Clinical prior authorization applies — age, diagnosis, prior therapies, biomarkers

Prior authorization review will apply clinical criteria including patient age, diagnosis-specific criteria, prior therapies (including prior anti-PD-1/PD-L1 exposure), biomarker status where specified (dMMR/MSI-H, POLE/POLD1, TMB, PD-L1), ECOG performance status, and absence of contraindicating systemic immunosuppression.

• Applies to medical benefit prior authorization and clinical review processes.
• Review includes age (use in individuals under 19 years is a specific review trigger).
• Biomarker and prior therapy information must be provided when required for the indication.

Prior authorization required — include diagnosis, line of therapy, biomarkers

Prior authorization is required and requests must include clinical information showing the diagnosis, intended line of therapy, prior treatments, ECOG performance status (when specified), and biomarker status when applicable (dMMR/MSI-H, POLE/POLD1, TMB, PD-L1).

• Policy specifies documentation of diagnosis and line of therapy for each tumor-specific criterion.
• Provide prior therapy history (e.g., prior platinum chemotherapy for NSCLC, prior anti-angiogenic regimens for RCC) when indicated.
• Include PD-L1, dMMR/MSI-H, POLE/POLD1 or TMB results when these biomarkers are required for coverage.

PA requires indication-specific documentation (diagnosis, ECOG 0–2, prior therapy, biomarkers)

Prior authorization approvals require indication-specific documentation: confirm diagnosis, current ECOG performance status 0–2 (or Karnofsky 60–100 where specified), prior therapy history per the indication, and biomarker results when applicable.

• For many indications the policy requires ECOG 0–2 as part of the approval criteria.
• Document prior exposure or absence of prior anti‑PD‑1/PD‑L1 agents as noted per indication.
• Submit laboratory/pathology reports showing dMMR/MSI‑H, POLE/POLD1, TMB, or PD‑L1 when those are part of the indication.

Prior systemic therapy requirements for NSCLC and urothelial cancer

For NSCLC and urothelial carcinoma, prior systemic therapy or documented progression on specified systemic regimens is required per the indication (e.g., progression on or after platinum-based chemotherapy for metastatic NSCLC; progression during/after platinum-containing chemotherapy or within 12 months of neoadjuvant/adjuvant platinum for urothelial carcinoma).

• NSCLC metastatic setting: progression on or after platinum-based chemotherapy; EGFR/ALK alterations must have progressed on approved targeted therapy before PD‑1 use.
• Urothelial carcinoma: progression during/after platinum-containing chemotherapy or progression within 12 months of neoadjuvant/adjuvant platinum chemo.
• Neoadjuvant/adjuvant NSCLC uses are specified separately (neoadjuvant with platinum-doublet for resectable tumors ≥4 cm or node positive).

Required prior therapies (colorectal, RCC examples)

Several indications explicitly require prior specific therapies before nivolumab coverage — e.g., metastatic colorectal cancer after progression on fluoropyrimidine, oxaliplatin, and irinotecan; RCC after one or two prior anti‑angiogenic regimens.

• Colorectal (MSI‑H/dMMR): progression following fluoropyrimidine, oxaliplatin, and irinotecan for metastatic disease.
• RCC: confirmation of disease progression after one or two prior anti‑angiogenic regimens (examples listed: axitinib, bevacizumab, pazopanib, sorafenib, sunitinib).

Step therapy added — see revision history

A step therapy requirement was added to the policy; see the policy revision history for details of the new step therapy requirement and effective dates.

• Document History entry notes: 'A new step therapy was added for use of Opdivo Qvantig.'
• Coding and policy updates are listed in the Document History (05/16/2025 entry).

Indication and guideline documentation — FDA label or NCCN support required

Documentation submitted with the PA must support the indicated FDA‑labeled use or NCCN substitution where applicable; when substituting for IV nivolumab reference the relevant NCCN 1 or 2A recommendations.

• Provide clinical notes and citations that align the requested use with an FDA indication or NCCN 1/2A recommendation for substitution.
• Package insert states Opdivo Qvantig may be substituted for intravenous nivolumab and is not indicated in combination with ipilimumab.

Supportive documentation — histology and prior therapy evidence

Supportive documentation must demonstrate histologic confirmation and specific prior therapy history when required by the indication (e.g., histologic confirmation of RCC with clear‑cell component; prior anti‑angiogenic therapy for RCC; prior platinum chemotherapy for NSCLC).

• Include pathology reports confirming histology where the indication specifies (RCC clear‑cell component).
• Provide treatment records showing prior anti‑angiogenic or platinum‑based chemotherapy when required by the tumor‑specific criteria.

Required clinical documentation — ECOG, prior PD‑1/PD‑L1 exposure, immunosuppression status

Required clinical documentation includes current ECOG performance status (0–2 or Karnofsky 60–100 where specified), explicit record of prior exposure to anti‑PD‑1/PD‑L1 agents (or confirmation of no prior exposure where required), and documentation that the patient is not receiving systemic immunosuppressant therapy for autoimmune or chronic conditions.

• ECOG 0–2 is repeatedly required across indications; record the score in clinical notes.
• Document prior anti‑PD‑1/PD‑L1 treatment history and whether the patient is currently on systemic immunosuppression (a contraindication).

Age-based review trigger — under 19 years may prompt non‑coverage

Use in individuals under 19 years of age is a specific review trigger; pediatric use may be subject to non‑coverage if the listed pediatric criteria are not met.

• Policy lists 'Individual is under 19 years of age' as a criterion for review.
• Requests for pediatric use must meet the applicable diagnosis‑specific pediatric criteria to be considered medically necessary.

Triggers for denial — prior PD‑1/PD‑L1, systemic immunosuppression, ECOG not met

Denial is likely when the patient has prior treatment with another anti‑PD‑1 or anti‑PD‑L1 agent (where the indication excludes prior checkpoint inhibitor) or when the patient is receiving systemic immunosuppressant therapy for autoimmune/chronic conditions; failure to meet ECOG performance status requirements is also a common denial trigger.

• Many indications explicitly require the patient 'has not received treatment with another anti‑PD‑1 or anti‑PD‑L1 agent.'
• Active systemic immunosuppression for autoimmune disease is repeatedly listed as exclusion/contraindication.
• ECOG performance status outside the required range (not 0–2) can render the request not medically necessary.

Disallowed combination — do not request with IV ipilimumab (Yervoy)

Opdivo Qvantig used in combination with intravenous ipilimumab (Yervoy) is not approved; requests for that combination or for indications that do not meet the policy criteria may be denied.

• Package insert and policy state Opdivo Qvantig is not indicated/approved in combination with ipilimumab.
• Policy exclusion language: 'When Opdivo Qvantig is used in combination with intravenous ipilimumab (Yervoy)' is a non‑approval condition.