Pharmacy Prior Authorization Criteria

Revlimid (lenalidomide)

Indications for Prior Authorization

Revlimid (lenalidomide)

• For diagnosis of Myelodysplastic Syndromes
  Indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

  Limitations of Use: Not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials. [A]

• For diagnosis of Multiple Myeloma
  In combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). Also indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

  Limitations of Use: Not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials. [A]

• For diagnosis of Mantle Cell Lymphoma (MCL)
  Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

  Limitations of Use: Not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials. [A]

• For diagnosis of Follicular Lymphoma (FL)
  Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

  Limitations of Use: Not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials. [A]

• For diagnosis of Marginal Zone Lymphoma (MZL)
  Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

  Limitations of Use: Not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials. [A]

Criteria

Brand Revlimid, Generic lenalidomide

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes, Multiple Myeloma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

• Diagnosis of ONE of the following:
• Symptomatic or transfusion-dependent anemia due to myelodysplastic syndrome (MDS) associated with a deletion 5q abnormality [2]
OR
• Multiple Myeloma
OR
• Relapsed or progressed mantle cell lymphoma (MCL)
OR
• Follicular lymphoma (FL) that has been previously treated
OR
• Marginal zone lymphoma (MZL) that has been previously treated

Brand Revlimid, Generic lenalidomide

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes, Multiple Myeloma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-04-18, 2023-06-20, 2023-04-28, 2023-04-22, 2022-04-21, 2021-09-27, 2021-05-26, 2020-04-30

References

1. Revlimid Prescribing Information. Celgene Corporation. Princeton, NJ. March 2023.
2. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available by subscription at: www.nccn.org. Accessed March 8, 2024.

---

End Notes

1. Although the prescribing information for Revlimid states that it is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials due to the increased risk of mortality, current NCCN practice guideline still recommends single agent lenalidomide or in combination with rituximab for relapsed/refractory CLL. [1, 2]

---

Revision History

• 2024-04-18: 2024 annual review - no criteria changes, background updates.
• 2023-06-20: Removal of specialist requirement
• 2023-04-28: Program update to remove criteria and only leave the diagnosis and specialist requirements.
• 2023-04-22: Updated drug examples of MCL therapies to just "chemotherapy". Added generic lenalidomide 2.5 and 20mg strengths.
• 2022-04-21: Annual review - added generic lenalidomide capsules. Updated references.
• 2021-09-27: Annual review - updated references. Added EHB formulary.
• 2021-05-26: Annual review - updated references. Added EHB formulary.
• 2020-04-30: Annual review - removed reference to drug name in reauth criteria; updated references.

---