BlueCross BlueShield of Tennessee Medical Policy Manual

Infliximab-dyyb

NDC CODE(S)

00069-0809-XX - Inflectra 100MG SOLR (PFIZER U.S.)

DESCRIPTION

Infliximab-dyyb is a chimeric IgG1-kappa monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α).  It is a biosimilar agent for infliximab with the same biological activities attributed to infliximab, which include induction of proinflammatory cytokines such as IL-1 and IL-6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

Indication

Loading Doses

Maintenance Dosing

Maximum Dose & Frequency

Rheumatoid Arthritis

3 mg/kg at weeks 0, 2, & 6

3 mg/kg every 8 weeks thereafter

Up to 10 mg/kg every 4 weeks

Ankylosing Spondylitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 6 weeks thereafter

5 mg/kg every 6 weeks

Crohn’s Disease & Ulcerative Colitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 8 weeks thereafter

Up to 10 mg/kg every 8 weeks

Psoriatic Arthritis, Plaque Psoriasis, Behçet’s Uveitis

5 mg/kg at weeks 0, 2, & 6

5 mg/kg every 8 weeks thereafter

5 mg/kg every 8 weeks

Takayasu’s Arteritis

5mg/kg at weeks 0, 2, 6

5mg/kg every 8 weeks thereafter; 3 to 5mg/kg every 6 weeks as steroid-sparing agent

5 mg/kg every 8 weeks

Management of Immune Checkpoint Inhibitor Related Toxicity

 

5 mg/kg at weeks 0,2

 

N/A

 

N/A

Dose escalation (up to the maximum dose and frequency specified above) may occur upon clinical

review on a case by case basis provided that the patient has ALL or the following:

  • Shown an initial response to therapy

  • Received the three loading doses at the dose AND interval specified above

  • Received a minimum of one maintenance dose at the dose AND interval specified above

  • Responded to therapy (by treatment week 16) with subsequent loss of response

  • Dose escalation may either increase the dose OR decrease the interval provided it does not exceed ANY ONE of the following limits:

    • Dose increase by no more than 2 mg/kg

    • Interval decrease by no more than 2 weeks

Note:

  • Prior to escalating doses a patient's neutralizing IFX-antibodies should be assessed and addition of a DMARD (e.g., thiopurine or MTX), if not already on such therapy, should be considered.

  • Criteria for disease-specific response to therapy are noted in section IV. Patients with moderate to severe heart failure (NYHA Functional Class III/IV; LVEF ≤35%) should not receive doses in excess of 5 mg/kg.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

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

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, February). Infliximab. Retrieved March 9, 2018 from MICROMEDEX Healthcare Series. 

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Infliximab. Retrieved December 14, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, April). Center for Drug Evaluation and Research. INFLECTRA (infliximab-dyyb) for injection, for intravenous use. Retrieved December 14, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf. 

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE:  4/2/2019

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 = 10 mg

DIAGNOSIS

MAXIMUM UNITS

Loading Dose:

  • Rheumatoid Arthritis (RA)

  • Management of immune checkpoint inhibitor toxicity

  • All other indications

 

  • 40 billable units at weeks 0, 2, 6

  • 60 billable units at weeks 0, 2

  • 60 billable units at weeks 0, 2, 6

Maintenance Dose:

  • Rheumatoid Arthritis (RA)

  • Crohn’s Disease/Ulcerative Colitis

  • Ankylosing spondylitis

  • All other indications except management of immune checkpoint inhibitor toxicity

 

 

  • 100 billable units every 4 weeks

  • 100 billable units every 8 weeks

  • 60 billable units every 6 weeks

  • 60 billable units every 8 weeks