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Medical Policy: 05.01.34
Original Effective Date: April 2011
Reviewed: March 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Ipilimumab, marketed under the trade name Yervoy™ (Bristol-Meyers Squibb, Princeton, NJ) is a fully human, monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to potentiate an antitumor T-cell response.
In a recent phase III study, ipilimumab was shown to improve overall survival in patients with advanced melanoma. Patients receiving ipilimumab plus a peptide vaccine had a median survival of 10 months, compared with 6.4 months for patients receiving the vaccine alone (p < 0.001). Compared with the peptide vaccine alone, ipilimumab showed a near doubling of the rates of survival at 12 months (46% vs 25%) and 24 months (24% vs 14%). Ipilimumab was approved by the United States Food and Drug Administration (FDA) to treat patients with unresectable or metastatic melanoma. The FDA approval comes with a black box warning prompted by severe, life-threatening or fatal immune-mediated adverse reactions experienced during phase II and phase III trials of ipilimumab. The majority of these reactions initially manifested during treatment, however some occurred weeks to months after discontinuation of treatment. Ipilimumab is administered intravenously (3mg/kg) over 90 minutes every 3 weeks for a total of 4 doses.
Ipilimumab is currently being studied in a number of clinical trials for other indications including, but not limited to, prostate cancer, non-small-cell lung cancer, neuroblastoma, histiocytoma of the bone, and pancreatic cancer.
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Prior Approval:
Not applicable
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Policy:
Ipilimumab may be considered medically necessary for the treatment of unresectable or metastatic melanoma.
Ipilimumab is considered investigational for all other indications.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- J9228 Injection, ipilimumab, 1 mg
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Selected References:
- Hodi FS, O’Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363(8):711-23.
- Weber J, Thompson JA, Hamid O et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009;15:5591-8.
- Wolchok JD, Neyns B, Linette G et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 2010;11:155-64.
- O’Day SJ, Maio M, Chiarion-Sileni V et al. Efficacy and safety of ipilimumab monotherapy in patients with previously treated, advanced melanoma: a multicenter, single-arm phase II study. Ann Oncol 2010 February 10 [Epub ahead of print].
- Wolchok JD, Weber JS, Hamid O et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Camcer Immun. 2010 Oct 20;10:9-14.
- Spagnolo F, Caltabiano G, Queirolo P. Uveal melanoma. Cancer Treat Rev. 2012 Jan 12. [Epub ahead of print].
- Patel SP, Woodman SE. Profile of ipilimumab and its role in the treatment of metastatic melanoma. Drug Des Devel Ther. 2011;5:489-95. Epub 2011 Dec 16.
- Lemech C, Arkenau HT. Novel treatments for metastatic cutaneous melanoma and the management of emergent toxicities. Clin Med Insights Oncol. 2012; 6:53-66. Epub 2012 Jan 5.
- Mansh M. Ipilimumab and cancer immunotherapy: a new hope for advanced stage melanoma. Yale J Biol Med. 2011 Dec;84(4):381-9.
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Policy History:
Date Reason Action
April 2011 Literature review New policy
March 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark 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 Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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