Biologic Immunomodulators - Rituxan Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

PA applies to new starts only

Initial Evaluation

Rituxan will be approved when ONE of the following is met:

1. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication AND 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 180 days
      OR
   2. The prescriber states the patient is currently being treated with the requested medication
      OR
2. ALL of the following:
   1. ONE of the following:
      1. The patient has a diagnosis of rheumatoid arthritis 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 patient has another FDA labeled indication or an indication that is supported in CMS approved compendia*
         AND
   2. The patient has been screened for hepatitis B infection measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) and has begun therapy, if appropriate, prior to receiving the requested medication
      AND
   3. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
      AND
   4. The patient does NOT have any FDA labeled limitation(s) of use for the requested medication that is not otherwise supported in NCCN guidelines

Length of approval: 12 months

*NOTES:

• Use of TWO preferred medications (Cyltezo, Enbrel, Hadlima, Humira, Rinvoq tablets, Xeljanz tablets, or Xeljanz XR) is required for diagnosis of rheumatoid arthritis
• ALL other diagnoses do NOT require any preferred medications

Renewal Evaluation

Rituxan 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 or an indication that is supported in CMS approved compendia for the requested medication
   AND
3. 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 180 days
      OR
   2. The prescriber states the patient is currently being treated with the requested medication
      OR
   3. ALL of the following
      1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
         AND
      2. The patient has had clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency)
         AND
      3. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
         AND
      4. The patient does NOT have any FDA labeled limitation(s) of use for the requested medication that is not otherwise supported in NCCN guidelines

Length of approval: 12 months