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HealthPartners

Coverage criteria policies

Tocilizumab (Actemra®)

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

Actemra requires prior authorization from 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

Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

Actemra is generally approved for use in patients diagnosed with moderate to severe rheumatoid arthritis or juvenile idiopathic arthritis when all of the following criteria are met:

Initial approvals

  1. Prescribed and followed by Rheumatology.
  2. Patient has had a trial and failure of an appropriate regimen of first-line therapy based on the indication for treatment:
    1. Rheumatoid Arthritis - DMARD therapy including concurrent use of two or three of the regimens below for at least 3 months or intolerance or a contraindication to use:
      1. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly)
      2. Hydroxychloroquine titrated to 200-400mg daily
      3. Sulfasalazine titrated to 2000mg-3000mg daily
      4. Leflunomide 10-20mg daily
    2. Juvenile Idiopathic Arthritis – First-line therapy includes:
      1. Concurrent use of the regimens below for at least 1 month:
        1. Continuous treatment with a NSAID at therapeutic doses; and,
        2. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly), or
      2. Patient is using requested medication as first-line therapy due to severe initial disease activity (per the ACR guidelines) including fever for >2 weeks plus at least one characteristic systemic feature or >4 affected joints.
  3. Patient has had at least a 3-month trial and failure, or intolerance or a contraindication to use, of:
    1. For self-administered therapies: two preferred biologic therapies (Enbrel and Humira).
      1. For professionally administered therapies: two preferred anti-TNF agents, based on indication:
        1. Rheumatoid Arthritis - One anti-TNF must be Remicade or Simponi Aria. Preferred agents include Remicade, Simponi Aria, Enbrel and Humira.
        2. Juvenile Idiopathic Arthritis – Preferred anti-TNF agents include Enbrel and Humira.
  4. The prescribed regimen is within the FDA-approved dosing regimen. A current patient weight is required for all requests.
    Adult patients – The FDA-approved regimen is a starting dose of 4 mg/kg every 4 weeks followed by an increase to 8 mg/kg every 4 weeks based on clinical response.
    Pediatric patients – FDA-approved pediatric dosing is as follows:

    Weight

    Polyarticular Juvenile Idiopathic Arthritis Every 4 Weeks

    Systemic Juvenile Idiopathic Arthritis Every 2 Weeks

    < 30 kg

    10 mg/kg

    12 mg/kg

    ≥ 30 kg

    8 mg/kg

    8 mg/kg

  1. No other biologic agent will be used concurrently to treat this indication.
  2. 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.

Authorizations will be provided for one year with the following limitations:

  • For IV regimens for Rheumatoid Arthritis and Polyarticular Juvenile Idiopathic Arthritis: A maximum of 13 infusions will be approved during any year.
  • For Systemic Juvenile Idiopathic Arthritis: A maximum of 26 infusions will be approved during any year.

Reauthorizations for biologic regimens of up to FDA-approved doses and frequencies

Renewals will be provided annually with provider attestation that they have seen the patient within the last fourteen months and the patient is benefiting from use of the medication.

Requests for more intense (dose or interval) biologic therapy than the FDA-approved regimen

All requests for regimens exceeding the FDA-approved regimen (including annual renewals) will require provider attestation that the off-label regimen is medically necessary.

CAR-T therapy induced cytokine release syndrome

Actemra is generally approved for use in adult and pediatric patients 2 years and older to be used for CAR-T therapy induced cytokine release syndrome when the following criteria are met:

  1. CAR-T drug therapy has been approved by HealthPartners; and
  2. A maximum of four, 800 unit doses is requested (total maximum 3200 units).

Re-authorization does not apply for cytokine release syndrome, as there is a maximum 3200 units per FDA label.

Definitions

Tocilizumab (Actemra®) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

Polyarticular Juvenile Idiopathic Arthritis (PJIA) – Tocilizumab is indicated for use in patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

Rheumatoid arthritis (RA) – Tocilizumab is indicated for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Systemic Juvenile Idiopathic Arthritis (SJIA) – Tocilizumab is indicated for use in patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

Giant Cell Arteritis (GCA) – Tocilizumab is indicated for adult patients with giant cell arteritis.

CAR-T therapy induced cytokine release syndrome – Tocilizumab is indicated for adult and pediatric patients 2 years and older with CAR-T drug therapy, to be used for CAR-T therapy induced cytokine release syndrome.

Actemra may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used.

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.

HCPCS

Code

Description

J3262

Injection, tocilizumab, 1 mg

J3590

Unclassified Biologics (for 162mg/0.9mL)

NDC Codes

Individually packaged, single-use vials

Code

Description

50242013501

Actemra 80 mg/4mL

50242013801

Actemra 162 mg/0.9mL

50242013601

Actemra 200 mg/10mL

50242013701

Actemra 400 mg/20mL

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. Actemra Full Prescribing Information; Genentech, Inc., South San Francisco, CA; May 2017.
  2. Singh JA, Furst DE, Bharat A, et al., 2012 Update of the 2008 ACR Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Research 2012:64(5):625-639
  3. Smolen JS, Landewe R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-975.

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Policy activity

  • 05/05/2010 - Date of origin
  • 04/01/2018 - Effective date
Review date
  • 08/2017
Revision date
  • 02/05/2018

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