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Coverage criteria policies

Golimumab (Simponi ARIA®) - Minnesota Health Care Programs

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

Simponi ARIA for infusion requires prior authorization from Pharmacy Administration.

Coverage

Simponi ARIA is generally approved for use in patients diagnosed with moderate to severe rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis 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. Ankylosing Spondylitis – Use of first-line therapy including all of the regimens below:
      1. Continuous treatment with a NSAID at therapeutic doses for one month; and,
      2. For patients with only peripheral disease, local corticosteroid injections when the disease process permits; and,
      3. For patients with only peripheral disease, methotrexate 20mg for at least 3 months or Sulfasalazine titrated to 2000mg to 3000mg daily for at least 3 months.
  3. The prescribed regimen is within the FDA-approved dosing regimen. A current patient weight is required for all Simponi ARIA requests.
  4. No other biologic agent will be used concurrently to treat this indication.

Authorizations will be provided for one year at a maximum of 15 infusions during the first year and 13 infusions in subsequent years.

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

Simponi ARIA for infusion is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate, Active Psoriatic Arthritis (PsA), and Active Ankylosing Spondylitis (AS).

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

    Code

    Description

    J1602

    Injection, golimumab, 1mg, for intravenous use (Simponi ARIA)

NDC Code

    Code

    Description

    57894035001

    Simponi ARIA 50mg / 4mL solution

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. Simponi ARIA Full Prescribing Information; Janssen Biotech, Inc., Horsham, PA; Revised February 2018.
  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

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

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