BlueCross BlueShield of Tennessee Medical Policy Manual

Infliximab-abda

NDC CODE(S)

0006-4305-XX Renflexis 100 MG vial SAMSUNG BIOEPIS

DESCRIPTION

Infliximab-abda is a chimeric IgG1κ monoclonal antibody specific for human tumor necrosis factor-alpha (TNFα). It is the second biosimilar agent approved by the FDA for infliximab.  It has 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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

LOADING DOSE

MAINTENANCE DOSE

MAXIMUM DOSE

Ankylosing Spondylitis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 6 weeks thereafter

Up to 5mg/kg every 6 weeks

60 billable units

Crohn’s Disease Ulcerative Colitis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 8 weeks thereafter

Up to 10mg/kg every 8 weeks

100 billable units

Plaque Psoriasis, Psoriatic Arthritis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 8 weeks thereafter

Up to 5mg/kg every 8 weeks

60 billable units/8 weeks

Rheumatoid Arthritis

3mg/kg at weeks 0, 2, 6

40 billable units

3mg/kg every 8 weeks thereafter

Up to 10mg/kg every 4 weeks

100 billable units/4 weeks

*Due to proprietary considerations, FDA approval was NOT granted to pediatric ulcerative colitis

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).

SOURCE

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Renflexis™ (infliximab-abda) for injection, for intravenous use. Retrieved April 24, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/29/2017

MOST RECENT REVIEW DATE:  6/29/2017

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

Infliximab-abda (Renflexis™)
  1. Is this the initial request for treatment with this agent?

If yes, go to question #2

If no, go to question #13

  1. Is there documentation of a prior trial of both infliximab (Remicade®) AND golimumab infusion (Simponi® Aria) for the treatment of ANY ONE of the following?

If yes, go to question #3

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

  1. Is there documentation of testing for presence of ALL of the following?

If yes, go to question #4

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

  1. Is there documentation of understanding of necessity of absence of ALL of the following?

If yes, go to question #5

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

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

If yes, go to question #12

If no, go to question #6

  1. Does the individual have a diagnosis of moderately to severely active Crohn’s disease with ALL of the following?

If yes, go to question #12

If no, go to question #7

  1. Does the individual have a diagnosis of moderately to severely active Fistulizing Crohn’s disease with ALL of the following?

If yes, go to question #12

If no, go to question #8

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

If yes, go to question #12

If no, go to question #9

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

If yes, go to question #12

If no, go to question #10

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

If yes, go to question #12

If no, go to question #11

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

If yes, go to question #12

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

  1. Is the request for any one of the following for an initial authorization period of 6 months?

INDICATION(S)

LOADING DOSE

MAINTENANCE DOSE

MAXIMUM DOSE

Ankylosing Spondylitis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 6 weeks thereafter

Up to 5mg/kg every 6 weeks

60 billable units

Crohn’s Disease Ulcerative Colitis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 8 weeks thereafter

Up to 10mg/kg every 8 weeks

100 billable units

Plaque Psoriasis, Psoriatic Arthritis

5mg/kg at weeks 0, 2, 6

60 billable units

5mg/kg every 8 weeks thereafter

Up to 5mg/kg every 8 weeks

60 billable units/8 weeks

Rheumatoid Arthritis

3mg/kg at weeks 0, 2, 6

40 billable units

3mg/kg every 8 weeks thereafter

Up to 10mg/kg every 4 weeks

100 billable units/4 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 all initial approval criteria for diagnosis and use of agent in questions 2-11?

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 to the agent?

If yes, go to question #15

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

  1. Does the individual have continued monitoring for tuberculosis, hepatitis B and other serious infections?

If yes, go to question #16

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

  1. Does the individual have disease response for diagnosis ankylosing spondylitis as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, and/or morning stiffness?

If yes, go to question #17

If no, go to question #19

  1. Are there 60 billable units or less requested every 6 weeks for 6 months or less?

If yes, go to question #18

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

  1. Is the dosage requested up to 5mg/kg every 6 weeks for 6 months or less?

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 have disease response for diagnosis of moderately to severely active Crohn’s disease, age 6 years and above, with improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extraintestinal complications, and use of anti-diarrheal drugs?

If yes, go to question #21

If no, go to question #20

  1. Does the individual have disease response for a diagnosis of moderately to severely active fistulizing Crohn’s disease with improvement in signs and symptoms compared to baseline such as a reduction in number of enterocutaneous fistulas draining upon gentle compression?

If yes, go to question #21

If no, go to question #23

  1. Are there 100 billable units or less requested every 8 weeks for 6 months or less?

If yes, go to question #22

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

  1. Is the dosage requested up to 10mg/kg every 8 weeks for 6 months or less?

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 have disease response for a diagnosis of ANY ONE of the following?

If yes, go to question #24

If no, go to question #26

  1. Are there up to 60 billable units requested every 8 weeks for 6 months or less?

If yes, go to question #25

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

  1. Is the dosage requested up to 5mg/kg every 8 weeks for 6 months or less?

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 have disease response for a diagnosis of rheumatoid arthritis with improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts?

If yes, go to question #27

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

  1. Are there up to 100 billable units requested every 4 weeks for 6 months or less?

If yes, go to question #28

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

  1. Is the dosage requested up to 10mg/kg every 4 weeks for 6 months or less?

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.