Subject: Thalomid 2368-A SGM P2022
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 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; February 2021.
- 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® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 4, 2022.
- DRUGDEX® System (electronic version). Micromedex Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed October 4, 2022.
- Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; Updated September 21, 2022. https://online.lexi.com. Accessed October 4, 2022.
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 15, 2023
