Pomalyst (Pomalidomide) Annual Review Date: 09/17/2020

Policy: Pomalyst (pomalidomide) Annual Review Date: 09/17/2020

Last Revised Date: 09/17/2020

OVERVIEW Pomalyst is a thalidomide analogue FDA indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Pomalyst is contraindicated in pregnancy as it is a known human teratogen that causes severe life-threatening birth defects. Pomalyst is available only through a restricted program called Pomalyst REMS.

POLICY STATEMENT This policy involves the use of Pomalyst. Prior authorization is recommended for pharmacy benefit coverage of Pomalyst. Approval is recommended for those who meet the conditions of coverage in the Criteria and Initial/Extended Approval for the diagnosis provided. Conditions Not Recommended for Approval are listed following the recommended authorization criteria. Requests for uses not listed in this policy will be reviewed for evidence of efficacy and for medical necessity on a case-by-case basis.

Because of the specialized skills required for evaluation and diagnosis of patients treated with Pomalyst as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Pomalyst be prescribed by or in consultation with a physician who specializes in the condition being treated. In order to be considered for coverage, this drug must be prescribed by or in consultation with a hematologist or oncologist. All approvals for initial therapy are provided for the initial approval duration noted below.

RECOMMENDED AUTHORIZATION CRITERIA Coverage of Pomalyst is recommended in those who meet the following criteria:

1. Multiple Myeloma Criteria. Patient must meet the following criteria (a, b, c, d and e): a. Patient is at least 18 years of age; AND b. Patient has a diagnosis of multiple myeloma; AND c. Patient has tried two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor (bortezomib or carfilzomib); AND d. Patient has demonstrated disease progression on or within 60 days of completion of the last therapy; AND e. Pomalyst is prescribed in combination with dexamethasone unless contraindicated or not tolerated.

This document is subject to the disclaimer found at https://www.medmutual.com/For-Providers/Policies-and-Standards/CorporateMedicalDisclaimer.aspx and is subject to change. https://www.medmutual.com/For-Providers/Policies-and-Standards/Prescription-Drug-Resources.aspx

2. Systemic Light Chain Amyloidosis Criteria. Approve for relapsed/refractory disease in combination with dexamethasone for patients at least 18 years of age.

3. Kaposi Sarcoma Criteria. Patient must meet the following criteria (a, b, c, d, and e): a. Patient is at least 18 years of age b. The patient meets ONE of the following: a. The patient has AIDS-related Kaposi Sarcoma and is using Pomalyst after failure of highly active antiretroviral therapy (HAART); OR b. The patient is HIV-negative; AND c. Patient is being treated for relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease; AND d. Disease has progressed on or not responded to first-line systemic therapy; AND e. Disease has progressed on alternate first-line systemic therapy.

4. Central Nervous System (CNS) Lymphoma Criteria. Patient must meet the following criteria (a and b): a. Patient is at least 18 years of age b. Treatment is for relapsed or refractory disease as a single agent in one of the following (i, ii, iii, or iv): i. Patients who have received prior whole brain radiation therapy; OR ii. Patients who have received a prior high-dose methotrexate-based regimen without prior radiation therapy; OR iii. Patients receiving Pomalyst in combination with whole brain radiation therapy or involved field radiation therapy who have received a prior high-dose methotrexate-based regimen without prior radiation therapy after no response or short response duration (<12 months) to prior regimen; OR iv. Patients who have received prior high-dose chemotherapy with stem cell rescue.

5. Patients with another indication that is not listed but is cited in the National Comprehensive Cancer Network (NCCN) guidelines as a category 1, 2A, or 2B recommendation Criteria. Prescriber will provide specific diagnosis for documentation. Approve.

6. Patient has been started on Pomalyst Criteria. Approve for an indication or condition addressed as an approval in this document.

Initial Approval/ Extended Approval. A) Initial Approval: 365 days B) Extended Approval: 365 days ______

Documentation Requirements:

The Company reserves the right to request additional documentation as part of its coverage determination process. The Company may deny reimbursement when it has determined that the drug provided or services performed were not medically necessary, investigational or experimental, not within the scope of benefits afforded to the member and/or a pattern of billing or other practice has been found to be either inappropriate or excessive. Additional documentation supporting medical necessity for the services provided must be made available upon request to the Company. Documentation requested may include patient records, test results and/or credentials of the provider ordering or performing a service. The Company also reserves the right to modify, revise, change, apply and interpret this policy at its sole discretion, and the exercise of this discretion shall be final and binding.

REFERENCES 1. Pomalyst (pomalidomide) Prescribing Information. Celgene Corporation, Summit NJ. May 2018 2. Pomalidomide Monograph. Lexicomp® Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised July 31, 2018. Accessed September 10, 2018. 3. The NCCN Drugs & Biologics Compendium. © 2020 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed 9 September 2020. Search terms: pomalidomide 4. The NCCN AIDS-Related Kaposi Sarcoma Practice Guidelines in Oncology (Version 1.2018). © 2018 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed September 10, 2018. 5. The NCCN Mutiple Myeloma Clinical Practice Guidelines in Oncology (Version 1.2019). © 2018 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed September 10, 2018. 6. Pomalidomide. In: DRUGDEX [online database]. Truven Health Analytics. Greenwood Village, CO. Last updated 12 August 2020. Accessed 9 September 2020.