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HealthPartners

Coverage criteria policies

Abatacept (Orencia®)

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

Orencia 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

Orencia injection for intravenous use is generally approved for use in patients diagnosed with moderate to severe rheumatoid arthritis, psoriatic arthritis, or juvenile idiopathic arthritis when all 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. Moderate to Severe 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. Psoriatic Arthritis - First line therapy including 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)
    3. 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).
    2. For professionally administered therapies: two preferred anti-TNF agents, based on indication:
      1. Rheumatoid Arthritis and Psoriatic 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 intravenous therapy requests.
    Adults – The doses below are administered at 0, 2 and 4 weeks, then every 4 weeks

    Weight

    Dose

    < 60 kg

    500 mg

    60 kg to 100 kg

    750 mg

    > 100 kg

    1000 mg

    Pediatic patients weighing <75 kg receive 10mg/kg per dose. Pediatric patients weighing more than 75 kg should following the adult dosing regimen.

  1. No other biologic agent will be used concurrently to treat this indication; and
  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: A maximum of 15 infusions will be approved during the first year and 13 infusions will be approved in subsequent years. No more than 4 vials may be billed for each infusion event.
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.

Definitions

Abatacept (Orencia) inhibits T cell activation, inhibits the production of several cytokines, and lowers serum concentrations of inflammatory products.

Orencia is FDA-approved for:

  1. Adult Rheumatoid Arthritis - moderately to severely active rheumatoid arthritis in adults. It may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
  2. Juvenile Idiopathic Arthritis – moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 6 years and older. It may be used as monotherapy or concomitantly with methotrexate.
  3. Adult Psoriatic Arthritis – treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use - Orencia should not be given concomitantly with TNF antagonists.

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.

NDC Codes:

Codes

Description

00003218710

Orencia 250 mg single use vial

00003218811

Orencia 125 mg/mL syringe

00003218851

Orencia Clickject 125 mg/mL auto injection solution

00003281411

Orencia 50mg/0.4mL syringe

00003281811

Orencia 87.5mg/0.7mL syringe

HCPCS Codes:

Codes

Description

J0129

Injection, abatacept, 10 mg

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. Orencia Full Prescribing Information; Bristol-Myers Squibb Co., Princeton, NJ; March 2017
  2. 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.
  3. 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.

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Policy activity

  • 07/05/2006 - Date of origin
  • 09/01/2017 - Effective date
Review date
  • 08/2017
Revision date
  • 08/14/2017

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