Print Crohn's Disease and Ulcerative Colitis

Crohn's Disease and Ulcerative Colitis

 

Adalimumab (Humira(R))
Certolizumab pegol (Cimzia(R))
Golimumab (Simponi(R))
Infliximab (Remicade(R))
Natalizumab (Tysabri(R))

DESCRIPTION

Adalimumab (Humira®) is a recombinant human monoclonal antibody that inhibits TNF-alpha. Adalimumab (Humira®) binds specifically to TNF-alpha and inhibits its interaction with cell surface receptors.

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.

Golimumab (Simponi®) is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein).

Infliximab (Remicade®) is a monoclonal antibody that blocks activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha). Overproduction of TNF-alpha leads to inflammation in conditions such as Crohn's, rheumatoid arthritis, and other autoimmune diseases. It is believed that infliximab (Remicade®) reduces intestinal inflammation in patients with Crohn's disease by binding to and neutralizing TNF-alpha on the cell membrane and in the blood.

Natalizumab (Tysabri®) is a recombinant humanized IgG4K monoclonal antibody. The specific mechanisms by which it exerts its effects in Crohn’s disease have not been fully defined.  

FDA APPROVED INDICATIONS

Crohn's Disease

Adalimumab (Humira®) 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. It is also indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Certolizumab pegol (Cimzia®) is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Infliximab (Remicade®) is indicated for reducing signs and symptoms and inducing and maintaining clinical remission of Crohn's disease in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Infliximab (Remicade®) is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.

Natalizumab (Tysabri®) is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s disease therapies and inhibitors of TNF-alpha. In Crohn’s disease, natalizumab (Tysabri®) should not be used in combination with immunosuppressants or inhibitors of TNF-alpha.

 

Ulcerative Colitis

Adalimumab (Humira®) is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Humira® has not been established in patients who have lost response to or were intolerant to TNF blockers.

Golimumab (Simponi®) is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

Infliximab (Remicade®) is indicated for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Related medical policies -

 

POLICY

Prior authorization is required.

Adalimumab (Humira®) is considered medically necessary for adults with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy or who have lost response to or are intolerant to infliximab (Remicade®). (Six adalimumab (Humira®) injections for the first three weeks and beginning at Week 4, a maintenance dose of 40mg every other week will be covered.)

Effective 09/28/12, Humira® is also considered medically necessary for adults with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).  (Six adalimumab (Humira®) injections for the first three weeks (Day 1 160mg and Day 15 80mg) and beginning Day 29, a maintenance dose of 40mg every other week will be covered). After 8 weeks of therapy, documentation of clinical remission must be submitted for continued therapy. Humira® is not medically necessary for patients who have lost response to or were intolerant to TNF blockers.

Certolizumab pegol (Cimzia®) is considered medically necessary for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Effective 04/01/11, new starts are only considered for Cimzia® after failed treatment with Humira. (Six certolizumab pegol (Cimzia®) injections (3 kits) for the first four weeks, then a maintenance dose of 400mg (1 kit) every four weeks will be covered.)

Golimumab (Simponi®) is considered medicall necessary in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Failure of Humira® is required before coverage of Simponi® will be approved. For new starts, Simponi will be approved at three Simponi® injections for the two weeks (Day 0 200mg and Day 15 100mg) and a maintenance dose of 100mg every month will be covered).

Infliximab (Remicade®) is considered medically necessary for moderate to severe Crohn's Disease, fistulizing Crohn's disease, and moderate to severe ulcerative colitis. Failure of Humira® or Cimzia® is required before coverage of Remicade® will be approved for treatment of adult patients with Crohn's disease.

Natalizumab (Tysabri®) is considered medically necessary for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s disease therapies and inhibitors of TNF-alpha. Failure of Humira® is required before coverage of Tysabri® will be approved.

Patients and physicians attempting to obtain approval for natalizumab (Tysabri®) must meet all requirements outlined by the CD Touch™ program and have registered with the CD Touch™ prescribing program.

 

POLICY EXCEPTIONS

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. 

 

POLICY GUIDELINES

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

 

POLICY HISTORY

1999: Approved by Pharmacy & Therapeutics Committee

12/23/1999: Rheumatoid Arthritis coverage added

1/29/2001: Indications and usage added

10/11/2001: Centocor Important Drug Warning added

11/1/2001: Indications and Usage, "Off Label" uses, Boxed Warning moved to the "Policy" section. Centocor Drug Warning # 2 added to "Policy" section.

1/30/2002: Crohn's disease, moderate-severe added

5/1/2002: Type of Service and Place of Service deleted

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted

10/21/2003: "Infliximab (Remicade®)" medical policy renamed "Infliximab (Remicade®) for Treatment of Crohn’s Disease", treatment of rheumatic arthritis merged with "Anti-Rheumatic Biologicals" medical policy, approved by the Pharmacy & Therapeutics Committee, ICD-9 diagnosis code range 555.0-555.9 listed separately

1/15/2004: Recommended dosing added, Code Reference section updated, CPT code 90782 deleted, ICD-9 diagnosis code 99.29 deleted

1/22/2004: Nova Factor new telephone and fax numbers added. Telephone # 1-866-591-9075 and fax # 1-866-591-9094 deleted

2/13/2004: "and reducing and maintaining clinical remission" added to "Description" section

8/15/2005: Recommended dosing deleted

10/31/2005: Description section updated, FDA approved indications revised.Policy section updated: changed preferred provider to Accredo and changed the telephone # from 1-866-489-1899 to 1-866-240-3373.Sources updated; Remicade® added.

11/4/2005: Code reference section updated, ICD9 diagnosis codes 556.0 - 556.9 added; descriptors on ICD9 diagnosis codes 555.0 - 555.9 added and  HCPCS code J1745 updated

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

3/5/2007: Policy name changed from "Infliximab (Remicade®) for Treatment of Crohn's Disease and Ulcerative Colitis" to "Crohn's Disease and Ulcerative Colitis". Adalimumab (Humira®) description and indication added. HCPCS J0135 added. Removed boxed warning and package insert warning information for infliximab (Remicade® ).

5/2/2007: Policy updated. Failure of Humira® is required before approval of Remicade® for anti-TNF naive patients with Crohn's disease added.

3/10/2008: Natalizumab (Tysabri®) prescribing information for use in Crohn's disease added. CuraScript and Accredo listed as preferred providers for Tysabri®. Code reference updated; J2323 added.

5/9/2008: Certolizumab pegol (Cimzia®) prescribing information for use in Crohn's disease added. Accredo is the preferred provider for Cimzia®.

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

03/31/2011: Policy statement for Cimzia updated to state that effective 04/01/11, new starts are only considered for Cimzia after failed treatment with Humira. Added "adult" to the Remicade policy statement. 

11/27/2012: Policy description and statement updated regarding Humira®.  Policy statement revised to state that effective 09/28/12, Humira® is also considered medically necessary for adults with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).  (Six adalimumab (Humira®) injections for the first three weeks (Day 1 160mg and Day 15 80mg) and beginning Day 29, a maintenance dose of 40mg every other week will be covered). After 8 weeks of therapy, documentation of clinical remission must be submitted for continued therapy. Humira® is not medically necessary for patients who have lost response to or were intolerant to TNF blockers.  

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.

11/15/2013: Policy reviewed; no changes to policy statement. Policy re-formatted for clarity purposes. Added J0718 to the Code Reference section.

01/01/2014: Policy description and statement updated regarding Simponi®. Policy statement revised to state that Simponi® is considered medicall necessary in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Failure of Humira® is required before coverage of Simponi® will be approved. For new starts, Simponi will be approved at three Simponi® injections for the two weeks (Day 0 200mg and Day 15 100mg) and a maintenance dose of 100mg every month will be covered). Added HCPCS J1602 to the Code Reference section.

 

SOURCE(S)

Micromedex, 1998

USPDI 1998

Remicade® Prescribing Information

Humira® Prescribing Information

Tysabri® Prescribing Information

Cimzia® Prescribing Information

Simponi® Prescribing Information

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

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

Covered Codes

Code Number

Description

CPT-4

 

 

ICD-9 Procedure

ICD-9 Diagnosis

555.0, 555.1, 555.2, 555.9

Regional enteritis ( includes Crohn's Disease) code range

556.0 - 556.9

Ulcerative colitis code range

HCPCS

J0135

Injection, adalimumab (Humira®), 20 mg 

J0718

Injection, certolizumab pegol (Cimzia®), 1 mg  

J1602

Injection, golimumab (Simponi®), 1 mg, for intravenous use

J1745

Injection, infliximab (Remicade®) 10 mg

J2323

Injection, natalizumab, 1 mg

 

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