Adalimumab* Printer-Friendly Version   

Medical Policy: 05.01.01 
Original Effective Date: July 2004 
Reviewed: April 2008 
Revised:  

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

Description: 

Adalimumab, marketed under the trade name Humira®, is a fully human monoclonal antibody specific for human tumor necrosis factor (TNF). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that hallmark these diseases.

Adalimumab is indicated for reducing the signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderate to severe active rheumatoid arthritis (RA) who have failed to show an adequate response to one or more of the disease modifying antirheumatic drugs (DMARDs).  Adalimumab may be used alone, or in combination with methotrexate or certain other DMARDS.

Adalimumab is indicated, as monotherapy or in combination with DMARDs, for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis.

Adalimumab is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Adalimumab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; and reducing signs and symptoms and inducing clinical remission in these patients if they have lost response to or are intolerant to infliximab.

Adalimumab is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies have failed.

Adalimumab is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

Prior Approval is recommended. Submit a prior approval/treatment request now.

Policy: 

Ankylosis Spondylitis

Adalimumab for the treatment of ankylosing spondylitis may be considered medically necessary for the following criteria:

• individual is 18 years of age or older
• patients who have shown an inadequate response to one or more of the following:
  • glucocorticoids
  • methotrexate
  • sulfasalazine

Crohn’s Disease

Adalimumab for the treatment of Crohn’s disease may be considered medically necessary for the following criteria:

• individual is 18 years of age or older
• in patients with moderately to severely active Crohn's disease for reducing signs and symptoms and inducing and maintaining clinical remission
• in patients with an inadequate response to one or more of the following:
  • glucocorticoids
  • methotrexate
  • sulfasalazine
• OR in patients if they have lost response to or are intolerant of infliximab

Juvenile Idiopathic Arthritis

Adalimumab for the treatment of Juvenile Idiopathic Arthritis (JIA) may be considered medically necessary for the following criteria:

• individual is 4 years of age or older
• patient is at least 15kg
• patients have shown inadequate response to one or more of the following:
  • glucocorticoids
  • methotrexate
  • sulfasalazine

Plaque Psoriasis

Adalimumab for the treatment of plaque psoriasis may be considered medically necessary for the following criteria:

• individual is 18 years of age or older
• to reduce the signs and symptoms of moderate to severe plaque psoriasis
• patient is a candidate for systemic therapy or phototherapy
• patients who have shown an inadequate response to one or more of the following:
  • azathioprine
  • methotrexate
  • oral or injectable gold
  • hydroxychloroquine
  • leflunomide
  • D-penicillamine
  • sulfasalazine

Psoriatic Arthritis

Adalimumab for the treatment of active psoriatic arthritis may be considered medically necessary for the following criteria:

• individual is 18 years of age or older
• to reduce the signs and symptoms of active arthritis in psoriatic arthritis
• patients who have shown an inadequate response to one or more of the following:
  • azathioprine
  • methotrexate
  • oral or injectable gold
  • hydroxychloroquine
  • leflunomide
  • D-penicillamine
  • sulfasalazine

Rheumatoid Arthritis:

Adalimumab for the treatment of rheumatoid arthritis may be considered medically necessary for the following criteria:

• individual is 18 years of age or older
• treatment of moderate to severe active rheumatoid arthritis
• patients who have shown an inadequate response to one or more of the following:
  • azathioprine
  • methotrexate
  • oral or injectable gold
  • hydroxychloroquine
  • leflunomide
  • D-penicillamine
  • sulfasalazine

Any patient being considered for adalimumab to treat any of the above indications must have been evaluated for active and latent tuberculosis prior to the initiation of adalimumab therapy.

Due to the potential for serious infection, concurrent use of adalimumab with interleukin-1 antagonists and other anti-TNF agents is not recommended, according to the manufacturer and the Food and Drug Administration (FDA).

Adalimumab is considered investigational treatment under the following circumstances:

• For any condition not listed above, including, but not limited to:
  • ulcerative colitis
  • multiple sclerosis

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT** codes, Alpha Numeric HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• HCPCS code J0135 Injection, adalimumab, 20 mg  

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Selected References: 

• Keystone EC, Kavanaugh AF, Sharp JT et al.  Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial.  Arthritis Rheum.  2004 May;50(5):1400-11.
• Weinblatt ME, Keystone EC, Furst DE et al.  Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial.  Clin Exp Rheumatol. 2004 Jan-Feb;22(1):34-5.
• Den Broeder AA, Creemers MC, van Gestel AM, van Riel PL.  Dose titration using the Disease Activity Score (DAS28) in rheumatoid arthritis patients treated with anti-TNF-alpha.  Rheumatology (Oxford)  2002 Jun;41(6):638-42.
• Mease PJ, Gladman SS, Ritchlin CT et al. Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. (ADEPT) Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005 Oct;52(10):3279-89.
• Van der Heijde D, Kivitz A, Schiff MH et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006 Jul;54(7):2136-46.
• Sandborn WJ, Hanauer S, et al. An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease.  Am J Gastroenterol. 2004 Oct;99(10):1984-9.
• Hanauer SB, Sandborn WJ, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial.  Gastroenterology. 2006 Feb;130(2):323-33; quiz 591.
• Colombel JF, Sandborn WJ, et al.  Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65.
• Reed MR, taylor AL. Tumor necrosis factor inhibitors in ankylosing spondylitis. Intern Med J. 2008 Apr 14 [Epub ahead of print].
• Alonso-Ruiz A Pijoan JI, Ansuategui E et al. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Dosird. 2008 Apr 17;9(1):52.
• Saad AA, Symmons DP, Noyce PR et al. Risks and benefits of tumor necrosis factor-a inhibitors in the management of psoriatic arthritis: systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2008 Mar 15 [Epub ahead of print].
• Lutt JR, Deodhar A. Rheumatoid arthritis: strategies in the management of patients showing an inadequate response to TNF alpha antagonists. Drugs. 2008;68(5):591-606.
• van der Bijl AE, Breedveld FC, Antoni CE et al. An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and anti-infliximab antibody status. Clin Rheumatol. 2008 Mar 19 [Epub ahead of print].
• Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006893. 

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Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309

*Prior Approval is recommended.

**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.

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.