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HealthPartners

Coverage criteria policies

Ustekinumab (Stelara®)

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

Stelara 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

Stelara is generally approved for use in patients diagnosed with moderate to severe psoriatic arthritis and plaque psoriasis when all the following criteria are met:

Initial authorizations
  1. Prescribed and followed by Dermatology or Gastroenterology.
  2. Patient has had a trial and failure of an appropriate regimen of first-line therapy based on the indication for treatment:
    1. Plaque psoriasisFirst-line therapy including concurrent use of two of the regimens below for at least 3 months or intolerance or a contraindication to use:
      1. Topical corticosteroid therapy
      2. Phototherapy: at least 20-30 treatments given 2-3 times weekly Note: Home units are supported in certain situations (See the Home Phototherapy medical policy)
      3. Methotrexate 5mg-15mg weekly (GI intolerance requires trial of SC/IM methotrexate at 5mg-15mg weekly) in combination with folic acid supplementation
      4. Cyclosporine at a dose of at least 2.5 – 5 mg/kg/day until disease control achieved
      5. Acitretin at a dose of at least 25 mg 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. Crohn’s Disease – First line therapy including one of the following:
      1. Treatment with any of the following corticosteroid regimens for two weeks has been ineffective or is contraindicated:
        1. Prednisone 40-60 mg daily
        2. Oral budesonide 9 mg daily
        3. Budesonide rectal; or
      2. Inability to taper off one of the corticosteroid regimens above; or
      3. Breakthrough disease while stabilized for at least 3 months on one of the following therapies:
        1. Azathioprine 2-3 mg/kg daily
        2. 6-mercaptopurine 1-1.5 mg/kg daily
        3. Methotrexate 20mg weekly (GI intolerance requires trial of SC/IM methotrexate at 20mg weekly); and
  3. The prescribed regimen is within the FDA-approved dosing regimen. A current patient weight is required for all requests.

Indication

FDA-approved regimen

Plaque Psoriasis

  • For patients weighing ≤100kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
  • For patients weighing >100kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Psoriatic Arthritis

  • The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
  • For patients with co-existent moderate-to-severe plaque psoriasis weighing > 100kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Crohn’s Disease

  • The recommended dose is 90 mg every 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
  1. When administered by a health-care professional as part of a quarterly assessment of disease activity. Requests for self-administration of Stelara will be reviewed for medical necessity
  2. No other biologic agent will be used concurrently to treat this indication.
  3. 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 a limitation of a maximum of 5 procedures during the first year and 4 annually thereafter.

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.

Definitions

STELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with:

  1. Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  2. Active psoriatic arthritis alone or in combination with methotrexate.
  3. Moderately to severely active Crohn’s disease (CD) who have:
    1. failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or
    2. failed or were intolerant to treatment with one or more TNF blockers.

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

Code

Description

J3357

Ustekinumab, for subcutaneous injection, 1 mg

J3358

Ustekinumab, for intravenous injection, 1mg

NDC Codes

Codes

Description

57894006002

Stelara 45 MG/0.5ML SOLN

57894006003

Stelara 45 MG/0.5ML SOSY

57894006103

Stelara 90 MG/ML SOSY

57894005427

Stelara 130 MG/26ML SOLN

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. Stelara Full Prescribing Information; Janssen Biotech, Horsham, PA; Revised June 2018.
  2. Menter A, Korman NJ, Elmets CA, et al., Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2011;65:137-74.
  3. Hsu S, Papp KA, Lebwohl MG, et al., Consensus guidelines for the mangaement of plaque psoriasis. Arch Dermatol 2012 ;148 (1): 95-102.

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Policy activity

  • 05/06/2010 - Date of origin
  • 01/01/2018 - Effective date
Review date
  • 08/2018
Revision date
  • 01/01/2018

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