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Medical Policy: 05.01.28
Original Effective Date: June 2010
Reviewed: July 2011
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:
Ustekinumab, marketed as STELARA™, is a human IgG1κ monoclonal antibody against the p40 subunit of the interleukin (IL) -12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. Ustekinumab is indicated for the treatment of adult patients (18 years of age and older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Administered by subcutaneous injection, based on weight, the recommended dosage is administered initially and 4 weeks later, followed by subsequent administrations every 12 weeks. The safety and efficacy of ustekinumab have not been evaluated beyond two years.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment request now.
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Policy:
Ustekinumab may be considered medically necessary for the treatment of plaque psoriasis in adult patients (18 years of age and older) who are candidates for phototherapy or systemic therapy.
Any patient being considered for ustekinumab treatment should have been evaluated for active and latent tuberculosis (TB) prior to initiating treatment. Treatment of latent TB should be initiated prior to initiating treatment with ustekinumab.
The safety of ustekinumab in patients with a history of or a known malignancy has not been evaluated. Patients should be counseled about the risk of malignancies while receiving ustekinumab.
Ustekinumab is considered investigational for any indication not identified above.
The safety and efficacy of ustekinumab have not been evaluated beyond 2 years.
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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.
- J3357 Injection, ustekinumab, 1 mg
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Selected References:
- Lebwohl M, Papp K, Han C et al. Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. Br J Dermatol. 2009 Nov 9 [Epub ahead of print].
- Scanlon JV, Exter BP, Steinberg M et al. Ustekinumab: treatment of adult moderate-to-severe chronic plaque psoriasis. Ann Pharmacother. 2009 Sep; 43(9):1456-65. Epub 2009 Aug 11.
- Patel RV, Clark LN, Lebwohl M et al. Treatments for psoriasis and the risk of malignancy. J Am Acad Dermatol. 2009 Jun; 60(6):1001-17. Epub 2009 Apr 2.
- Gottlieb A, Menter A, Mendelsohn A et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomized, double-blind, placebo-controlled, cross-over trial. Lancet. 2009 Feb 21; 373 (9664): 633-40. Epub 2009 Feb 11.
- Leonardi CL, Kimball AB, Papp KA et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX1). Lancet. 2008 May 17; 371(9625):1665-74.
- Papp KA, Langley RG, Lebwohl M et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody in patients with psoriasis: 52-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17; 371(9625):1675-84.
- Griffiths CEM, Strober BE, van de Kerkhof P et al. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. N Engl J Med 2010; 362(2): 118-28.
- Herrier RN. Advances in the treatment of moderate-to-severe plaque psoriasis. Am J Health Syst Pharm. 2011 May 1; 68(9):795-806.
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Policy History:
Date Reason Action
July 2011 Annual review 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 © 2010 American Medical Association. All Rights Reserved.
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