BlueCross BlueShield of Tennessee Medical Policy Manual
Canakinumab (Ilaris®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Periodic Fever Syndromes:
Cryopyrin-Associated Periodic Syndromes (CAPS)
Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and pediatric patients 4 years of age and older including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)
Ilaris is indicated for the treatment of TRAPS in adult and pediatric patients.
Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
Ilaris is indicated for the treatment of HIDS and MKD in adult and pediatric patients.
Familial Mediterranean Fever (FMF)
Ilaris is indicated for the treatment of FMF in adult and pediatric patients.
Still’s Disease (Adult-Onset Still’s Disease [AOSD] and systemic Juvenile Idiopathic Arthritis [sJIA])
Ilaris is indicated for the treatment of active Still’s disease, including AOSD and sJIA in patients 2 years of age and older.
Gout Flares
Ilaris is indicated for the symptomatic treatment of adult patients with gout flares in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Compendial Uses
Pseudogout
All other indications are considered experimental/investigational and not medically necessary.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) and Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
Chart notes, medical record documentation, or laboratory result (if applicable) indicating number of active flares within the last 6 months and Physician’s Global Assessment (PGA) score or C-reactive protein (CRP) level.
Familial Mediterranean Fever (FMF) (initial requests only)
Systemic Juvenile Idiopathic Arthritis (sJIA) and Adult-onset Still’s disease (AOSD)
Initial requests
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable).
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Gout and pseudogout flares (initial requests only)
Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with one of the following:
COVERAGE CRITERIA
Periodic Fever Syndromes
Authorization of 12 months may be granted for members 4 years of age or older for treatment of CAPS when both of the following criteria are met:
Authorization of 12 months may be granted for treatment of TRAPS when both of the following criteria are met:
Authorization of 12 months may be granted for treatment of HIDS/MKD when both of the following criteria are met:
Authorization of 12 months may be granted for treatment of FMF when all of the following criteria are met:
Systemic Juvenile Idiopathic Arthritis (sJIA)
Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic indicated for active sJIA.
Authorization of 12 months may be granted for members 2 years of age or older for treatment of active sJIA when the member has active systemic features (e.g., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis).
Adult-Onset Still’s Disease (AOSD)
Authorization of 12 months may be granted for adult members who have previously received a biologic indicated for active AOSD.
Authorization of 12 months may be granted for adult members for treatment of active AOSD when both of the following criteria are met:
Gout and Pseudogout Flares
Authorization of 12 months may be granted for adult members for the treatment of flares for gout and pseudogout (also known as calcium pyrophosphate deposition disease) when both of the following criteria are met:
CONTINUATION OF THERAPY
Systemic Juvenile Idiopathic Arthritis (sJIA)
Authorization of 12 months may be granted for all members 2 years of age or older (including new members) who are using the requested medication for sJIA and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Adult-Onset Still’s Disease (AOSD)
Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for AOSD and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:
Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)
Authorization of 12 months may be granted for all members 4 years of age or older (including new members) who are using the requested medication for CAPS, including FCAS and MWS, and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.
All Other Diagnoses
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for an indication outlined in the coverage criteria and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.
OTHER
For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.
If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug.
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.
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).
REFERENCES
ORIGINAL EFFECTIVE DATE: 3/11/2010
MOST RECENT REVIEW DATE: 9/30/2025
ID_CHS
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.