Subject: Thalomid 2368-A SGM P2023
Policy:
I. 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.
A. FDA-Approved Indications
1. Thalomid in combination with dexamethasone is indicated for the treatment of patients
with newly diagnosed multiple myeloma (MM).
2. Erythema Nodosum Leprosum (ENL)
a. Acute treatment of the cutaneous manifestations of moderate to severe ENL.
b. Maintenance therapy for prevention and suppression of the cutaneous manifestations
of ENL recurrence
Limitations of Use: Thalomid is not indicated as monotherapy for ENL treatment in the
presence of moderate to severe neuritis.
B. Compendial Uses
1. Multiple Myeloma
2. Myelofibrosis-associated anemia
3. Multicentric Castleman disease
4. Aphthous stomatitis
5. Kaposi sarcoma
6. Chronic graft-versus-host disease
7. Crohn’s disease
8. Histiocytic neoplasms
i. Langerhans cell histiocytosis
ii. Rosai-Dorfman disease
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Multiple Myeloma
Authorization of 12 months may be granted for treatment of multiple myeloma.
B. Myelofibrosis-associated Anemia
Authorization of 12 months may be granted for treatment of myelofibrosis-associated
anemia when all of the following criteria are met:
1. The requested medication will be given as a single agent or in combination with
prednisone
2. The member has serum erythropoietin (EPO) levels of either of the following:
a. 500 mU/mL or greater
b. Less than 500 mU/mL and no response or loss of response to erythropoiesis-
stimulating agents
C. Erythema Nodosum Leprosum
Authorization of 12 months may be granted for treatment and prevention of erythema
nodosum leprosum.
D. Crohn’s Disease
Authorization of 12 months may be granted for treatment of Crohn’s disease.
E. Kaposi Sarcoma
Authorization of 12 months may be granted for treatment of Kaposi sarcoma as subsequent
therapy.
F. Chronic Graft-versus-Host Disease
Authorization of 12 months may be granted for treatment of chronic graft-versus-host
disease.
G. Multicentric Castleman Disease
Authorization of 12 months may be granted for treatment of multicentric Castleman disease.
H. Aphthous Stomatitis
Authorization of 12 months may be granted for treatment of AIDS-related aphthous
stomatitis and recurrent aphthous stomatitis in immunocompromised members.
I. Histiocytic Neoplasms
Authorization of 12 months may be granted for treatment of histiocytic neoplasms, including
Langerhans cell histiocytosis and Rosai-Dorfman disease, as a single agent.
III. CONTINUATION OF THERAPY
A. Multiple Myeloma, Multicentric Castleman Disease, Histiocytic Neoplasms, and
Kaposi sarcoma
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for multiple myeloma, multicentric Castleman Disease, histiocytic
neoplasms, or Kaposi sarcoma when there is no evidence of unacceptable toxicity or
disease progression while on the current regimen.
B. All Other Indications
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section II, other than multiple myeloma,
multicentric Castleman disease, histiocytic neoplasms, or Kaposi sarcoma, who have
improvement in symptoms and no unacceptable toxicity.
Place of Service:
Outpatient
The above policy is based on the following references:
- Thalomid [package insert]. Summit, NJ: Celgene Corporation; March 2023.
- AHFS Drug Information. (Adult and Pediatric) Bethesda, MD. American Society of Health System Pharmacists, Inc. Electronic version. Updated March 28, 2022. Available with subscription. URL: http://online.lexi.com/lco. Accessed October 4, 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 6, 2023.
- DRUGDEX® System (electronic version). Micromedex Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed October 6, 2023.
- Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; Updated September 28, 2023. https://online.lexi.com. Accessed October 6, 2023.
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.
April 17, 2024
