing Information (March 2026), the Opdivo Qvantig Prescribing Information (November 2025), and the NCCN Drugs & Biologics Compendium. Indications and criteria in the policy reflect recent label conversions (examples: accelerated approvals converted to full approvals for CRC, HCC, cHL), pediatric age expansions, addition of the Opdivo Qvantig subcutaneous formulation and strengths, and off‑label NCCN‑supported uses incorporated by plan P&T decisions. These sources and P&T updates are the basis for the Coverage Determinations / Indication‑Specific Criteria and the revision notes summarized in the policy.

Background & Definitions

Background: Opdivo (nivolumab) is a programmed death receptor‑1 (PD‑1) blocking monoclonal antibody; Opdivo Qvantig is a subcutaneous formulation of nivolumab co‑formulated with hyaluronidase. Product availability and unit strengths are specified in the definitions and product availability sections (Opdivo vials: 40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL, 240 mg/24 mL; Opdivo Qvantig unit doses: 300 mg/5,000 units and 600 mg/10,000 units, with additional 900 mg/15,000 and 1,200 mg/20,000 unit regimens described). Dose rounding and vial selection guidance are provided in Appendix E (see weight‑based vial recommendations) and Appendix F lists states with prohibitions on redirection/step therapy.

Definitions

AVDDoxorubicin, vinblastine, dacarbazine (chemotherapy combination)

CPSCombined Positive Score for PD-L1 tumor expression (used with CPS ≥1 thresholds)

MSI-HMicrosatellite instability-high; molecular biomarker qualifying tumors for immunotherapy per policy

dMMRMismatch repair deficient; molecular biomarker qualifying tumors for immunotherapy per policy

Coverage Determinations / Indication-Specific Summary (from Revisions)

Coverage Determinations / Indication‑Specific Criteria — summary and revision highlights: The policy enforces indication‑specific clinical criteria and documents multiple recent revisions: (1) restriction of certain first‑line combination regimens (e.g., unresectable advanced/metastatic ESCC, gastric, GEJ, and esophageal adenocarcinoma combined with chemotherapy) to tumors with PD‑L1 ≥ 1%; (2) addition of Opdivo Qvantig subcutaneous formulation and indication‑specific dosing strengths and pediatric weight/age allowances; (3) operational coding update adding HCPCS J9289 for the nivolumab/hyaluronidase product; (4) expansion of covered off‑label NCCN compendium uses (multiple tumor types added per P&T/NCCN); (5) updates to duration and dosing limits including specific maximum continued therapy durations (e.g., adjuvant durations up to 1 year, many metastatic or recurrent indications up to 2 years, specified cycle limits such as 13 cycles for adjuvant NSCLC and defined neoadjuvant cycle limits); (6) inclusion of state‑specific appendices and redirection/step therapy exceptions (Appendix F) and an Illinois step therapy bypass per IL HB 5395; and (7) operational and PI‑driven dose revisions (examples: weight‑ and fixed‑dose conversions and regimen ceiling changes). This block functions as a high‑level clinical changelog summarizing the policy decisions and coverage changes without duplicating the document‑level timeline.

Revision History

11.2025addition

Opdivo Qvantig prescribing information published (Nov 2025) with subcutaneous formulation dosing strengths (300 mg/5,000 units; 600 mg/10,000 units; 1,200 mg/20,000 units) and indications for multiple tumor types including CRC and HCC.

06.2025coding_addition

HCPCS code J9289 added for nivolumab/hyaluronidase-nvhy (Opdivo Qvantig) to recognize the new product for billing.

03.2026pi_update

Opdivo Prescribing Information updated (March 2026) reflecting conversions from accelerated to full approvals, pediatric expansions, and other indication-specific PI changes referenced in policy.

Policy Summary

Payermhn

PolicyOPDIVO (PDF)

Policy CodePolicy CP.PHAR.121

Change TypeMultiple additions/revisions (coding, indications, dosing, durations, state exceptions)

Effective DateAug 1, 2015

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets approval criteria and obtain prior authorization when required.

SourceLink

On This Page

If treatment is as combination with ipilimumab, documentation of intended combination regimen per FDA labeling (including dosing and sequence) is required.

Dose and schedule consistent with FDA-approved regimen or compendia-supported regimen; do not exceed labeled dose limits.

I. Initial Approval Criteria - Non-Small Cell Lung Cancer (NSCLC)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Indication specific
- Resectable NSCLC (tumors ≥ 4 cm or node positive) in the neoadjuvant setting in combination with platinum-doublet chemotherapy, followed by single-agent adjuvant Opdivo or Opdivo Qvantig per FDA-approved regimen.
- Metastatic NSCLC with PD-L1 ≥ 1% by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, where Opdivo (or Opdivo Qvantig if FDA-approved for that scenario) is being used per FDA labeling.
- Metastatic or recurrent NSCLC with progression on or after platinum-based chemotherapy; patients with EGFR or ALK aberrations must have disease progression on FDA-approved targeted therapy prior to receiving Opdivo/Opdivo Qvantig.
- First-line metastatic NSCLC in combination with ipilimumab (and chemotherapy where indicated) per FDA-approved regimen and tumor genomic/PD-L1 requirements as described in labeling.
Dose and schedule must follow FDA-approved regimen; adhere to labeled dose limits and maximum cumulative dose where specified.

I. Initial Approval Criteria - Malignant Pleural Mesothelioma

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Diagnosis of unresectable malignant pleural mesothelioma as first-line treatment per FDA-approved indication.
Use consistent with FDA-approved regimen and dose limits.

I. Initial Approval Criteria - Renal Cell Carcinoma (RCC)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
ONE of
- Advanced (including metastatic) renal cell carcinoma (RCC) per FDA labeling as monotherapy or in combination (e.g., with ipilimumab) where indicated; includes first-line use for intermediate or poor risk patients when per labeling.
- Use following prior combination nivolumab + ipilimumab when indicated per FDA labeling (including when Opdivo Qvantig is specifically authorized by labeling for post‑combination maintenance).
Dose and schedule consistent with FDA-approved regimen; adhere to labeled dose limits.

I. Initial Approval Criteria - Classical Hodgkin Lymphoma (cHL)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
ONE of
- Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and other agents per FDA-approved regimen for patients age ≥ 12 years where indicated.
- Relapsed or refractory cHL after autologous HSCT and brentuximab vedotin, or after ≥ 3 lines of systemic therapy that included autologous HSCT, per FDA-approved indication for nivolumab.
Dose and schedule consistent with FDA labeling; adhere to age limits (≥ 12 years where specified).

I. Initial Approval Criteria - Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
Use consistent with FDA-approved dosing and schedule; Opdivo Qvantig may be authorized when FDA labeling permits.

I. Initial Approval Criteria - Urothelial Carcinoma (UC)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
ONE of
- Adjuvant treatment of adult patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection, per FDA indication.
- Unresectable or metastatic UC as first-line in combination with cisplatin and gemcitabine where FDA approved, or for locally advanced or metastatic UC with progression during or following platinum-containing chemotherapy or progression within 12 months of neoadjuvant/adjuvant platinum, per labeling.
Dose and schedule consistent with FDA-approved regimen; adhere to labeled dose limits.

I. Initial Approval Criteria - Hepatocellular Carcinoma (HCC)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Hepatocellular carcinoma (HCC) per FDA-approved indications: first-line treatment in combination with ipilimumab where indicated, use following prior combination nivolumab + ipilimumab where specified, or for patients previously treated with sorafenib as labeled.
Dose and schedule consistent with FDA-approved regimen and product-specific authorization (Opdivo vs Opdivo Qvantig) as applicable.

I. Initial Approval Criteria - Esophageal Cancer (including ESCC and EGJ)

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Adjuvant treatment of adult patients with completely resected esophageal or gastroesophageal junction (EGJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy (CRT), per FDA labeling.
Dose and schedule consistent with FDA-approved regimen; adhere to labeled limits.

I. Initial Approval Criteria - Gastric, GEJ, and Esophageal Adenocarcinoma

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma per FDA-approved indications (including as adjuvant or first-line combinations with chemotherapy or ipilimumab where specified).
Dose and schedule consistent with FDA-approved regimen; adhere to labeled dose limits.

I. Initial Approval Criteria - Off-Label NCCN Compendium Recommended Indications

Covered when ALL of the following criteria are met:

ALL of the following

Prescribed by an oncologist.
Off‑label uses that are recommended by the NCCN Compendium may be considered when documentation supports the specific NCCN-recommended indication and regimen.
Dose, schedule, and patient eligibility must match the NCCN Compendium recommendation; provide supporting documentation from the NCCN Compendium citation.

III. Diagnoses/Indications NOT authorized

Not authorized (NOT covered) for the following diagnoses/indications:

ANY of the following

Diagnoses or uses not listed in FDA-approved indications or supported by the NCCN Compendium for nivolumab/Opdivo or Opdivo Qvantig.
Use in settings where safety or efficacy has not been established per FDA labeling or guideline support.

Coverage Determinations / Indication-Specific Criteria

Coverage determinations are made per indication-specific criteria listed above. Additional general requirements apply:

ALL of the following

Prescriber is an oncologist (documented in the medical record).
Therapy must follow FDA-approved dosing, schedule, and maximum dose limits unless an evidence-based exception is documented (e.g., NCCN recommendation).
When PD-L1 expression or MSI-H/dMMR status is required by the FDA indication, documentation of testing results (including test name and value, e.g., PD-L1 ≥ 1%, or MSI-H/dMMR positive) must be submitted.
For indications requiring prior lines of therapy (e.g., progression after platinum chemotherapy, prior autologous HSCT and brentuximab vedotin, prior sorafenib), documentation of prior therapies and dates is required.
Quantity limits: do not exceed the FDA-labeled dose and frequency; document weight-based dosing calculations when applicable.

Provide literature citations or guidelines supporting the off-label regimen

Documentation Required

Document PD-L1 and molecular status

Document PD-L1 expression and relevant molecular status (e.g., EGFR, ALK, MSI/MMR) when required by the indication to establish appropriateness of therapy.

Include test name, result, and date of testing
Attach pathology or molecular report

Documentation Required

Off-label use documentation

Off-label use must be documented with clinical justification and citations. Requests for indications that are non-covered should be identified to prevent inappropriate approvals.

Include detailed clinical rationale and supporting references
If indication is not supported by evidence, deny per policy

Denial Risk

Non-covered indications

Non-covered indications — therapies requested for indications not supported by this policy or lacking adequate evidence may be denied. Examples include uses outside listed FDA-approved or evidence-supported indications.

See policy 'Not Medically Necessary' criteria for specifics
Denial may be issued if documentation does not meet criteria

Billing Rule

Dose limit verification

Verify dose limits and maximum permitted quantity before authorization. Requests exceeding policy dose limits require explicit justification and supportive evidence.

Confirm mg/kg or flat dosing matches policy limits
Document weight used for mg/kg calculations

Billing Rule

HCPCS code usage

Use the appropriate HCPCS J-code when billing. Submissions should reference the correct code for nivolumab product formulation to ensure proper processing.

Use J9289 or J9299 as applicable for nivolumab formulations
Include NDC and vial size on claim when available

Billing Rule

Use appropriate HCPCS J-code

Use the appropriate HCPCS J-code for the billed formulation and route. Incorrect J-code selection may lead to claim denials or processing delays.

J9289 — nivolumab, specify per policy when applicable
J9299 — product-specific when applicable

Documentation Required

Dose rounding / vial selection

When documenting dose rounding or vial selection, show calculations used for rounding, expected waste, and rationale for vial sizes chosen to minimize waste and align with dosing policy.

Provide patient weight and per-dose mg required
Document chosen vial sizes and expected leftover (waste)

Step Therapy

Step therapy exceptions and state-specific rules

Step therapy exceptions apply as specified by state law or payer-specific rules. Document attempts of required first-line therapies or provide justification for bypass when requesting an exception.

If a step is bypassed, include clinical rationale and supporting records
Reference state-specific rules (e.g., IL HB 5395) where applicable

Step Therapy

Step therapy / bypass per state law

Some states mandate step therapy bypass or have specific requirements for prior authorization. Ensure compliance with applicable state statutes when processing exceptions.

Follow state law for step therapy/bypass (e.g., IL HB 5395)
Document attempts and outcomes of required step agents

Prior Authorization

Approval duration requirement

Authorizations are issued for a defined duration. Ensure documentation supports the requested approval length and include plan for monitoring and reauthorization when applicable.

Include requested approval duration and clinical rationale
Follow policy-specified approval durations for initial and continuation therapy

Opdivo QvantigSubcutaneous formulation of nivolumab co-formulated with hyaluronidase (nivolumab/hyaluronidase‑nvhy) available in unit doses (300 mg/5,000 units and 600 mg/10,000 units)

RedirectionPolicy term referring to directing patients to alternative cancer therapies; some states prohibit step therapy/redirection for advanced/metastatic cancers (see Appendix F)

PD-L1Programmed death‑ligand 1; tumor expression quantified (percent or CPS) with threshold ≥1% used for certain indications

MSI-H/dMMRCombined label used in policy to denote microsatellite instability‑high or mismatch repair deficient tumor status which can qualify tumors for indicated immunotherapy uses

1Q2026annual_review

1Q2026 annual review: multiple policy updates including melanoma (added resectable stage III/limited local satellite/in-transit recurrence or nodal recurrence), malignant pleural mesothelioma (removed 'unresectable' requirement), RCC (added HLRCC-associated RCC), cHL (criteria changes and added post-allogeneic HCT use, added combo with Adcetris/ICE for relapsed disease), added off-label NCCN indications (appendiceal neoplasms, squamous cell skin cancer, uterine sarcoma), and jurisdictional/operational updates (see Appendix F and IL HB 5395).

operational_change

Initial approval duration for maintenance/chronic indications extended from 6 months to 12 months (applies to Medicaid/HIM standard; commercial differs per policy).

appendix_update

Appendix F added/updated listing states with regulations against redirections in cancer therapies (including FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX) and jurisdictional exceptions; IL HB 5395 added step therapy bypass for Illinois HIM.

2021-2026indication_updates

Multiple indication, dosing, and duration updates across 2021–2026 reflecting FDA approvals and NCCN compendium changes (examples include NSCLC neoadjuvant/adjuvant cycles increased to up to 4 neoadjuvant cycles and adjuvant max 13 cycles; PD-L1 ≥1% requirement for certain first-line combinations; CRC and HCC full approvals and pediatric extensions).

04.2022 / 10.2024dose_clarification

Dose limit revisions for combination regimens (e.g., NSCLC with ipilimumab revised to fixed 360 mg every 3 weeks per PI; neoadjuvant NSCLC increased from 3 cycles/9 weeks to 4 cycles/12 weeks; adjuvant NSCLC up to 13 cycles).

06.2025coverage_restriction

Revised coverage that limits first-line combination therapy in unresectable advanced/metastatic ESCC, gastric/GEJ, and esophageal adenocarcinoma to tumors expressing PD-L1 ≥1% (policy reflects PI/NCCN changes).

latestsummary_statusLatest

Policy current; includes Opdivo and Opdivo Qvantig clinical criteria, HCPCS codes (including added J9289), expanded indications/off-label NCCN uses, updated dosing and duration rules, Appendix F state redirection guidance, and IL HB 5395 step therapy bypass.