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Immunomodulators

Drug - Immunomodulators

March 2018

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**
Infectra
Kevzara 
Kineret*** 
Orencia
Otezla
Remicade
Renflexis
Siliq
Simponi
Stelara
Taltz
Xeljanz
Xeljanz XR

Table 2. Tiered Approach to PDL Immunomodulator Category

Tier 1 Tier 2 Tier 3
Enbrel
Humira

Cimzia
Cosentyx
Inflectra  
Orencia
Renflexis  
Stelara

Actemra* 
Entyvio
Ilaris**
Kevzara 
Kineret*** 
Otezla
Remicade
Siliq  
Simponi
Taltz
Xeljanz
Xeljanz XR  

* See Actemra PA criteria sheet

** See Ilaris PA criteria sheet

*** See Kineret PA criteria sheet

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

Actemra®*, Cimzia®, Enbrel®, Humira®, Inflectra®, Kevzara®, Kineret®***, Orencia®, Remicade®, Renflexis™, Simponi®, Xeljanz®, Xeljanz XR®

  • Enbrel®, Humira®
    • 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
  • Cimzia®, Inflectra®, Orencia®, Renflexis™ (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Actemra®*, Kineret®***, Kevzara®, Remicade®, Simponi®, 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

Cimzia®, Cosentyx™, Enbrel®, Humira®, Inflectra®, Orencia®, Otezla®, Remicade®, Renflexis™, Simponi®, Stelara™, Taltz™

  • Enbrel®, Humira®
    • 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
  • Cimzia®, Cosentyx™, Inflectra®, Orencia®, Renflexis™, Stelara™ (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Otezla®, Remicade®, Simponi®, 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.)

Ankylosing Spondylitis

Cimzia®, Enbrel®, Cosentyx™, Humira®, Inflectra®, Remicade®, Renflexis™, Simponi®

  • Enbrel®, Humira®
    • 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
  • Cimzia®, Cosentyx™, Inflectra®, Renflexis™ (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed at least one tier 1 product
  • Remicade®, 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

Actemra®*, Enbrel®, Humira®, Ilaris**, Orencia®

  • Enbrel®, Humira®
    • Diagnosis of juvenile rheumatoid arthritis AND
    • Patient is at least 2 years of age OR weighs at least 10 kg 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

Cosentyx™, Enbrel®, Humira®, Inflectra®, Otezla®, Remicade®, Renflexis™, Siliq™, Stelara™, Taltz™

  • Enbrel®, Humira®
    • 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™, Inflectra®, Renflexis™, 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®, Remicade®, Siliq™, 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®, Entyvio®, Humira®, Inflectra®, Remicade®, Renflexis™, Stelara™

  • Humira®
    • 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®, Inflectra®, Renflexis™, Stelara™ (Non-Preferred Tier 2 Drugs)
    • The above criteria have been met AND
    • Patient has tried and failed one tier 1 product (Table 2.)
  • Entyvio®, Remicade® (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.)
    • Patient has had a negative anti-JCV test

Ulcerative Colitis

Entyvio®, Humira®, Inflectra®, Remicade®, Renflexis™, Simponi®

  • Humira®
    • 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
  • Inflectra®, Renflexis™ (Non-Preferred Tier 2 Drugs) 
    • The above criteria have been met AND
    • Patient has tried and failed one tier 1 product (Table 2.)
  • Entyvio®, Remicade®, 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.)
    • Patient has had a negative anti-JCV test

Hidradenitis Suppurativa

Humira®

  • Humira®
    • Diagnosis of Hidradenitis Suppurativa AND
    • Prescribed by a dermatologist AND
    • Patient is 18 years of age or older 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®

  • 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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