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Immunomodulators

Drug - Immunomodulators

December 2016

Therapeutic area - Arthritis, Psoriasis, Ankylosing Spondolytis, Ulcerative Colitis, Crohn's Disease, Dermatology

In general, patients must sequentially try and fail a tier 1 product prior to using a tier 2 product and try and fail a tier 1 and a tier 2 product prior to approval of a tier 3 product.

All drugs in the immunomodulators PDL category (Table 1) require prior authorization. Providers should fax the completed Immunomodulator Drug Authorization Form (DHS-5212) (PDF) to the MHCP Prescription Drug Prior Authorization Agent.

  • All patients currently on therapy (history of drug in the last 60 days) will be approved
  • Clinical criteria for prior authorization are dependent upon the drug, indication and recipient diagnosis
  • 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 in its label

Table 1. Preferred Drug List

Preferred Nonpreferred
Enbrel
Humira
Actemra
Cimzia
Cosentyx
Entyvio
Ilaris
Kineret
Orencia
Otezla
Remicade
Simponi
Stelara
Taltz
Xeljanz
Xeljanz XR


Table 2. Tiered Approach to PDL Immunomodulator Category

Tier 1 Tier 2 Tier 3
Enbrel
Humira

Cimzia
Cosentyx
Orencia
Remicade
Stelara

Actemra
Entyvio
Ilaris
Kineret
Otezla
Simponi
Taltz
Xeljanz
Xeljanz XR  


Exclusion criteria

Coverage is not provided for use of TNF – a blocking agent (Humira®, Cimzia®, Enbrel®, Simponi™ 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

Approval Criteria for New Patients

Rheumatoid Arthritis

  • Orencia®, Humira®, Kineret®, Cimzia®, Enbrel®, Remicade®, Simponi®, Actemra®
    • Diagnosis of rheumatoid arthritis AND
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections AND
    • Patient has had RA for ≤6 months (early RA) AND has high disease activity OR
    • 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
    • Patient has had RA for ≥6 months (intermediate or long-term disease duration) AND has high disease activity
  • Orencia®, Cimzia®, Remicade®, (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Kineret®, Simponi®, Actemra®, Xeljanz®, Xeljanz XR® (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)

Psoriatic Arthritis

  • Enbrel®, Humira®, Cosentyx™, Remicade®, Stelara™, Simponi®, Cimzia®
    • Diagnosis of psoriatic arthritis AND
    • Rheumatology consult with date or Dermatology consult with date AND
    • Inadequate response to any one non-steroidal anti-inflammatory drug (NSAID) OR
    • 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
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Remicade®, Cimzia®, Cosentyx™, Stelara™ (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Simponi®, Otezla® (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • For Otezla, patient is 18 years of age or older AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)

Ankylosing Spondylitis 

  • Enbrel®, Humira®, Cosentyx™, Remicade®, Simponi®, Cimzia®
    • Diagnosis of ankylosing spondylitis AND
    • 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
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Remicade®, Cimzia®, Cosentyx™(Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Simponi® (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)

Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis 

  • Enbrel®, Humira®, Orencia®, Actemra®, Ilaris
    • Diagnosis of juvenile rheumatoid arthritis AND
    • Patient is at least 2 years of age AND
    • Inadequate response to one Disease-Modifying Anti-Rheumatic Drug (DMARD) (sulfasalazine, methotrexate, hydroxychloroquine, leflunomide, minocycline)
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Orencia®, (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed all tier 1 products (Table 2.)
  • Actemra®, Ilaris (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)

Plaque Psoriasis

  • Enbrel®, Humira®, Cosentyx™, Remicade®, Stelara™, Taltz™
    • Diagnosis of plaque psoriasis AND
    • Prescribed by a dermatologist AND
    • Failed to adequately respond to a topical agent AND
    • Failed to adequately respond to at least one oral treatment (cyclosporin, methotrexate) AND
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Cosentyx™, Remicade®, Stelara™ (Non-Preferred Tier 2 Drugs)
    • The above criteria has been met AND
    • Patient has tried and failed at least one tier 1 product (Table 2.) 
  • Otezla®, Taltz™ (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2)

Crohn's Disease 

  • Cimzia®, Humira®, Remicade®, Entyvio®
    • Diagnosis of Crohn’s Disease AND
    • Failed to adequately respond to 2 or more conventional therapies (e.g. sulfasalzine, mesalamine, antibiotics, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate) OR 
    • Patient has fistulizing Crohn’s disease AND
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Cimzia®, Remicade® (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed one tier 1 product (Table 2.)
  • Entyvio® (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient is 18 years of age or older AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)
    • Patient has had a negative anti-JCV test

Ulcerative Colitis 

  • Humira®, Remicade®, Entyvio®, Simponi®
    • Diagnosis of Ulcerative Colitis AND
    • Failed to adequately respond to two or more of the following standard therapies: Corticosteroids, 5-aminosalicylic acid agents, Immunosuppresants, Thiopurines
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections
  • Remicade® (Non-Preferred Tier 2 Drugs) 
    • The above criteria have been met AND
    • Patient has tried and failed one tier 1 product (Table 2.)
  • Entyvio®, Simponi® (Non-Preferred Tier 3 Drugs)
    • The above criteria have been met AND
    • Patient is 18 years of age or older AND
    • Patient has tried and failed at least one tier 1 product AND one tier 2 product prior to approval of a tier 3 product (Table 2.)
    • Patient has had a negative anti-JCV test

Hidradenitis Suppurativa

  • Humira®
    • Diagnosis of Hidradenitis Suppurativa AND
    • Prescribed by a dermatologist AND
    • Failed to adequately respond to two or more of the following therapies: Corticosteroids, antibiotics, immunosuppressants AND
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections

Uveitis

  • Humira®
    • Diagnosis of non-infectious intermediate, posterior and panuveitis AND
    • Patient is 18 years of age or older AND
    • Prescribed by an ophthalmologist AND
    • Failed to adequately respond to three or more of the following therapies: topical glucocorticoids, intraocular glucocorticoid injections,  oral glucocorticoids, immunosuppressants AND
    • Negative tuberculin test or if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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