Skip to main content
HealthPartners

Coverage criteria policies

Canakinumab (ILARIS®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Canakinumab (ILARIS) requires prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Canakinumab (Ilaris) is generally covered subject to the indications listed below when all of the following criteria are met, and per member plan documents.

Initial Authorizations:
  1. Patients diagnosed with any one of the following with qualifications
    1. 2 years and older with Active Systemic Juvenile Idiopathic Arthritis (SJIA); or
    2. 4 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), or,
    3. Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); or,
    4. Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); or,
    5. Familial Mediterranean Fever (FMF); and,
  2. The patient and/or guardian has attested that they will adhere to the treatment plan; and,
  3. Ilaris is prescribed within the FDA-approved dosing regimen; and,
  4. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial authorizations will be approved for 12 months.

Reauthorizations:

Annual reauthorizations will require medical chart documentation that the patient has been seen within the past 12 months and that markers or symptoms of disease are improved by therapy. These include but may not be limited to reduced symptoms of disease and inflammatory markers, including serum C-reactive protein for Periodic Fever Syndromes or normalization of erythrocyte sedimentation rate for SJIA.

Reauthorizations will be approved for 12 months.

Definitions

ILARIS is an interleukin-1β blocker indicated for the treatment of:

Periodic Fever Syndromes:

    · Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including:

      o Familial Cold Autoinflammatory Syndrome (FCAS)

      o Muckle-Wells Syndrome (MWS)

    · Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.

    · Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.

    · Familial Mediterranean Fever (FMF) in adult and pediatric patients.

Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

J0638

Injection, canakinumab, 1 mg

NDC

Codes

Description

00078058261

Ilaris 150 MG SOLR

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. “ILARIS” package insert. Novartis Pharmaceuticals Corporation, East Hanover, NJ. 12/2016.

Go to

Policy activity

  • 11/05/2018 - Date of origin
  • 01/01/2019 - Effective date

Related content