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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-56

Original Effective Date: 01/01/12

Reviewed: 10/12/16

Revised: 02/16/17

Subject: Thalidomide (Thalomid®) Capsules

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Thalidomide (Thalomid®) was approved by the U.S. Food and Drug Administration (FDA) in July 1998 for the treatment of erythema nodosum leprosum (ENL) and later in May 2006 for newly diagnosed multiple myeloma (MM). Celgene, the manufacturer of thalidomide, previously received orphan drug designation from the FDA for the approved indications (ENL – 1995, MM – 1998), and also received designations for several off-label indications (treatment of primary brain malignancies - 1998, Crohn's disease – 1999, Kaposi's sarcoma - 1998, HIV-wasting syndrome - 1996, myelodysplastic syndrome (MDS) – 2004, severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients - 1995, and treatment of mycobacterium infections – 1993). While the mechanism of action of thalidomide is not completely understood, it is known that the agent selectively reduces levels of tumor necrosis factor alpha by accelerating degradation of messenger RNA encoding protein.

National Comprehensive Cancer Network (NCCN) Guidelines for Multiple Myeloma (Version 3.2016), Non-Hodgkin’s Lymphomas (Version 3.2016), Systemic Light Chain Amyloidosis (Version 1.2016), and Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma (Version 2.2016) include category 1 and/or 2A recommendations for use of thalidomide in some capacity in each disease state and/or disease subtypes.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

The initiation of thalidomide meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met, AND thalidomide will NOT be used in combination with another immunomodulatory drug [i.e., lenalidomide (Revlimid®) or pomalidomide (Pomalyst®)]:

1. Multicentric Castleman’s disease (CD)

a. Thalidomide is used as monotherapy or in combination with rituximab (Rituxan®)

b. Treatment is used as second-line or later therapy for relapsed, refractory, or progressive disease

c. Member’s dosage does not exceed 200 mg daily obtained using the fewest number of capsules possible

2. Multiple Myeloma (MM)

a. Member has active (symptomatic) multiple myeloma

b. Laboratory documentation of the member’s baseline (i.e., within 30 days prior to initiating treatment with thalidomide) serum monoclonal protein (M-protein) as detected by serum protein electrophoresis (SPEP) is provided

c. Member’s dosage does not exceed 200 mg daily obtained using the fewest number of capsules possible

3. Systemic Light Chain Amyloidosis (SLCA)

a. The diagnosis has been validated by confirming the presence of amyloid deposits in tissue AND the deposits are composed of light chains

b. Laboratory documentation of the member’s baseline (i.e., within 30 days prior to initiating treatment with thalidomide) serum free light chains (SFLC) as detected by serum free light chain assay (SFLCA) is provided

c. Member is receiving concomitant dexamethasone unless contraindicated or member is steroid-intolerant (contraindication or intolerance must be specified)

d. Member’s dosage does not exceed 200 mg daily obtained using the fewest number of capsules possible

4. Waldenström's Macroglobulinemia (a.k.a., Lymphoplasmacytic Lymphoma)

a. Member has symptomatic disease (e.g., hyperviscosity, neuropathy, symptomatic adenopathy or organomegaly, amyloidosis, cryoglobulinemia, cold agglutinin disease, presence of cytopenia)

b. Laboratory documentation of the member’s baseline (i.e., within 30 days prior to initiating treatment with thalidomide) serum IgM level is provided

c. Thalidomide is used as monotherapy or in combination with rituximab (Rituxan®)

d. Member’s dosage does not exceed 200 mg daily obtained using the fewest number of capsules possible

5. Erythema Nodosum Leprosum (ENL)

a. ONE of the following:

i. Member is currently having acute cutaneous manifestations of moderate to severe ENL

ii. Thalidomide is for maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence

b. Member’s dosage does not exceed 400 mg daily obtained using the fewest number of capsules possible

6. Lupus Erythematosus

a. Member has moderate to severe cutaneous manifestations resulting in impaired quality of life

b. Member has previously tried and failed an adequate trial (at least 60 days), has persistent intolerable adverse effects, or has a contraindications to ALL of the following (the adverse effects and/or contraindications must be specified):

i. Hydroxychloroquine

ii. At least TWO immunosuppressant drugs (i.e., azathioprine, cyclosporine, leflunomide, methotrexate, or mycophenolate)

iii. An oral retinoid (i.e., acitretin or isotretinoin)

c. Member’s dosage does not exceed 200 mg daily obtained using the fewest number of capsules possible

7. Refractory, chronic graft-versus-host disease (GVHD) following bone marrow transplant (BMT)

a. Member has a diagnosis of chronic GVHD (defined as occurring at least 100 days after BMT)

b. Member is using lenalidomide as salvage therapy for highly refractory disease. The member must have previously failed or have contraindications to ALL of the following treatments:

i. Corticosteroids

ii. Calcineurin inhibitor (e.g., cyclosporine or tacrolimus)

iii. Sirolimus

iv. Mycophenolate mofetil

v. Methotrexate

c. Member’s dosage does not exceed 800 mg daily obtained using the fewest number of capsules possible

Duration of approval: 6 months

Continuation of thalidomide (Thalomid®) meets the definition of medical necessity when ALL of the following are met:

1. Authorization/reauthorization for thalidomide has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of multiple myeloma, systemic light chain amyloidosis, multicentric Castleman’s disease, Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma, chronic GVHD, lupus erythematosus with cutaneous manifestations, or erythema nodosum leprosum, OR the member previously met ALL indication-specific initiation criteria.

2. ANY of the following based on the indication for use:

a. Multiple myeloma:

i. If less than18 months of treatment – a serum M-protein value decrease of 25% or more* compared to baseline, or is undetectable, AND no increase in the size or number of lytic bone lesions after at least two cycles of treatment with thalidomide – laboratory documentation of the follow-up serum-M protein must be submitted

ii. 18 or more months of treatment - provider attestation that the member had not had disease progression during thalidomide treatment

*An exception is permitted if a baseline serum M-protein value is unavailable. Follow-up laboratory documentation of the serum-M protein still must be submitted, and the non-lab requirements still must be met (i.e., no increase in the size or number of lytic bone lesion). If the follow-up serum M-protein is still detectable, the physician must provide an attestation of a beneficial clinical response.

b. Systemic light chain amyloidosis:

i. If less than18 months of treatment - there has been a reduction (improvement) in the member’s SFLC level as compared to baseline# after at least two cycles of treatment with thalidomide - laboratory documentation of the SFLC level must be submitted

ii. If 18 or more months of treatment -- provider attestation that the member had not had disease progression during pomalidomide treatment

#An exception is permitted if a baseline SFLC value is unavailable. Follow-up laboratory documentation of the SFLC level still must be submitted. The physician must provide an attestation of a beneficial clinical response.

c. All other indications – The member has had a benefical response to treatment per physician attestation

3. Thalidomide is NOT used in combination with another immunomodulatory drug [i.e., lenalidomide (Revlimid®) or pomalidomide (Pomalyst®)]

4. The member’s dosage does not exceed the following:

a. Multicentric Castleman’s disease, Lupus erythematosus, Waldenström's macroglobulinemia, Multiple Myeloma or Systemic Light Chain Amyloidosis – 200 mg daily obtained using the fewest number of capsules possible

b. Erythema Nodosum Leprosum (ENL) – 400 mg daily obtained using the fewest number of capsules possible

c. Chronic graft-versus-host disease (GVHD) – 800 mg daily obtained using the fewest number of capsules possible

Thalidomide meets the definition of medical necessity when used for ANY of the following designated Orphan Drug indications, the members has previously failed first-line treatment, the dosage does not exceed 400 mg daily (obtained using the fewest number of capsules possible), AND thalidomide will NOT be used in combination with another immunomodulatory drug (i.e., lenalidomide or pomalidomide):

1. Treatment of HIV-associated wasting syndrome

2. Treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised members (e.g., members with AIDS)

3. Treatment of primary brain malignancies (e.g. glioblastoma multiforme, hemangioblastomatosis, etc.)

4. Treatment of Crohn's disease

5. Treatment of Kaposi's sarcoma

6. Treatment of the clinical manifestations of mycobacterial infection caused by Mycobacterium tuberculosis and non-tuberculous mycobacteria

7. Treatment of myelodysplastic syndrome (MDS)

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Thalidomide is indicated for: (1) the treatment of patients with newly diagnosed multiple myeloma in combination with dexamethasone, (2) acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL), and (3) as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide is NOT indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

• Multiple myeloma: 200 mg once daily. The recommended dose of dexamethasone is 40 mg/day on days 1-4, 9-12, and 17-20 every 28 days.

• Erythema nodosum leprosum: 100 to 300 mg/day for an episode of cutaneous ENL. Patients weighing less than 50 kilograms should be started at the low end of the dose range. Up to 400 mg/day for severe cutaneous ENL. In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly and eventually tapered and discontinued when the neuritis has ameliorated. Dosing should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks. Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.

Dosage Adjustments

• Renal impairment: no dosage adjustment is needed

• Hepatic impairment: no clinical studies have been conducted in patients with hepatic impairment

• Toxicity: No specific dosage recommendations are given in the package insert. Consider dose reduction, delay, or discontinuation in patients who develop NCI CTC (National Cancer Institute Common Toxicity Criteria) Grade 3 or 4 adverse reactions and/or based on clinical judgment.

Drug Availability

• Capsules: 50 mg, 100 mg, 150 mg and 200 mg

PRECAUTIONS:

Boxed Warning

• Embryo-fetal toxicity: If thalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects. Pregnancy must be excluded before start of treatment. Prevent pregnancy thereafter by the use of two reliable methods of contraception. Thalidomide is only available through a restricted distribution program, the THALOMID REMS™ program (formerly known as the System for Thalomid Education and Prescribing Safety (S.T.E.P.S.®) program).

• Venous thromboembolism: Significant increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma receiving thalidomide with dexamethasone. Ischemic heart disease (including myocardial infarction) and stroke have been observed. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism. Consider thromboprophylaxis based on an assessment of individual patients’ underlying risk factors.

Contraindications

• Pregnancy

• Hypersensitivity to thalidomide

Precautions/Warnings

• Thrombocytopenia: including Grade 3 or 4 occurrences, has been reported in association with the clinical use of thalidomide. Monitor blood counts, including platelet counts. Dose reduction, delay, or discontinuation may be required.

• Tumor lysis syndrome: Monitor patients at risk (e.g., those with high tumor burden prior to treatment) and take appropriate precautions.

• Peripheral neuropathy: Examine patients at monthly intervals for the first 3 months of thalidomide therapy and periodically thereafter for signs or symptoms of peripheral neuropathy. Consider electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and thereafter every 6 months in an effort to detect asymptomatic neuropathy.

• Increased HIV viral load: Measure viral load after the first and third months of treatment and every 3 months thereafter

• Bradycardia: Monitor patients for bradycardia and possible syncope. Dose reduction or discontinuation may be required.

• Seizures: Monitor patients with a history of seizures or at risk for the development of seizures closely for clinical changes that could precipitate acute seizure activity.

• Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Do NOT resume thalidomide following discontinuation for these reactions.

• Neutropenia: Patients may require dose interruption and/or dose reduction.

• Dizziness and Orthostatic Hypotension: Advise patients to sit upright for a few minutes prior to standing up from a recumbent position

• Drowsiness and Somnolence: Instruct patients to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness.

• Drug Interactions: Use caution if other drugs which have sedative and hypnotic properties, slow cardiac conduction and/or cause peripheral neuropathy must be used.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

A30.0 – A30.9

Leprosy [Hansen's disease]

A31.0

Pulmonary mycobacterial infection

A31.1

Cutaneous mycobacterial infection

A31.8

Other mycobacterial infections

A31.9

Mycobacterial infection, unspecified

B20

Human immunodeficiency virus [HIV] disease (must be billed in combination with K12.0 or R64)

C46.0 – C46.9

Kaposi's sarcoma

C70.0 – C70.9

Malignant neoplasm of meninges

C71.0 – C71.9

Malignant neoplasm of brain

C83.00 – C83.09

Small cell B-cell lymphoma

C88.0

Waldenström macroglobulinemia

C90.00

Multiple myeloma not having achieved remission

C90.01

Multiple myeloma in remission

C90.02

Multiple myeloma in relapse

C90.10

Plasma cell leukemia not having achieved remission

C90.12

Plasma cell leukemia, in relapse

C90.20

Extramedullary plasmacytoma not having achieved remission

C90.21

Extramedullary plasmacytoma in remission

C90.22

Other immunoproliferative neoplasms, in relapse

C90.30

Solitary plasmacytoma not having achieved remission

C90.31

Solitary plasmacytoma in remission

C90.32

Solitary plasmocytoma in relapse

C92.10

Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission

D46.0

Refractory anemia without sideroblasts, so stated

D46.1

Refractory anemia with sideroblasts

D46.20 – D46.21

Refractory anemia with excess of blasts

D46.4

Refractory anemia, unspecified

D46.9

Myelodysplastic syndrome, unspecified [use for preleukaemia (syndrome) NOS]

D46.A

Refractory cytopenia with multilineage dysplasia

D46.B

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

D46.Z

Other myelodysplastic syndromes

D47.Z2

Castleman disease

D47.Z9

Neoplasm of uncertain behavior of plasma cells

D89.811

Chronic graft-versus-host disease

D89.812

Acute on chronic graft-versus-host disease

E85.9

Amyloidosis, unspecified

K12.0

Recurrent oral aphthae

K50.00 – K50.919

Crohn's disease (regional enteritis)

L52

Erythema nodosum

L93

Lupus erythematosus

R64

Cachexia

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Common Terminology Criteria for Adverse Events (CTCAE): standardized definitions for adverse events published by the National Cancer Institute to describe the severity of organ toxicity for patients receiving cancer therapy. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved.

Heavy chain: the larger component of an immunoglobulin. There are five types: IgG, IgA, IgM, IgD, and IgE.

Immunoglobulins (a.k.a., antibodies): proteins made by normal plasma cells that have an important role in fighting infection as part of the humoral immune response. Antibodies are composed of two heavy chains and two light chains that form a larger complex. Each plasma cell produces only one type of heavy chain and one type of light chain.

Light chain: the smaller component of an immunoglobulin. There are two types: kappa and lambda.

Minimal response (MR) (according to the Revised Uniform Response Criteria by the International Myeloma Working Group) ALL of the following:

• ≥25% but ≤49% reduction of serum M-protein

• Reduction in 24-hour urine M-protein by 50% to 89%

• In addition, if present at baseline, 25% to 49% reduction in size of soft tissue plasmacytomas is also required

No increase in size or number of lytic bone lesions (development of compression fractures dose not exclude response).

Multiple Myeloma: a malignant neoplasm of plasma cells in which the plasma cells proliferate and invade the bone marrow, causing destruction of the bone and resulting in pathologic fracture and bone pain. It is the most common type of monoclonal gammopathy, characterized by presence of a monoclonal immunoglobulin (immunoglobulin recognized as a single protein), Bence Jones proteins in the urine, anemia, and lowered resistance to infection. Also called plasma cell myeloma.

Myeloma Protein (M-Protein): a nonfunctional immunoglobulin protein or protein fragment produced by malignant plasma cells (or myeloma cells). Since myeloma cells are monoclonal, the M-proteins for a given patient are structurally identical. Both portions of an immunoglobulin (the heavy chain and light chain) can be found in the serum, while only light chains can be found in the urine.

Non-Hodgkin’s Lymphoma: a large group of lymphatic cancers that comprise approximately 90% of all diagnosed lymphomas. All lymphomas are defined as cancerous growth of lymphocytes, better known as white blood cells, which are the body's primary defense against infection and disease. In lymphoma, these lymphocytes mutate and reproduce uncontrollably, crowding out healthy cells and forming tumors.

Plasma cell: a fully differentiated B lymphocyte (a type of white blood cell) that is specialized for immunoglobulin production and is found primarily in bone marrow.

Plasmacytoma: a discrete tumor consisting of neoplastic, monoclonal (originating from a single cell) plasma cells in either bone or soft tissue (extramedullary).

Refractory (cancer): cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment or it may become resistant during treatment.

Serum Protein Electrophoresis (SPEP) – a test that detects and quantifies the amount of M-protein in the serum. An serum M-protein of greater than 30 g/L is consistent with a diagnosis of MM.

Smoldering (Asymptomatic) myeloma: defined as M-protein in serum of 30 g/dL or more AND/OR bone marrow clonal plasma cells of 10% or more and no related organ or tissue impairment (no end organ damage, including bone lesions) or symptoms.

RELATED GUIDELINES:

Autologous Bone Marrow and Stem Cell Transplantation 02-38241-01

Bortezomib (Velcade®) IV 09-J0000-92

Carfilzomib (Kyprolis) IV, 09-J1000-81

Daratumumab (Darzalex) IV, 09-J2000-49

Doxorubicin HCl Liposome (Doxil®) IV 09-0000-91

Elotuzumab (Empliciti) IV, 09-J2000

Etanercept (Enbrel®) 09-J0000-38

Infliximab (Rituxan®) 09-J0000-39

Interferons for Oncology Use 09-J0000-37

Ixazomib (Ninlaro), 09-J2000-51

Lenalidomide (Revlimid®) 09-J0000-80

Melphalan, Captisol-Enabled (Evomela®) IV, 09-J2000-61

Panobinostat (Farydak®), 09-J2000-37

Pomalidomide (Pomalyst®) Capsule, 09-J1000-95

Zoledronic Acid IV (Reclast®; Zometa®) 09-J0000-72

OTHER:

None

REFERENCES:

  1. Baret I and De Haes P. Thalidomide: Still an important second-line treatment in refractory cutaneous lupus erythematosus? J Dermatolog Treat. 2015 Apr;26(2):173-7.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Sept 23]. Available from: http://www.clinicalpharmacology.com/.
  3. Dignan FL, Amrolia P, Clark A, et al. Diagnosis and management of chronic graft-versus-host disease. Br J Haematol. 2012 Jul;158(1):46-61. Epub 2012 Apr 26.
  4. Dimopoulos MA, Gertz MA, Kastritis E, et al. Update on treatment recommendations from the Fourth International Workshop on Waldenstrom's Macroglobulinemia. J Clin Oncol. 2009 Jan 1;27(1):120-6.
  5. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Sept 23]. Available from: http://www.thomsonhc.com/.
  6. Jacobson JM, Spritzler J, Fox L, et al: Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection.. J Infect Dis 1999; 180:61-7.
  7. Multiple myeloma treatment guidelines [Internet]. Version 3.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 28]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf
  8. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 23]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  9. Non-Hodgkin’s Lymphomas treatment guidelines [Internet]. Version 3.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 28]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.
  10. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016 Sept 23]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  11. Parker PM, Chao N, Nademanee A, et al: Thalidomide as salvage therapy for chronic graft-versus-host disease. Blood 1995; 86:3604-3609.
  12. Systemic Light Chain Amyloidosis treatment guidelines [Internet]. Version 1.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 28]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/amyloidosis.pdf.
  13. Thalomid (thalidomide) capsule [package insert]. Celgene Corporation: Summit, NJ. August 2015.
  14. Treon SP, Soumerai JD, Branagan AR, et al. Thalidomide and rituximab in Waldenstrom macroglobulinemia. Blood. 2008 Dec 1;112(12):4452-7.
  15. Vogelsang GB, Farmer ER, Hess AD, et al: Thalidomide for the treatment of chronic graft-versus-host disease. N Engl J Med 1992; 326:1055-1058.
  16. Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma treatment guidelines [Internet]. Version 2.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 28]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/waldenstroms.pdf
  17. Winkelmann RR, Kim GK, Del Rosso JQ, et al. Treatment of Cutaneous Lupus Erythematosus: Review and Assessment of Treatment Benefits Based on Oxford Centre for Evidence-based Medicine Criteria. J Clin Aesthet Dermatol. 2013 Jan; 6(1): 27–38.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

12/15/12

Review and revision to guideline; consisting of updating position statement, dosage and administration, contraindications, precautions and warnings, exceptions and references

11/15/13

Review and revision to guideline; consisting of revision and reformatting position statement, dosage/administration, precautions, decision tree, and references

11/15/14

Review and revision to guideline; consisting of description and references

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Review and revision to guideline consisting of updating the description, position statement, dosage/administration, precautions, billing/coding, definitions, related guidelines, and references.

10/01/16

Revision: ICD-10 code updates

11/15/16

Review and revision to guideline consisting of updating the description, position statement, dosage/administration, precautions, billing/coding, definitions, related guidelines, and references

02/16/17

Revision: Update to Position Statement.

Date Printed: June 23, 2017: 06:33 PM