Subject: Thalomid 2368-A SGM P2021
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered covered benefits 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.
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: not indicated as monotherapy for ENL treatment in the presence of moderate to severe
neuritis
B. Compendial Uses
1. Myelofibrosis-related anemia
2. Multicentric Castleman’s disease
3. AIDS-related aphthous stomatitis
4. Kaposi’s sarcoma
5. Chronic graft-versus-host disease
6. Crohn’s disease
7. 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-related Anemia
Authorization of 12 months may be granted for treatment of myelofibrosis-related anemia when all of the
following criteria are met:
1. The requested medication will be given in combination with prednisone
2. The member has serum erythropoietin 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 erythropoietic stimulating agents
C. Erythema Nodosum Leprosum
Authorization of 12 months may be granted for treatment of erythema nodosum leprosum.
D. Crohn’s Disease
Authorization of 12 months may be granted for treatment of Crohn’s disease.
E. Kaposi’s Sarcoma
Authorization of 12 months may be granted for treatment of Kaposi’s 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’s Disease
Authorization of 12 months may be granted for treatment of multicentric Castleman’s disease.
H. AIDS-related Aphthous Stomatitis
Authorization of 12 months may be granted for treatment of AIDS-related aphthous stomatitis.
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’s Disease, Histiocytic Neoplasms, and Kaposi’s sarcoma
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization
for an indication listed in Section II 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’s disease, histiocytic
neoplasms, or Kaposi’s 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; February 2021.
- American Society of Health System Pharmacists. AHFS Drug Information. (Adult and Pediatric) Bethesda, MD. Electronic version, 2021. Available with subscription. URL: http://online.lexi.com/lco. Accessed October 5, 2021.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 5, 2021.
- DRUGDEX® System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed October 5, 2021.
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 16, 2022
