BlueCross BlueShield of Tennessee Medical Policy Manual

Canakinumab

NDC CODE(S)

00078-0734-XX Ilaris 150 MG/ML SOLN (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.

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

Cryopyrin-Associated Periodic Syndromes (wt >40kg)

150 mg SC every 8 weeks

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 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).

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

SOURCES

Lexi-Comp Online. (2018). AHFS DI. Canakinumab. Retrieved September 19, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, June). Canakinumab. Retrieved September 18, 2018 from MICROMEDEX Healthcare Series.

National Organization for Rare Disorders, Inc. (NORD). (2011) Familial cold autoinflammatory syndrome. Retrieved September 18, 2018 from https://rarediseases.org/rare-diseases/familial-cold-autoinflammatory-syndrome/. 

National Organization for Rare Disorders, Inc. (NORD). (2018). Familial mediterranean fever. Retrieved September 18, 2018 from https://rarediseases.org/rare-diseases/familial-mediterranean-fever/.  

National Organization for Rare Disorders, Inc. (NORD). (2017) Mevalonate kinase deficiency. Retrieved September 18, 2018 from https://rarediseases.org/rare-diseases/hyper-igd-syndrome/. 

National Organization for Rare Disorders, Inc. (NORD). (2011) Muckle-Wells syndrome. Retrieved September 18, 2018 from https://rarediseases.org/rare-diseases/muckle-wells-syndrome/.

National Organization for Rare Disorders, Inc. (NORD). (2016) Tumor necrosis factor receptor-associated periodic syndrome. Retrieved September 18, 2018 from https://rarediseases.org/rare-diseases/tumor-necrosis-factor-receptor-associated-periodic-syndrome/. 

U. S. Food and Drug Administration. (2016, December). Center for Drug Evaluation and Research. Ilaris® (canakinumab) injection for subcutaneous use.  Retrieved September 18, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/11/2010

MOST RECENT REVIEW DATE:  1/31/2019

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

MAXIMUM UNITS

Cryopyrin-Associated Periodic Syndromes 150 billable units every 8 weeks (56 days)
Familial Mediterranean Fever 300 billable units every 4 weeks (28 days)
Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency 300 billable units every 4 weeks (28 days)
Systemic Juvenile Idiopathic Arthritis 300 billable units every 4 weeks (28 days)
Tumor Necrosis Factor Receptor Associated Periodic Syndrome 300 billable units every 4 weeks (28 days)