Biologic Immunomodulators - Rinvoq tablet Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Rinvoq tablet will be approved when ALL of the following are met:

1. The patient has an FDA labeled indication for the requested medication
   AND
2. ONE of the following:
   1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 90 days
      OR
   2. The prescriber states the patient is currently being treated with the requested medication AND provided clinical justification to support that the patient is at risk if therapy is changed 
      OR
   3. ONE of the following:
      1. BOTH of the following:
         1. The patient has an FDA labeled indication other than moderate to severe atopic dermatitis for the requested medication
            AND
         2. ONE of the following:
            1. The patient’s medication history indicates use of preferred Tumor Necrosis Factor (TNF) medication(s)*
               OR 
            2. The patient has an intolerance or hypersensitivity to preferred TNF medication(s)*
               OR 
            3. The patient has an FDA labeled contraindication to preferred TNF medication(s)*
               OR 
            4. The request is for an FDA labeled indication that is not covered by preferred TNF medication(s)* 
               OR
      2. The patient has a diagnosis of moderate to severe atopic dermatitis AND ONE of the following:
         1. The patient’s medication history indicates use of TWO conventional prerequisite medications (i.e., ONE formulary topical corticosteroid AND ONE formulary topical calcineurin inhibitor) for the requested indication*
            OR 
         2. The patient has an intolerance or hypersensitivity to TWO conventional prerequisite medications (i.e., ONE formulary topical corticosteroid AND ONE formulary topical calcineurin inhibitor) for the requested indication*
            OR
         3. The patient has an FDA labeled contraindication to TWO conventional prerequisite medications (i.e., ONE formulary topical corticosteroid AND ONE formulary topical calcineurin inhibitor) for the requested indication* 
            AND
3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
4. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

*NOTES

• Use of TWO conventional prerequisite medications is required for diagnosis of moderate to severe atopic dermatitis
• NO preferred TNF medications are required for diagnosis of pediatric psoriatic arthritis or non-radiographic axial spondyloarthritis
• Formulary conventional prerequisite medications for atopic dermatitis include: Calcineurin inhibitors (e.g., tacrolimus ointment) and topical corticosteroids (fluocinonide cream, halobetasol cream/ointment, triamcinolone cream/ointment, etc.)

For HC Enhanced and MAPD Classic formularies:

• Use of ONE preferred TNF (Enbrel, Hadlima, Humira, or Simlandi) is required for diagnoses of ankylosing spondylitis, rheumatoid arthritis, adult psoriatic arthritis, or juvenile idiopathic arthritis
• Use of ONE preferred TNF (Hadlima, Humira, or Simlandi) is required for diagnoses of ulcerative colitis or Crohn’s disease

For Basic formulary:

• Use of ONE preferred TNF (Enbrel, Hadlima, or Simlandi) is required for diagnoses of ankylosing spondylitis, rheumatoid arthritis, adult psoriatic arthritis, or juvenile idiopathic arthritis
• Use of ONE preferred TNF (Hadlima or Simlandi) is required for diagnoses of ulcerative colitis or Crohn’s disease

Length of approval: 12 months

Renewal Evaluation

Rinvoq tablet will be approved when ALL of the following are met: 

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. The patient has an FDA labeled indication for the requested medication AND
3. The patient has had clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency)
   AND
4. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
5. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
   AND
6. The requested dose is within FDA labeled dosing for the requested indication

Length of approval: 12 months