BlueCross BlueShield of Tennessee Medical Policy Manual

Canakinumab

NDC CODE(S)

00078-0582-xx - Ilaris 180 mg injection (Novartis)

DESCRIPTION

Canakinumab is a recombinant fully human anti-interleukin-1beta (anti-IL-1β) monoclonal antibody.  It selectively blocks the action of IL-1β without affecting other interleukin-1 (IL-1) types.  IL-1β is a key proinflammatory cytokine.  It mediates local and systemic responses to infection and tissue injury.  When activated, it induces multiple effects that include fever, sensitization to pain, and destruction of bone and cartilage.

IL-1β is activated by the cryopyrin inflammasome, a multi-protein cellular complex which normally responds to stimuli from microbes and dead cells to convert pro-IL-1β to its immunologically active form. Cryopyrin is encoded by the NLRP-3 gene.  Cryopyrin-associated periodic syndrome (CAPS) is a spectrum of rare inherited inflammatory disorders or cryopyrinopathies caused by mutations in the NLRP-3 gene.  This results in excessive activity of the cryopyrin inflammasome, overproduction of activated IL-1 β and increased inflammation.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Cryopyrin-Associated Periodic Syndromes (wt >40kg) 150 mg SC every 8 weeks
Cryopyrin-Associated Periodic Syndromes (wt = 15kg-40kg) 2 mg/kg SC every 8 weeks. May be increased to 3 mg/kg if inadequate response
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF)

Body weight less than or equal to 40 kg

The recommended starting dose is 2 mg/kg every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF)

Body weight greater than 40 kg

The recommended starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate
Systemic Juvenile Idiopathic Arthritis (SJIA)

4 mg/kg (with a maximum of 300mg) for patients with a body weight greater than or equal to 7.5kg. Administer subcutaneously every 4 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 canakinumab for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Canakinumab. Retrieved October 20, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, October). Canakinumab. Retrieved October 20, 2016 from MICROMEDEX Healthcare Series.

U. S.. Food and Drug Administration. (2016, September). Center for Drug Evaluation and Research. Ilaris® (canakinumab) injection for subcutaneous use.  Retrieved October 20, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/11/2010

MOST RECENT REVIEW DATE:  12/1/2016

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

Canakinumab (Ilaris ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #9

  1. Has the individual been evaluated and screened for the presence of latent tuberculosis (TB) infection?

If yes, go to question #3

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

  1. Does the individual have a diagnosis of a Periodic Fever Syndrome?

If yes, go to question #4

If no, go to question #6

  1. Does the individual have a diagnosis of Cryopyrin-Associated Periodic Syndrome (CAPS) and ALL of the following?

If yes, go to question #7

If no, go to question #5

  1. Is the individual 2 years of age or older with a diagnosis of ANY ONE of the following requesting treatment as a single agent?

If yes, go to question #7

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

  1. Does the individual have a diagnosis of systemic juvenile idiopathic arthritis (SJIA) with ALL of the following?

If yes, go to question #7

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

  1. Does the individual meet ALL of the following?

If yes, go to question #8

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

  1. Is the request for ANY ONE of the following billable units and dosage?

Cryopyrin-Associated Periodic Syndromes (wt >40kg)

150  billable units every 8 weeks

150 mg SC every 8 weeks

Cryopyrin-Associated Periodic Syndromes (wt = 15kg-40kg)

80 to 120 billable units or less every 8 weeks

2 mg/kg SC every 8 weeks. May be increased to 3 mg/kg if inadequate response

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF)

160 billable units or less every 4 weeks

Body weight less than or equal to 40 kg

The recommended starting dose is 2 mg/kg every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF)

150 to 300 billable units every 4 weeks

Body weight greater than 40 kg

The recommended starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate

Systemic Juvenile Idiopathic Arthritis (SJIA)

300 billable units every 4 weeks

4 mg/kg (with a maximum of 300mg) for patients with a body weight greater than or equal to 7.5kg. Administer subcutaneously every 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 the initial approval criteria in questions 2 through 8?

If yes, go to question #10

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

  1. Does the individual have a diagnosis of a Cryopyrin-Associated Periodic Syndrome?

If yes, go to question #11

If no, go to question #12

  1. Is disease response indicated by improvement in patient’s symptoms from baseline and improvement in serum levels of C-Reactive Protein (CRP) and Serum Amyloid A (SAA) from baseline?

If yes, go to question #14

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

  1. Does the individual have a diagnosis of Systemic Juvenile Idiopathic Arthritis?

If yes, go to question #13

If no, go to question #14

  1. Is disease response indicated by improvement in patient’s symptoms from baseline and normalization of serum levels of C-Reactive Protein (CRP)?

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 including severe hypersensitivity reactions, serious infections such as TB and macrophage activation syndrome (MAS) as well as ongoing monitoring for TB?

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.