Biologic Immunomodulators - Orencia Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Orencia 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. The patient’s diagnosis is indicated for preferred biologic immunomodulator medication(s)* AND ONE of the following:
         1. The patient’s medication history indicates use of preferred biologic immunomodulator medication(s)*
            OR
         2. The patient has an intolerance or hypersensitivity to preferred biologic immunomodulator medication(s)*
            OR
         3. The patient has an FDA labeled contraindication to preferred biologic immunomodulator medication(s)*
            OR
      2. The request is for an FDA labeled indication that is not covered by preferred biologic immunomodulator medication(s)*
         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

*NOTE:

• Use of TWO preferred medications (Enbrel, Hadlima, Humira, Rinvoq tablets, Rinvoq solution, or Simlandi) is required for diagnosis of juvenile idiopathic arthritis
• Use of TWO preferred medications (Enbrel, Hadlima, Humira, Rinvoq tablets, or Simlandi) is required for diagnosis of rheumatoid arthritis
• For patients 18 years of age or over, use of TWO preferred medications (Cosentyx, Enbrel, Hadlima, Humira, Otezla, Rinvoq tablets, Rinvoq solution, Simlandi, Skyrizi, Stelara, or Tremfya) is required for diagnosis of psoriatic arthritis
• For patients between 6 and less than 18 years of age, use of ONE preferred medication (Cosentyx) is required for diagnosis of psoriatic arthritis
• For patients between 2 and less than 6 years of age, NO preferred medication is required for diagnosis of psoriatic arthritis
• NO preferred medication is required for diagnosis of prophylaxis of acute graft vs host disease

Length of approval: 12 months

Renewal Evaluation

Orencia 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