Immunomodulators

Drug - Immunomodulators

September 2019

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.

• The patient stabilized on the current regimen will be approved. Stabilization on the current regimen is defined as having the prescription filled at least two times in the past 90 days AND MHCP (either FFS or Managed Care) has paid for the previous two fills or chart notes indicating fill/refill history if patient is new to Medical Assistance and pharmacy claims data is not readily available.
• Continuation of Therapy overrides are not available to bypass generic or biosimilar substitution
• 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* Ilumya Inflectra Kevzara Kineret* Olumiant Orencia Otezla* Remicade Renflexis Siliq Simponi Simponi Aria Skyrizi Stelara Taltz Tremfya 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 Tremfya	Actemra* Entyvio Ilaris* Ilumya Kevzara Kineret* Olumiant Otezla* Remicade Siliq Simponi Simponi Aria Skyrizi Taltz Xeljanz  Xeljanz XR

*Please refer to the drug-specific PA criteria for FDA-approved indications not on this document.

Exclusion Criteria

Coverage is not provided for use of TNF - a blocking agent (Humira®, Cimzia®, Enbrel®, Simponi®, Simponi Aria® 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®, Olumiant®, Orencia®, Remicade®, Renflexis™, Simponi®, Simponi Aria®, 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®, Olumiant®, Remicade®, Simponi®, Simponi Aria®, Xeljanz®, Xeljanz XR® (Nonpreferred 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®, Simponi Aria®, Stelara™, Taltz™, Xeljanz®, Xeljanz XR®

• 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 an 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™ (Nonpreferred Tier 2 Drugs)
  • The above criteria have been met AND
  • Patient has tried and failed at least one tier 1 product
• Otezla®, Remicade®, Simponi®, Simponi Aria®, Taltz™, Xeljanz®, Xeljanz XR® (Nonpreferred 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®, Simponi Aria®

• Enbrel®, Humira®
  • Diagnosis of ankylosing spondylitis 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™ (Nonpreferred Tier 2 Drugs)
  • The above criteria have been met AND
  • Patient has tried and failed at least one tier 1 product
• Remicade®, Simponi®, Simponi Aria® (Nonpreferred 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®, 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® (Nonpreferred Tier 2 Drugs)
  • The above criteria have been met AND
  • Patient has tried and failed all tier 1 products (Table 2.)
• Actemra® (Nonpreferred 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®, Ilumya™, Inflectra®, Otezla®, Remicade®, Renflexis™, Siliq™, Skyrizi™, Stelara™, Taltz™, Tremfya®

• 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 (cyclosporine, 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
• Cimzia®, Cosentyx™, Inflectra®, Renflexis™, Stelara™, Tremfya® (Nonpreferred Tier 2 Drugs)
  • The above criteria has been met AND
  • Patient has tried and failed at least one tier 1 product (Table 2)
• Ilumya™, Otezla®, Remicade®, Siliq™, Skyrizi™, Taltz™ (Nonpreferred 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)
  • For Siliq, the patient must not have Crohn’s disease

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™ (Nonpreferred Tier 2 Drugs)
  • The above criteria have been met AND
  • Patient has tried and failed one tier 1 product (Table 2.)
• Entyvio®, Remicade® (Nonpreferred 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®, Xeljanz®

• 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 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
• Inflectra®, Renflexis™ (Nonpreferred Tier 2 Drugs)
  • The above criteria have been met AND
  • Patient has tried and failed one tier 1 product (Table 2.)
• Entyvio®, Remicade®, Simponi®, Xeljanz®, (Nonpreferred 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 12 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 made by an ophthalmologist and substantiated by documentation submitted at time of request AND
  • Patient is 2 years of age or older AND
  • Prescribed by an ophthalmologist or rheumatologist 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