WHA
 

Rituxan Hycela (rituximab and hyaluronidase human)

Indications for Prior Authorization

Rituxan Hycela (rituximab and hyaluronidase human)
  • For diagnosis of Follicular Lymphoma
    Indicated for the treatment of adult patients with: 1) Relapsed or refractory, follicular lymphoma as a single agent 2) Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy 3) Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

  • For diagnosis of Diffuse Large B-cell Lymphoma
    Indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

  • For diagnosis of Chronic Lymphocytic Leukemia (CLL)
    Indicated for the treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).

  • For diagnosis of Limitations of Use:
    Initiate treatment with Rituxan Hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion. Rituxan Hycela is not indicated for the treatment of non-malignant conditions.

Criteria

Rituxan Hycela

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Follicular Lymphoma

  • Diagnosis of follicular lymphoma
    • AND
  • One of the following:
    • Disease is relapsed or refractory
      • OR
    • Patient exhibited complete or partial response to prior treatment with rituximab in combination with chemotherapy
      • OR
    • Disease is non-progressing or stable following prior treatment with first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
      • OR
    • Both of the following:
      • Disease is previously untreated
        • AND
      • Medication is used in combination with first-line chemotherapy
    AND
  • One of the following:
    • Trial and failure, or intolerance to Ruxience
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing treatment regimen
Rituxan Hycela

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Follicular Lymphoma

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • One of the following:
    • Trial and failure, or intolerance to Ruxience
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Rituxan Hycela

Prior Authorization

Length of Approval: 12 months [A]
For diagnosis of Diffuse Large B-cell Lymphoma

  • Diagnosis of diffuse large B-cell lymphoma
    • AND
  • Disease is previously untreated
    • AND
  • Medication is being used in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy
    • AND
  • One of the following:
    • Trial and failure, or intolerance to Ruxience
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing treatment regimen
Rituxan Hycela

Prior Authorization

Length of Approval: 12 months [B]
For diagnosis of Chronic Lymphocytic Leukemia

  • Diagnosis of chronic lymphocytic leukemia
    • AND
  • Medication is being used in combination with fludarabine and cyclophosphamide (FC) therapy
    • AND
  • One of the following:
    • Trial and failure, or intolerance to Ruxience
      • OR
    • Continuation of therapy for patients currently in the midst of an ongoing treatment regimen

  • Guideline ID
    GL-548205

  • Formulary
    premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    Jul 26, 2017

P & T Revisions

2026-03-31, 2025-12-18, 2025-12-18, 2025-03-24, 2024-04-19, 2023-06-05, 2023-04-04, 2022-04-05, 2021-09-27, 2021-05-21, 2021-04-07, 2020-03-25, 2020-03-05

  1. Rixtuan Hycela Prescribing Information. Genentech, Inc. South San Francisco, CA. June 2021.
  2. Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006;24(19):3121-3127.
  3. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed March 25, 2024.
  4. Salles G, Seymour JF, Lopez-Guillermo A, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomized controlled trial. Lancet. 2011;377(9759):42-51.
  1. Treatment for DLBCL consists of up to 8 cycles of 21 days each, a total duration of 6 months [1,3]. There is little evidence that use of rituximab as continuation therapy following R-CHOP induction provides additional benefit above induction alone. [2] This is in contrast with follicular lymphoma, where evidence does support maintenance [4] therapy and NCCN recommends consolidation with rituximab monotherapy [3]. However, to account for potential delays in therapy without interrupting treatment, a 12 month authorization is provided.
  2. Treatment for CLL consists of up to 6 cycles of 28 days each, a total duration of 6 months [1]. To account for potential delays in therapy without interrupting treatment, a 12 month authorization is provided.
  3. An FDA-approved biosimilar is an appropriate substitute for rituximab. [3]
  4. The FDA defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. [4]
  • 2026-03-31: 2026 Annual Review. No clinical criteria changes. Updated product name to remove generic name of drug in parenthesis
  • 2025-12-18: No criteria change, bulk copy oRX-EHB
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-03-24: 2025 UM Annual Review. No changes
  • 2024-04-19: 2024 annual review. No changes to clinical content. Updated references.
  • 2023-06-05: Removed prescriber requirement.
  • 2023-04-04: Annual review - updated references.
  • 2022-04-05: Annual review - updated references.
  • 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-04-07: Annual review - updated references.
  • 2020-03-25: 2020 Annual Review - No changes to criteria
  • 2020-03-05: Revised criteria: added embedded step, removed induction dose requirement.