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Adalimumab (Humira®) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Increased levels of TNF are also found in psoriasis plaques. Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.

Alefacept (Amevive®) is an immunosuppressive dimeric fusion protein that interferes with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/CD2 interaction. Activation of T lymphocytes involving the interaction between LFA-3 on antigen-presenting cells and CD2 on T lymphocytes plays a role in the pathophysiology of chronic plaque psoriasis.

Etanercept (Enbrel®) is a dimeric fusion protein that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors. Etanercept inhibits binding of both TNFa and TNFß to cell surface TNF receptors, rendering TNF biologically inactive which can result in a significant reduction in inflammation.

Infliximab (Remicade®) is a monoclonal antibody that blocks activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha).

Ustekinumab (Stelara™) is a human IgG1k monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses.

Raptiva® was voluntarily withdrawn from the market by the manufactuer, Genentech^TM effective June 8, 2009.  This was the result of several cases of reported progressive multifocal leukoencephalopathy in patients who were taking Raptiva® .

FDA APPROVED INDICATIONS

Alefacept (Amevive®), adalimumab (Humira®), ustekinumab (Stelara™), and etanercept (Enbrel®) are approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Infliximab (Remicade®) is indicated for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate

Other:

See Anti-Rheumatic Biologicals medical policy.

See Infliximab (Remicade®)  for Treatment of Crohn's Disease and Ulcerative Colitis 

See also Phototherapy medical policy 

IDENTIFICATION

Generic Name: Etanercept
Brand Name: Enbrel®

Generic Name: Alefacept
Brand Name: Amevive®

Generic Name: Infliximab
Brand Name: Remicade®

Generic Name: Adalimumab
Brand Name: Humira®

Generic Name: Ustekinumab
Brand Name: Stelara™

Alefacept (Amevive®), etanercept (Enbrel®), adalimumab (Humira®), ustekinumab (Stelara™), and Infliximab (Remicade®) are considered medically necessary for adults age 18 and older with moderate to severe chronic plaque psoriasis only when systemic therapy or phototherapy is indicated and the following criteria have been met:

1. Patient has a diagnosis of chronic plaque psoriasis, determined by a board certified dermatologist, present for greater than 1 year and involving 10% or more of total body surface area as determined by the Psoriasis Area and Severity Index (PASI).
2. Patient has failed treatment with at least 1 of the following systemic or photo therapies:

3.  Effective 04/01/11, new starts are only considered for Enbrel or Stelara after failed treatment with Humira.

4. For Amevive® only:

5.   For Remicade® only:

• Documentation of failure with Enbrel®, Raptiva®, Humira®, Stelara™, or Amevive® must be provided

For the first three months of treatment, Enbrel® will be covered at 50mg twice weekly dosing. A reduction to a maintenance dose of 50mg per week should be obtained.

For the first week of treatment, two Humira® injections (80mg) will be covered followed by a maintenance dose of 40mg every other week starting one week after the initial dose.

For the first month of treatment, two Stelara™ injections (45mg or 90mg dosage) will be covered followed by a maintenance dose of 45mg or 90mg every twelve weeks.

For entanercept (Enbrel®) use in rheumatoid arthritis, JRA, psoriatic arthritis, and ankylosing spondylitis, refer to Anti-Rheumatic Biologicals medical policy.

For Infliximab (Remicade®) use in Crohn's disease and ulcerative colitis, refer to Crohn's Disease and Ulcerative Colitis medical policy.  For infliximab (Remicade®) use in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, refer to Anti-Rheumatic Biologicals medical policy. 

For adalimumab (Humira®) use in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, refer to Anti-Rheumatic Biologicals medical policy. 

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

8/24/2004: Alefacept (Amevive®) and Efalizumab (Raptiva®) medical policies merged with Chronic Plaque Psoriasis medical policy and archived

9/30/2004: Code Reference section completed

10/28/2005:  Description section updated; deleted the statement "of the p75 TNF receptor" in the Etanercept definition; chart updated to include PUVB and PUVA.  FDA approved indications revised; deleted dosing information, added link to Anti-Rheumatic Biologicals medical policy.  Policy section updated; Accredo telephone # for Enbrel®  changed from 1-866-489-1899 to 1-866-240-3373.  Fax # changed from 1-866-489-1901 to 1-866-481-7762.  Accredo telephone # for Raptiva® changed from 1-866-898-0136 to 1-866-240-3373.  Fax # changed from 1-866-898-0136 to 1-866-481-7762.  CuraScript telephone # changed from 1-888-875-8062 to 1-877-462-6211.  Fax # changed from 1-888-875-8050 to 1-877-462-6234. Under Alefacept deleted step 2 about patient response to corticosteroids treatment.  Added statement about Entanercept use and link to Anti-Rheumatic Biologicals medical policy.   Sources updated;  Raptiva® added

11/04/2005:  Code Reference section updated, the drug's brand name added to the description of codes J0215 (Amevive®), J1438 (Enbrel®) and S0162 (Raptiva®)

11/2005:  Approved by Pharmacy & Therapeutics (P & T) Committee

6/27/2006: CuraScript fax number changed to 1-866-239-5502

8/22/2006: Coverage of Enbrel dosing addressed

9/27/2006: Remicade® information added to policy

2/16/2007: Fax number for Enbrel® and Remicade® changed from 1-866-481-7762 to 1-866-489-1901. Added Accredo telephone and fax number for Raptiva®

4/24/2007: Remicade® added to drug table

10/17/2007: Added Accredo is our preferred provider for Amevive®

2/4/2008: Added Humira® prescribing information. J0135 added.

01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.

3/9/2008: Notice of withdrawal of Raptiva® from the market added to policy.

10/30/2009: Policy Subtitle updated to add Ustekinumab (Stelara™), and to remove Efalizumab (Raptiva®), Description Section updated with Ustekinumab (Stelara™) description, FDA indication, and identification names, Effectiveness of Treatment Table removed, and Efalizumab (Raptiva®) description removed, Policy Statement Section updated to add Ustekinumab (Stelara™) medically necessary and treatment information, Policy Sources Section updated to add Ustekinumab (Stelara™) prescribing information, Coding Section updated to add CPT4 code J3490 to Covered Codes Table to be used to code Ustekinumab (Stelara™), HCPCS code S0162 removed from Covered Codes Table.

02/28/2011: Added new HCPCS J3357 for Stelara™ to the Code Reference section.

03/31/2011: Policy statement updated to state that effective 04/01/11, new starts are only considered for Enbrel or Stelara after failed treatment with Humira.

01/09/2013:  Added the following to the Policy Exceptions section:  State Health Plan (State and School Employees):  Prior authorization is not required for State Health Plan members.  However, these biologic drugs will be reviewed for medical necessity based on medical policy guidelines.

American Academy of Dermatology Association, Guidelines of Care for Psoriasis. Available at: http://www.aadassociation.org/Guidelines/psoriasis.html. 

Biogen, Inc. Amevive (alefacept) package insert.

Facts & Comparisons. Amevive monograph.

Genetech, Raptiva product information. Available at: http://www.gene.com/gene/products/information/immunological/raptiva/insert.jsp. Accessed November 2003.

Enbrel (etanercept) package insert.

Clinical Pharmacology Online. Methotrexate monograph. Available at: http://cp.gsm.com. Accessed June 2004.

Clinical Pharmacology Online. Cyclosporine monograph. Available at: http://cp.gsm.com. Accessed June 2004.

Laburte C, et al. Efficacy and safety of oral cyclosporin A for long-term treatment of chronic severe plaque psoriasis. Br J Dermatol. 1 Mar 2004; 130 (3): 366-75.

Raptiva® Prescribing Information (added 10-28-2005)

Remicade® Prescribing Information (added 9-27-2006)

Humira® Prescribing Information (added 2-4-2008)

Stelara™ Prescribing Information (added 10-29-2009)

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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