Coverage Policies

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Effective Date: 04/01/2015 Title: Opdivo (Nivolumab)
Revision Date: 04/01/2019 Document: BI480:00
CPT Code(s): J9299
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Opdivo (Nivolumab) requires prior authorization.

2)    Opdivo is used to treat a number of different types of cancer.

Medical Statement

Opdivo (Nivolumab) is considered medically necessary for patients with:


1.    Unresectable or metastatic melanoma as a single-agent or in combination with Yervoy (ipilimumab)

2.    Metastatic squamous non-small cell lung cancer (NSCLC) who have experienced progression on or after platinum-based chemotherapy with a performance status of 0-2;

3.    Kidney cancer (clear cell) as subsequent therapy as a single agent for relapse or for surgically unresectable stage IV disease with predominant clear cell histology that progressed on prior tyrosine kinase inhibitor therapy. Opdivo may also be used as first line treatment for advanced renal cell cancer in combination with Yervoy (ipilimumab);

4.    Very advanced and recurrent/persistent head and neck cancer if disease progression experienced on or after platinum-containing chemotherapy;

5.    Classical Hodgkin Lymphoma age 18 years and older;

6.    Small cell lung cancer (SCLC) with a performance status of 0-2 who have relapsed within 6 months following complete or partial response with initial treatment or for primary progressive disease;

7.    Unresectable advanced or metastatic colon or rectal cancer;

8.    Locally advanced or metastatic bladder cancer;

9.    Hepatocellular cancer.

QualChoice considers Opdivo experimental and investigational for all other indications, including the following (not an all-inclusive list):

§  Breast cancer;

§  Cervical cancer;

§  Gastric cancer;

§  Glioblastoma;

§  Non-Hodgkin lymphoma;

§  Ovarian cancer;

§  Pancreatic cancer;

§  Prostate cancer;

§  Sarcomatoid carcinoma of the lung;

§  Sarcomas (e.g., Ewing`s family of tumors, osteosarcoma, rhabdomyosarcoma, and soft tissue sarcomas).

Codes Used in this BI:

J9299 – Injection, Nivolumab, 1mg (Opdivo) effective 1/01/2016


1.    Opdivo Prescribing Information.  Bristol Myers Squibb.  March 2019.

2.    NCCN Compendium.  Accessed online 02-04-2019.

3.    Clinical Pharmacology.  Accessed online 02-04-2019.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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