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Rituximab Medicare Part B – Step Therapy

Medicare Policy
Version Date: 01/01/2023

Part B Step Therapy Criteria for Approval

Riabni, Rituxan, and Rituxan Hycela will be approved when ALL of the following are met:

  1. The requested medication is being used for ONE of the following:
    1. An FDA approved indication
      OR
    2. An indication in CMS approved compendia
      AND
  2. ONE of the following:
    1. Information has been provided that indicates the patient has been treated with the requested medication in the past 365 days
      OR
    2. There is documentation that the patient has had an ineffective treatment response to the active ingredient(s) of ALL preferred medication(s)
      OR
    3. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to the active ingredient(s) of ALL preferred medication(s)
      OR
    4. The prescriber has submitted documentation indicating ALL preferred medication(s) are likely to be ineffective or are likely to cause an adverse reaction or other harm to the patient
      OR
    5. BOTH of the following (for oncology indications):
      1. The National Comprehensive Cancer Network (NCCN) does NOT specify the preferred medication(s) as a preferred regimen for the requested indication
        AND
      2. NCCN specifies the requested medication as a preferred regimen for the requested indication

Length of approval: 12 months

See table of preferred medications below

NOTES:

  • Rituxan Hycela is NOT indicated for non-oncologic diagnoses
  • Prerequisite medications may require prior review under Medicare Part D or Medicare Part B. Medicare Part D prerequisites will not be required for Medical Only members.
  • Length of approval may be shorter due to provider network participation status.
  • Coverage of one Medicare Part B Step Therapy medication could equate to multiple medication authorizations when they share the same Medicare Part B Step Therapy criteria.
  • LCD/NCD criteria review completed, if applicable, in addition to the Plan’s Medicare Part B Step Therapy criteria.
Targeted Part B MedicationPreferred Medications*†
Riabni (rituximab-arrx)Ruxience (rituximab-pvvr) and Truxima (rituximab-abbs)
Rituxan (rituximab)Ruxience (rituximab-pvvr) and Truxima (rituximab-abbs)
Rituxan Hycela (rituximab and hyaluronidase human)Ruxience (rituximab-pvvr) and Truxima (rituximab-abbs)

*Preferred medications may vary based upon indication

†Preferred medications require prior authorization under the member’s medical (Part B) benefit