BlueCross BlueShield of Tennessee Medical Policy Manual

Nivolumab (Intravenous)

NDC CODE(S)

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

 

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

 

00003-3734-XX Opdivo 240 MG/24 ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE))

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.  

POLICY 

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum based therapy. Patients with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.

 

RENEWAL CRITERIA
INDICATION(S) DOSAGE & ADMINISTRATION

Merkel Cell

3 mg/kg every 2 weeks

CRC

Single agent:

240 mg every 2 weeks, until disease progression or unacceptable toxicity.

In combination with ipilimumab:

3 mg/kg every 3 weeks for 4 doses, then 240 mg every 2 weeks until disease progression or unacceptable toxicity.

Anal Cancer

240 mg every 2 weeks or 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity.

Melanoma

Single agent:

240 mg every 2 weeks OR 480 mg every 4 weeks

Adjuvant single-agent treatment:

240 mg every 2 weeks or 480 mg every 4 weeks, until disease recurrence or unacceptable toxicity for up to 1 year  

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 or 480 mg every 4 weeks

NSCLC,MSI-H/dMMR cHL, CCHN, HCC and Urothelial Carcinoma

240 mg every 2 weeks or 480 mg every 4 weeks, until disease progression or unacceptable toxicity.

SCLC

Single agent:

240 mg every 2 weeks until disease

progression or unacceptable toxicity

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

Renal Cell Carcinoma

Single-agent:

240 mg every 2 weeks or 480 mg every 4 weeks, until disease progression or unacceptable toxicity.

In combination with ipilimumab:

3 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then follow single-agent regimen

CNS Metastases

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

Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following:

Weight ≥ 67 kg

• Standard dose 240 mg IV every 2 weeks OR 480 mg IV every 4 weeks

Weight is 53 kg to 67 kg:

Use 200 mg IV every 2 weeks OR 400 mg IV every 4 weeks

Weight is < 53kg:

• Use 160 mg IV every 2 weeks OR 320 mg IV every 4 weeks

Note: This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed.

Adjuvant use in the treatment of melanoma patients can be authorized up to a maximum of 12 months of therapy.

Refer to DOSAGE LIMITS below

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).

SOURCES 

Lexicomp Online. (2018). AHFS DI. Nivolumab. Retrieved October 15, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, October). Nivolumab. Retrieved October 15, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Nivolumab. Retrieved October 15, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, August). Center for Drug Evaluation and Research. Opdivo™ (nivolumab) injection, for intravenous use. Retrieved October 15, 2018 from http://packageinserts.bms.com/pi/pi_opdivo.pdf. 

ORIGINAL EFFECTIVE DATE:  2/5/2015

MOST RECENT REVIEW DATE:  3/2/2019

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.

This document has been classified as public information.

 

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 1 mg

DIAGNOSIS

BILLABLE UNITS

PER UNIT TIME (days)  

Merkel Cell, Anal Carcinoma

340 BU

14 days
Melanoma (in combination with ipilimumab)

Initial: 140 BU

Followed by: 480 BU

21 days x 4 doses

28 days

Melanoma/RCC (as a single agent), NSCLC, cHL, SCCHN, MSI-H/dMMR CRC, HCC & Urothelial Carcinoma

480 BU

28 days

CRC and SCLC (as a single agent)

240 BU

14 days

CRC (in combination with ipilimumab)

Initial: 340 BU

Followed by: 240 BU

21 days x 4 doses

14 days

RCC (in combination with ipilimumab)

Initial: 340 BU

Followed by: 480 BU

21 days x 4 doses

28 days

SCLC (in combination with ipilimumab)

Initial: 340 BU

Followed by: 340 BU

21 days x 4 doses

14 days

CNS Metastases (in combination with ipilimumab)

Initial: 140 BU

Followed by: 340 BU

21 days x 4 doses

14 days