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Anakinra (Kineret®) works by blocking the biologic activity of IL-1 by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses.

Abatacept (Orencia®) is the first in a new class of agents known as selective modulators of a co-stimulatory signal that is required for full T-cell activation.  It has been shown in vitro to decrease T-cell proliferation and inhibit the production of tumor necrosis factor alpha, interferon-gamma and interleukin-2.

Rituximab (Rituxan®) is a genetically engineered protein that binds specifically to CD20, a protein found on the surface of B-cells at certain stages in their lifecycle.  In laboratory experiments, it has been shown that once the rituximab molecule attaches to the B-cell, it initiates B-cell lysis.  B-cells are found in abnormally high numbers within the inflamed joints of people with rheumatoid arthritis.

Certolizumab pegol (Cimzia®) is the first pegylated anti-TNF alpha. It has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

Tocilizumab (Actemra®) is an interleukin-6 (IL-6) receptor inhibitor.  IL-6 is a proinflammatory cytokine produced by a variety of cell types such as T- and B- cells.  IL-6 has been shown to be involved  in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion and is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.

Tofacitinib (Xeljanz®) is an inhibitor of Janus kinases (JAK). JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function.

FDA APPROVED INDICATIONS:

Rheumatoid Arthritis:

Adalimumab (Humira®) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with  moderately to severely active rheumatoid arthritis.  It can be used alone or in combination with methotrexate (MTX) or other non-biologic disease modifying antirheumatic drugs (DMARDs).

Etanercept (Enbrel®) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.  It can be initiated in combination with MTX or used alone. 

Anakinra (Kineret®) is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more DMARDs.  It can be used alone or in combination with DMARDs other than TNF blocking agents.

Infliximab (Remicade®), in combination with MTX, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.

Abatacept (Orencia®) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. It can be used as a monotherapy or concomitantly with DMARDs other than TNF antagonists.

Rituximab (Rituxan®) in combination with methotrexate is indicated for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Golimumab (Simponi®) is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate.

Certolizumab pegol (Cimzia®) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis.

Tocilizumab (Actemra®) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.

Tofacitinib (Xeljanz) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis:

Etanercept (Enbrel®) is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function,  in patients with psoriatic arthritis. It can be used in combination with MTX in patients who do not respond adequately to MTX alone.

Adalimumab (Humira®) is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in adult patients with active arthritis in patients with psoriatic arthritis.  It can be used alone or in combination with non-biologic DMARDs.

Infliximab (Remicade®) is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.

Golimumab (Simponi®) is indicated for the treatment of active psoriatic arthritis in adults, alone or in combination with methotrexate.

Ankylosing Spondylitis:

Adalimumab (Humira®) is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Etanercept (Enbrel®) is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Infliximab (Remicade®) is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Golimumab (Simponi®) is indicated for the treatment of active ankylosing spondylitis in adults.

Juvenile Idiopathic Arthritis:

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

Abatacept (Orencia®) is indicated for reducing signs and symptoms in pediatric patients six years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept Orencia® may be used as monotherapy or concomitantly with methotrexate.

Etanercept (Enbrel®) is indicated for reducing signs and symptoms of moderately to severely active polyarticular JIA in patients two years of age and older.

Tocilizumab (Actemra®) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients two years of age and older.

Other:

See Crohn's Disease and Ulcerative Colitis and Chronic Plaque Psoriasis medical policies.

IDENTIFICATION:

Generic Name:  Abatacept
Brand Name:  Orencia®

Generic Name: Adalimumab
Brand Name: Humira®

Generic Name: Anakinra
Brand Name: Kineret®

Generic Name: Certolizumab pegol
Brand Name:Cimzia®

Generic Name: Etanercept
Brand Name: Enbrel®

Generic Name: Golimumab
Brand Name: Simponi®

Generic Name: Infliximab
Brand Name: Remicade®

Generic Name:  Rituximab
Brand Name: Rituxan®

Generic Name:  Tocilizumab
Brand Name: Actemra®

Generic Name:  Tofacitinib
Brand Name: Xeljanz®

Before consideration of coverage may be made, it should be established that the patient has been unresponsive to conventional methods of treatment such as physical therapy, non-steroidal anti-inflammatory agents (NSAIDs) and local/oral steroids. The patient must also have failed at least one disease modifying antirheumatic drug (DMARD). Failure of DMARD therapy is not required for ankylosing spondlitis.

Etanercept (Enbrel®) is considered medically necessary for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. Effective 04/01/11, new starts are only considered for Enbrel after failed treatment with Humira.

Anakinra (Kineret®) is considered medically necessary for rheumatoid arthritis.  Effective 04/01/11, new starts are only considered for Kineret after failed treatment with Humira.

Adalimumab (Humira®) is considered medically necessary for rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. Once weekly dosing with Humira may only be considered after failed therapy using every other week dosing.

Infliximab (Remicade®) may be considered medically necessary for rheumatoid arthritis after failed treatment with Enbrel, Humira, Simponi, or Kineret, for ankylosing spondylitis after failed treatment with Enbrel, Humira, or Simponi, and for psoriatic arthritis after failed treatment with Enbrel, Simponi or Humira. 

Abatacept (Orencia®) may be considered medically necessary for rheumatoid arthritis after failed treatment with Enbrel, Humira, Simponi or Kineret and for juvenile idiopathic arthritis after failed treatment with Enbrel or Humira. 

Rituximab (Rituxan®) may be considered medically necessary for rheumatoid arthritis after failed treatment with Enbrel, Humira, Simponi or Kineret. 

Golimumab (Simponi®) may be considered medically necessary in adults for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Effective 04/01/11, new starts are only considered for Simponi after failed treatment with Humira.

Certolizumab (Cimzia®) may be considered medically necessary in adults with moderately to severely active rheumatiod arthritis. Effective 04/01/11, new starts are only considered for Cimzia after failed treatment with Humira.

Tocilizumab (Actemra®) may be considered medically necessary for systemic juvenile idiopathic arthritis and in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least two of the following medications: Enbrel® , Humira® , Remicade®, Cimzia® and Simponi®.

Effective 10/15/12, Tocilizumab (Actemra®) may be considered medically necessary for systemic juvenile idiopathic arthritis and in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least one of the following medications: Enbrel® , Humira® , Remicade®, Cimzia® and Simponi®.

Tofacitinib (Xeljanz®) may be considered medically necessary for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate and after failed treatment with at least one of the following medications: Enbrel®, Humira®, Simponi®, Kineret®, Cimzia®, Rituxan, Remicade®, or Orencia®. Dosage should not exceed 10mg/day (60 tablets/month).

For infliximab (Remicade®), certolizumab pegol (Cimzia®), or adalimumab (Humira®) use in Crohn's disease and infliximab (Remicade®) use in ulcerative colitis, refer to Crohn's Disease and Ulcerative Colitis medical policy. 

For etanercept (Enbrel®), adalimumab (Humira®), or infliximab (Remicade®) use in psoriasis, refer to Chronic Plaque Psoriasis 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.

1/22/2004: Nova Factor new telephone and fax numbers added for Remicade, Enbrel, Humira and Kineret. Telephone # 1-866-591-9075 and fax # 1-866-591-9094 deleted for Remicade. Prior authorization requirement for Enbrel, Humira and Kineret added which is effective 2/2/04.

3/15/2004: Policy section second sentence; Once weekly dosing with Humira may only be considered with documentation of failed therapy using every other week dosing "of Humira and after failed treatment with Enbrel" deleted. The sentence now reads: "Once weekly dosing with Humira may only be considered with documentation of failed therapy using every other week dosing."

5/3/2004: Policy section; Infliximab coverage expanded for rheumatoid arthritis if failed treatment with Humira or Kineret. Coverage sentence now reads: "Infliximab (Remicade®) may be considered medically necessary for rheumatoid arthritis after failed treatment with Enbrel, Humira or Kineret."

6/3/2004: Policy section first paragraph "but not limited to" added, HCPCS J1745 added

1/24/2005: New FDA approved indication - coverage expanded - Infliximab (Remicade) is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.  Sources updated

10/28/2005:  Description section updated. FDA approved indications revised;  recommended dosing information deleted; link to Ulcerative Colitis and Chronic Plaque Psorias medical policy added;  deleted Off-Label uses under identification. Policy section updated; changed preferred provider to Accredo and changed the telephone # from 1-866-489-1899 to 1-866-240-3373. Deleted statement "including, but not limited to, methotrexate"; changed two to one for number of DMARDs the patient must fail.  Deleted statements about Infliximab and its use in the treatment of Crohn's disease and removed link to the Treatment of Crohn's Disease medical policy.   Added statement about etanercept use in psoriasis and link to Chronic Plaque Psoriasis medical policy.   Sources updated;  Anakinra (Kineret®), Adalimumab (Humira®), and Infliximab (Remicade®) added.

11/04/2005:  Code Reference section updated, HCPCS codes J1438, J1745, J3490 moved from the CPT section on the table to the HCPCS section, the drug Enbrel added to the description of code J1438, the drug Remicade added to the description of code J1745.

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

1/2006:  Approved by Pharmacy & Therapeutics (P&T) Committee. 

1/23/2006Policy updated to add Abatacept (Orencia®).  Prior authorization requirement added for Orencia.  Policy section updated to distinguish Accredo as the preferred provider for Remicade, Enbrel, Humira and Kineret.  Orencia telephone and fax numbers added.  Code Reference section updated to add J7799 as a covered HCPCS code.

2/7/2006: Code reference table updated: code J0135 added, Adalimumab and Humira deleted from the description of code J3490.

3/14/2006: Policy updated to add Rituximab (Rituxan®).  Prior authorization required added for Rituxan.  Policy section updated to add Accredo and CuraScript as preferred providers for Rituxan. Policy section updated to add: contact Blue Cross Blue Shield of MS for Orencia.  HCPCS J9310 code added to policy

3/30/2006: Policy updated to state failure of DMARD therapy is not required for ankylosing spondylitis

04/2006: Approved by Pharmacy & Therapeutics ( P&T) Committee

6/29/2006: CuraScript fax number changed from 877-462-6234 to 866-239-5502

7/14/2006: Policy section updated; Accredo deleted as preferred provider for Rituximab (Rituxan®).

8/21/2006: FDA Approved Indications and Policy section updated to add ankylosing spondylitis for Humira.

12/27/2006: Code reference section updated per the 2007 HCPCS revisions

1/2/2007: Code reference section updated; ICD-9 codes 714.81, 714.9, and 714.89 deleted

4/27/2007: Updated policy section. Deleted information to contact Blue Cross & Blue Shield of Missisippi for Orencia. Added Orenica to CuraScript and Accredo as our preferred provider. Added Rituxan to Accredo as our preferred provider

4/10/2008: Added juvenile idiopathic arthritis as an indication for Humira

4/23/2008: Added juvenile idiopathic arthritis as an indication for Orenica

7/29/2008: Updated FDA approved indication for Abatacept (Orenica®)

12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions

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

05/11/2009: Policy section updated with addition of Golimumab (Simponi®) may be considered medically necessary in adults for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Prior authorization required. 

05/18/2009: Policy section updated with addition of Certolizumab pegol (Cimzia®) may be considered medically necessary in adults with moderately to severely active rheumatoid arthritis. Prior authorization required.

02/22/2010:  Policy section updated with addition of Tocilizumab (Actemra®).  Tocilizumab (Actemra®) may be considered medically necessary in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least two of the following medications: Enbrel® , Humira® , Remicade®, Cimzia® and Simponi®. Prior authorization is required. Added HCPCS Code J3590 to Covered Codes Table for Actemra®.

02/28/2011: Added new HCPCS code J3262 for Actemra® to the Code Reference section. 

03/31/2011: The first policy statement was updated to state that failure of DMARD therapy is not required for ankylosing spondlitis. The policy statements regarding Enbrel, Kineret, Simponi, and Cimzia were revised to state that effective 04/01/11, new starts are only considered after failed treatment with Humira.

01/17/2012: Policy description updated. Policy statement for Actemra® updated regarding coverage criteria for systemic juvenile idiopathic arthritis. "Failure of DMARD therapy is not required for ankylosing spondlitis" was deleted from the policy statement for Enbrel®. Also changed "rheumatoid" to "idiopathic in the Enbrel® statement. Replaced "with documentation of failed therapy" with "after failed therapy" in the policy statement for Humira®.

11/27/2012: Policy description and statement updated regarding Tocilizumab (Actemra®). Policy statement revised to state that effective 10/15/12, Tocilizumab (Actemra®) may be considered medically necessary for systemic juvenile idiopathic arthritis and in adults with moderately to severely active rheumatoid arthritis after failed treatment with at least one of the following medications: Enbrel® , Humira® , Remicade®, Cimzia® and Simponi®.

01/09/2013:  Added the following to the Policy Exceptions section: State Health Plan (State and School Employees):  The Anti-Rheumatic Biologicals listed in this policy do not require prior authorization. However, they will be reviewed for medical necessity based on medical policy guidelines.

03/06/2013:  Policy updated to add coverage criteria for Tofacitinib (Xeljanz®), which may be considered medically necessary for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate and after failed treatment with at least one of the following medications: Enbrel®, Humira®, Simponi®, Kineret®, Cimzia®, Rituxan, Remicade®, or Orencia®. Dosage should not exceed 10mg/day (60 tablets/month). Prior authorization is required. Added J8499 to the Code Reference section.

Etanercept (Enbrel®) Prescribing Information

Anakinra (Kineret®) Prescribing Information (added 10-28-2005)

Adalimumab (Humira®) Prescribing Information (added 10-28-2005)

Drug Facts and Comparisons. Available at www.efactsweb.com Accessed October, 2003.

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis – 2002 update. Arthritis Rheum. 2002; 46:328-46.

http://www.fda.gov/  (added 1-24-2005)

Infliximab (Remicade®) Prescribing Information (added 10-28-2005)

Orencia® Prescribing Information (added 1-23-2006).

Rituxan® Prescribing Information (added 3-7-2006)

Simponi® Prescribing Information (added 5-11-2009)

Cimzia® Prescribing Information (added 5-18-2009)

Actemra® Prescribing Information (added 2-22-2010)

Xeljanz® Prescribing Information (added 3-06-2013) 

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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