REVLIMID (lenalidomide)

REVLIMID (lenalidomide) 

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• Multiple myeloma (MM), in combination with dexamethasone.
• MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
• Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
• Previously treated follicular lymphoma (FL), in combination with a rituximab product.
• Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Limitation of Use:

• REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Coverage Criteria:

Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), or Multiple Myeloma (MM):

• Chart note documentation confirms use of Revlimid for treatment of MCL, MZL, or MM.

Follicular Lymphoma (FL):

• Chart note documentation confirms use of Revlimid for treatment of FL; AND
• One of the following:
  • Revlimid will be used in combination with a rituximab product, OR
  • The patient has been treated with one prior therapy for FL (examples include, but not limited to: bendamustine [Treanda®] + obinutuzumab [Gazyva®] or rituximab; CHOP [cyclophosphamide, doxorubicin, vincristine, prednisone] + obinutuzumab or rituximab; CVP [cyclophosphamide, vincristine, prednisone] + obinutuzumab or rituximab; rituximab monotherapy; chlorambucil with or without rituximab; cyclophosphamide with or without rituximab).

Myelodysplastic Syndromes (MDS):

• Chart note documentation confirms use of Revlimid for treatment of MDS; AND
• One of the following:
  • The patient has symptomatic anemia, OR
  • The patient has transfusion-dependent anemia, OR
  • The patient has anemia that is not controlled with an erythroid stimulating agent (ESA) (e.g., Epogen®/Procrit® [epoetin alfa injection], Aranesp® [darbepoetin alfa injection])

Dosing:

• MM combination therapy: up to 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.
• MM maintenance therapy following auto-HSCT: up to 10 mg once daily.
• MCL: up to 25 mg once daily orally on Days 1-21 of repeated 28-day cycles.
• MDS: up to 10 mg once daily.
• FL or MZL: up to 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles.
   

Coverage Duration:

1 year.

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Revlimid is dose adjusted for hematologic toxicities, non-hematologic adverse reactions, and in patients with renal impairment (see package insert for full dosing information).

Review History:

• 10/15/2020 – Annual review.
• 01/08/2021 – Annual review; updated formatting; added limitation of use; updated dosing.

References:

• Revlimid (lenalidomide) capsules [package insert]. Summit, NJ: Celgene.; October 2019.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – B-Cell Lymphoma, version 4.2020 – October 13, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed January 04, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Multiple Myeloma, version 4.2021 – December 10, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed January 04, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Myelodysplastic Syndromes, version 2.2021 – December 24, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed January 04, 2021