Confidential Medical History - Diagnostic Center of Medicine

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5.04.11
Section:
Prescription Drugs
Effective Date:
January 1, 2013
Subsection:
Biologic
Original Policy Date:
December 7, 2011
Subject:
Sylatron
Page:
1 of 7
Last Review Status/Date:
December 6, 2012
Sylatron
Description
Sylatron (peginterferon alfa-2b)
Background
Sylatron (peginterferon alfa-2b) is an alfa interferon, a cytokine whose mechanism of action in
patients with melanoma is unknown. 1 Sylatron was approved by the FDA on March 29, 2011.2
Peginterferon alfa-2b is also sold under the brand name Peg-Intron.4 It is possible that some
prescribers might attempt to use Sylatron for any of the uses for which Peg-Intron might be
used, both labeled (e.g., hepatitis C)4 and off-label (including renal cell carcinoma, chronic
myelogenous leukemia, condyloma acuminatum in patients with treatment-resistant-HIV
infection, and essential thrombocythemia).5 Sylatron and Peg-Intron are dosed differently and
are available in different dosages. Peg-Intron is available in 50, 80, 120, and 150 mcg/0.5 mL
single-use vials, dosed by body weight 1 mcg/kg/week SQ for up to 48 weeks.4 Sylatron is
available in 296, 444, and 888 mcg single-use powder vials, dosed by body weight at 6
mcg/kg/wk SQ for 8 doses, followed by 3 mcg/kg/wk SQ for up to 5 years.1
NCCN Drugs & Biologics Compendium recommends Peginterferon alfa-2b as the primary
treatment as a single agent for newly diagnosed CML, defined as Philadelphia chromosomepositive AND/OR BCR-ABL-positive, in rare patients unable to tolerate imatinib, dasatinib, or
nilotinib or are post transplant without remission or with relapse. 6,7
5.04.11
Section:
Prescription Drugs
Effective Date:
January 1, 2013
Subsection:
Biologic
Original Policy Date:
December 7, 2011
Subject:
Sylatron
Page:
2 of 5
Regulatory Status
FDA-approved indication: Sylatron is an alpha interferon indicated for the adjuvant treatment of
melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical
resection including complete lymphadenectomy.1
Sylatron has the following black-box warning regarding depression and other neuropsychiatric
disorders: “The risk of serious depression, with suicidal ideation and completed suicides, and
other serious neuropsychiatric disorders are increased with alpha interferons, including
Sylatron. Permanently discontinue Sylatron in patients with persistently severe or worsening
signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not
resolve after stopping Sylatron.”
Sylatron prescribing information contains warnings about adverse reactions including:
neuropsychiatric (including suicide, suicidal and homicidal ideation, depression, and an
increased risk of relapse of recovering drug addicts, aggressive behavior, psychoses,
hallucinations, bipolar disorders, mania, and encephalopathy), cardiovascular (including
myocardial infarction, bundle-branch block, ventricular tachycardia, supraventricular arrhythmia,
hypotension, cardiomyopathy, and angina pectoris), ocular (including a decrease in visual acuity
or blindness due to retinopathy, macular edema, retinal artery or vein thrombosis, retinal
hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal
detachment), hepatic (Sylatron increases the risk of hepatic decompensation and death in
patients with cirrhosis), and endocrinopathy (hypothyroidism, hyperthyroidism, and diabetes
mellitus).1
Sylatron is contraindicated in patients with a history of anaphylaxis reaction to peginterferon
alfa-2b or interferon alfa-2b, autoimmune hepatitis, or hepatic decompensation (Child-Pugh
score >6 [class B and C]).
Related policies
Alferon N, Intron A
Policy
This policy statement applies to clinical review performed for pre-service (Prior Approval,
Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.
5.04.11
Section:
Prescription Drugs
Effective Date:
January 1, 2013
Subsection:
Biologic
Original Policy Date:
December 7, 2011
Subject:
Sylatron
Page:
3 of 5
Prior-Approval Requirements
Diagnosis
Patient must have ONE of the following diagnoses
1. Melanoma
AND ALL of the following:
A. Gross or microscopic nodal involvement, and
B. Had surgical resection including complete lymphadenectomy, and
C. Request is being made within 84 days (12 weeks) of surgical resection
2. Chronic myelogenous leukemia (CML) in the first chronic phase that are Philadelphia
chromosome-positive AND/OR BCR-ABL positive
AND
Unable to tolerate tyrosine kinase inhibitors e.g. Gleevec (imatinib), Sprycel
(dasatinib) or Tasigna (nilotinib)
OR
Is post transplant without remission or with relapse
AND NONE of the following:
1. Autoimmune hepatitis
2. Decompensated hepatic disease
3. Uncontrolled major depression – patient must be monitored for signs and symptoms
of depression and other psychiatric symptoms during treatment
5.04.11
Section:
Prescription Drugs
Effective Date:
January 1, 2013
Subsection:
Biologic
Original Policy Date:
December 7, 2011
Subject:
Sylatron
Page:
4 of 5
Prior – Approval Renewal Requirements
Patient must have ALL of the following
1. Is currently receiving Sylatron therapy
2. Is being monitored for signs and symptoms of depression and other psychiatric disorders
Policy Guidelines
Pre - PA Allowance
None
Prior - Approval Limits
Duration
12 months
Prior – Approval Renewal Limits
Duration
12 months per renewal, for up to 5 years total treatment time
Rationale
Summary
Sylatron is an alpha interferon indicated for the adjuvant treatment of melanoma with
microscopic or gross nodal involvement within 84 days of definitive surgical resection including
complete lymphadenectomy.
NCCN Drugs & Biologics Compendium recommends Peginterferon alfa-2b as the primary
treatment as a single agent for newly diagnosed CML, defined as Philadelphia chromosomepositive AND/OR BCR-ABL-positive, in rare patients unable to tolerate imatinib, dasatinib, or
nilotinib or are post transplant without remission or with relapse.
Sylatron has the following black-box warning regarding depression and other neuropsychiatric
disorders: “The risk of serious depression, with suicidal ideation and completed suicides, and
other serious neuropsychiatric disorders are increased with alpha interferons, including
Sylatron. Permanently discontinue Sylatron in patients with persistently severe or worsening
signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not
resolve after stopping Sylatron.”
5.04.11
Section:
Prescription Drugs
Effective Date:
January 1, 2013
Subsection:
Biologic
Original Policy Date:
December 7, 2011
Subject:
Sylatron
Page:
5 of 5
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of
Sylatron while maintaining optimal therapeutic outcomes.
References
1. Sylatron [package insert]. Kenilworth, NJ: Schering Corporation; March 2011.
2. U.S. Food and Drug Administration. Label and approval history.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_
ApprovalHistory#apphist. Accessed May 3, 2011.
3. Eggermont AMM, Suciu S, Santinami M, et al. Adjuvant therapy with pegylated interferon
alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC
18991, a randomised phase III trial. Lancet. 2008;372:117-26.
4. Peg-Intron [package insert]. Whitehouse Station, NJ: Schering Corporation; February 2011.
5. Drugdex® System. Thomson Micromedex. http://www.thomsonhc.com. (accessed May 2,
2011).
6. The NCCN Drugs & Biologics Compendium, 2011 National Comprehensive Cancer
Network, Inc.
http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=318
7. http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf Accessed 11/11/11
Policy History
Date
Action
December 2011
New Policy
Keywords
This policy was approved by the FEP® Pharmacy and Therapeutics Committee on
December 6, 2012 and is effective January 1, 2013.
Signature on File
__________________________
James A. Ferrendelli, M.D.
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