BlueCross BlueShield of Tennessee Medical Policy Manual

Nivolumab

NDC CODE(S)

00003-3772-XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S.)

 

00003-3774-XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB U.S.)

DESCRIPTION

Nivolumab is a human monoclonal antibody classified as an IgG4 kappa immunoglobulin.  It blocks the interaction with PD-1, programmed death receptor-1, and its ligands PD-L1 and PD-L2.  When the PD-1 receptor found on T-cells binds with its ligands, T-cell proliferation and cytokine production is inhibited.  Some tumors cause increased production of PD-1 ligands and can contribute to the inhibition of active T-cell immune surveillance of tumors. Nivolumab releases pathway-mediated inhibition of the immune response, including the anti-tumor immune response, which results in decreased tumor growth.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION

Classical Hodgkin Lymphoma, Colorectal cancer and SCCHN

3 mg/kg every 2 weeks

Melanoma

Single agent:

240 mg every 2 weeks

 

In combination with ipilimumab:

1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 240 mg every 2 weeks

NSCLC, RCC, Urothelial Carcinoma

240 mg every 2 weeks

SCLC

Single agent:

3 mg/kg every 2 weeks

 

In combination with ipilimumab:

1 mg/kg to 3 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of nivolumab for the treatment or prevention of other conditions or diseases.

SOURCES

Lexicomp Online. (2017). AHFS DI. Nivolumab. Retrieved July 18, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, June). Nivolumab. Retrieved July 18, 2017 from MICROMEDEX Healthcare Series. 

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Nivolumab. Retrieved July 18, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Opdivo™ (nivolumab) injection, for intravenous use. Retrieved August 14, 2017 from http://packageinserts.bms.com/pi/pi_opdivo.pdf.     

ORIGINAL EFFECTIVE DATE:  2/5/2015

MOST RECENT REVIEW DATE:  9/12/2017

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Nivolumab (Opdivo®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #12

  1. Does the individual have a diagnosis of urothelial carcinoma (bladder cancer) that is ALL of the following?

If yes, go to question #11

If no, go to question #3

  1. Does the individual have a diagnosis of Colorectal Cancer and ALL of the following?

If yes, go to question #11

If no, go to question #4

  1. Does the individual have a diagnosis of Hodgkin lymphoma classified as classical disease and requesting single agent therapy for ANY ONE of the following?

If yes, go to question #11

If no, go to question #5

  1. Does the individual have a diagnosis of melanoma with ALL of the following?

If yes, go to question #11

If no, go to question #6

  1. Does the individual have a diagnosis of malignant pleural mesothelioma with treatment that is subsequent systemic therapy of ANY ONE of the following?

If yes, go to question #11

If no, go to question #7

  1. Does the individual have a diagnosis of non-small cell lung cancer (NSCLC) with ALL of the following?

If yes, go to question #11

If no, go to question #8

  1. Does the individual have a diagnosis of renal cell carcinoma (RCC) (i.e., kidney cancer) if ALL of the following?

If yes, go to question #11

If no, go to question #9

  1. Does the individual have a diagnosis of small cell lung cancer (SCLC) with ALL of the following?

If yes, go to question #11

If no, go to question #10

  1. Does the individual have a diagnosis of squamous cell carcinoma of the head and neck (SCCHN) if ALL of the following?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 340 billable units or less every 14 days for ANY ONE of the following for an authorization period of 6 months?

INDICATION(S) DOSAGE & ADMINISTRATION

Classical Hodgkin Lymphoma, Colorectal cancer and SCCHN

3 mg/kg every 2 weeks

Melanoma

Single agent:

240 mg every 2 weeks

 

In combination with ipilimumab:

1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 240 mg every 2 weeks

NSCLC, RCC, Urothelial Carcinoma

240 mg every 2 weeks

SCLC

Single agent:

3 mg/kg every 2 weeks

 

In combination with ipilimumab:

1 mg/kg to 3 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 11?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in tumor size or tumor spread?

If yes, go to question #14

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as rash, grade 3 or 4 pneumonitis, grade 4 colitis, other immune-mediated adverse reactions, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.