Subject: Pomalyst SGM 2234-A P2024

Drug

POMALYST  (pomalidomide)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

• Treatment of multiple myeloma, in combination with dexamethasone, in adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of their last therapy
• Treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in adult patients with KS who are human immunodeficiency virus (HIV)-negative

Compendial Uses²

• Systemic light chain amyloidosis
• Primary central nervous system lymphoma
• POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome
• Multiple myeloma

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Multiple Myeloma^1-2

Authorization of 12 months may be granted for treatment of multiple myeloma when any of the following criteria are met:

• The member has previously received at least two prior regimens for multiple myeloma including an immunomodulatory agent and proteasome inhibitor and the requested medication will be used in one of the following regimens:
  • In combination with elotuzumab and dexamethasone
  • In combination with ixazomib and dexamethasone if lenalidomide- or anti-CD-38 refractory
  • In combination with cyclophosphamide and dexamethasone
  • In combination with isatuximab-irfc and dexamethasone if bortezomib- or lenalidomide-refractory
  • In combination with dexamethasone
  • In combination with selinexor and dexamethasone
  • As a single agent
• The member has previously received at least one prior regimen for multiple myeloma and the requested medication will be used in one of the following regimens:
  • In combination with carfilzomib and dexamethasone
  • In combination with bortezomib and dexamethasone if lenalidomide- or anti-CD-38 refractory
  • In combination with carfilzomib, daratumumab, and dexamethasone
  • In combination with daratumumab and dexamethasone if immunomodulatory agent and proteasome inhibitor were previously given and the disease is bortezomib- or lenalidomide-refractory

Systemic Light Chain Amyloidosis²

Authorization of 12 months may be granted for treatment of relapsed or refractory systemic light chain amyloidosis in combination with dexamethasone.

Kaposi Sarcoma^1,2

Authorization of 12 months may be granted for the treatment of Kaposi sarcoma when either of the following criteria are met:

• The requested medication will be used in combination with antiretroviral therapy for the treatment of HIV-related Kaposi sarcoma
• Member is HIV-negative

Primary Central Nervous System Lymphoma²

Authorization of 12 months may be granted for treatment of primary central nervous system lymphoma as a single agent.

POEMS Syndrome²

Authorization of 12 months may be granted for treatment of POEMS syndrome in combination with dexamethasone.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Pomalyst [package insert]. Princeton, NJ: Bristol Myers Squibb Company; March 2023.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 1, 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

May 18, 2025