ModifiedmhnPolicy CP.PHAR.121

Nivolumab (Opdivo) and Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig) coverage

Defines medical necessity, provider documentation, and approval criteria for coverage of nivolumab (Opdivo) and nivolumab/hyaluronidase-nvhy (Opdivo Qvantig) across multiple oncologic indications for health plans affiliated with Centene (Commercial, HIM, Medicaid). Applies to prescribers and payers reviewing prior authorization requests.

Policy Summary

Payermhn

PolicyNivolumab (Opdivo) and Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig) coverage

Policy CodePolicy CP.PHAR.121

Change TypeMultiple clinical and coding updates (added indications, revised HCC criteria, added SC product and HCPCS)

Effective DateAug 1, 2015

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, oncologist prescriber (or consultation), age, required biomarker status, prior therapies and regimen-specific dosing to support coverage.

SourceLink

POLICY UPDATE CHANGES

Criteria were added for first‑line use in ESCC in combination with ipilimumab (Yervoy) or with fluoropyrimidine‑ and platinum‑containing chemotherapy; FDA‑approved indications updated.

HCC criteria revised: added options for prior use of atezolizumab+bevacizumab or durvalumab (Imfinzi) and removed prior checkpoint‑inhibitor exclusion per NCCN guidance.

Opdivo Qvantig (SC formulation) was added to the policy with pediatric extensions and new dosing strengths; HCPCS J9289 was added.

Maximum durations and dose limits were updated (e.g., neoadjuvant cycles increased from 3 to 4; maximum durations for adjuvant and metastatic settings defined).

Multiple off‑label indications per NCCN compendium were added or updated (e.g., bone, CNS, pediatric indications, mesothelioma, Kaposi sarcoma, various rare tumors).

MultipleFDA indications

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Coverage Criteria and Indication-specific Rules

Initial Therapy — Melanoma

Covered when ALL of the following are met:

Melanoma initial criteria: 1) Diagnosis of melanoma meeting one of: a) unresectable or metastatic; b) resected stage IIB, IIC, III, or IV; c) resectable stage III or limited local satellite/in‑transit or nodal recurrence (off‑label). 2) Prescribed by or in consultation with an oncologist. 3) Age ≥ 12 years. 4) If Opdivo Qvantig: member weight ≥ 30 kg AND prescribed as a single agent. 5) If Opdivo: prescribed as a single agent OR in combination with Yervoy (ipilimumab) — prior authorization for Yervoy may be required. 6) Request meets one of: a) dose does not exceed the maximum indicated regimen in section V (see Appendix E for dose rounding); OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

From Initial Approval Criteria - Melanoma

Initial Therapy — Non‑Small Cell Lung Cancer

Covered when ALL of the following are met (resectable, recurrent, advanced, or metastatic NSCLC):

NSCLC general: 1) Diagnosis of resectable, recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC). 2) Prescribed by or in consultation with an oncologist. 3) Age ≥ 18 years. 4) Member has not previously progressed on a PD‑1/PD‑L1 inhibitor (e.g., pembrolizumab, atezolizumab, durvalumab).

General requirements

Resectable NSCLC regimens: For resectable NSCLC both must be met: a) Prescribed as either i) neoadjuvant treatment with platinum‑doublet chemotherapy for up to 4 cycles; OR ii) adjuvant single‑agent following neoadjuvant platinum‑doublet chemotherapy AND disease mutation status negative for EGFR and ALK; AND b) tumors ≥ 4 cm OR node‑positive disease.tumors ≥ 4 cm or node positive

Resectable pathway

Recurrent/advanced/metastatic NSCLC regimens: For recurrent/advanced/metastatic NSCLC: a) single‑agent use when disease has progressed on or after systemic therapy; OR b) Opdivo in combination with Yervoy when: i) disease mutation status is unknown or negative for EGFR/ALK/ROS1/BRAF/MET exon 14/RET and member has not received prior systemic therapy for advanced disease; OR ii) disease mutation positive and member has received mutation‑specific treatment; OR iii) disease positive for a RET rearrangement; AND ii) either PD‑L1 tumor expression ≥ 1% OR Opdivo is being used in combination with Yervoy ± a platinum‑based regimen.PD‑L1 ≥ 1% for some pathways

Advanced disease pathway

Dose limits: Request must meet one of: a) dose does not exceed the maximum indicated regimen in section V (see Appendix E for dose rounding); OR b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN. Prior authorization may be required for Yervoy.

Dose and regimen requirement

Initial Therapy — Malignant Pleural Mesothelioma

Covered when ALL of the following are met:

Mesothelioma general: 1) Diagnosis of malignant pleural mesothelioma. 2) Prescribed by or in consultation with an oncologist. 3) Age ≥ 18 years.

General requirements

Opdivo regimen options: For Opdivo: a) first‑line in combination with Yervoy; OR b) if not given first‑line, as subsequent therapy in combination with Yervoy or as a single agent (off‑label). Prior authorization may be required for Yervoy.

Opdivo use pathways

Opdivo Qvantig: For Opdivo Qvantig: prescribed as subsequent therapy as a single agent (off‑label).

Qvantig pathway

Dose constraints: Request meets one of: a) Opdivo dose does not exceed 360 mg every 3 weeks; OR b) dose is within FDA maximum limit for any FDA‑approved indication OR supported by practice guidelines/peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Malignant Pleural Mesothelioma — Initial/Continuation