Medical Policy

Effective Date:10/01/2010 Title:Cimzia (Certolizumabpegol)
Revision Date:02/01/2019 Document:BI275:00
CPT Code(s):J0717
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Cimzia is used to treat severe Rheumatoid Arthritis, Crohn’s disease, ankylosing spondylitis, psoriasis, and psoriatic arthritis.

2)    Cimzia requires pre-authorization.

3)    For the treatment of psoriasis, you must first try topical agents, phototherapy, and a non-biologic DMARD drug.

4)    Cimzia is a specialty drug and must be obtained through the contracted specialty pharmacy.

Medical Statement

For all covered conditions, Cimzia will be covered only when member does not have active infection and has been tested for tuberculosis.

1.    Crohn’s Disease          
Certolizumab Pegol (Cimzia®) is considered medically necessary for members 18 years of age or older with moderately-to-severely active Crohn`s disease as manifested by any of the following signs/symptoms:

a)    Diarrhea;

b)    Abdominal pain;

c)    Bleeding;

d)    Weight loss;

e)    Perianal disease;

f)     Internal fistulae;

g)    Intestinal obstruction;

h)   Megacolon;

i)     Extra-intestinal manifestations: arthritis or spondylitis; and

2.    Rheumatoid Arthritis

For adults 18 years of age or older with moderately to severely active rheumatoid arthritis (at least 6 swollen and tender joints, at least 45 minutes of morning stiffness, and elevated ESR or CRP unless patient on corticosteroids)

3.    Ankylosing Spondylitis

For adults 18 years of age or older with active ankylosing spondylitis   AND

4.    Psoriatic Arthritis

a)    For adults 18 years of age or older with active psoriatic arthritis AND

b)    At least 3 swollen and tender joints

5.    Psoriasis

a)    For adults 18 years of age or older with moderate-to-severe plaque psoriasis AND

b)   Plaque psoriasis has been present for more than 1 year AND

c)    Ten percent or more body surface area (BSA) is affected by plaque psoriasis AND

d)   Members has a history of failure of at least a 3-month trial of, contraindication, or intolerance to ALL of the following:

1.    Topical therapy with corticosteroids, Vitamin D analogs (e.g. calcitriol, calcipotriene), calcineurin inihibtor (e.g. tacrolimus, pimecrolimus), or salicylic acid combination product AND

2.    Phototherapy of at least 3 months duration with narrow-band UVB (in the office or at home) used alone or in combination with topical or systemic therapy (See BI 029 for additional information regarding UV light therapy) This requirement may be waived in any of the following situations: a) history or presence of melanoma or other skin cancer, lupus erythematosus, or xeroderma pigmentosum, b) psoriasis involving areas around the eye where eye protection may cause blockage of phototherapy to affected area, c) documented systemic disease involving the joints (meeting specific criteria for psoriatic arthritis), or 4) very severe plaque thickness or scaling (4 on a scale of 0 to 4) AND

3.    Systemic therapy of at least 3 months duration with methotrexate or other non-biologic DMARD. This requirement may be waived in any of the following situations: a) member has chronic hepatic disease, b) member has acquired immunodeficiency syndrome (AIDS), c) member is pregnant or breast-feeding, or d) member has anemia, neutropenia, or thrombocytopenia

 

Codes Used In This BI:

J0718             Injection Certolizumab Pegol, 1mg (code deleted 1-1-14)

J0717             Injection Certolizumab Pegol, 1mg

Limits

Cimzia is considered experimental/Investigative for all other uses.

Because there are no studies supporting concomitant therapy with any two biologics, and because combinations have resulted in increases in serious infections, only one biologic will be covered at a time.

Reference

1)    American College of Rheumatology; Model Biologics Policy 2010.

2)    Singh AJ, Furst DA, Bharat A, et al.  2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirehumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis.  Arthritis Care & research. 2012; 64(5):625-639.

3)    U.S. Food and Drug Administration (FDA). FDA approves Cimzia to treat Crohn`s disease. FDA News. Rockville, MD; April 22, 2008. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html. Accessed May 20, 2008.

4)    Choy EH, Hazleman B, Smith M, et al. Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: A phase II double-blinded, randomized, dose-escalating trial. Rheumatology (Oxford). 2002; 41(10):1133-1137.

5)    National Horizon Scanning Centre (NHSC). Certolizumab pegol for moderate to severe Crohn`s disease - horizon scanning review. Birmingham, UK: NHSC; 2004.

6)    National Horizon Scanning Centre (NHSC). Certolizumab pegol (Cimzia) for rheumatoid arthritis - horizon scanning review. Birmingham, UK: NHSC; 2005.

7)    Schreiber S, Rutgeerts P, Fedorak RN, et al; CDP870 Crohn`s Disease Study Group. A randomized, placebo-controlled trial of Certolizumab pegol (CDP870) for treatment of Crohn`s disease. Gastroenterology. 2005; 129(3):807-818.

8)    Sandborn WJ, Feagan BG, Stoinov S, et al; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn`s disease. N Engl J Med. 2007; 357(3):228-238.

9)    Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al; PRECISE 2 Study Investigators. Maintenance therapy with Certolizumab pegol for Crohn`s disease. N Engl J Med. 2007; 357(3):239-250.

10)   Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn`s disease. Cochrane Database Syst Rev. 2008 ;( 1):CD006893.

11)   Rutgeerts P, Schreiber S, Feagan B, et al; CDP870 Crohn`s Disease Study Group. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn`s disease. Int J Colorectal Dis. 2008; 23(3):289-296.

12)   Keystone E, Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Findings of a fifty-two-week phase III, multicenter, randomized double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008; 58(11):3319-3329.

13)   Smolen J, Landewé RB, Mease P, et al. Efficacy and safety of Certolizumab pegol plus methotrexate in active rheumatoid arthritis: The RAPID 2 study. A randomized controlled trial. Ann Rheum Dis. 2009; 68(6):797-804.

14)   Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, et al. Efficacy and safety of Certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying Antirehumatic therapy: The FAST4WARD study. Ann Rheum Dis. 2009; 68(6):805-811.

15)   Cimzia Product Information. UCB, Inc. June 2018.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.