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Coverage criteria policies

Immunomodulators (Actemra®, Cimzia®, Entyvio®, Inflectra®, Orencia®, Remicade®, Renflexis®, 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

Immunomodulators (Actemra®, Cimzia®, Entyvio®, Inflectra®, Orencia®, Remicade®, Renflexis®, Simponi Aria®) require prior authorization from HealthPartners Pharmacy Administration.

The medications listed in this policy are professionally administered, and generally process on the medical benefit.

Certain medications in this policy (such as Actemra, Cimzia, and Orencia) may also have formulations available for self-administration. Self-administered products generally process on the pharmacy benefit, and may have different coverage criteria from that listed below.

Coverage

Preferred Drug List

Preferred

Non-Preferred

Cimzia

Actemra

Inflectra

Entyvio

Orencia

Remicade

Renflexis

Simponi Aria

Rheumatoid Arthritis:

Preferred: Cimzia, Inflectra, Orencia, Renflexis

  1. Diagnosis of rheumatoid arthritis; and,
  2. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  3. Patient does not have an active infection or a history of recurring infections; and,
  4. One of the following two criteria are met:
    1. Patient has had RA for ≤6 months (early RA) and has high disease activity; or,
    2. Patient has had RA for ≥6 months (intermediate or long-term disease duration) and has moderate disease activity and has an inadequate response to a disease modifying antirheumatic drug (DMARD) (methotrexate, hydroxychloroquine, leflunomide, minocycline or sulfasalazine); or,
    3. Patient has had RA for ≥6 months (intermediate or long-term disease duration) and has high disease activity.

Non-Preferred: Actemra, Remicade, Simponi Aria

  1. The above criteria have been met; and,
  2. Patient has tried and failed at least one preferred product; and,
  3. If the request is for Remicade or Simponi Aria, patient has tried and failed either Inflectra or Renflexis.
Psoriatic Arthritis:

Preferred: Cimzia, Inflectra, Orencia, Renflexis

  1. Diagnosis of psoriatic arthritis; and,
  2. Rheumatology consult with date or Dermatology consult with date; and,
  3. Inadequate response to any one non-steroidal anti-inflammatory drug (NSAID); or,
  4. Contraindication to treatment with a NSAID or to any one of the following disease modifying anti-rheumatic drugs (DMARDs) (methotrexate, leflunomide, cyclosporine or sulfasalazine); and,
  5. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  6. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Remicade, Simponi Aria

  1. The above criteria have been met; and,
  2. Patient has tried and failed either Inflectra or Renflexis.
Ankylosing Spondylitis:

Preferred: Cimzia, Inflectra, Renflexis

  1. Diagnosis of ankylosing spondylitis; and,
  2. Inadequate response to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and to any one of the Disease-Modifying Anti-Rheumatic Drugs (DMARDs) (sulfasalazine, methotrexate, hydroxychloroquine, leflunomide, minocycline); and,
  3. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  4. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Remicade

  1. The above criteria have been met; and,
  2. Patient has tried and failed either Inflectra or Renflexis.
Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis:

Preferred: Orencia

  1. Diagnosis of juvenile rheumatoid arthritis; and,
  2. Patient is at least 2 years of age or weighs at least 10 kg; and,
  3. Inadequate response to one Disease-Modifying Anti-Rheumatic Drug (DMARD) (sulfasalazine, methotrexate, hydroxychloroquine, leflunomide, minocycline); and,
  4. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  5. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Actemra

  1. The above criteria have been met; and,
  2. Patient has tried and failed Orencia.
Plaque Psoriasis:

Preferred: Inflectra and Renflexis:

  1. Diagnosis of plaque psoriasis; and,
  2. Prescribed by a dermatologist; and,
  3. Failed to adequately respond to a topical agent; and,
  4. Failed to adequately respond to at least one oral treatment (cyclosporin, methotrexate); and,
  5. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  6. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Remicade

  1. The above criteria have been met; and,
  2. Patient has tried and failed either Inflectra or Renflexis.
Crohn's Disease:

Preferred: Cimzia, Inflectra, Renflexis

  1. Diagnosis of Crohn’s Disease; and,
  2. Failed to adequately respond to 2 or more conventional therapies (e.g. sulfasalzine, mesalamine, antibiotics, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate); or,
  3. Patient has fistulizing Crohn’s disease; and,
  4. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  5. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Entyvio, Remicade

  1. The above criteria have been met; and,
  2. Patient has tried and failed at least one preferred product; and,
  3. If the request is for Remicade, patient has tried and failed either Inflectra or Renflexis.
Ulcerative Colitis:

Preferred: Inflectra and Renflexis:

  1. Diagnosis of Ulcerative Colitis; and,
  2. Failed to adequately respond to two or more of the following standard therapies: Corticosteroids, 5-aminosalicylic acid agents, Immunosuppresants, Thiopurines; and,
  3. Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request; and,
  4. Patient does not have an active infection or a history of recurring infections.

Non-Preferred: Entyvio, Remicade

  1. The above criteria have been met; and,
  2. Patient has tried and failed either Inflectra or Renflexis.
Reauthorization Criteria:

Patients currently on therapy (history of drug in the last 60 days) may be approved.

Indications that are not covered

  • Approval will not be given if the patient is using more than one biologic at a time (combination therapy) or if the drug being requested does not have the specific FDA approved indication and FDA-approved dosing regimen in its label.
  • Coverage is not provided for use of TNF – a blocking agent (Cimzia, Simponi Aria, Inflectra, Renflexis or Remicade) in patients with any of the following conditions:
    • Moderate or severe heart failure (NYHA Class III or IV) or
    • History of treated lymphoproliferative disease of < 5 years in the past or
    • Acute or chronic liver disease graded as Child-Pugh class B or C or
    • Multiple sclerosis or other demyelinating disorder.

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

Codes

Description

J0717

Injection, certolizumab pegol, 1 mg

Q5103

Injection, infliximab-dyyb, biosimilar, (Inflectra), 10 mg

J0129

Injection, abatacept, 10 mg

Q5104

Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg

J3262

Injection, tocilizumab, 1 mg

J3380

Injection, vedolizumab, 1 mg

J1745

Injection, infliximab, excludes biosimilar, 10 mg

J1602

Injection, golimumab, 1 mg, for intravenous use

NDC Codes

Codes

Description

50474070062

Cimzia 2 X 200 MG KIT

00069080901

Inflectra 100 MG SOLR

00003218710

Orencia 250 MG SOLR

00006430501

Renflexis 100 MG SOLR

00006430502

Renflexis 100 MG SOLR

50242013501

Actemra 80 MG/4ML SOLN

50242013601

Actemra 200 MG/10ML SOLN

50242013701

Actemra 400 MG/20ML SOLN

64764030020

Entyvio 300 MG SOLR

57894003001

Remicade 100 MG SOLR

57894035001

Simponi Aria 50 MG/4ML 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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/immunomodulators.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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