Revlimid. Revlimid (lenalidomide) Description. Section: Prescription Drugs Effective Date: July 1, 2015

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Revlimid Page: 1 of 6 Last Review Date: June 19, 2015 Revlimid Description Revlimid (lenalidomide) Background Revlimid is classed as an immunomodulator and is a chemical derivative of thalidomide. Although the exact mechanism of action is unknown, lenalidomide also has anti-inflammatory and anticancer properties. It selectively inhibits secretion of inflammatory cells, enhances the activity of immunity cells, and inhibits the growth of new blood vessels. The medication stops the growth of myeloma cells by causing cell cycle arrest and cell death. Revlimid is pregnancy category X, and may cause severe birth defects or fetal death (1,2). Regulatory Status FDA labeled indications: Revlimid is a thalidomide analogue indicated for the treatment of patients with: 1. Multiple myeloma (MM), in combination with dexamethasone; 2. 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; 3. Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included Velcade (bortezomib). Limitations 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 (2).

2 Subject: Revlimid Page: 2 of 6 Off Label Uses: Revlimid can be used as first line therapy for the treatment of multiple myeloma. The National Comprehensive Cancer Network (NCCN) Multiple Myeloma Panel guidelines recommend the use of Revlimid and dexamethasone as category 1 primary treatment option based clinical studies done (3). Revlimid can be used in the used in the treatment of both patients with previously untreated and relapsed /refractory indolent Non-Hodgkin s lymphoma. The combination Revlimid and Rituxan was also evaluated in a phase II study with previously untreated indolent Non-Hodgkin s lymphoma. The National Comprehensive Cancer Network (NCCN) for Non-Hodgkin s Lymphoma Panel guidelines recommend Revlimid for mantle cell lymphoma (MCL) whose disease has relapsed or progressed after one prior therapy; follicular lymphoma used in combination with Rituxan (rituximab); chronic lymphocytic leukemia (CLL) whose disease has relapsed or progressed after one prior therapy, used in combination with Rituxan; diffuse large B-cell lymphoma whose disease has relapsed or progressed after one prior therapy, used in combination with Rituxan (4). Revlimid is a pregnancy category X medication, and includes a boxed warning citing embryofetal toxicity, hematologic toxicity and venous thromboembolism. If Revlimid is used during pregnancy, it may cause birth defects or embryo-fetal death. Pregnancy must be excluded before start of treatment. Pregnancy must be prevented during treatment by the use of two reliable methods of contraception (2). Revlimid can cause significant neutropenia and thrombocytopenia. For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the first 8 weeks and monthly thereafter (2). Revlimid has a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma receiving Revlimid with dexamethasone (2). Revlimid is available only through a restricted distribution program called the Revlimid REMS program (formerly known as the RevAssist program ) (2). Safety and effectiveness of Revlimid in pediatric patients below the age of 18 years have not been established (2). Related policies

3 Subject: Revlimid Page: 3 of 6 Arzerra, Gazyva, Kyprolis, Imbruvica, Pomalyst, Rituxan, Treanda, Velcade, Zydelig Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Revlimid may be considered medically necessary in patients 18 years of age and older for the treatment of multiple myeloma and used in combination with dexamethasone or another corticosteroid, myelodysplastic syndromes (MDS) due to low- or intermediate-1-risk, transfusion-dependent anemia, laboratory confirmation of the deletion 5q abnormality in which complete blood counts should be monitored weekly for the first 8 weeks of therapy and at least monthly thereafter, and mantle cell lymphoma (MCL) whose disease has relapsed or progressed after one prior therapy; follicular lymphoma used in combination with Rituxan (rituximab); chronic lymphocytic leukemia (CLL) whose disease has relapsed or progressed after one prior therapy, used in combination with Rituxan; diffuse large B-cell lymphoma whose disease has relapsed or progressed after one prior therapy, used in combination with Rituxan. Prescriber and patient must be enrolled with the Revlimid REMS Program. Revlimid is considered investigational for patients less than 18 years of age and for all other indications. Prior-Approval Requirements Age Diagnoses 18 years of age or older Patient must have ONE of the following: 1. Multiple myeloma (MM) a. Must be used in combination with dexamethasone or another corticosteroid 2. Myelodysplastic syndromes (MDS) a. Low- or intermediate-1 risk b. Transfusion-dependent anemia c. Laboratory confirmation of the deletion 5q cytogenetic abnormality i. Complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter

4 Subject: Revlimid Page: 4 of 6 3. Mantle cell lymphoma (MCL) a. Disease must have relapsed or progressed after one prior therapy 4. Follicular lymphoma 5. Chronic lymphocytic leukemia (CLL) b. Disease must have relapsed or progressed after one prior therapy 6. Diffuse large B-cell lymphoma b. Disease must have relapsed or progressed after one prior therapy AND ALL of the following: 1. Prescriber and patient must be enrolled with the Revlimid REMS Program (formerly known as the RevAssist Program) Prior Approval Renewal Requirements Diagnoses Patient must have ONE of the following: 1. Multiple myeloma (MM) 2. Myelodysplastic syndromes (MDS) a. Complete blood counts monitored at least monthly 3. Mantle cell lymphoma (MCL) 4. Follicular lymphoma 5. Chronic lymphocytic leukemia 6. Diffuse large B-cell lymphoma

5 Subject: Revlimid Page: 5 of 6 AND ALL of the following: 1. Prescriber and patient must be enrolled with the Revlimid REMS Program (formerly known as the RevAssist Program) Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 12 months Prior Approval Renewal Limits Duration 12 months Rationale Summary Revlimid is classed as an immunomodulator and is a chemical derivative of thalidomide. It is indicated for the treatment of patients with multiple myeloma (MM), 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, and mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and diffuse large B-cell lymphoma. To avoid embryo-fetal exposure to Revlimid it is only available through a restricted distribution program. Prescribers must be certified with the Revlimid REMS Program (formerly known as the RevAssist Program). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Revlimid while maintaining optimal therapeutic outcomes. References 1. Clinical Pharmacology Web Site. Accessed April 22, Revlimid [package insert]. Summit, NJ: Celgene Corp; February 2015.

6 Subject: Revlimid Page: 6 of 6 3. NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma, version I.2015; August NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin s Lymphomas, version I. 2015; August Policy History Date August 2014 September 2014 October 2014 November 2014 December 2014 February 2015 June 2015 Action New addition to PA Annual review Removal of Multiple Myeloma one prior therapy requirement Removal of the requirement combination with dexamethasone or another corticosteroid in the Multiple Myeloma renewal section Rewording of the Myelodysplastic syndromes (MDS) Annual review and reference update Addition of follicular lymphoma, chronic lymphocytic leukemia (CLL), and diffuse large B-cell lymphoma. Change to mantle cell lymphoma to only require 1 prior therapy instead of 2 and removal of requirement of Velcade being tried and failed Annual review and reference update Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on June 19, 2015 and is effective July 1, Deborah M. Smith, MD, MPH