Pharmacy Prior Authorization Criteria

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.

  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.

• 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.

  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.

• 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).

  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 (rituximab and hyaluronidase human)

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 (rituximab and hyaluronidase human)

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 (rituximab and hyaluronidase human)

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 (rituximab and hyaluronidase human)

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

P & T Revisions

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

References

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.

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End Notes

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]

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Revision History

• 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.

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